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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04909801
Registration number
NCT04909801
Ethics application status
Date submitted
28/05/2021
Date registered
2/06/2021
Date last updated
31/12/2024
Titles & IDs
Public title
A Study to Compare the Response to Treatment With Abatacept vs Adalimumab, on Background Methotrexate, in Adults With Early, Seropositive, and Shared Epitope-positive Rheumatoid Arthritis and an Inadequate Response to Methotrexate
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Scientific title
A Randomized, Head-to-head, Single-blind Study to Compare the Response to Treatment With Subcutaneous Abatacept vs Adalimumab, on Background Methotrexate, in Adults With Early, Seropositive Rheumatoid Arthritis Who Have "Shared Epitope" HLA Class II Risk Alleles and Have an Inadequate Response to Methotrexate
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Secondary ID [1]
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2020-000350-96
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Secondary ID [2]
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IM101-863
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Inflammatory and Immune System
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Rheumatoid arthritis
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Abatacept
Treatment: Drugs - Adalimumab
Treatment: Drugs - Methotrexate
Experimental: Arm 1: Abatacept + Methotrexate -
Experimental: Arm 2: (Adalimumab + Methotrexate) followed by (Abatacept + Methotrexate) -
Treatment: Drugs: Abatacept
Abatacept SC (125 mg) once weekly
Treatment: Drugs: Adalimumab
Adalimumab SC (40 mg) once every 2 weeks
Treatment: Drugs: Methotrexate
Methotrexate oral/parenteral maximum tolerated dose (minimum 15 mg and maximum 25 mg weekly)
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of SE+ Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response at Week 24
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Assessment method [1]
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The ACR 50 definition of improvement is a 50% improvement over baseline in tender and swollen joint counts (#1 and #2) and a 50% improvement in 3 of the 5 remaining core data set measures (Participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, and acute phase reactant value). Baseline value is the last assessment taken prior to first dose of single-blind study medication.
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Timepoint [1]
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Baseline, week 24
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Secondary outcome [1]
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Percentage of SE+ Participants Achieving Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein Remission (DAS28-CRP < 2.6) at Week 24
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Assessment method [1]
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0
DAS28-CRP is a continuous variable which is a composite of 4 variables: the number of tender joints out of a pre-specified 28 joints, the number of swollen joints out of a pre-specified 28 joints, C-reactive protein in mg/L (CRP) and participant assessment of disease activity measure on a visual analogue scale (VAS) of 100mm. DAS28-CRP scores range from 0 to 10; higher scores indicate more active disease. DAS28-CRP is calculated using the following formula: DAS28-CRP(4) = 0.56\*sqrt(TJC28) + 0.28\*sqrt(SJC28) + 0.36\*ln(CRP+1) + 0.014\*GH + 0.96 where t28 = number of painful joints from 28 joints, sw28 = number of swollen joints from 28 joints, CRP = c-reactive protein in mg/L, and GH = general health or patient's global assessment of disease activity on a 100 mm VAS.
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Timepoint [1]
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Week 24
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Secondary outcome [2]
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Percentage of Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response at Week 24
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Assessment method [2]
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The ACR 50 definition of improvement is a 50% improvement over baseline in tender and swollen joint counts (#1 and #2) and a 50% improvement in 3 of the 5 remaining core data set measures (Participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, and acute phase reactant value). Baseline value is the last assessment taken prior to first dose of single-blind study medication.
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Timepoint [2]
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Baseline, week 24
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Secondary outcome [3]
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Percentage of SE+ Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) at Week 24
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Assessment method [3]
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0
CDAI is a simple linear sum of the following four components: Tender joint counts out of 28 joints, Swollen joint counts out of 28 joints, Participant global assessment of disease activity (0-10cm), Physicians global assessment of disease activity (0-10cm). CDAI scores range from 2-76; higher scores indicate more active disease. CDAI is calculated using the following formula: TJC + SJC + PGA + MDGA where TJC = number of painful joints from 28 joints, SJC = number of swollen joints from 28 joints, PGA = patient global assessment on a visual analog scale 0-10 cm, and MDGA = physician global assessment on a visual analog scale 0-10 cm.
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Timepoint [3]
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Week 24
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Secondary outcome [4]
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Adjusted Mean Change From Baseline in SE+ Participant-Reported Pain Visual Analog Scale (VAS) at Week 24
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Assessment method [4]
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Participant-reported pain by a 0-100mm visual analog scale; higher score indicates more pain. Baseline value is the last assessment taken prior to first dose of single-blind study medication. Change from Baseline = Post-baseline - Baseline value.
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Timepoint [4]
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Baseline, week 24
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Secondary outcome [5]
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Percentage of SE+ Participants Meeting 20% Improvement in American College of Rheumatology Criteria (ACR20) Response Over Time
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Assessment method [5]
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0
The ACR 20 definition of improvement is a 20% improvement over baseline in tender and swollen joint counts (#1 and #2) and a 20% improvement in 3 of the 5 remaining core data set measures (Participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, and acute phase reactant value). Baseline value is the last assessment taken prior to first dose of single-blind study medication.
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Timepoint [5]
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0
Baseline, day 29, 57, 85, 113, 141, 169
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Secondary outcome [6]
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0
Percentage of SE+ Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response Over Time
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Assessment method [6]
0
0
The ACR 50 definition of improvement is a 50% improvement over baseline in tender and swollen joint counts (#1 and #2) and a 50% improvement in 3 of the 5 remaining core data set measures (Participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, and acute phase reactant value). Baseline value is the last assessment taken prior to first dose of single-blind study medication.
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Timepoint [6]
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0
Baseline, day 29, 57, 85, 113, 141, 169
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Secondary outcome [7]
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Percentage of SE+ Participants Meeting 70% Improvement in American College of Rheumatology Criteria (ACR70) Response Over Time
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Assessment method [7]
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0
The ACR 70 definition of improvement is a 70% improvement over baseline in tender and swollen joint counts (#1 and #2) and a 70% improvement in 3 of the 5 remaining core data set measures (Participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, and acute phase reactant value). Baseline value is the last assessment taken prior to first dose of single-blind study medication.
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Timepoint [7]
0
0
Baseline, day 29, 57, 85, 113, 141, 169
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Secondary outcome [8]
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Percentage of SE+ Participants Achieving Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein Remission (DAS28-CRP < 2.6) Over Time
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Assessment method [8]
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0
DAS28-CRP is a continuous variable which is a composite of 4 variables: the number of tender joints out of a pre-specified 28 joints, the number of swollen joints out of a pre-specified 28 joints, C-reactive protein in mg/L (CRP) and participant assessment of disease activity measure on a visual analogue scale (VAS) of 100mm. DAS28-CRP scores range from 0 to 10; higher scores indicate more active disease. DAS28-CRP is calculated using the following formula: DAS28-CRP(4) = 0.56\*sqrt(TJC28) + 0.28\*sqrt(SJC28) + 0.36\*ln(CRP+1) + 0.014\*GH + 0.96 where t28 = number of painful joints from 28 joints, sw28 = number of swollen joints from 28 joints, CRP = c-reactive protein in mg/L, and GH = general health or patient's global assessment of disease activity on a 100 mm VAS.
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Timepoint [8]
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0
Day 29, 57, 85, 113, 141, 169
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Secondary outcome [9]
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0
Percentage of SE+ Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) Over Time
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Assessment method [9]
0
0
CDAI is a simple linear sum of the following four components: Tender joint counts out of 28 joints, Swollen joint counts out of 28 joints, Participant global assessment of disease activity (0-10cm), Physicians global assessment of disease activity (0-10cm). CDAI scores range from 2-76; higher scores indicate more active disease. CDAI is calculated using the following formula: TJC + SJC + PGA + MDGA where TJC = number of painful joints from 28 joints, SJC = number of swollen joints from 28 joints, PGA = patient global assessment on a visual analog scale 0-10 cm, and MDGA = physician global assessment on a visual analog scale 0-10 cm.
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Timepoint [9]
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0
Day 29, 57, 85, 113, 141, 169
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Secondary outcome [10]
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Percentage of SE+ Participants Achieving Simple Disease Activity Index Remission (SDAI <= 3.3) Over Time
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Assessment method [10]
0
0
SDAI is a simple linear sum of the following five components: Tender joint counts out of 28 joints, Swollen joint counts out of 28 joints, Participant global assessment of disease activity (0-10cm), Physicians global assessment of disease activity (0-10cm), high-sensitivity C-reactive protein (hsCRP mg/dL). SDAI total scores range from 0-86; higher scores indicate more active disease. SDAI is calculated using the following formula: TJC + SJC + PGA + MDGA + CRP where TJC = number of painful joints from 28 joints, SJC = number of swollen joints from 28 joints, PGA = patient global assessment on a visual analog scale 0-10 cm, MDGA = physician global assessment on a visual analog scale 0-10 cm, and CRP = c-reactive protein in mg/dL.
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Timepoint [10]
0
0
Day 29, 57, 85, 113, 141, 169
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Secondary outcome [11]
0
0
Percentage of Participants Meeting 20% Improvement in American College of Rheumatology Criteria (ACR20) Response Over Time
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Assessment method [11]
0
0
The ACR 20 definition of improvement is a 20% improvement over baseline in tender and swollen joint counts (#1 and #2) and a 20% improvement in 3 of the 5 remaining core data set measures (Participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, and acute phase reactant value). Baseline value is the last assessment taken prior to first dose of single-blind study medication.
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Timepoint [11]
0
0
Baseline, day 29, 57, 85, 113, 141, 169
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Secondary outcome [12]
0
0
Percentage of Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response Over Time
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Assessment method [12]
0
0
The ACR 50 definition of improvement is a 50% improvement over baseline in tender and swollen joint counts (#1 and #2) and a 50% improvement in 3 of the 5 remaining core data set measures (Participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, and acute phase reactant value). Baseline value is the last assessment taken prior to first dose of single-blind study medication.
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Timepoint [12]
0
0
Baseline, day 29, 57, 85, 113, 141, 169
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Secondary outcome [13]
0
0
Percentage of Participants Meeting 70% Improvement in American College of Rheumatology Criteria (ACR70) Response Over Time
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Assessment method [13]
0
0
The ACR 70 definition of improvement is a 70% improvement over baseline in tender and swollen joint counts (#1 and #2) and a 70% improvement in 3 of the 5 remaining core data set measures (Participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, and acute phase reactant value). Baseline value is the last assessment taken prior to first dose of single-blind study medication.
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Timepoint [13]
0
0
Baseline, day 29, 57, 85, 113, 141, 169
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Secondary outcome [14]
0
0
Percentage of Participants Achieving Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein Remission (DAS28-CRP < 2.6) Over Time
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Assessment method [14]
0
0
DAS28-CRP is a continuous variable which is a composite of 4 variables: the number of tender joints out of a pre-specified 28 joints, the number of swollen joints out of a pre-specified 28 joints, C-reactive protein in mg/L (CRP) and participant assessment of disease activity measure on a visual analogue scale (VAS) of 100mm. DAS28-CRP scores range from 0 to 10; higher scores indicate more active disease. DAS28-CRP is calculated using the following formula: DAS28-CRP(4) = 0.56\*sqrt(TJC28) + 0.28\*sqrt(SJC28) + 0.36\*ln(CRP+1) + 0.014\*GH + 0.96 where t28 = number of painful joints from 28 joints, sw28 = number of swollen joints from 28 joints, CRP = c-reactive protein in mg/L, and GH = general health or patient's global assessment of disease activity on a 100 mm VAS.
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Timepoint [14]
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0
Day 29, 57, 85, 113, 141, 169
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Secondary outcome [15]
0
0
Percentage of Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) Over Time
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Assessment method [15]
0
0
CDAI is a simple linear sum of the following four components: Tender joint counts out of 28 joints, Swollen joint counts out of 28 joints, Participant global assessment of disease activity (0-10cm), Physicians global assessment of disease activity (0-10cm). CDAI scores range from 2-76; higher scores indicate more active disease. CDAI is calculated using the following formula: TJC + SJC + PGA + MDGA where TJC = number of painful joints from 28 joints, SJC = number of swollen joints from 28 joints, PGA = patient global assessment on a visual analog scale 0-10 cm, and MDGA = physician global assessment on a visual analog scale 0-10 cm.
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Timepoint [15]
0
0
Day 29, 57, 85, 113, 141, 169
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Secondary outcome [16]
0
0
Percentage of Participants Achieving Simple Disease Activity Index Remission (SDAI <= 3.3) Over Time
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Assessment method [16]
0
0
SDAI is a simple linear sum of the following five components: Tender joint counts out of 28 joints, Swollen joint counts out of 28 joints, Participant global assessment of disease activity (0-10cm), Physicians global assessment of disease activity (0-10cm), high-sensitivity C-reactive protein (hsCRP mg/dL). SDAI total scores range from 0-86; higher scores indicate more active disease. SDAI is calculated using the following formula: TJC + SJC + PGA + MDGA + CRP where TJC = number of painful joints from 28 joints, SJC = number of swollen joints from 28 joints, PGA = patient global assessment on a visual analog scale 0-10 cm, MDGA = physician global assessment on a visual analog scale 0-10 cm, and CRP = c-reactive protein in mg/dL.
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Timepoint [16]
0
0
Day 29, 57, 85, 113, 141, 169
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Secondary outcome [17]
0
0
Adjusted Mean Change From Baseline in Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein (DAS28-CRP) Over Time for SE+ Participants
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Assessment method [17]
0
0
DAS28-CRP is a continuous variable which is a composite of 4 variables: the number of tender joints out of a pre-specified 28 joints, the number of swollen joints out of a pre-specified 28 joints, C-reactive protein in mg/L (CRP) and participant assessment of disease activity measure on a visual analogue scale (VAS) of 100mm. DAS28-CRP scores range from 0 to 10; higher scores indicate more active disease. Remission was defined as DAS28-CRP \< 2.6. DAS28-CRP is calculated using the following formula: DAS28-CRP(4) = 0.56\*sqrt(TJC28) + 0.28\*sqrt(SJC28) + 0.36\*ln(CRP+1) + 0.014\*GH + 0.96 where t28 = number of painful joints from 28 joints, sw28 = number of swollen joints from 28 joints, CRP = c-reactive protein in mg/L, and GH = general health or patient's global assessment of disease activity on a 100 mm VAS. Baseline value is the last assessment taken prior to first dose of single-blind study medication. Change from Baseline = Post-baseline - Baseline value.
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Timepoint [17]
0
0
Baseline, day 29, 57, 85, 113, 141, 169
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Secondary outcome [18]
0
0
Adjusted Mean Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time for SE+ Participants
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Assessment method [18]
0
0
CDAI is a simple linear sum of the following four components: Tender joint counts out of 28 joints, Swollen joint counts out of 28 joints, Participant global assessment of disease activity (0-10cm), Physicians global assessment of disease activity (0-10cm). CDAI scores range from 2-76; higher scores indicate more active disease. CDAI remission was defined as =\<2.8. CDAI is calculated using the following formula: TJC + SJC + PGA + MDGA where TJC = number of painful joints from 28 joints, SJC = number of swollen joints from 28 joints, PGA = patient global assessment on a visual analog scale 0-10 cm, and MDGA = physician global assessment on a visual analog scale 0-10 cm. Baseline value is the last assessment taken prior to first dose of single-blind study medication. Change from Baseline = Post-baseline - Baseline value.
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Timepoint [18]
0
0
Baseline, day 29, 57, 85, 113, 141, 169
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Secondary outcome [19]
0
0
Adjusted Mean Change From Baseline in Simple Disease Activity Index (SDAI) Over Time for SE+ Participants
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Assessment method [19]
0
0
SDAI is a simple linear sum of the following five components: Tender joint counts out of 28 joints, Swollen joint counts out of 28 joints, Participant global assessment of disease activity (0-10cm), Physicians global assessment of disease activity (0-10cm), high-sensitivity C-reactive protein (hsCRP mg/dL). SDAI total scores range from 0-86; higher scores indicate more active disease. Remission was defined as SDAI =\< 3.3. SDAI is calculated using the following formula: TJC + SJC + PGA + MDGA + CRP where TJC = number of painful joints from 28 joints, SJC = number of swollen joints from 28 joints, PGA = patient global assessment on a visual analog scale 0-10 cm, MDGA = physician global assessment on a visual analog scale 0-10 cm, and CRP = c-reactive protein in mg/dL. Baseline value is the last assessment taken prior to first dose of single-blind study medication. Change from Baseline = Post-baseline - Baseline value.
Query!
Timepoint [19]
0
0
Baseline, day 29, 57, 85, 113, 141, 169
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Secondary outcome [20]
0
0
Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for SE+ Participants
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Assessment method [20]
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0
1. Tender joint count (standard 68 joint count) 2. Swollen joint count (standard 66 joint count) 3. Participant global assessment of pain (a 0-100mm visual analog scale with 100 mm being the worst pain) 4. Participant global assessment of disease activity (a 0-100mm visual analog scale with 100 mm being the highest disease activity) 5. Physician global assessment of disease activity (a 0-100mm visual analog scale with 100 mm being the worst case) 6. Participant assessment of physical function Health Assessment Questionnaire Disability Index (HAQ-DI) (increasing scores for the 8 disability categories indicate increasing level of difficulty). HAQDI is calculated by summing the adjusted categories scores and dividing by the number of categories answered 7. C-reactive protein (increasing levels indicate increasing level of disease) Baseline value is the last assessment taken prior to first dose of single-blind study medication. Change from Baseline=Post-baseline - Baseline value.
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Timepoint [20]
0
0
Baseline, day 29, 57, 85, 113, 141, 169
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Secondary outcome [21]
0
0
Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for SE+ Participants
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Assessment method [21]
0
0
1. Tender joint count (standard 68 joint count) 2. Swollen joint count (standard 66 joint count) 3. Participant global assessment of pain (a 0-100mm visual analog scale with 100 mm being the worst pain) 4. Participant global assessment of disease activity (a 0-100mm visual analog scale with 100 mm being the highest disease activity) 5. Physician global assessment of disease activity (a 0-100mm visual analog scale with 100 mm being the worst case) 6. Participant assessment of physical function Health Assessment Questionnaire Disability Index (HAQ-DI) (increasing scores for the 8 disability categories indicate increasing level of difficulty). HAQDI is calculated by summing the adjusted categories scores and dividing by the number of categories answered 7. C-reactive protein (increasing levels indicate increasing level of disease) Baseline value is the last assessment taken prior to first dose of single-blind study medication. Change from Baseline=Post-baseline - Baseline value.
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Timepoint [21]
0
0
Baseline, day 29, 57, 85, 113, 141, 169
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Secondary outcome [22]
0
0
Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 6 Over Time for SE+ Participants
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Assessment method [22]
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0
6) Participant assessment of physical function Health Assessment Questionnaire Disability Index (HAQ-DI). For the eight disability categories (Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities), there is an aids or devices variables to record the type of assistance. If aids or devices and/or assistance from another person are checked for a category, the score is set to 2 (much difficulty), if the original score is 0 (no difficulty) or 1 (some difficulty). HAQ-DI is then calculated by summing the adjusted categories scores and dividing by the number of categories answered (increasing scores for the 8 disability categories questionnaire indicate increasing level of difficulty with 0 being the lowest score "without any difficulty" and 3 being the highest score "unable to do". Baseline value is the last assessment taken prior to first dose of single-blind study medication. Change from Baseline=Post-baseline - Baseline value.
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Timepoint [22]
0
0
Baseline, day 29, 57, 85, 113, 141, 169
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Secondary outcome [23]
0
0
Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 7 Over Time for SE+ Participants
Query!
Assessment method [23]
0
0
1. Tender joint count (standard 68 joint count) 2. Swollen joint count (standard 66 joint count) 3. Participant global assessment of pain (a 0-100mm visual analog scale with 100 mm being the worst pain) 4. Participant global assessment of disease activity (a 0-100mm visual analog scale with 100 mm being the highest disease activity) 5. Physician global assessment of disease activity (a 0-100mm visual analog scale with 100 mm being the worst case) 6. Participant assessment of physical function Health Assessment Questionnaire Disability Index (HAQ-DI) (increasing scores for the 8 disability categories indicate increasing level of difficulty). HAQDI is calculated by summing the adjusted categories scores and dividing by the number of categories answered 7. C-reactive protein (increasing levels indicate increasing level of disease) Baseline value is the last assessment taken prior to first dose of single-blind study medication. Change from Baseline=Post-baseline - Baseline value.
Query!
Timepoint [23]
0
0
Baseline, day 29, 57, 85, 113, 141, 169
Query!
Secondary outcome [24]
0
0
Adjusted Mean Change From Baseline in Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein (DAS28-CRP) Over Time for All Participants
Query!
Assessment method [24]
0
0
DAS28-CRP is a continuous variable which is a composite of 4 variables: the number of tender joints out of a pre-specified 28 joints, the number of swollen joints out of a pre-specified 28 joints, C-reactive protein in mg/L (CRP) and participant assessment of disease activity measure on a visual analogue scale (VAS) of 100mm. DAS28-CRP scores range from 0 to 10; higher scores indicate more active disease. Remission was defined as DAS28-CRP \< 2.6. DAS28-CRP is calculated using the following formula: DAS28-CRP(4) = 0.56\*sqrt(TJC28) + 0.28\*sqrt(SJC28) + 0.36\*ln(CRP+1) + 0.014\*GH + 0.96 where t28 = number of painful joints from 28 joints, sw28 = number of swollen joints from 28 joints, CRP = c-reactive protein in mg/L, and GH = general health or patient's global assessment of disease activity on a 100 mm VAS. Baseline value is the last assessment taken prior to first dose of single-blind study medication. Change from Baseline = Post-baseline - Baseline value.
Query!
Timepoint [24]
0
0
Baseline, day 29, 57, 85, 113, 141, 169
Query!
Secondary outcome [25]
0
0
Adjusted Mean Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time for All Participants
Query!
Assessment method [25]
0
0
CDAI is a simple linear sum of the following four components: Tender joint counts out of 28 joints, Swollen joint counts out of 28 joints, Participant global assessment of disease activity (0-10cm), Physicians global assessment of disease activity (0-10cm). CDAI scores range from 2-76; higher scores indicate more active disease. CDAI remission was defined as =\<2.8. CDAI is calculated using the following formula: TJC + SJC + PGA + MDGA where TJC = number of painful joints from 28 joints, SJC = number of swollen joints from 28 joints, PGA = patient global assessment on a visual analog scale 0-10 cm, and MDGA = physician global assessment on a visual analog scale 0-10 cm. Baseline value is the last assessment taken prior to first dose of single-blind study medication. Change from Baseline = Post-baseline - Baseline value.
Query!
Timepoint [25]
0
0
Baseline, day 29, 57, 85, 113, 141, 169
Query!
Secondary outcome [26]
0
0
Adjusted Mean Change From Baseline in Simple Disease Activity Index (SDAI) Over Time for All Participants
Query!
Assessment method [26]
0
0
SDAI is a simple linear sum of the following five components: Tender joint counts out of 28 joints, Swollen joint counts out of 28 joints, Participant global assessment of disease activity (0-10cm), Physicians global assessment of disease activity (0-10cm), high-sensitivity C-reactive protein (hsCRP mg/dL). SDAI total scores range from 0-86; higher scores indicate more active disease. Remission was defined as SDAI =\< 3.3. SDAI is calculated using the following formula: TJC + SJC + PGA + MDGA + CRP where TJC = number of painful joints from 28 joints, SJC = number of swollen joints from 28 joints, PGA = patient global assessment on a visual analog scale 0-10 cm, MDGA = physician global assessment on a visual analog scale 0-10 cm, and CRP = c-reactive protein in mg/dL. Baseline value is the last assessment taken prior to first dose of single-blind study medication. Change from Baseline = Post-baseline - Baseline value.
Query!
Timepoint [26]
0
0
Baseline, day 29, 57, 85, 113, 141, 169
Query!
Secondary outcome [27]
0
0
Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for All Participants
Query!
Assessment method [27]
0
0
1. Tender joint count (standard 68 joint count) 2. Swollen joint count (standard 66 joint count) 3. Participant global assessment of pain (a 0-100mm visual analog scale with 100 mm being the worst pain) 4. Participant global assessment of disease activity (a 0-100mm visual analog scale with 100 mm being the highest disease activity) 5. Physician global assessment of disease activity (a 0-100mm visual analog scale with 100 mm being the worst case) 6. Participant assessment of physical function Health Assessment Questionnaire Disability Index (HAQ-DI) (increasing scores for the 8 disability categories indicate increasing level of difficulty). HAQDI is calculated by summing the adjusted categories scores and dividing by the number of categories answered 7. C-reactive protein (increasing levels indicate increasing level of disease) Baseline value is the last assessment taken prior to first dose of single-blind study medication. Change from Baseline=Post-baseline - Baseline value.
Query!
Timepoint [27]
0
0
Baseline, day 29, 57, 85, 113, 141, 169
Query!
Secondary outcome [28]
0
0
Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for All Participants
Query!
Assessment method [28]
0
0
1. Tender joint count (standard 68 joint count) 2. Swollen joint count (standard 66 joint count) 3. Participant global assessment of pain (a 0-100mm visual analog scale with 100 mm being the worst pain) 4. Participant global assessment of disease activity (a 0-100mm visual analog scale with 100 mm being the highest disease activity) 5. Physician global assessment of disease activity (a 0-100mm visual analog scale with 100 mm being the worst case) 6. Participant assessment of physical function Health Assessment Questionnaire Disability Index (HAQ-DI) (increasing scores for the 8 disability categories indicate increasing level of difficulty). HAQDI is calculated by summing the adjusted categories scores and dividing by the number of categories answered 7. C-reactive protein (increasing levels indicate increasing level of disease) Baseline value is the last assessment taken prior to first dose of single-blind study medication. Change from Baseline=Post-baseline - Baseline value.
Query!
Timepoint [28]
0
0
Baseline, day 29, 57, 85, 113, 141, 169
Query!
Secondary outcome [29]
0
0
Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 6 Over Time for All Participants
Query!
Assessment method [29]
0
0
6) Participant assessment of physical function Health Assessment Questionnaire Disability Index (HAQ-DI). For the eight disability categories (Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities), there is an aids or devices variables to record the type of assistance. If aids or devices and/or assistance from another person are checked for a category, the score is set to 2 (much difficulty), if the original score is 0 (no difficulty) or 1 (some difficulty). HAQ-DI is then calculated by summing the adjusted categories scores and dividing by the number of categories answered (increasing scores for the 8 disability categories questionnaire indicate increasing level of difficulty with 0 being the lowest score "without any difficulty" and 3 being the highest score "unable to do". Baseline value is the last assessment taken prior to first dose of single-blind study medication. Change from Baseline=Post-baseline - Baseline value.
Query!
Timepoint [29]
0
0
Baseline, day 29, 57, 85, 113, 141, 169
Query!
Secondary outcome [30]
0
0
Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 7 Over Time for All Participants
Query!
Assessment method [30]
0
0
1. Tender joint count (standard 68 joint count) 2. Swollen joint count (standard 66 joint count) 3. Participant global assessment of pain (a 0-100mm visual analog scale with 100 mm being the worst pain) 4. Participant global assessment of disease activity (a 0-100mm visual analog scale with 100 mm being the highest disease activity) 5. Physician global assessment of disease activity (a 0-100mm visual analog scale with 100 mm being the worst case) 6. Participant assessment of physical function Health Assessment Questionnaire Disability Index (HAQ-DI) (increasing scores for the 8 disability categories indicate increasing level of difficulty). HAQDI is calculated by summing the adjusted categories scores and dividing by the number of categories answered 7. C-reactive protein (increasing levels indicate increasing level of disease) Baseline value is the last assessment taken prior to first dose of single-blind study medication. Change from Baseline=Post-baseline - Baseline value.
Query!
Timepoint [30]
0
0
Baseline, day 29, 57, 85, 113, 141, 169
Query!
Secondary outcome [31]
0
0
Adjusted Mean Change From Baseline in 36-item Short Form Survey (SF-36) Over Time for SE+ Participants
Query!
Assessment method [31]
0
0
SF-36 is a generic 36-item questionnaire measuring health-related quality of life, which covers 8 health dimensions within 2 components. The physical component summary (PCS) consists of these 4 subscales: Physical functioning, Role-physical, Bodily pain, General health. The mental component summary (MCS) consists of these 4 subscales: Vitality, Social functioning, Role-emotional, Mental health. Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100, with a higher score indicating better quality of life. The 8 subscales will be scored using norm-based methods that have standardized the T-scores to a mean of 50 and a standard deviation of 10 in the general population.
Query!
Timepoint [31]
0
0
Up to week 24
Query!
Secondary outcome [32]
0
0
Adjusted Mean Change From Baseline in SF-36 Over Time for All Participants
Query!
Assessment method [32]
0
0
SF-36 is a generic 36-item questionnaire measuring health-related quality of life, which covers 8 health dimensions within 2 components. The physical component summary (PCS) consists of these 4 subscales: Physical functioning, Role-physical, Bodily pain, General health. The mental component summary (MCS) consists of these 4 subscales: Vitality, Social functioning, Role-emotional, Mental health. Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100, with a higher score indicating better quality of life. The 8 subscales will be scored using norm-based methods that have standardized the T-scores to a mean of 50 and a standard deviation of 10 in the general population.
Query!
Timepoint [32]
0
0
Up to week 24
Query!
Secondary outcome [33]
0
0
Adjusted Mean Change From Baseline in 36-item Short Form Survey (SF-36) at Week 104 for SE+ Participants
Query!
Assessment method [33]
0
0
The SF-36 v2.0, which covers 8 health dimensions within 2 components. The physical component summary (PCS) of the SF-36 consists of these 4 subscales: Physical functioning, Role-physical, Bodily pain, General health. The mental component summary (MCS) of the SF-36 consists of these 4 subscales: Vitality, Social functioning, Role-emotional, Mental health. The scores range from 0 to 100, with a higher score indicating better quality of life. The 2 summary scores (PCS and MCS) will be calculated by taking a weighted linear combination of the 8 individual subscales. Baseline value is the last assessment taken prior to first dose of single-blind study medication. Change from Baseline = Post-baseline - Baseline value.
Query!
Timepoint [33]
0
0
Up to week 24
Query!
Secondary outcome [34]
0
0
Adjusted Mean Change From Baseline in 36-item Short Form Survey (SF-36) at Week 104 for All Participants
Query!
Assessment method [34]
0
0
The SF-36 v2.0, which covers 8 health dimensions within 2 components. The physical component summary (PCS) of the SF-36 consists of these 4 subscales: Physical functioning, Role-physical, Bodily pain, General health. The mental component summary (MCS) of the SF-36 consists of these 4 subscales: Vitality, Social functioning, Role-emotional, Mental health. The scores range from 0 to 100, with a higher score indicating better quality of life. The 2 summary scores (PCS and MCS) will be calculated by taking a weighted linear combination of the 8 individual subscales. Baseline value is the last assessment taken prior to first dose of single-blind study medication. Change from Baseline = Post-baseline - Baseline value.
Query!
Timepoint [34]
0
0
Up to week 24
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Eligibility
Key inclusion criteria
* Early rheumatoid arthritis (RA), defined as symptoms of RA that started = 12 months prior to screening and satisfied the American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) 2010 criteria for the classification of RA at some point during the 12-month period
* Naïve to any targeted (biologic or nonbiologic) disease-modifying antirheumatic drugs (DMARDs), conventional synthetic DMARDs other than methotrexate (MTX), or investigational therapies for RA
* Treated with MTX for at least 12 weeks, with a stable dose of oral or parenteral MTX for at least 4 weeks prior to randomization
* Anti-cyclic citrullinated peptide-2 (Anti-CCP-2) test that is > 3× the upper limit of normal and are positive for rheumatoid factor (RF) according to central lab testing during screening
* At least a Disease Activity Score 28-joint count calculated using C-reactive protein (DAS28-CRP) = 3.2 at screening
* At least 3 tender and at least 3 swollen joints at screening and at randomization
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
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Query!
Sex
Both males and females
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Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Women who are breastfeeding
* Autoimmune disease other than RA (e.g., psoriasis, systemic lupus erythematosus [SLE], vasculitis, seronegative spondyloarthritis, inflammatory bowel disease, Sjogren's syndrome) or currently active fibromyalgia
* History of or current inflammatory joint disease other than RA (e.g., psoriatic arthritis, gout, reactive arthritis, Lyme disease)
* At risk for tuberculosis
* Recent acute infection
* History of chronic or recurrent bacterial infection (e.g., chronic pyelonephritis, osteomyelitis, bronchiectasis)
* History of infection of a joint prosthesis or artificial joint
* History of systemic fungal infections (such as histoplasmosis, blastomycosis, or coccidiomycosis)
* History of primary immunodeficiency
* Current clinical findings or a history of a demyelinating disorder
* 5 or more joints cannot be assessed for tenderness or swelling
Other protocol-defined inclusion/exclusion criteria apply
Query!
Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Query!
Query!
Query!
Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
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Date of first participant enrolment
Anticipated
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Actual
15/09/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/09/2027
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Actual
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Sample size
Target
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Accrual to date
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Final
338
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
0
0
Local Institution - 0072 - Botany
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Recruitment hospital [2]
0
0
Local Institution - 0062 - Paramatta
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Recruitment hospital [3]
0
0
Local Institution - 0063 - Maroochydore
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Recruitment hospital [4]
0
0
Local Institution - 0102 - Woodville South
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Recruitment hospital [5]
0
0
Local Institution - 0064 - Camberwell
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Recruitment hospital [6]
0
0
Local Institution - 0065 - Geelong
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Recruitment hospital [7]
0
0
Local Institution - 0105 - Ivanhoe
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Recruitment postcode(s) [1]
0
0
2019 - Botany
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Recruitment postcode(s) [2]
0
0
2150 - Paramatta
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Recruitment postcode(s) [3]
0
0
4558 - Maroochydore
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Recruitment postcode(s) [4]
0
0
5011 - Woodville South
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Recruitment postcode(s) [5]
0
0
3124 - Camberwell
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Recruitment postcode(s) [6]
0
0
3220 - Geelong
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Recruitment postcode(s) [7]
0
0
3079 - Ivanhoe
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
California
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Colorado
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Maryland
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Minnesota
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Country [5]
0
0
United States of America
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State/province [5]
0
0
New Jersey
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Country [6]
0
0
United States of America
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State/province [6]
0
0
New York
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Country [7]
0
0
United States of America
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State/province [7]
0
0
North Carolina
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Oregon
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Pennsylvania
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Country [10]
0
0
United States of America
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State/province [10]
0
0
Tennessee
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Country [11]
0
0
United States of America
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State/province [11]
0
0
Texas
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Country [12]
0
0
United States of America
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State/province [12]
0
0
Wisconsin
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Country [13]
0
0
Argentina
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State/province [13]
0
0
Buenos Aires
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Country [14]
0
0
Argentina
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State/province [14]
0
0
Tucuman
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Country [15]
0
0
Argentina
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State/province [15]
0
0
Cordoba
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Country [16]
0
0
Czechia
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State/province [16]
0
0
Brno
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Country [17]
0
0
Czechia
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State/province [17]
0
0
Praha 2
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Country [18]
0
0
France
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State/province [18]
0
0
Montpellier
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Country [19]
0
0
France
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State/province [19]
0
0
Rouen
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Country [20]
0
0
France
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State/province [20]
0
0
Strasbourg
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Country [21]
0
0
France
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State/province [21]
0
0
Toulouse
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Country [22]
0
0
Germany
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State/province [22]
0
0
Berlin
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Country [23]
0
0
Germany
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State/province [23]
0
0
Bonn
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Country [24]
0
0
Germany
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State/province [24]
0
0
Freiburg
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Country [25]
0
0
Germany
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State/province [25]
0
0
Hamburg
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Country [26]
0
0
Germany
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State/province [26]
0
0
Planegg
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Country [27]
0
0
Italy
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State/province [27]
0
0
Catania
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Country [28]
0
0
Italy
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State/province [28]
0
0
Pavia
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Country [29]
0
0
Italy
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State/province [29]
0
0
Perugia
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Country [30]
0
0
Italy
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State/province [30]
0
0
Roma
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Country [31]
0
0
Japan
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State/province [31]
0
0
Aichi
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Country [32]
0
0
Japan
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State/province [32]
0
0
Fukuoka
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Country [33]
0
0
Japan
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State/province [33]
0
0
Hokkaido
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Country [34]
0
0
Japan
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State/province [34]
0
0
Miyagi
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Country [35]
0
0
Japan
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State/province [35]
0
0
Nagasaki
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Country [36]
0
0
Japan
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State/province [36]
0
0
Saitama
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Country [37]
0
0
Japan
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State/province [37]
0
0
Tokyo
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Country [38]
0
0
Mexico
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State/province [38]
0
0
Distrito Federal
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Country [39]
0
0
Mexico
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State/province [39]
0
0
Jalisco
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Country [40]
0
0
Mexico
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State/province [40]
0
0
SAN LUIS Potosi
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Country [41]
0
0
Mexico
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State/province [41]
0
0
Yucatán
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Country [42]
0
0
Mexico
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State/province [42]
0
0
Chihuahua
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Country [43]
0
0
Poland
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State/province [43]
0
0
Kujawsko-pomorskie
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Country [44]
0
0
Poland
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State/province [44]
0
0
Bydgoszcz
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Country [45]
0
0
Poland
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State/province [45]
0
0
Elblag
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Country [46]
0
0
Spain
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State/province [46]
0
0
A Coruña
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Country [47]
0
0
Spain
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State/province [47]
0
0
Madrid
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Country [48]
0
0
Spain
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State/province [48]
0
0
Santander
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Country [49]
0
0
Switzerland
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State/province [49]
0
0
Basel
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Country [50]
0
0
Switzerland
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State/province [50]
0
0
St. Gallen
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Country [51]
0
0
Taiwan
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State/province [51]
0
0
Kaohsiung Niao Sung Dist
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Country [52]
0
0
Taiwan
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State/province [52]
0
0
New Taipei City
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Country [53]
0
0
Taiwan
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State/province [53]
0
0
Taichung City
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Country [54]
0
0
Taiwan
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State/province [54]
0
0
Taichung
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Country [55]
0
0
Taiwan
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State/province [55]
0
0
Tainan
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Country [56]
0
0
United Kingdom
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State/province [56]
0
0
Staffordshire
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Country [57]
0
0
United Kingdom
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State/province [57]
0
0
Hull
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Country [58]
0
0
United Kingdom
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State/province [58]
0
0
London
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Bristol-Myers Squibb
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to evaluate the superiority in efficacy of abatacept compared with adalimumab, on background methotrexate, in adults with early, seropositive, and shared epitope-positive rheumatoid arthritis and an inadequate methotrexate response.
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Trial website
https://clinicaltrials.gov/study/NCT04909801
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
Bristol-Myers Squibb
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Address
0
0
Bristol-Myers Squibb
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
Query!
Address
0
0
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Country
0
0
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Phone
0
0
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Fax
0
0
Query!
Email
0
0
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/01/NCT04909801/Prot_SAP_000.pdf
Statistical analysis plan
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/01/NCT04909801/Prot_SAP_000.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT04909801
Download to PDF