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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02504268




Registration number
NCT02504268
Ethics application status
Date submitted
20/07/2015
Date registered
21/07/2015
Date last updated
4/06/2019

Titles & IDs
Public title
Effects of Abatacept in Patients With Early Rheumatoid Arthritis
Scientific title
A Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination With Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults With Early Rheumatoid Arthritis Who Are Methotrexate Naive
Secondary ID [1] 0 0
2015-001275-50
Secondary ID [2] 0 0
IM101-550
Universal Trial Number (UTN)
Trial acronym
AVERT-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Abatacept
Treatment: Drugs - Methotrexate
Other interventions - Abatacept Placebo
Other interventions - Methotrexate Placebo

Experimental: Combination Therapy: Abatacept + Methotrexate - Abatacept 125 mg subcutaneous injection once per week + Methotrexate at least 15mg per week tablet or capsule orally once per week

Active Comparator: Methotrexate treatment - Methotrexate at least 15mg per week tablet or capsule orally

Placebo Comparator: Abatacept Placebo - Placebo for Abatacept subcutaneous injection once per week

Placebo Comparator: Methotrexate Placebo - Placebo to match Methotrexate capsule orally once per week


Treatment: Drugs: Abatacept


Treatment: Drugs: Methotrexate


Other interventions: Abatacept Placebo


Other interventions: Methotrexate Placebo


Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Subjects in Simple Disease Activity Index (SDAI) Remission at Week 24 - Simple Disease Activity Index (SDAI) is calculated using the following formula: TJC + SJC + PGA + MDGA + CRP (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) SDAI Remission is defined as SDAI <= 3.3.
Using a logistic regression model that includes treatment arm, randomization stratification factor, and baseline SDAI as continuous variable and point estimate of adjusted ORs, corresponding 95% CI and p-value was provided. SDAI total score range: 0 to 86. SDAI <= 3.3 indicates disease remission and SDAI >26 = high disease activity.
Timepoint [1] 0 0
Week 24
Secondary outcome [1] 0 0
Percentage of Subjects in Disease Activity Score (DAS)28 - C-reactive Protein (CRP) Remission at Week 24 - DAS28-CRP = Disease Activity Score 28 based on C-reactive protein DAS28-CRP Remission is defined as DAS28-CRP <= 2.6 Using a logistic regression model that includes treatment arm, stratification variable and baseline measure as continuous variable and point estimate of adjusted ORs, corresponding 95% CI and p-value was provided.
Timepoint [1] 0 0
Week 24
Secondary outcome [2] 0 0
Percentage of Subjects in SDAI Remission at Week 52 - Simple Disease Activity Index (SDAI) is calculated using the following formula: TJC + SJC + PGA + MDGA + CRP (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) SDAI Remission is defined as SDAI <= 3.3. Using a logistic regression model that includes treatment arm, randomization stratification factor, and baseline SDAI as continuous variable and point estimate of adjusted ORs, corresponding 95% CI and p-value was provided. SDAI total score range: 0 to 86. SDAI <= 3.3 indicates disease remission and SDAI >26 = high disease activity.
Timepoint [2] 0 0
Week 52
Secondary outcome [3] 0 0
Mean Change From Baseline in Radiographic Progression of Joint Damage as Measured by Modified Sharp/Van Der Heijide Total Sharp Scores (TSS) at Week 52 - The Modified Total Sharp Score (mTSS) is calculated as the bilateral sum of erosion and Joint Space Narrowing (JSN) scores across all joints of the hands and feet.The score range for mTSS is 0-448. Higher scores indicate more joint damage. The mean change from baseline in TSS using modified Sharp/van der Heijide scores was assessed using a rank-based nonparametric ANCOVA model.
Timepoint [3] 0 0
Week 52
Secondary outcome [4] 0 0
Percentage of Subjects in Boolean Remission at Week 52 - Boolean Remission is defined as Tender joint count less than 1, Swollen joint count less than 1, CRP less than 1 mg/dL, patient global assessment less than 1 (on 0 to 10 VAS scale). Logistic regression was used for this endpoint.
Timepoint [4] 0 0
Week 52

Eligibility
Key inclusion criteria
For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com



- Rheumatoid arthritis (RA) diagnosis less than 6 months

- CRP > 3 mg/L or Erythrocyte Sedimentation Rate (ESR) = 28 mm/h

- At least 3 swollen and 3 tender joints

- Anti-citrullinated protein antibodies (ACPA) positive
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- At risk for tuberculosis

- Have acute infection

- Have chronic or recurrent bacterial or serious latent viral infection

- History of malignancies in the last 5 years except squamous skin, basal skin or
cervical carcinoma

- Previous treatment with any conventional or biologic Disease-modifying anti rheumatic
drugs (DMARD)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,TAS,VIC
Recruitment hospital [1] 0 0
Local Institution - Maroochydore
Recruitment hospital [2] 0 0
Local Institution - Southport
Recruitment hospital [3] 0 0
Local Institution - Hobart
Recruitment hospital [4] 0 0
Local Institution - Camberwell
Recruitment hospital [5] 0 0
Local Institution - Coffs Harbour
Recruitment postcode(s) [1] 0 0
4558 - Maroochydore
Recruitment postcode(s) [2] 0 0
4215 - Southport
Recruitment postcode(s) [3] 0 0
7000 - Hobart
Recruitment postcode(s) [4] 0 0
3124 - Camberwell
Recruitment postcode(s) [5] 0 0
2450 - Coffs Harbour
Recruitment outside Australia
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Argentina
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Buenos Aires
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Argentina
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Santa FE
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Cordoba
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Szolnok
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Veszprem
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Israel
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Haifa
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Israel
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Petach Tikva
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Israel
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Ramat-gan
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Israel
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Tel Hashomer
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Zrifin
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Catania
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Romania
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Bucharest
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Bucuresti
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Singapore
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Gauteng
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Spain
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Barcelona
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Malmo
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Uppsala
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Taipei
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Taoyuan
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Greater Manchester
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North Yorkshire
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United Kingdom
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Hull

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine if abatacept is effective in the treatment of early
rheumatoid arthritis.
Trial website
https://clinicaltrials.gov/show/NCT02504268
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications