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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03086343




Registration number
NCT03086343
Ethics application status
Date submitted
20/03/2017
Date registered
22/03/2017
Date last updated
22/03/2019

Titles & IDs
Public title
A Phase 3 Study to Compare Upadacitinib to Abatacept in Subjects With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease- Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response or Intolerance to Biologic DMARDs ( SELECT-CHOICE )
Scientific title
A Phase 3, Randomized, Active-Controlled, Double Blind Study Comparing Upadacitinib (ABT-494) to Abatacept in Subjects With Moderately to Severely Active Rheumatoid Arthritis With Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) on Stable Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARDs)
Secondary ID [1] 0 0
2016-000933-37
Secondary ID [2] 0 0
M15-925
Universal Trial Number (UTN)
Trial acronym
SELECT-CHOICE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis (RA) 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 - Upadacitinib matching placebo
Treatment: Drugs - Abatacept matching placebo
Treatment: Drugs - Upadacitinib
Treatment: Drugs - Abatacept

Active Comparator: Abatacept followed by upadacitinib - Intravenous (IV) infusion of abatacept at Baseline, Week 2, Week 4, Week 8, Week 12, Week 16 and Week 20 followed by upadacitinib starting at week 24 up to 5 years.

Experimental: Upadacitinib - Once daily for 24 weeks during Period 1 and up to 5 years during Period 2.


Treatment: Drugs: Upadacitinib matching placebo
Oral tablet

Treatment: Drugs: Abatacept matching placebo
IV infusion

Treatment: Drugs: Upadacitinib
Oral Tablet

Treatment: Drugs: Abatacept
IV infusion

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

Outcomes
Primary outcome [1] 0 0
Change in Disease Activity Score (DAS) 28 C-Reactive Protein (CRP) (non-inferiority) - The Disease Activity Score (DAS)28 is a validated index of rheumatoid arthritis disease activity. Scores on the DAS28 range from 0 to 10.
Timepoint [1] 0 0
At week 12
Secondary outcome [1] 0 0
Proportion of participants achieving Disease Activity Score (DAS) 28 based Clinical Remission (CR) - Proportion of participants achieving Clinical Remission (CR) as defined by a clinical response Disease Activity Score (DAS)28 C-Reactive Protein (CRP) less than 2.6. The DAS28 is a validated index of rheumatoid arthritis disease activity. Scores on the DAS28 range from 0 to 10. A DAS28 score greater than 5.1 indicates high disease activity, a DAS28 score less than or equal to 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates CR.
Timepoint [1] 0 0
At week 12
Secondary outcome [2] 0 0
Change in Disease Activity Score (DAS) 28 C-Reactive Protein (CRP) (superiority) - The DAS28 is a validated index of rheumatoid arthritis disease activity. Scores on the DAS28 range from 0 to 10.
Timepoint [2] 0 0
At week 12

Eligibility
Key inclusion criteria
- Diagnosis of rheumatoid arthritis (RA) for >= 3 months.

- Participants have been treated for >= 3 months with >= 1 bDMARD therapy, but continue
to exhibit active RA or had to discontinue due to intolerability or toxicity,
irrespective of treatment duration and have never received abatacept prior to the
first dose of study drug.

- Participants have been receiving csDMARD therapy >= 3 months and on a stable dose for
>= 4 weeks prior to the first dose of study drug. The following csDMARDs are allowed:
methotrexate (MTX), sulfasalazine, hydroxychloroquine, chloroquine, and leflunomide. A
combination of up to two background csDMARDs is allowed except the combination of MTX
and leflunomide.

- Meets the following criteria: >= 6 swollen joints (based on 66 joint counts) and >= 6
tender joints (based on 68 joint counts) at Screening and Baseline Visits and hsCRP >=
3 mg/L at Screening .
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to
upadacitinib, tofacitinib, baricitinib and filgotinib).

- Prior exposure to abatacept

- History of any arthritis with onset prior to age 17 years or current diagnosis of
inflammatory joint disease other than RA. Current diagnosis of secondary Sjogren's
Syndrome is permitted

- Laboratory values meeting the following criteria within the Screening period prior to
the first dose of study drug: serum aspartate transaminase > 2 × upper limit of normal
(ULN); serum alanine transaminase > 2 × ULN; estimated glomerular filtration rate by
simplified 4-variable Modification of Diet in Renal Disease formula < 40 milli liter
(mL)/minute/1.73 meter (m)^2; total white blood cell count < 2,500/micro liter (µL);
absolute neutrophil count < 1,500/µL; platelet count < 100,000/µL; absolute lymphocyte
count < 800/µL; and hemoglobin < 10 g/ deciliter (dL).

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,SA,VIC
Recruitment hospital [1] 0 0
Rheumatology Research Unit /ID# 159174 - Maroochydore
Recruitment hospital [2] 0 0
The Queen Elizabeth Hospital /ID# 159175 - Woodville
Recruitment hospital [3] 0 0
Western Health Footscray Hospi /ID# 157968 - Footscray
Recruitment postcode(s) [1] 0 0
4558 - Maroochydore
Recruitment postcode(s) [2] 0 0
5011 - Woodville
Recruitment postcode(s) [3] 0 0
3011 - Footscray
Recruitment outside Australia
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Truro

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The comparison of safety and efficacy of upadacitinib versus abatacept in participants with
rheumatoid arthritis on a stable background conventional synthetic Disease Modifying
Anti-Rheumatic Drug (csDMARD) who have an inadequate response or intolerance to biologic
DMARDs.
Trial website
https://clinicaltrials.gov/show/NCT03086343
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
AbbVie Inc.
Address 0 0
AbbVie
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