SELECT-CHOICE

A Phase 3 Study to Compare an Active Drug 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

Brief summary

The comparison of safety and efficacy of an active drug 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.

Interventional study

Status:
Active, not recruiting
Conditions:
Rheumatoid Arthritis (RA)
Enrollment:
613 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M15-925
Allocation:
Randomized
Intervention model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Purpose:
Treatment

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Eligibility criteria

Participant attributes:
Male and Female

Age:

18 Years and older.

Main Inclusion Criteria:

- Diagnosis of rheumatoid arthritis (RA) for ≥ 3 months who also fulfill the 2010
American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR)
classification criteria for RA

- Participants have been treated for ≥ 3 months prior to the screening visit 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
high-sensitivity C-reactive protein (hsCRP) ≥ 3 mg/L at Screening

Main 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
mL/minute/1.73 meter (m)^2; total white blood cell count < 2,500/ μL; absolute
neutrophil count < 1,500/μL; platelet count < 100,000/μL; absolute lymphocyte count <
800/μL; and hemoglobin < 10 g/dL

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