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

• Register: ClinicalTrials.gov
• Last refreshed on: 3 March 2025
• Main ID: NCT04909801
• Date of registration: 28/05/2021
• Prospective Registration: Yes
• Primary sponsor: Bristol-Myers Squibb
• 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
• 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
• Date of first enrolment: September 15, 2021
• Target sample size: 338
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT04909801
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Czechia, France, Germany, Italy, Japan, Mexico, Poland, Spain, Switzerland, Taiwan, United Kingdom, United States

Contacts

• Name: Bristol-Myers Squibb
• Affiliation: Bristol-Myers Squibb

Key inclusion & exclusion criteria

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

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


Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: Adalimumab

Drug: Abatacept

Drug: Methotrexate

Primary Outcome(s)

Percentage of SE+ Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response at Week 24 [Time Frame: Baseline, week 24]

Secondary Outcome(s)

Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for SE+ Participants [Time Frame: Baseline, day 29, 57, 85, 113, 141, 169]

Adjusted Mean Change From Baseline in 36-item Short Form Survey (SF-36) at Week 104 for All Participants [Time Frame: Up to week 24]

Adjusted Mean Change From Baseline in 36-item Short Form Survey (SF-36) Over Time for SE+ Participants [Time Frame: Up to week 24]

Adjusted Mean Change From Baseline in Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein (DAS28-CRP) Over Time for All Participants [Time Frame: Baseline, day 29, 57, 85, 113, 141, 169]

Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 6 Over Time for All Participants [Time Frame: Baseline, day 29, 57, 85, 113, 141, 169]

Adjusted Mean Change From Baseline in Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein (DAS28-CRP) Over Time for SE+ Participants [Time Frame: Baseline, day 29, 57, 85, 113, 141, 169]

Adjusted Mean Change From Baseline in SE+ Participant-Reported Pain Visual Analog Scale (VAS) at Week 24 [Time Frame: Baseline, week 24]

Percentage of SE+ Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) at Week 24 [Time Frame: Week 24]

Percentage of Participants Meeting 70% Improvement in American College of Rheumatology Criteria (ACR70) Response Over Time [Time Frame: Baseline, day 29, 57, 85, 113, 141, 169]

Percentage of SE+ Participants Achieving Simple Disease Activity Index Remission (SDAI <= 3.3) Over Time [Time Frame: Day 29, 57, 85, 113, 141, 169]

Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for SE+ Participants [Time Frame: Baseline, day 29, 57, 85, 113, 141, 169]

Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 7 Over Time for SE+ Participants [Time Frame: Baseline, day 29, 57, 85, 113, 141, 169]

Adjusted Mean Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time for All Participants [Time Frame: Baseline, day 29, 57, 85, 113, 141, 169]

Adjusted Mean Change From Baseline in Simple Disease Activity Index (SDAI) Over Time for All Participants [Time Frame: Baseline, day 29, 57, 85, 113, 141, 169]

Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 7 Over Time for All Participants [Time Frame: Baseline, day 29, 57, 85, 113, 141, 169]

Percentage of Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) Over Time [Time Frame: Day 29, 57, 85, 113, 141, 169]

Percentage of Participants Achieving Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein Remission (DAS28-CRP < 2.6) Over Time [Time Frame: Day 29, 57, 85, 113, 141, 169]

Percentage of Participants Meeting 20% Improvement in American College of Rheumatology Criteria (ACR20) Response Over Time [Time Frame: Baseline, day 29, 57, 85, 113, 141, 169]

Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 6 Over Time for SE+ Participants [Time Frame: Baseline, day 29, 57, 85, 113, 141, 169]

Adjusted Mean Change From Baseline in Simple Disease Activity Index (SDAI) Over Time for SE+ Participants [Time Frame: Baseline, day 29, 57, 85, 113, 141, 169]

Percentage of SE+ Participants Achieving Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein Remission (DAS28-CRP < 2.6) at Week 24 [Time Frame: Week 24]

Percentage of SE+ Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response Over Time [Time Frame: Baseline, day 29, 57, 85, 113, 141, 169]

Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for All Participants [Time Frame: Baseline, day 29, 57, 85, 113, 141, 169]

Adjusted Mean Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time for SE+ Participants [Time Frame: Baseline, day 29, 57, 85, 113, 141, 169]

Percentage of Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response at Week 24 [Time Frame: Baseline, week 24]

Percentage of Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response Over Time [Time Frame: Baseline, day 29, 57, 85, 113, 141, 169]

Percentage of SE+ Participants Meeting 70% Improvement in American College of Rheumatology Criteria (ACR70) Response Over Time [Time Frame: Baseline, day 29, 57, 85, 113, 141, 169]

Adjusted Mean Change From Baseline in 36-item Short Form Survey (SF-36) at Week 104 for SE+ Participants [Time Frame: Up to week 24]

Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for All Participants [Time Frame: Baseline, day 29, 57, 85, 113, 141, 169]

Adjusted Mean Change From Baseline in SF-36 Over Time for All Participants [Time Frame: Up to week 24]

Percentage of Participants Achieving Simple Disease Activity Index Remission (SDAI <= 3.3) Over Time [Time Frame: Day 29, 57, 85, 113, 141, 169]

Percentage of SE+ Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) Over Time [Time Frame: Day 29, 57, 85, 113, 141, 169]

Percentage of SE+ Participants Achieving Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein Remission (DAS28-CRP < 2.6) Over Time [Time Frame: Day 29, 57, 85, 113, 141, 169]

Percentage of SE+ Participants Meeting 20% Improvement in American College of Rheumatology Criteria (ACR20) Response Over Time [Time Frame: Baseline, day 29, 57, 85, 113, 141, 169]

Secondary ID(s)

IM101-863

U1111-1247-1367

2020-000350-96

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 15/10/2024
• URL: https://clinicaltrials.gov/ct2/show/results/NCT04909801