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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| ClinicalTrials.gov Identifier: NCT04909801 |
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Recruitment Status :
Active, not recruiting
First Posted : June 2, 2021
Last Update Posted : November 7, 2023
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Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Rheumatoid Arthritis | Drug: Abatacept Drug: Adalimumab Drug: Methotrexate | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 327 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official 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 |
| Actual Study Start Date : | September 15, 2021 |
| Actual Primary Completion Date : | June 14, 2023 |
| Estimated Study Completion Date : | September 3, 2025 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Rheumatoid arthritis
| Arm | Intervention/treatment |
|---|---|
| Experimental: Arm 1: Abatacept + Methotrexate |
Drug: Abatacept
Abatacept SC (125 mg) once weekly
Other Names:
Drug: Methotrexate Methotrexate oral/parenteral maximum tolerated dose (minimum 15 mg and maximum 25 mg weekly) |
| Experimental: Arm 2: (Adalimumab + Methotrexate) followed by (Abatacept + Methotrexate) |
Drug: Abatacept
Abatacept SC (125 mg) once weekly
Other Names:
Drug: Adalimumab Adalimumab SC (40 mg) once every 2 weeks
Other Name: Humira® Drug: Methotrexate Methotrexate oral/parenteral maximum tolerated dose (minimum 15 mg and maximum 25 mg weekly) |
Primary Outcome Measures :
- Proportion of shared epitope-positive (SE+) participants meeting 50% improvement in American College of Rheumatology criteria (ACR50) response [ Time Frame: At week 24 ]
Secondary Outcome Measures :
- Proportion of SE+ participants achieving Disease Activity Score 28-joint count calculated using C-reactive protein (DAS28-CRP) remission (DAS28-CRP < 2.6) [ Time Frame: At week 24 ]
- Proportion of whole study population participants meeting ACR50 response [ Time Frame: At week 24 ]
- Proportion of SE+ participants achieving Clinical Disease Activity Index (CDAI) remission (CDAI ≤ 2.8) [ Time Frame: At week 24 ]
- Mean change from baseline in SE+ participant-reported pain by visual analog scale (VAS) [ Time Frame: At week 24 ]
- Proportion of SE+ subset achieving 20% improvement in American College of Rheumatology criteria (ACR20) responses [ Time Frame: Up to 104 weeks ]
- Proportion of SE+ whole population achieving ACR20 responses [ Time Frame: Up to 104 weeks ]
- Proportion of SE+ subset achieving 50% improvement in American College of Rheumatology criteria (ACR50) responses [ Time Frame: Up to 104 weeks ]
- Proportion of SE+ whole population achieving ACR50 responses [ Time Frame: Up to 104 weeks ]
- Proportion of SE+ subset achieving 70% improvement in American College of Rheumatology criteria (ACR70) responses [ Time Frame: Up to 104 weeks ]
- Proportion of SE+ whole population achieving ACR70 responses [ Time Frame: Up to 104 weeks ]
- Proportion of SE+ subset achieving Disease Activity Score (DAS) remission [ Time Frame: Up to 104 weeks ]
- Proportion of SE+ whole population achieving DAS remission [ Time Frame: Up to 104 weeks ]
- Proportion of SE+ subset achieving Clinical Disease Activity Index (CDAI) remission [ Time Frame: Up to 104 weeks ]
- Proportion of SE+ whole population achieving CDAI remission [ Time Frame: Up to 104 weeks ]
- Proportion of SE+ subset achieving Simple Disease Activity Index (SDAI) remission over the Single-blind Treatment Period (SBTP) [ Time Frame: Up to 104 weeks ]
- Proportion of SE+ subset achieving Simple Disease Activity Index (SDAI) remission over the Open-label Treatment Period (OLTP) [ Time Frame: Up to 104 weeks ]
- Proportion of SE+ whole population achieving SDAI remission over the SBTP [ Time Frame: Up to 104 weeks ]
- Proportion of SE+ whole population achieving SDAI remission over the OLTP [ Time Frame: Up to 104 weeks ]
- Mean changes from baseline in DAS28-CRP [ Time Frame: Up to 104 weeks ]
- Mean changes from baseline in CDAI [ Time Frame: Up to 104 weeks ]
- Mean changes from baseline in SDAI over the SBTP [ Time Frame: Up to 104 weeks ]
- Mean changes from baseline in SDAI over the OLTP [ Time Frame: Up to 104 weeks ]
- Mean changes from baseline in the 7 ACR core components over the SBTP [ Time Frame: Up to 104 weeks ]
- Mean changes from baseline in the 7 ACR core components over the OLTP [ Time Frame: Up to 104 weeks ]
- Mean change from baseline in 36-item Short Form Survey (SF-36) in SE+ subset at week 24 and week 104 [ Time Frame: Up to 104 weeks ]
- Mean change from baseline in SF-36 in SE+ whole population at week 24 and week 104 [ Time Frame: Up to 104 weeks ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04909801
Locations
Show 75 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Additional Information:
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT04909801 |
| Other Study ID Numbers: |
IM101-863 2020-000350-96 ( EudraCT Number ) U1111-1247-1367 ( Registry Identifier: WHO ) |
| First Posted: | June 2, 2021 Key Record Dates |
| Last Update Posted: | November 7, 2023 |
| Last Verified: | November 2023 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Bristol-Myers Squibb:
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Abatacept Adalimumab BMS-188667 Humira® |
Methotrexate Orencia® Rheumatoid Arthritis |
Additional relevant MeSH terms:
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Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Adalimumab Methotrexate Abatacept Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs |
Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Nucleic Acid Synthesis Inhibitors Tumor Necrosis Factor Inhibitors Anti-Inflammatory Agents Immune Checkpoint Inhibitors Antineoplastic Agents, Immunological |