Study of Abatacept (BMS-188667) in Subjects With Active Rheumatoid Arthritis on Background Non-biologic DMARDS (Disease Modifying Antirheumatic Drugs) Who Have an Inadequate Response to Anti-TNF Therapy
Status and phase
Completed
Phase 3
Conditions
Rheumatoid Arthritis
Treatments
Drug: Non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)
Drug: Anti-Tumor Necrosing Factor (TNF) Therapy
Drug: Abatacept
Details and patient eligibility
About
The purpose of this study is to summarize the safety and tolerability of abatacept during 6 months of combined treatment with one or more of the background non-biologic disease modifying anti-rheumatic drugs (DMARDs) approved for rheumatoid arthritis (RA) in subjects with active RA. Secondary objectives assessed the clinical efficacy of combination treatment, including disease activity, physical function, and quality of life outcomes.
Enrollment
1,286 patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- Completed double-blind portion of the IM101064 study.
- Rheumatoid arthritis (RA) for greater than 1 year from the time of initial diagnosis
- American College of Rheumatology (ACR) functional class I, II, III
- Subjects currently or previously received an anti-TNF therapy at an approved labeled dose for at least 3 months
Exclusion criteria
- Subjects with active vasculitis of a major organ system (except subcutaneous rheumatoid nodules)
- History of cancer within the last 5 years (other than non-melanoma skin cell cancers cured by local resection)
Trial design
Primary purpose
Treatment
Allocation
Non-Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
1,286 participants in 3 patient groups
Open-label Abatacept (ABA)-Previous User
Experimental group
Description:
In participants who have had an inadequate efficacy response or intolerance on previous TNF-antagonist therapy (off therapy for at least 2 months), open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
Treatment:
Drug: Non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)
Drug: Abatacept
Open-label ABA-Current User
Experimental group
Description:
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
Treatment:
Drug: Non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)
Drug: Abatacept
Drug: Anti-Tumor Necrosing Factor (TNF) Therapy
Long-term ABA
Experimental group
Description:
Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
Treatment:
Drug: Non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)
Drug: Abatacept
Trial contacts and locations
148
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Data sourced from clinicaltrials.gov
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