Status:
COMPLETED
Efficacy and Safety Study of Abatacept Subcutaneous Plus Methotrexate in Inducing Remission in Adults With Very Early Rheumatoid Arthritis
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The primary purpose of the protocol is to demonstrate the ability of abatacept plus methotrexate to induce remission in patients with very early rheumatoid arthritis after 12 months of treatment and t...
Eligibility Criteria
Inclusion
- Key
- Presence of active clinical synovitis in at least 2 joints, 1 of which must have been a small joint, for a minimum of 8 weeks prior to screening
- Onset of persistent symptoms ≤ 2 years prior to screening
- Positive test result for anticyclic citrullinated peptides 2
- Methotrexate naive or with minimum exposure to methotrexate, defined as no more than 10 mg/week for ≤4 weeks and no methotrexate dose for 1 month prior to screening visit
- Biologic naive, including no treatment with an investigational biologic prior to screening
- Disease Activity Score 28 based on C-reactive protein score ≥3.2 at screening
- Withdrawal from any treatment with chloroquine, hydroxychloroquine, and/or sulfasalazine (wash-out) for a minimum of 28 days prior to randomization
- If receiving oral corticosteroids, on a stable low dose (≤ 10 mg/day prednisone equivalent) for at least 4 weeks
- Able to undergo magnetic resonance imaging
- Key
Exclusion
- Meeting diagnostic criteria for other rheumatic disease (eg, lupus erythematosus)
- Treatment with an intravenous, intramuscular, or intraarticular corticosteroid within 4 weeks prior to randomization
- Scheduled for or anticipating joint replacement surgery
- Presence of concomitant illness likely to require systemic glucocorticosteroid therapy during the study, in the opinion of the investigator
- History of malignancy in the last 5 years
- Any serious bacterial infection within the last 3 months not treated or resolved with antibiotics, or any chronic or recurrent bacterial infection
- At risk for tuberculosis
- Evidence of active or latent bacterial or viral infection at the time of potential enrollment, including human immunodeficiency or herpes zoster virus or cytomegalovirus that resolved less than 2 months prior to enrollment
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
511 Patients enrolled
Trial Details
Trial ID
NCT01142726
Start Date
December 1 2010
End Date
October 1 2014
Last Update
January 14 2016
Active Locations (73)
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1
Rheumatology Associates Of North Alabama, P.C.
Huntsville, Alabama, United States, 35801
2
St. Joseph'S Mercy Clinic
Hot Springs, Arkansas, United States, 71913
3
Sarasota Arthritis Research Center
Sarasota, Florida, United States, 34239
4
Coeur D'Alene Arthrit Clin
Coeur d'Alene, Idaho, United States, 83814