Efficacy and Safety Study of Abatacept Subcutaneous Plus Methotrexate in Inducing Remission in Adults With Very Early Rheumatoid Arthritis
Status: | Completed |
---|---|
Conditions: | Arthritis, Rheumatoid Arthritis |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | December 2010 |
End Date: | October 2014 |
A Phase 3b, Randomized, Active Controlled Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination With Methotrexate in Inducing Clinical Remission Compared to Methotrexate Monotherapy in Adults With Very Early RA
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 to maintain remission following 6 months of drug withdrawal.
methotrexate to induce remission in patients with very early rheumatoid arthritis after 12
months of treatment and to maintain remission following 6 months of drug withdrawal.
Key Inclusion Criteria:
- 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 Criteria:
- 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
We found this trial at
16
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MetroHealth Med Ctr The MetroHealth System is one of the largest, most comprehensive health care...
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