Rheumatoid Arthritis Clinical Trial
Verified date | December 2007 |
Source | Swedish Orphan Biovitrum |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The purpose of this study is to evaluate the effect of anakinra (IL-1 ra) and pegsunercept (PEG sTNF-RI) when they are used together in improving the signs and symptoms of rheumatoid arthritis. The study will also evaluate the safety of the combination treatment and its effect on slowing down bone and joint destruction due to rheumatoid arthritis. The results will be compared to the effect when only 1 single medication (anakinra or pegsunercept) is used.
Status | Completed |
Enrollment | 0 |
Est. completion date | December 2002 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
- diagnosed with rheumatoid arthritis for at least 6 months - must be taking methotrexate * must not take DMARDS other than methotrexate during the study - must not have had previous treatment with and protein-based TNF-alpha inhibitor (eg. etanercept, infliximab, PEG sTNF-RI, or D2E7) - must not have had previous treatment with anakinra - subjects must meet tender and swollen joint requirements at screening, have morning stiffness, and/or have elevated acute phase reactants |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Amgen |
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