Rheumatoid Arthritis Clinical Trial
Official title:
An Open-Label, Multicentre, Extension Study of the Combination of Etanercept and Methotrexate in Rheumatoid Arthritis Subjects
Verified date | May 2011 |
Source | Wyeth is now a wholly owned subsidiary of Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Ethics Commission |
Study type | Interventional |
This study is an open label extension of a previously completed double-blind, randomized study comparing etanercept and methotrexate in subjects with active rheumatoid arthritis. All subjects will receive combination treatment with etanercept and methotrexate.
Status | Completed |
Enrollment | 300 |
Est. completion date | September 2005 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Subjects who completed the previous double-blind,randomized study. - Ability to reconstitute and self-inject test etanercept (ETN) or have a designee who can do so. Exclusion Criteria: - Dose of prednisone>10 mg/day (or equivalent) or dose changed within 2 weeks before week 0 evaluation. - Clinically relevant concurrent medical events including: uncompensated congestive heart failure (CHF), diagnosis of multiple sclerosis or other central demyelinating diseases, presence or history of confirmed blood dyscrasias, cancer or history of cancer, serious infection within 1 month of test article administration or active infection at week 0. |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Wyeth is now a wholly owned subsidiary of Pfizer |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To evaluate the long-term safety of the combination of etanercept and methotrexate in adults with RA who have completed the previous double-blind, randomized study. | |||
Secondary | To evaluate the long-term clinical efficacy and x-ray progression of the combination of etanercept and methotrexate in adults with RA who have completed the previous double-blind, randomized study. |
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