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Open-Label Extension Treatment With TNFR:Fc for Participating Patients in TNFR:Fc Clinical Trial 016.0012

Information source: Amgen
Information obtained from ClinicalTrials.gov on December 31, 2007
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rheumatoid Arthritis

Intervention: Etanercept (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Amgen

Official(s) and/or principal investigator(s):
MD, Study Director, Affiliation: Amgen

Summary

This is an open label, multicenter study for extended treatment of patients who have participated in the Immunex clinical study 016. 0012. The primary objective of this study is to evaluate the long term safety of TNFR: Fc in patients with early stage rheumatoid arthritis.

Clinical Details

Study design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study

Primary outcome: To evaluate long term safety of TNFR:Fc in patients with early stage rheumatoid arthritis. Improvement in physical function/disability and quality of life will be determined.

Secondary outcome: To evaluate long term biologic activity of TNFR:Fc in various patient populations with rheumatoid arthritis.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: - Previous enrollment in Immunex protocol 016. 0012.

No clinically significant adverse events thought to be due to TNFR: Fc during previous treatment. Negative serum pregnancy test not more than 14 days before the first dose of study drug in females of childbearing potential. No more than one NSAID at a dose not greater than the maximum recommended dose and stable for at least two weeks prior to administration of TNFR: Fc. Exclusion Criteria: Previous receipt of TNFR: Fc (p55), antibody to TNF, anti-CD4 antibody, or diphtheria IL-2 fusion protein. Receipt of investigational drugs or biologics (other than TNFR: Fc) within interval between study drug in 016. 0012 and this study. Receipt of DMARDs (e. g., hydroxychloroquine, oral or injectable gold, azathioprine, cyclosporin, D-penicillamine, sulfasalazine, minocycline, or leflunomide) other than MTX within two weeks prior to the first dose of TNFR: Fc in this study. Receipt of cyclophosphamide within 1 month prior to the first dose of TNFR: Fc in this study.

Locations and Contacts

Additional Information

AmgenTrials clinical trials website

Starting date: December 1998
Ending date: January 2009
Last updated: December 20, 2007

Page last updated: December 31, 2007

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