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
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
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.
Minimum age: 18 Years.
Maximum age: N/A.
Inclusion Criteria: - Previous enrollment in Immunex protocol 016. 0012.
No clinically significant adverse events thought to be due to TNFR: Fc during previous
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
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
Locations and Contacts
AmgenTrials clinical trials website
Starting date: December 1998
Ending date: January 2009
Last updated: December 20, 2007