Open-Label Extension Treatment With TNFR:Fc for Participating Patients in TNFR:Fc Clinical Trials
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 (TNFR:Fc) (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 study was designed to provide all adult and pediatric arthritis patients (placebo and
TNFR: Fc treated) who have participated in clinical trials with TNFR: Fc the opportunity to
receive continued treatment with TNFR: Fc. The primary objective of this study is to examine
safety parameters.
Clinical Details
Study design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
Primary outcome: To evaluate long term safety of RNFR:Fc in various patient populations with 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: 4 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria: - Previous enrollment in Immunex protocols
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 [p75]) within 1 month
prior to the first dose of TNFR: Fc in this study.
Receipt of DMARDs or methotrexate (except patients from 16. 0014) within two weeks prior to
the first dose of TNFR: Fc in this study.
Receipt of cyclophosphamide within six months prior to the first dose of TNFR: Fc in this
study.
Receipt of cyclosporin within two weeks prior to the first dose of TNFR: Fc in this study.
Locations and Contacts
Additional Information
AmgenTrials clinical trials website
Starting date: April 1997
Ending date: January 2009
Last updated: December 20, 2007
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