Status:
COMPLETED
Open-Label Extension Treatment With Etanercept (TNFR:Fc) for Participating Patients in Etanercept (TNFR:Fc) Clinical Trials
Lead Sponsor:
Amgen
Collaborating Sponsors:
Immunex Corporation
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
4+ years
Phase:
PHASE3
Brief Summary
This study was designed to provide all adult and pediatric arthritis patients (placebo and etanercept(TNFR:Fc) treated) who have participated in clinical trials with etanercept (TNFR:Fc) the opportuni...
Eligibility Criteria
Inclusion
- Previous enrollment in Immunex protocols
- No clinically significant adverse events thought to be due to etanercept (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 etanercept (TNFR:Fc).
Exclusion
- 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 etanercept (TNFR:Fc) in this study.
- Receipt of DMARDs or methotrexate (except patients from 16.0014) within two weeks prior to the first dose of etanercept (TNFR:Fc) in this study.
- Receipt of cyclophosphamide within six months prior to the first dose of (etanercept (TNFR:Fc) in this study.
- Receipt of cyclosporin within two weeks prior to the first dose of etanercept (TNFR:Fc) in this study.
Key Trial Info
Start Date :
April 1 1997
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
639 Patients enrolled
Trial Details
Trial ID
NCT00357903
Start Date
April 1 1997
End Date
April 1 2009
Last Update
February 9 2017
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