Open-Label Extension Treatment With Tumor Necrosis Factor Receptor Fusion Protein (TNFR:Fc) for Participating Patients in Tumor Necrosis Factor Receptor Fusion Protein (TNFR:Fc) Clinical Trials
Phase 3
4 Years
N/A
4 Years
N/A
Not Enrolling
Both
Rheumatoid Arthritis
Both
Rheumatoid Arthritis
Trial Information
Open-Label Extension Treatment With Tumor Necrosis Factor Receptor Fusion Protein (TNFR:Fc) for Participating Patients in Tumor Necrosis Factor Receptor Fusion Protein (TNFR:Fc) Clinical Trials
Inclusion Criteria:
- 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 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 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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Total Exposure to Etanercept With Gaps
Outcome Description:
Total participant exposure to etanercept (Enbrel) with gaps
Outcome Time Frame:
Up to 10 years
Safety Issue:
No
Principal Investigator
MD
Investigator Role:
Study Director
Investigator Affiliation:
Amgen
Authority:
Canada: Health Canada
Study ID:
20021618
NCT ID:
NCT00357903
Start Date:
April 1997
Completion Date:
April 2009
Related Keywords:
- Rheumatoid Arthritis
- Rheumatoid Arthritis, Etanercept, Long-term Safety, Enbrel
- Arthritis
- Arthritis, Rheumatoid
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