Open-Label Extension Treatment With Etanercept (TNFR:Fc) for Participating Patients in Etanercept (TNFR:Fc) Clinical Trial 016.0012
Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Rheumatoid Arthritis
Both
Rheumatoid Arthritis
Trial Information
Open-Label Extension Treatment With Etanercept (TNFR:Fc) for Participating Patients in Etanercept (TNFR:Fc) Clinical Trial 016.0012
Inclusion Criteria:
- Previous enrollment in Immunex protocol 016.0012.- 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 etanercept (TNFR:Fc) (p55), antibody to TNF, anti-CD4 antibody,
or diphtheria IL-2 fusion protein.
- Receipt of investigational drugs or biologics (other than etanercept (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 etanercept (TNFR:Fc) in this study.
- Receipt of cyclophosphamide within 1 month 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, calculated as the sum of the times on treatment for all participants. Gaps of up to 14 days from the last treatment in a previous Etanercept study were ignored in calculating time on treatment.
Outcome Time Frame:
Up to 8 years
Safety Issue:
No
Principal Investigator
MD
Investigator Role:
Study Director
Investigator Affiliation:
Amgen
Authority:
Canada: Health Canada
Study ID:
20021623
NCT ID:
NCT00356590
Start Date:
December 1998
Completion Date:
April 2009
Related Keywords:
- Rheumatoid Arthritis
- Rheumatoid Arthritis
- Etanercept
- Long-term Safety
- Enbrel
- Arthritis
- Arthritis, Rheumatoid
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