Open-Label Extension Treatment With Etanercept (TNFR:Fc) for Participating Patients in Etanercept (TNFR:Fc) Clinical Trial 016.0012

Amgen

Status and phase

Completed

Phase 3

Conditions

Rheumatoid Arthritis

Treatments

Biological: Etanercept

Study type

Interventional

Funder types

Industry

Identifiers

NCT00356590

20021623

16.0023

Details and patient eligibility

About

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 etanercept (TNFR:Fc) in patients with early stage rheumatoid arthritis.

Enrollment

468 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.