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

Amgen

Status and phase

Completed

Phase 3

Conditions

Rheumatoid Arthritis

Treatments

Biological: Etanercept

Study type

Interventional

Funder types

Industry

Identifiers

NCT00357903

16.0018

20021618

Details and patient eligibility

About

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 opportunity to receive continued treatment with etanercept (TNFR:Fc). The primary objective of this study is to examine safety parameters.

Enrollment

639 patients

Sex

All

Ages

4+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.