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

Information source: Amgen
Information obtained from ClinicalTrials.gov on December 31, 2007
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rheumatoid Arthritis

Intervention: Etanercept (TNFR:Fc) (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Amgen

Official(s) and/or principal investigator(s):
MD, Study Director, Affiliation: Amgen

Summary

This study was designed to provide all adult and pediatric arthritis patients (placebo and TNFR: Fc treated) who have participated in clinical trials with TNFR: Fc the opportunity to receive continued treatment with TNFR: Fc. The primary objective of this study is to examine safety parameters.

Clinical Details

Study design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study

Primary outcome: To evaluate long term safety of RNFR:Fc in various patient populations with rheumatoid arthritis. Improvement in physical function/disability and quality of life will be determined.

Secondary outcome: To evaluate long term biologic activity of TNFR:Fc in various patient populations with rheumatoid arthritis.

Eligibility

Minimum age: 4 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: - Previous enrollment in Immunex protocols

No clinically significant adverse events thought to be due to 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 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 TNFR: Fc in this study. Receipt of DMARDs or methotrexate (except patients from 16. 0014) within two weeks prior to the first dose of TNFR: Fc in this study. Receipt of cyclophosphamide within six months prior to the first dose of TNFR: Fc in this study. Receipt of cyclosporin within two weeks prior to the first dose of TNFR: Fc in this study.

Locations and Contacts

Additional Information

AmgenTrials clinical trials website

Starting date: April 1997
Ending date: January 2009
Last updated: December 20, 2007

Page last updated: December 31, 2007

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