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Study Evaluating the Combination of Etanercept and Methotrexate in Rheumatoid Arthritis Subjects

Information source: Wyeth
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rheumatoid Arthritis

Intervention: Etanercept (Drug); Methotrexate (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Wyeth

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth
Trial Manager, Principal Investigator, Affiliation: For Germany, MedinfoDEU@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Sweden, Denmark and Norway, MedInfoNord@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Belgium, trials-BEL@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Greece, decresg@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Czech Republic, WPPGCLI@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Romania, WPVIMED@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Poland, WPWZMED@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Spain, Italy, Portugal, the Netherlands, and Finland, clinicaltrialinfo@wyeth.com

Summary

This study is an open label extension of a previously completed double-blind, randomized study comparing etanercept and methotrexate in subjects with active rheumatoid arthritis. All subjects will receive combination treatment with etanercept and methotrexate.

Clinical Details

Official title: An Open-Label, Multicentre, Extension Study of the Combination of Etanercept and Methotrexate in Rheumatoid Arthritis Subjects

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study

Primary outcome: To evaluate the long-term safety of the combination of etanercept and methotrexate in adults with RA who have completed the previous double-blind, randomized study.

Secondary outcome: To evaluate the long-term clinical efficacy and x-ray progression of the combination of etanercept and methotrexate in adults with RA who have completed the previous double-blind, randomized study.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subjects who completed the previous double-blind,randomized study.

- Ability to reconstitute and self-inject test etanercept (ETN) or have a designee who

can do so.

Exclusion Criteria:

- Dose of prednisone>10 mg/day (or equivalent) or dose changed within 2 weeks before

week 0 evaluation.

- Clinically relevant concurrent medical events including: uncompensated congestive

heart failure (CHF), diagnosis of multiple sclerosis or other central demyelinating diseases, presence or history of confirmed blood dyscrasias, cancer or history of cancer, serious infection within 1 month of test article administration or active infection at week 0.

Locations and Contacts

Additional Information

Starting date: June 2004
Ending date: September 2005
Last updated: May 17, 2006

Page last updated: June 20, 2008

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