Study Evaluating the Combination of Etanercept and Methotrexate in Rheumatoid Arthritis Subjects
An Open-Label, Multicentre, Extension Study of the Combination of Etanercept and Methotrexate in Rheumatoid Arthritis Subjects
3 other identifiers
interventional
300
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 rheumatoid-arthritis
Started Jun 2004
Shorter than P25 for phase_4 rheumatoid-arthritis
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
November 9, 2005
CompletedFirst Posted
Study publicly available on registry
November 11, 2005
CompletedMay 18, 2011
May 1, 2011
November 9, 2005
May 17, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Wyeth is now a wholly owned subsidiary of Pfizer
- PRINCIPAL INVESTIGATOR
Trial Manager
For Germany, MedinfoDEU@wyeth.com
- PRINCIPAL INVESTIGATOR
Trial Manager
For Sweden, Denmark and Norway, MedInfoNord@wyeth.com
- PRINCIPAL INVESTIGATOR
Trial Manager
For Belgium, trials-BEL@wyeth.com
- PRINCIPAL INVESTIGATOR
Trial Manager
For Greece, decresg@wyeth.com
- PRINCIPAL INVESTIGATOR
Trial Manager
For Czech Republic, WPPGCLI@wyeth.com
- PRINCIPAL INVESTIGATOR
Trial Manager
For Romania, WPVIMED@wyeth.com
- PRINCIPAL INVESTIGATOR
Trial Manager
For Poland, WPWZMED@wyeth.com
- PRINCIPAL INVESTIGATOR
Trial Manager
For Spain, Italy, Portugal, the Netherlands, and Finland, clinicaltrialinfo@wyeth.com
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 9, 2005
First Posted
November 11, 2005
Study Start
June 1, 2004
Study Completion
September 1, 2005
Last Updated
May 18, 2011
Record last verified: 2011-05