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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00252668 |
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Date of registration:
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09/11/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study Evaluating the Combination of Etanercept and Methotrexate in Rheumatoid Arthritis Subjects
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Scientific title:
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An Open-Label, Multicentre, Extension Study of the Combination of Etanercept and Methotrexate in Rheumatoid Arthritis Subjects |
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Date of first enrolment:
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June 2004 |
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Target sample size:
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300 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00252668 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Contacts
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Czech Republic, WPPGCLI@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Romania, WPVIMED@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Greece, decresg@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Sweden, Denmark and Norway, MedInfoNord@wyeth.com |
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Name:
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Medical Monitor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Wyeth is now a wholly owned subsidiary of Pfizer |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Germany, MedinfoDEU@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Spain, Italy, Portugal, the Netherlands, and Finland, clinicaltrialinfo@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Belgium, trials-BEL@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Poland, WPWZMED@wyeth.com |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Rheumatoid Arthritis
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Intervention(s)
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Drug: Methotrexate
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Drug: Etanercept
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Primary Outcome(s)
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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.
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Secondary Outcome(s)
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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.
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Secondary ID(s)
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B1801221
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0881A1-101631
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0881A1-400
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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