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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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12 December 2020 |
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Main ID: |
NCT00141830 |
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Date of registration:
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30/08/2005 |
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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 ERB-041 With Methotrexate in Rheumatoid Arthritis
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Scientific title:
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A Randomized, Parallel, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of 3 Oral Doses of ERB-041 in Subjects With Rheumatoid Arthritis on a Background of Methotrexate Therapy |
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Date of first enrolment:
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August 2005 |
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Target sample size:
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159 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00141830 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double.
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Phase:
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Phase 2
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Countries of recruitment
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Canada
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Hungary
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Italy
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Mexico
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Spain
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United States
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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 South Africa, please contact ZAFinfo@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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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Clinical diagnosis of active rheumatoid arthritis for at least 6 months and on a
stable dose of methotrexate for at least 12 weeks
- Rheumatoid arthritis onset after 16 years of age
Exclusion Criteria:
- Any significant health problem other than rheumatoid arthritis
- History of male or female reproductive system cancer
- Clinically significant laboratory abnormalities
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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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 plus ERB-041 for 12 weeks
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Drug: Placebo for 12 weeks
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Primary Outcome(s)
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-ACR 20 response at Week 12
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Secondary Outcome(s)
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Secondary efficacy measures include ACR 50 and ACR 70 response.
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Secondary ID(s)
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B2381010
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3142A1-202
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2005-001319-23
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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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