Study Evaluating ERB-041 With Methotrexate in Rheumatoid Arthritis
NCT00141830
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- 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
- Any significant health problem other than rheumatoid arthritis
- History of male or female reproductive system cancer
- Clinically significant laboratory abnormalities
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Descriptive Information | |||||||
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Brief Title ICMJE | Study Evaluating ERB-041 With Methotrexate in Rheumatoid Arthritis | ||||||
Official Title ICMJE | 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 | ||||||
Brief Summary | The primary objective of this study is to compare the efficacy and safety of 3 dose levels of oral ERB-041 administered daily for 12 weeks versus placebo in subjects with active rheumatoid arthritis who have had a suboptimal response to therapy with stable doses of methotrexate (MTX). | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 2 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment | ||||||
Condition ICMJE | Rheumatoid Arthritis | ||||||
Intervention ICMJE |
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Study Arms ICMJE | Not Provided | ||||||
Publications * | Roman-Blas JA, Castañeda S, Cutolo M, Herrero-Beaumont G. Efficacy and safety of a selective estrogen receptor ? agonist, ERB-041, in patients with rheumatoid arthritis: a 12-week, randomized, placebo-controlled, phase II study. Arthritis Care Res (Hoboken). 2010 Nov;62(11):1588-93. doi: 10.1002/acr.20275. Epub 2010 Jun 15. | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE | 159 | ||||||
Original Enrollment ICMJE | 260 | ||||||
Actual Study Completion Date ICMJE | October 19, 2006 | ||||||
Actual Primary Completion Date | October 19, 2006 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 80 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Canada, Hungary, Italy, Mexico, Spain, United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT00141830 | ||||||
Other Study ID Numbers ICMJE | 3142A1-202 B2381010 ( Other Identifier: Pfizer ) 2005-001319-23 ( EudraCT Number ) | ||||||
Has Data Monitoring Committee | Not Provided | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE | Not Provided | ||||||
Responsible Party | Wyeth is now a wholly owned subsidiary of Pfizer | ||||||
Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | ||||||
Verification Date | September 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |