Study Evaluating ERB-041 With Methotrexate in Rheumatoid Arthritis
NCT00141830
Last updated date
ABOUT THIS STUDY
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).
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
18-80 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Any significant health problem other than rheumatoid arthritis
- History of male or female reproductive system cancer
- Clinically significant laboratory abnormalities
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Advanced Information
| Descriptive Information | |||||||
|---|---|---|---|---|---|---|---|
| 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 |
| ||||||
| 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:
| ||||||
| Sex/Gender ICMJE |
| ||||||
| 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 |
| ||||||
| 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 | |||||||