Study Evaluating ERB-041 With Methotrexate in Rheumatoid Arthritis
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
3 other identifiers
interventional
159
6 countries
35
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 rheumatoid-arthritis
Started Aug 2005
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 30, 2005
CompletedFirst Posted
Study publicly available on registry
September 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 19, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
October 19, 2006
CompletedSeptember 29, 2020
September 1, 2020
1.2 years
August 30, 2005
September 25, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
-ACR 20 response at Week 12
Secondary Outcomes (1)
Secondary efficacy measures include ACR 50 and ACR 70 response.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Any significant health problem other than rheumatoid arthritis
- History of male or female reproductive system cancer
- Clinically significant laboratory abnormalities
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
Unknown Facility
Largo, Florida, 33773, United States
Unknown Facility
Palm Harbor, Florida, 34684, United States
Unknown Facility
Sarasota, Florida, 34239, United States
Unknown Facility
Boise, Idaho, 83702, United States
Unknown Facility
Kansas City, Kansas, 66160, United States
Unknown Facility
Frederick, Maryland, 21702, United States
Unknown Facility
Albuquerque, New Mexico, 87131, United States
Unknown Facility
Charlotte, North Carolina, 28210, United States
Unknown Facility
Duncansville, Pennsylvania, 16635-0909, United States
Unknown Facility
Austin, Texas, 78705, United States
Unknown Facility
Dallas, Texas, 75231, United States
Unknown Facility
San Antonio, Texas, 78217, United States
Unknown Facility
Spokane, Washington, 99204, United States
Unknown Facility
La Crosse, Wisconsin, 54601, United States
Unknown Facility
Penticton, British Columbia, V2A 3G8, Canada
Unknown Facility
Newmarket, Ontario, L3Y 3R7, Canada
Unknown Facility
Toronto, Ontario, M5T 2S8, Canada
Unknown Facility
Montreal, Quebec, H2L 1S6, Canada
Unknown Facility
Trois-Rivières, Quebec, G8Z 1Y2, Canada
Unknown Facility
Saskatoon, Saskatchewan, S7K 0H6, Canada
Unknown Facility
Québec, G1W 4R4, Canada
Unknown Facility
Békéscsaba, 5600, Hungary
Unknown Facility
Budapest, 1027, Hungary
Unknown Facility
Veszprém, 8200, Hungary
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Brescia, 25100, Italy
Unknown Facility
Genova, 16132, Italy
Unknown Facility
Pavia, 27100, Italy
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Roma, 00100, Italy
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Siena, 53100, Italy
Unknown Facility
Jalisco, Guadalajara, 44620, Mexico
Unknown Facility
Delegacion Cuahutemoc, 06700, Mexico
Unknown Facility
Andalucia, Andalusia, 41013, Spain
Unknown Facility
Castilla La Mancha, 19002, Spain
Unknown Facility
Comunidad Valenciana, 46017, Spain
Unknown Facility
Madrid, 28040, Spain
Related Publications (1)
Roman-Blas JA, Castaneda S, Cutolo M, Herrero-Beaumont G. Efficacy and safety of a selective estrogen receptor beta 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.
PMID: 20556817DERIVED
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 South Africa, please contact ZAFinfo@wyeth.com
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2005
First Posted
September 1, 2005
Study Start
August 1, 2005
Primary Completion
October 19, 2006
Study Completion
October 19, 2006
Last Updated
September 29, 2020
Record last verified: 2020-09