Study Evaluating ERB-041 With Methotrexate in Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00141830
First received: August 30, 2005
Last updated: September 15, 2009
Last verified: September 2009

August 30, 2005
September 15, 2009
August 2005
August 2008   (final data collection date for primary outcome measure)
-ACR 20 response at Week 12
Same as current
Complete list of historical versions of study NCT00141830 on ClinicalTrials.gov Archive Site
Secondary efficacy measures include ACR 50 and ACR 70 response.
Same as current
Not Provided
Not Provided
 
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

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).

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Rheumatoid Arthritis
  • Drug: Methotrexate plus ERB-041 for 12 weeks
  • Drug: Placebo for 12 weeks
Not Provided
Roman-Blas JA, Castañeda S, Cutolo M, Herrero-Beaumont G. Efficacy and safety of a selective estrogen receptor β 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.
 
Completed
159
August 2008
August 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Hungary,   Italy,   Mexico,   Spain
 
NCT00141830
3142A1-202
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
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
Wyeth is now a wholly owned subsidiary of Pfizer
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP