Study Evaluating ERB-041 With Methotrexate in Rheumatoid Arthritis

Back to Search
Print
Bookmark Trial

NCT00141830

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
Study Location
Largo, Florida, 33773, United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links

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

By email

Contact

[email protected]

Call Now

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
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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

Call Now

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Advanced Search

Based on your search, you may also be interested in

Rheumatoid ArthritisStudy To Evaluate The Response To Enbrel And The Impact Of Rheumatoid Factor(RF) And Anti-Cyclic Citrullinated Peptide(Anti-CCP) In Rheumatoid Arthritis(RA) Patients
NCT04428424
  1. Baghdad,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Rheumatoid ArthritisTO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF-06651600, AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE
NCT04413617
  1. Winnipeg, Manitoba
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Rheumatoid ArthritisStudy Evaluating ERB-041 With Methotrexate in Rheumatoid Arthritis
NCT00141830
  1. Largo, Florida
  2. Palm Harbor, Florida
  3. Sarasota, Florida
  4. Boise, Idaho
  5. Kansas City, Kansas
  6. Frederick, Maryland
  7. Albuquerque, New Mexico
  8. Charlotte, North Carolina
  9. Duncansville, Pennsylvania
  10. Austin, Texas
  11. Dallas, Texas
  12. San Antonio, Texas
  13. Spokane, Washington
  14. La Crosse, Wisconsin
  15. Penticton, British Columbia
  16. Newmarket, Ontario
  17. Toronto, Ontario
  18. Montréal, Quebec
  19. Trois-Rivières, Quebec
  20. Saskatoon, Saskatchewan
  21. Quebec,
  22. Budapest,
  23. Békéscsaba,
  24. Veszprém,
  25. Brescia,
  26. Genova,
  27. Pavia,
  28. Roma,
  29. Siena,
  30. Jalisco, Guadalajara
  31. Delegacion Cuahutemoc,
  32. Andalucia,
  33. Castilla la Mancha,
  34. Comunidad Valenciana,
  35. Madrid,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Rheumatoid ArthritisStudy Of The Effects Of Atorvastatin On Cholesterol Levels In Rheumatoid Arthritis Patients Taking CP-690,550
NCT01059864
  1. Birmingham, Alabama
  2. Huntsville, Alabama
  3. Gilbert, Arizona
  4. Scottsdale, Arizona
  5. Upland, California
  6. Jacksonville, Florida
  7. Dayton, Ohio
  8. Mayfield Village, Ohio
  9. Greenville, South Carolina
  10. Allen, Texas
  11. Seoul,
  12. Seoul,
  13. Seoul,
  14. Seoul,
  15. Seoul,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
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
  • Drug: Methotrexate plus ERB-041 for 12 weeks
  • Drug: Placebo for 12 weeks
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
 (submitted: September 15, 2009)		159
Original Enrollment  ICMJE
 (submitted: August 30, 2005)		260
Actual Study Completion Date  ICMJE August 2008
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator:Trial ManagerFor South Africa, please contact [email protected]
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date September 2009

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