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Study Evaluating ERB-041 with Methotrexate in Rheumatoid Arthritis - Article


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Methotrexate

Rheumatrex; Trexall


Clinical Trial: Study Evaluating ERB-041 with Methotrexate in Rheumatoid Arthritis

This study is currently recruiting patients.
Verified by Wyeth August 2005

Sponsored by: Wyeth
Information provided by: Wyeth
ClinicalTrials.gov Identifier: NCT00141830

Purpose

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).
Condition Intervention Phase
Rheumatoid Arthritis
  Drug: Methotrexate plus ERB-041 for 12 weeks
 Drug: Placebo for 12 weeks
 Phase II

MedlinePlus related topics:  Rheumatoid Arthritis

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title: 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

Further Study Details: 
Primary Outcomes: -ACR 20 response at Week 12
Secondary Outcomes: Secondary efficacy measures include ACR 50 and ACR 70 response.
Expected Total Enrollment:  260

Study start: August 2005

Eligibility

Ages Eligible for Study:  18 Years   -   80 Years,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

Exclusion Criteria:

  • Any significant health problem other than rheumatoid arthritis
  • History of male or female reproductive system cancer
  • Clinically significant laboratory abnormalities

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00141830

Trial Manager       clinicaltrialinfo@wyeth.com

Florida
      Largo,  Florida,  33773,  United States; Not yet recruiting
  see Central Contact 

      Sarasota,  Florida,  34239,  United States; Not yet recruiting
  see Central Contact 

      Palm Harbor,  Florida,  34684,  United States; Not yet recruiting
  see Central Contact 

      Largo,  Florida,  33773,  United States; Not yet recruiting
  see Central Contact 

      Palm Harbor,  Florida,  34684,  United States; Recruiting
  see Central Contact 

Idaho
      Boise,  Idaho,  83702,  United States; Not yet recruiting
  see Central Contact 

Kansas
      Kansas City,  Kansas,  66160,  United States; Not yet recruiting
  see Central Contact 

Maryland
      Frederick,  Maryland,  21702,  United States; Not yet recruiting
  see Central Contact 

New Mexico
      Albuquerque,  New Mexico,  87131,  United States; Not yet recruiting
  see Central Contact 

North Carolina
      Charlotte,  North Carolina,  28210,  United States; Not yet recruiting
  see Central Contact 

Pennsylvania
      Duncansville,  Pennsylvania,  16635-0909,  United States; Recruiting
  see Central Contact 

Texas
      Dallas,  Texas,  75231,  United States; Recruiting
  see Central Contact 

      San Antonio,  Texas,  78217,  United States; Not yet recruiting
  see Central Contact 

      Austin,  Texas,  78705,  United States; Recruiting
  see Central Contact 

Washington
      Spokane,  Washington,  99204,  United States; Not yet recruiting
  see Central Contact 

Wisconsin
      La Crosse,  Wisconsin,  54601,  United States; Not yet recruiting
  see Central Contact 

Canada
      Quebec,  G1W 4R4,  Canada; Not yet recruiting
  see Central Contact 

Canada, British Columbia
      Penticton,  British Columbia,  V2A 3G8,  Canada; Not yet recruiting
  see Central Contact 

Canada, Ontario
      Toronto,  Ontario,  M5T 2S8,  Canada; Not yet recruiting
  see Central Contact 

      Newmarket,  Ontario,  L3Y 3R7,  Canada; Not yet recruiting
  see Central Contact 

Canada, Quebec
      Montréal,  Quebec,  H2L 1S6,  Canada; Not yet recruiting
  see Central Contact 

      Trois-Rivières,  Quebec,  G8Z 1Y2,  Canada; Not yet recruiting
  see Central Contact 

Canada, Saskatchewan
      Saskatoon,  Saskatchewan,  S7K 0H6,  Canada; Not yet recruiting
  see Central Contact 

Hungary
      Budapest,  1027,  Hungary; Not yet recruiting
  see Central Contact 

      Békéscsaba,  5600,  Hungary; Not yet recruiting
  see Central Contact 

      Budapest,  1027,  Hungary; Not yet recruiting
  see Central Contact 

      Veszprém,  8200,  Hungary; Not yet recruiting
  see Central Contact 

Italy
      Roma,  00100,  Italy; Not yet recruiting
  see Central Contact 

      Pavia,  27100,  Italy; Not yet recruiting
  see Central Contact 

      Siena,  53100,  Italy; Not yet recruiting
  see Central Contact 

      Genova,  16132,  Italy; Not yet recruiting
  see Central Contact 

      Brescia,  25100,  Italy; Not yet recruiting
  see Central Contact 

Mexico
      Delegacion Cuahutemoc,  06700,  Mexico; Not yet recruiting
  see Central Contact 

Mexico, Guadalajara
      Jalisco,  Guadalajara,  44620,  Mexico; Not yet recruiting
  see Central Contact 

Spain
      Madrid,  28040,  Spain; Not yet recruiting
  see Central Contact 

      Castilla la Mancha,  19002,  Spain; Not yet recruiting
  see Central Contact 

      Comunidad Valenciana,  46017,  Spain; Not yet recruiting
  see Central Contact 

      Andalucia,  41013,  Spain; Not yet recruiting
  see Central Contact 

Study chairs or principal investigators

Medical Monitor,  Study Director,  Wyeth Research   
Trial Manager,  Principal Investigator,  For South Africa, please contact ZAFinfo@wyeth.com   

More Information

Study ID Numbers:  3142A1-202
Last Updated:  August 31, 2005
Record first received:  August 30, 2005
ClinicalTrials.gov Identifier:  NCT00141830
Health Authority: United States: Food and Drug Administration; Mexico: National Institute of Public Health, Health Secretariat; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Canada: Health Canada; Spain: Ministry of Health; Hungary: National Institute of Pharmacy; South Africa: Medicines Control Council; Italy: Ministry of Health; Chile: Instituto de Salud Publica de Chile; Brazil: Committee of Ethics in Research
ClinicalTrials.gov processed this record on 2005-09-06


Source: ClinicalTrials.gov
Cache Date: September 7, 2005

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Page Updated: October 1, 2005
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