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
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • -ACR 20 response at Week 12

Secondary Outcome Measures:
  • Secondary efficacy measures include ACR 50 and ACR 70 response.

Enrollment: 159
Study Start Date: August 2005
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00141830

  Hide Study Locations
Locations
United States, Florida
Largo, Florida, United States, 33773
Palm Harbor, Florida, United States, 34684
Sarasota, Florida, United States, 34239
United States, Idaho
Boise, Idaho, United States, 83702
United States, Kansas
Kansas City, Kansas, United States, 66160
United States, Maryland
Frederick, Maryland, United States, 21702
United States, New Mexico
Albuquerque, New Mexico, United States, 87131
United States, North Carolina
Charlotte, North Carolina, United States, 28210
United States, Pennsylvania
Duncansville, Pennsylvania, United States, 16635-0909
United States, Texas
Austin, Texas, United States, 78705
Dallas, Texas, United States, 75231
San Antonio, Texas, United States, 78217
United States, Washington
Spokane, Washington, United States, 99204
United States, Wisconsin
La Crosse, Wisconsin, United States, 54601
Canada, British Columbia
Penticton, British Columbia, Canada, V2A 3G8
Canada, Ontario
Newmarket, Ontario, Canada, L3Y 3R7
Toronto, Ontario, Canada, M5T 2S8
Canada, Quebec
Montréal, Quebec, Canada, H2L 1S6
Trois-Rivières, Quebec, Canada, G8Z 1Y2
Canada, Saskatchewan
Saskatoon, Saskatchewan, Canada, S7K 0H6
Canada
Quebec, Canada, G1W 4R4
Hungary
Budapest, Hungary, 1027
Békéscsaba, Hungary, 5600
Veszprém, Hungary, 8200
Italy
Brescia, Italy, 25100
Genova, Italy, 16132
Pavia, Italy, 27100
Roma, Italy, 00100
Siena, Italy, 53100
Mexico
Jalisco, Guadalajara, Mexico, 44620
Delegacion Cuahutemoc, Mexico, 06700
Spain
Andalucia, Spain, 41013
Castilla la Mancha, Spain, 19002
Comunidad Valenciana, Spain, 46017
Madrid, Spain, 28040
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
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
  More Information

No publications provided by Wyeth is now a wholly owned subsidiary of Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00141830     History of Changes
Other Study ID Numbers: 3142A1-202
Study First Received: August 30, 2005
Last Updated: September 15, 2009
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 Pública de Chile
Brazil: National Committee of Ethics in Research

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Rheumatoid Arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on July 23, 2014