Study Evaluating ERB-041 With Methotrexate in Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00141830
Recruitment Status : Completed
First Posted : September 1, 2005
Last Update Posted : September 17, 2009
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

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).

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Methotrexate plus ERB-041 for 12 weeks Drug: Placebo for 12 weeks Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 159 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : August 2005
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. -ACR 20 response at Week 12

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00141830

  Hide Study 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
Quebec, Canada, G1W 4R4
Budapest, Hungary, 1027
Békéscsaba, Hungary, 5600
Veszprém, Hungary, 8200
Brescia, Italy, 25100
Genova, Italy, 16132
Pavia, Italy, 27100
Roma, Italy, 00100
Siena, Italy, 53100
Jalisco, Guadalajara, Mexico, 44620
Delegacion Cuahutemoc, Mexico, 06700
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
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For South Africa, please contact

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00141830     History of Changes
Other Study ID Numbers: 3142A1-202
First Posted: September 1, 2005    Key Record Dates
Last Update Posted: September 17, 2009
Last Verified: September 2009

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

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