Study Evaluating ERB-041 With Methotrexate in Rheumatoid Arthritis - Full Text View

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

Drug Information available for: Methotrexate

U.S. FDA Resources

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 as provided by Wyeth:

Primary Outcome Measures:

-ACR 20 response at Week 12

Secondary Outcome Measures:

Secondary efficacy measures include ACR 50 and ACR 70 response.

Estimated Enrollment:	260
Study Start Date:	August 2005

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

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

Show 35 Study Locations

Sponsors and Collaborators

Wyeth

Investigators

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

More Information

Study ID Numbers:	3142A1-202
Study First Received:	August 30, 2005
Last Updated:	February 26, 2007
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: National Committee of Ethics in Research

Keywords provided by Wyeth:

Rheumatoid Arthritis

Study placed in the following topic categories:

Folic Acid
Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis

Connective Tissue Diseases
Arthritis, Rheumatoid
Methotrexate
Rheumatic Diseases

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Immunologic Factors
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Reproductive Control Agents

Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal
Immunosuppressive Agents
Pharmacologic Actions
Therapeutic Uses
Abortifacient Agents
Antirheumatic Agents
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 13, 2009