Study Evaluating CCI-779 in Active Rheumatoid Arthritis on Concomitant Methotrexate Therapy - Full Text View

Study Evaluating CCI-779 in Active Rheumatoid Arthritis on Concomitant Methotrexate Therapy

This study has been terminated.

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00076206

Purpose

The primary objective of this study is to compare the therapeutic response and safety of 3 oral dose levels of CCI-779, with placebo in subjects with active rheumatoid arthritis (RA) who have been receiving stable doses of methotrexate (MTX) for at least 8 weeks.

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: CCI-779	Phase II

MedlinePlus related topics:

Rheumatoid Arthritis

Drug Information available for:

Methotrexate CCI 779

U.S. FDA Resources

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

Official Title:	A Double-Blind, Parallel, Placebo-Controlled, Randomized Study to Evaluate the Efficacy and Safety of 3 Different Oral Dose Levels (1, 2, And 4 Mg) of CCI-779 in Subjects With Active Rheumatoid Arthritis on Concomitant Methotrexate Therapy

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Meet American College of Rheumatology (ACR) criteria for RA
Have active RA consisting of ≥ 6 swollen and ≥ 6 painful joints
ACR functional class I-III

Exclusion Criteria

At screening the subject’s prior medications are reviewed. (Prior history of disease-modifying antirheumatic drug (DMARD) use is recorded, including the start and stop dates of the most recently taken DMARDs)
Significant concurrent medical diseases
Abnormal chest radiograph, including findings consistent with interstitial pneumonitis, granulomatous disease, or pleural effusion and/or infiltration

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00076206

Sponsors and Collaborators

Wyeth

Investigators


Study Director:	Medical Monitor, MD	Wyeth

More Information

Study ID Numbers:	3066A3-206
First Received:	January 15, 2004
Last Updated:	May 17, 2006
ClinicalTrials.gov Identifier:	NCT00076206
Health Authority:	United States: Food and Drug Administration

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 November 19, 2008