Study Evaluating TMI-005 in Active Rheumatoid Arthritis

This study has been completed.

Sponsor:

Information provided by:

Wyeth is now a wholly owned subsidiary of Pfizer

ClinicalTrials.gov Identifier:

NCT00095342

First received: November 2, 2004

Last updated: September 8, 2009

Last verified: September 2009

History of Changes

Purpose

The primary objective of this clinical research study is to compare the efficacy and the safety of 3 dose levels of oral TMI-005 in comparison with placebo in subjects with active Rheumatoid Arthritis (RA) who have been receiving stable doses of Methotrexate (MTX).

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: TMI-005	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 Double-Blind, Placebo-Controlled, Parallel, Randomized Study to Evaluate the Efficacy and Safety of 3 Oral Dose Levels of TMI-005 in Subjects With Active Rheumatoid Arthritis on a Background of Methotrexate

Resource links provided by NLM:

Genetics Home Reference related topics: rheumatoid arthritis

MedlinePlus related topics: Arthritis Rheumatoid Arthritis

U.S. FDA Resources

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


Enrollment:	390
Study Completion Date:	August 2005
Primary Completion Date:	August 2005 (Final data collection date for primary outcome measure)

Eligibility


Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Meet American College of Rheumatology (ACR) criteria for RA
Have active RA
Disease duration of at least 6 months
Disease onset at > 16 years of age.

Exclusion Criteria:

Any prior use of anti-TNF alpha biologics, rituximab, receipt of anti-CD4 or diphtheria interleukin-2 fusion protein or other immunosuppressive biologics (except for anakinra)
Largely or wholly incapacitated with the subject bedridden or confined to a wheelchair, permitting limited or no self-care
Pregnant or breastfeeding women or women planning to become pregnant during the study or within 12 weeks after the last dose of test article

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: NCT00095342

Locations


United States, Indiana

Indianapolis, Indiana, United States, 46250
United States, New York

Syracuse, New York, United States, 13210
United States, Pennsylvania

Duncansville, Pennsylvania, United States, 16635

West Reading, Pennsylvania, United States, 19611
Canada, Quebec

Montreal, Quebec, Canada, H2L 1S6

Ste-Foy, Quebec, Canada, G1W 4R4

Trois-Rivieres, Quebec, Canada, G8Z 1Y2
Canada, Saskatchewan

Saskatoon, Saskatchewan, Canada, S7K 0H6

Sponsors and Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer

Investigators


Study Director:	Medical Monitor, MD	Wyeth is now a wholly owned subsidiary of Pfizer

More Information


ClinicalTrials.gov Identifier:	NCT00095342 History of Changes
Other Study ID Numbers:	3140A1-200
Study First Received:	November 2, 2004
Last Updated:	September 8, 2009
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases	Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases

ClinicalTrials.gov processed this record on September 30, 2016

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