Study Evaluating TMI-005 in Active Rheumatoid Arthritis

September 8, 2009 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

390

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H2L 1S6
      • Ste-Foy, Quebec, Canada, G1W 4R4
      • Trois-Rivieres, Quebec, Canada, G8Z 1Y2
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7K 0H6
  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46250
    • New York
      • Syracuse, New York, United States, 13210
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
      • West Reading, Pennsylvania, United States, 19611

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (Actual)

August 1, 2005

Study Completion (Actual)

August 1, 2005

Study Registration Dates

First Submitted

November 2, 2004

First Submitted That Met QC Criteria

November 2, 2004

First Posted (Estimate)

November 3, 2004

Study Record Updates

Last Update Posted (Estimate)

September 10, 2009

Last Update Submitted That Met QC Criteria

September 8, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3140A1-200

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rheumatoid Arthritis

Clinical Trials on TMI-005

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jordan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe