Study Evaluating 2 Dosing Regimens of TRU-015 in Rheumatoid Arthritis - Tabular View

Tracking Information

First Received Date ^ICMJE

March 5, 2008

Last Updated Date

October 14, 2009

Start Date ^ICMJE

March 2008

Estimated Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

American College of Rheumatology (ACR) 50 response [ Time Frame: at week 24 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00634933 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Secondary efficacy measures include ACR responses and DAS-28. MRI, cytokines and B cells subsets and pharmacogenomics substudies will be performed and reported. [ Time Frame: Week 24 through week 52 ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Study Evaluating 2 Dosing Regimens of TRU-015 in Rheumatoid Arthritis

Official Title ^ICMJE

A Randomized, Parallel, Double-Blind, Placebo-controlled, Dose Regimen Finding Study to Evaluate the Safety and Efficacy of TRU-015 in Subjects With Active Seropositive Rheumatoid Arthritis on a Background of Methotrexate

Brief Summary

This study will evaluate the efficacy and safety of two dosing regimens of a compound known as TRU-015 in combination with methotrexate (MTX) in patients with active rheumatoid arthritis.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Active Rheumatoid Arthritis

Intervention ^ICMJE

Drug: TRU-015
Other: Placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

235

Estimated Completion Date

October 2010

Estimated Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Clinical diagnosis of active seropositive rheumatoid arthritis on a stable dose of methotrexate (7.5-25 mg weekly) for at least 12 weeks with or without a history of anti-TNF use.

Exclusion Criteria:

Any prior use of rituximab or other B cell depleting agents.
Any significant health problem other than rheumatoid arthritis
Clinically significant laboratory abnormalities

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada

Administrative Information

NCT ID ^ICMJE

NCT00634933

Responsible Party

Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth

Study ID Numbers ^ICMJE

3206K1-2203

Study Sponsor ^ICMJE

Wyeth

Collaborators ^ICMJE

Trubion Pharmaceuticals

Investigators ^ICMJE

Study Director:

Medical Monitor

Wyeth

Information Provided By

Wyeth

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP