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

This study is ongoing, but not recruiting participants.

First Received: March 5, 2008 Last Updated: October 14, 2009 History of Changes

Sponsor:	Wyeth
Collaborator:	Trubion Pharmaceuticals
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00634933

Purpose

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.

Condition	Intervention	Phase
Active Rheumatoid Arthritis	Drug: TRU-015 Other: Placebo	Phase II

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

Resource links provided by NLM:

MedlinePlus related topics: Rheumatoid Arthritis

U.S. FDA Resources

Further study details as provided by Wyeth:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Enrollment:	235
Study Start Date:	March 2008
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental	Drug: TRU-015
Arm 2: Experimental	Drug: TRU-015
Arm 3: Placebo Comparator	Other: Placebo

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00634933

Show 40 Study Locations

Sponsors and Collaborators

Wyeth

Trubion Pharmaceuticals

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3206K1-2203
Study First Received:	March 5, 2008
Last Updated:	October 14, 2009
ClinicalTrials.gov Identifier:	NCT00634933 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

Rheumatoid arthritis
anti CD20

Additional relevant MeSH terms:

Autoimmune Diseases
Immune System Diseases
Musculoskeletal Diseases
Joint Diseases

Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 30, 2009