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

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

MedlinePlus related topics:

Rheumatoid Arthritis

ChemIDplus related topics:

Methotrexate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), 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

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 ]

Estimated Enrollment:	216
Study Start Date:	March 2008
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	June 2011 (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

Contacts


Contact: Trial Manager		clintrialparticipation@wyeth.com

Show 30 Study Locations

Sponsors and Collaborators

Wyeth

Trubion Pharmaceuticals

Investigators


Study Director:	Medical Monitor	Wyeth

More Information

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3206K1-2203
First Received:	March 5, 2008
Last Updated:	August 7, 2008
ClinicalTrials.gov Identifier:	NCT00634933
Health Authority:	United States: Food and Drug Administration