Effect of SAR153191 (REGN88) With Methotrexate in Patients With Active Rheumatoid Arthritis Who Failed TNF-Î± Blockers

Status:	Archived
Conditions:	Arthritis, Rheumatoid Arthritis
Therapuetic Areas:	Rheumatology
Healthy:	No
Age Range:	Any
Updated:	7/1/2011
Start Date:	November 2010
End Date:	February 2012

A Randomized, Double-blind, Parallel-group, Placebo- and Active Calibrator-controlled Study Assessing the Clinical Benefit of SAR153191 Subcutaneous (SC) on Top of Methotrexate (MTX) in Patients With Active Rheumatoid Arthritis (RA) Who Have Failed Previous TNF-Î± Antagonists

Primary Objective:

- Demonstrate that SAR153191 on top of Methotrexate is superior in efficacy to Placebo for
the relief of signs and symptoms of Rheumatoid Arthritis (RA), in patients with active RA
who have failed up to 2 Tumor Necrosis Factor Î± (TNF-Î±) antagonists

Secondary Objectives:

- Assess the safety of SAR153191

- Document drug levels (pharmacokinetics) of SAR153191

- Define the relationship between SAR153191 drug exposures and selected serum proteins
(biomarkers) related to inflammation and SAR153191 drug activity

- Collect pharmacogenetic samples from blood and urine to predict effectiveness of
SAR153191

Total duration of study per patient is 13 - 22 weeks broken dow as follows:

- Screening: 1 - 4 weeks

- Treatment: 12 weeks

- Follow-up: 6 weeks post-treatment (for patients who will not continue in long term
extension study)

We found this trial at

sites

Clinical Trial Facility in Orlando Florida

Orlando, Florida 32806

from

Orlando, FL