(Roche WA 180063) A Randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with Myeloma Receptor Antagonist (MRA)

The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.

Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.

For further information, see Understanding Clinical Trials.

Principal Investigator

Joseph Markenson, MD

Summary

This is a 6 month study for patients diagnosed with RA for at least 6 months duration who currently have an inadequate clinical response to current DMARDs (Enbrel, Remicade or Humiara.)

For patients completing 24 weeks of treatment, they will have the option to enter an open-label extension for 5 years.

Number of patients to enroll:  8
Enrollment period: July 2005-July 2006

Inclusion/Exclusion Criteria

• Age 18 and older
• Must be taking stable DMARDs for 8 weeks prior to study entry.
• May be taking non-steroidal, anti-inflammatory medications (NSAIDs) and/or < 10 mg of prednisone or equivalent. Dose must be stable for at least 6 weeks prior to the 1st infusion (baseline visit). 
• Must have never had any anti-Tumor Necrosing Factor (TNF) therapy (Enbrel, Remicade or Humiara.).

Contact Information

Eileen McCullagh RN, ONC, CCRC
CRC Manager
212-774-7381

Peggy O’Donohue, RN, CCRC
Clinical Research Coordinator
212-774-2271

posted 4/17/2006