(Roche WA 180062) 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)

Institutional Review Board, Hospital for Special Surgery

April 17, 2006

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.

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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 anti-rheumatic therapies, including MTX and who have had an inadequate clinical response or were intolerant to treatment with one or more anti-TNF therapies (Enbrel, Remicade or Humiara).

The study is a double-blind study of a monthly infusion of MRA or placebo.  After 16 weeks of treatment there is escape therapy provided to patients who have not achieved 20% improvement in RA symptoms. A 5 year open-label protocol will be provided to patients who have completed the 24 weeks of treatment.

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

Inclusion/Exclusion Criteria

• Age 18 and older Must be taking MTX 10-25 mg/wk for 12 weeks prior to receiving the 1st infusion (baseline visit). Must discontinue all other Disease Modifying Anti Rheumatic Drugs (DMARDs) prior to receiving the 1st infusion (baseline visit) except MTX
• 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 had an inadequate response to anti-TNF treatment within 1 year prior to the 1st infusion (baseline visit) of 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