Research

RITAPS: A Pilot Study Of Rituximab For The Anticoagulation-Resistant Manifestations Of Antiphospholipid Syndrome (APS)

IRB Number: 27022
(inactive trial)

Institutional Review Board, Hospital for Special Surgery

July 18, 2007

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

Doruk Erkan, MD

Co-Investigators

Michael D. Lockshin, MD

Summary

Persistently antiphospholipid antibody (aPL)-positive patients, age 18 - 75 years of age, with anticoagulation-resistant manifestations of APS and fulfilling protocol defined study inclusion criteria will receive two doses of Rituximab, and will be followed for 6 and 12 months for clinical and safety outcomes, respectively.

Inclusion/Exclusion Criteria

Patients are eligible to take part in this study if their blood test is persistently positive for aPL and they have one or more of the aPL-related clinical problem(s) listed  below:

  • Low Platelet (blood cells involved in the prevention of bleeding) Count
  • Anemia (deficiency of red blood cells)
  • Heart Valve Disease
  • Skin Ulcers
  • Kidney Smal Vessel Blood Clots
  • Memory Problems

Contact Information

Joann Vega
Clinical Research Coordinator
Division of Rheumatology
Hospital for Special Surgery
535 East 70th Street, New York, NY 10021
Tel: 212.774.2795
Fax: 212.774.7298
vegaj@hss.edu



Request an Appointment