Clinical Trial: A Pilot Study of Rituximab for the Anticoagulation Resistant Manifestations of Antiphospholipid Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Pilot Study of Rituximab for the Anticoagulation Resistant Manifestations of Antiphospholipid Syndrome (RITAPS)

Brief Summary: RITuximab AntiphosPholipid Syndrome (RITAPS) Study is designed to evaluate whether a medication called rituximab would reduce the signs and symptoms of antiphospholipid antibody (aPL) -related certain clinical problems.

Detailed 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.

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; and/or memory problems.

Sponsor: Hospital for Special Surgery, New York

Current Primary Outcome: Safety [ Time Frame: 1 year ]

Original Primary Outcome:

Current Secondary Outcome: aPL profile and non-criteria aPL manifestations [ Time Frame: 6-12 months ]

Original Secondary Outcome:

Information By: Hospital for Special Surgery, New York

Dates:
Date Received: September 28, 2007
Date Started: September 2007
Date Completion:
Last Updated: March 23, 2017
Last Verified: March 2017