A Pilot Study of Rituximab for the Anticoagulation Resistant Manifestations of Antiphospholipid Syndrome (RITAPS)
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Pilot Study of Rituximab for the Anticoagulation Resistant Manifestations of Antiphospholipid Syndrome (RITAPS)|
- Safety [ Time Frame: 1 year ]
- aPL profile and non-criteria aPL manifestations [ Time Frame: 6-12 months ]
|Study Start Date:||September 2007|
|Study Completion Date:||January 2013|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
All patients will receive 1000 milligrams of rituximab by intravenous infusion on Days 1 and 15.
Rituximab 1000mg IV on Days 0 and 15
Other Name: Rituxan
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00537290
|United States, New York|
|Barbara Volcker Center for Women and Rheumatic Disease, Hospital for Special Surgery|
|New York, New York, United States, 10021|
|Principal Investigator:||Doruk Erkan, MD||Hospital for Special Surgery, New York|