A Pilot Study of Rituximab for the Anticoagulation Resistant Manifestations of Antiphospholipid Syndrome
Completed · Phase 2
Conditions studied: Antiphospholipid Syndrome
In brief
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.
Key facts
- Study ID
- NCT00537290
- Run by
- Hospital for Special Surgery, New York
- People needed
- 19
- Starts
- 2007-09-01
- Expected to finish
- 2013-01-01
- Last updated by the study team
- 2017-10-31
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- - Positive aPL profile defined as:
- Positive lupus anticoagulant test as defined by the International Society on Thrombosis and Haemostasis, on two or more occasions, at least 12 weeks apart and/or
- Positive anticardiolipin antibody (aCL) immunoglobulin G(Ig)G/M/A isotype, present in > 40U, on two or more occasions, at least 12 weeks apart and/or
- Positive anti-β2-glycoprotein-I (aβ2GPI) IgG/M/A isotype, present in > 40U, on two or more occasions, at least 12 weeks apart
- AND
- Clinical features attributable to aPL that are resistant to warfarin and/or heparin:
- Persistent thrombocytopenia and/or
- Persistent autoimmune hemolytic anemia and/or
- Cardiac valve disease and/or
- Chronic skin ulcers and/or
- Renal thrombotic microangiopathy and/or
- Cognitive dysfunction with/without white matter changes
- Exclusion Criteria (selected):
- > 4/11 American College of Rheumatology Classification Criteria for SLE
- Acute thrombosis
- History of stroke (only for patients with cognitive dysfunction)
- Positive Hepatitis B or C serology
- History of positive HIV
- Acute or chronic pancreatitis
- Treatment with any investigational agent within 4 weeks of screening
- Receipt of a live vaccine within 4 weeks prior to randomization
- Previous Treatment with Rituximab (MabThera® / Rituxan®)
- Previous treatment with Natalizumab (Tysabri®)
- Known active bacterial, viral fungal mycobacterial, or other infection
- Pregnancy
Where it is running
- Barbara Volcker Center for Women and Rheumatic Disease, Hospital for Special Surgery — New York, New York, United States
Full record on ClinicalTrials.gov
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