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

• Status: Completed
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital for Special Surgery, New York
• Collaborator: Genentech, Inc.
• Treatments: Rituximab

Criteria

Inclusion Criteria:

• - 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

• Concomitant malignancies or previous malignancies, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix

• History of psychiatric disorder that would interfere with normal participation in this protocol

• Significant cardiac or pulmonary disease