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

Hospital for Special Surgery (HSS)

Status and phase: Completed; Phase 2

Conditions: Antiphospholipid Syndrome

Treatments: Drug: Rituximab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00537290

IRB 27022

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 19 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

Rituximab

Experimental group

Description:

All patients will receive 1000 milligrams of rituximab by intravenous infusion on Days 1 and 15.

Treatment:

Drug: Rituximab