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

NCT ID: NCT00537290

Last Updated: 2017-10-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2013-01-31

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 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.

Conditions

Antiphospholipid Syndrome

Keywords

antiphospholipid syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rituximab

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

Group Type: EXPERIMENTAL

Rituximab

Intervention Type: DRUG

Rituximab 1000mg IV on Days 0 and 15

Interventions

Rituximab

Rituximab 1000mg IV on Days 0 and 15

Intervention Type: DRUG

Other Intervention Names

Rituxan

Eligibility 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

• > 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Hospital for Special Surgery, New York

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Doruk Erkan, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital for Special Surgery, New York

Locations

Barbara Volcker Center for Women and Rheumatic Disease, Hospital for Special Surgery

New York, New York, United States

Countries

United States

References

Erkan D, Vega J, Ramon G, Kozora E, Lockshin MD. A pilot open-label phase II trial of rituximab for non-criteria manifestations of antiphospholipid syndrome. Arthritis Rheum. 2013 Feb;65(2):464-71. doi: 10.1002/art.37759.

Reference Type: RESULT

PMID: 23124321 (View on PubMed)

Khattri S, Zandman-Goddard G, Peeva E. B-cell directed therapies in antiphospholipid antibody syndrome--new directions based on murine and human data. Autoimmun Rev. 2012 Aug;11(10):717-22. doi: 10.1016/j.autrev.2011.12.011. Epub 2012 Jan 16.

Reference Type: DERIVED

PMID: 22269862 (View on PubMed)

Related Links

http://www.hss.edu/clinical-trials-directory.asp

Hospital for Special Surgery Clinical Trials List

http://www.hss.edu/barbara-volcker.asp

Barbara Volcker Center for Women and Rheumatic Disease

Other Identifiers

IRB 27022

Identifier Type: -

Identifier Source: org_study_id