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

Antiphospholipid Syndrome Clinical Trial

— RITAPS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00537290
• Other study ID #: IRB 27022
• Status: Completed
• Phase: Phase 2
• First received: September 28, 2007
• Last updated: October 2, 2017
• Start date: September 2007
• Est. completion date: January 2013

Study information

• Verified date: October 2017
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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-ß2-glycoprotein-I (aß2GPI) 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

Related Conditions & MeSH terms

• Antiphospholipid Syndrome
• Syndrome

Intervention

Drug:
• Rituximab
Rituximab 1000mg IV on Days 0 and 15

Locations

Country	Name	City	State
United States	Barbara Volcker Center for Women and Rheumatic Disease, Hospital for Special Surgery	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York	Genentech, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Erkan D, Vega J, Ramón 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Experiencing Serious and Non Serious Adverse Events	Serious and non-serious adverse events were evaluated throughout 52 weeks + additional 4 months for the patients with low B cell counts.	52 weeks + additional 4 months if needed
Secondary	The Efficacy of Rituximab	Outcome measures scored as complete response(CR),partial(PR),and none(NR) at 24 weeks.For thrombocytopenia,CR defined as a platelet count of =150×109/µl,PR as 100-149,and NR as <100.For CVD,CR defined as the disappearance of cardiac lesions,PR as 50%improvement,and NR as no change.For skin ulcer,CR defined as disappearance,PR as 50% improvement,and NR as no change.For aPL nephropathy,CR defined as a normal serum creatinine level,inactive urinary sediment,and urinary protein:creatinine 0.5;PR as a serum cr level 15%above baseline,RBCs per high-power field 50%above baseline with no casts,50%improvement in the urinary prt:cr,and estimated GFR 10%above baseline;and NR as the absence of C/PR.For cognitive dysfunction,CR defined as normalization of the cognitive impairment index with 50%improvement,PR as abnormal index with 50%,and NR as no change.	24 weeks

External Links

•   Barbara Volcker Center for Women and Rheumatic Disease
•   Hospital for Special Surgery Clinical Trials List