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

NCT00537290 | Completed Phase 2 Results DMC

• 1 other identifier: IRB 27022
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Antiphospholipid Syndrome

Keywords

antiphospholipid syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The Efficacy of Rituximab

  24 weeks

Study Arms (1)

Rituximab

EXPERIMENTAL

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

Drug: Rituximab

Interventions

Rituximab DRUG

Rituximab 1000mg IV on Days 0 and 15

Also known as: Rituxan

Rituximab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

You may not qualify if:

• \> 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

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead
• Genentech, Inc.: collaborator

Study Sites (1)

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

New York, New York, 10021, United States

Location

Related Publications (2)

• 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.

  PMID: 23124321 RESULT

• 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.

  PMID: 22269862 DERIVED

Related Links

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

MeSH Terms

Conditions

Antiphospholipid Syndrome

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Doruk Erkan, MD
• Organization: Hospital for Special Surgery

erkand@hss.edu

212 774-2291

Study Officials

• Doruk Erkan, MD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2007
• First Posted: October 1, 2007
• Study Start: September 1, 2007
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: October 31, 2017
• Results First Posted: October 31, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)