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

This study has been completed.
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
Doruk Erkan, Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier:
NCT00537290
First received: September 28, 2007
Last updated: April 4, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Antiphospholipid Syndrome
Drug: Rituximab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of Rituximab for the Anticoagulation Resistant Manifestations of Antiphospholipid Syndrome (RITAPS)

Resource links provided by NLM:


Further study details as provided by Hospital for Special Surgery, New York:

Primary Outcome Measures:
  • Safety [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • aPL profile and non-criteria aPL manifestations [ Time Frame: 6-12 months ] [ Designated as safety issue: No ]

Enrollment: 19
Study Start Date: September 2007
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Rituximab
    Rituximab 1000mg IV on Days 0 and 15
    Other Name: Rituxan
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00537290

Locations
United States, New York
Barbara Volcker Center for Women and Rheumatic Disease, Hospital for Special Surgery
New York, New York, United States, 10021
Sponsors and Collaborators
Hospital for Special Surgery, New York
Genentech
Investigators
Principal Investigator: Doruk Erkan, MD Hospital for Special Surgery, New York
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Doruk Erkan, Principal Investigator, Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT00537290     History of Changes
Other Study ID Numbers: IRB 27022
Study First Received: September 28, 2007
Last Updated: April 4, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Hospital for Special Surgery, New York:
antiphospholipid syndrome

Additional relevant MeSH terms:
Antiphospholipid Syndrome
Autoimmune Diseases
Immune System Diseases
Rituximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 17, 2014