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: February 3, 2013

Last verified: February 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

September 28, 2007

Last Updated Date

February 3, 2013

Start Date ^ICMJE

September 2007

Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Safety [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00537290 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Not Provided

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Antiphospholipid Syndrome

Intervention ^ICMJE

Drug: Rituximab

Rituximab 1000mg IV on Days 0 and 15

Study Arm (s)

Not Provided

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 2013

Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00537290

Other Study ID Numbers ^ICMJE

IRB 27022

Has Data Monitoring Committee

Yes

Responsible Party

Doruk Erkan, Hospital for Special Surgery, New York

Study Sponsor ^ICMJE

Hospital for Special Surgery, New York

Collaborators ^ICMJE

Genentech

Investigators ^ICMJE

Principal Investigator:

Doruk Erkan, MD

Hospital for Special Surgery, New York

Information Provided By

Hospital for Special Surgery, New York

Verification Date

February 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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