Phase 2 N=19 Treatment

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

Antiphospholipid Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT00537290 ↗

Enrolled (actual)

Serious AEs

63.2%

Results posted

Oct 2017

Primary outcome: Primary: Number of Participants Experiencing Serious and Non Serious Adverse Events — 19 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Rituximab (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Hospital for Special Surgery, New York
Primary completion: Jan 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Experiencing Serious and Non Serious Adverse Events	19	—
SECONDARY The Efficacy of Rituximab	7; 4; 6; 2	—

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.

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 (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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00537290). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.