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Completed

NCT Number: NCT00537290

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

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.

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Key information

Conditions

Antiphospholipid Syndrome Autoimmune Diseases Immune System Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

New York, 10021, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rituximab

Drug

Rituximab 1000mg IV on Days 0 and 15

Other names: Rituxan

Primary outcomes

  1. Number of Participants Experiencing Serious and Non Serious Adverse Events

    Time frame: 52 weeks + additional 4 months if needed

    Serious and non-serious adverse events were evaluated throughout 52 weeks + additional 4 months for the patients with low B cell counts.

Secondary outcomes

  1. The Efficacy of Rituximab

    Time frame: 24 weeks

    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.

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Collaborators

  • Genentech, Inc.

Registry information

Official study title

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

Acronym: RITAPS

Important dates

Study start
2007
Primary completion
2013
Study completion
2013
First posted
Oct 1, 2007
Registry last updated
Oct 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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