A Pilot Study of Rituximab for the Anticoagulation Resistant Manifestations of Antiphospholipid Syndrome (RITAPS)
|ClinicalTrials.gov Identifier: NCT00537290|
Recruitment Status : Completed
First Posted : October 1, 2007
Results First Posted : October 31, 2017
Last Update Posted : October 31, 2017
|Condition or disease||Intervention/treatment||Phase|
|Antiphospholipid Syndrome||Drug: Rituximab||Phase 2|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Rituximab for the Anticoagulation Resistant Manifestations of Antiphospholipid Syndrome (RITAPS)|
|Study Start Date :||September 2007|
|Primary Completion Date :||January 2013|
|Study Completion Date :||January 2013|
All patients will receive 1000 milligrams of rituximab by intravenous infusion on Days 1 and 15.
Rituximab 1000mg IV on Days 0 and 15
Other Name: Rituxan
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00537290
|United States, New York|
|Barbara Volcker Center for Women and Rheumatic Disease, Hospital for Special Surgery|
|New York, New York, United States, 10021|
|Principal Investigator:||Doruk Erkan, MD||Hospital for Special Surgery, New York|