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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00537290
First Posted: October 1, 2007
Last Update Posted: October 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Hospital for Special Surgery, New York
Results First Submitted: April 20, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Antiphospholipid Syndrome
Intervention: Drug: Rituximab

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients who were ≥18 years of age, did not have other systemic autoimmune diseases, and fulfilled at least one of the laboratory criteria and one of the clinical criteria were eligible for inclusion in the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Laboratory criteria defined as positive results of a LAC test, positive aCL IgG/IgM/IgA isotype (≥40), and/or positive anti-β2GPI IgG/IgM/IgA isotype (≥40) on 2 or more occasions, at least 12 weeks apart. Clinical criteria defined as 1)persistent thrombocytopenia 2)Cardiovascular disease 3)skin ulcer 4)aPL nephropathy 5) cognitive dysfunction.

Reporting Groups
  Description
Rituximab

All patients will receive 1000 milligrams of rituximab by intravenous infusion on Days 1 and 15.

Rituximab: Rituximab 1000mg IV on Days 0 and 15


Participant Flow:   Overall Study
    Rituximab
STARTED   19 
COMPLETED   19 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients included in the study

Reporting Groups
  Description
Rituximab

All patients will receive 1000 milligrams of rituximab by intravenous infusion on Days 1 and 15.

Rituximab: Rituximab 1000mg IV on Days 0 and 15


Baseline Measures
   Rituximab 
Overall Participants Analyzed 
[Units: Participants]
 19 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      19 100.0% 
>=65 years      0   0.0% 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 40.5  (13.8) 
[1] The mean age of the patients
Sex: Female, Male [1] 
[Units: Participants]
Count of Participants
 
Female      11  57.9% 
Male      8  42.1% 
[1] Gender distribution
Race (NIH/OMB) [1] 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      0   0.0% 
White      17  89.5% 
More than one race      0   0.0% 
Unknown or Not Reported      2  10.5% 
[1] Race distribution
Region of Enrollment [1] 
[Units: Participants]
Count of Participants
 
United States   19 
[1] Region of the patients


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants Experiencing Serious and Non Serious Adverse Events   [ Time Frame: 52 weeks + additional 4 months if needed ]

2.  Secondary:   The Efficacy of Rituximab   [ Time Frame: 24 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Doruk Erkan, MD
Organization: Hospital for Special Surgery
phone: 212 774-2291
e-mail: erkand@hss.edu


Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT00537290     History of Changes
Other Study ID Numbers: IRB 27022
First Submitted: September 28, 2007
First Posted: October 1, 2007
Results First Submitted: April 20, 2017
Results First Posted: October 31, 2017
Last Update Posted: October 31, 2017