EVALUATION OF CLINICAL RESPONSE TO RITUXIMAB TREATMENT IN PATIENTS WITH ACQUIRED AUTOIMMUNE RECURRENT THROMBOTIC THROMBOCYTOPENIC PURPURA (TTP) - RITUXIMAB IN RECURRENT TTP
- Conditions
- THROMBOTIC THROMBOCYTOPENIC PURPURAMedDRA version: 9.1Level: LLTClassification code 10037562
- Registration Number
- EUCTR2010-018794-38-IT
- Lead Sponsor
- FONDAZIONE IRCCS CA` GRANDA OSPEDALE MAGGIORE POLICLINICO DI MILANO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
-DIAGNOSIS OF ACQUIRED AUTOIMMUNE RECURRENT TTP
-AGE >18 YEARS
-CLINICAL REMISSION AT THE TIME OF ENROLMENT
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
-PREGNANCY
-ONGOING INFECTION
-SEVERE CARDIAC DISEASE
-HISTORY OF HYPERSENSITIVITY TO RITUXIMAB
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: PREVENTION OF DISEASE RECURRENCES;Secondary Objective: -INHIBITION OF ANTI-ADAMTS13 AUTOANTIBODIES <br>-CORRELATION OF ADAMTS13 ACTIVITY WITH CLINICAL RESPONSE<br>-CORRELATION OF LYMPHOCYTE DEPLETION AND CLINICAL RESPONSE;Primary end point(s): RECURRENCE RATE AT THREE YEARS
- Secondary Outcome Measures
Name Time Method