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EVALUATION OF CLINICAL RESPONSE TO RITUXIMAB TREATMENT IN PATIENTS WITH ACQUIRED AUTOIMMUNE RECURRENT THROMBOTIC THROMBOCYTOPENIC PURPURA (TTP) - RITUXIMAB IN RECURRENT TTP

EVALUATION OF CLINICAL RESPONSE TO RITUXIMAB TREATMENT IN PATIENTS WITH ACQUIRED AUTOIMMUNE RECURRENT THROMBOTIC THROMBOCYTOPENIC PURPURA (TTP) - RITUXIMAB IN RECURRENT TTP

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2010-018794-38-IT
Enrollment
Unknown
Registered
2010-07-26
Start date
2010-02-23
Completion date
Unknown
Last updated
2014-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

THROMBOTIC THROMBOCYTOPENIC PURPURA MedDRA version: 9.1 Level: LLT Classification code 10037562

Interventions

Pharmaceutical Form: Concentrate for solution for injection Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- Trade Name: MABTHERA Pharmaceutical F

Sponsors

FONDAZIONE IRCCS CA` GRANDA OSPEDALE MAGGIORE POLICLINICO DI MILANO
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: -PREGNANCY -ONGOING INFECTION -SEVERE CARDIAC DISEASE -HISTORY OF HYPERSENSITIVITY TO RITUXIMAB

Design outcomes

Primary

MeasureTime frame
Main Objective: PREVENTION OF DISEASE RECURRENCES;Secondary Objective: -INHIBITION OF ANTI-ADAMTS13 AUTOANTIBODIES -CORRELATION OF ADAMTS13 ACTIVITY WITH CLINICAL RESPONSE -CORRELATION OF LYMPHOCYTE DEPLETION AND CLINICAL RESPONSE;Primary end point(s): RECURRENCE RATE AT THREE YEARS—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026