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

• Register: EUCTR
• Last refreshed on: 10 February 2014
• Main ID: EUCTR2010-018794-38-IT
• Date of registration: 26/07/2010
• Prospective Registration: No
• Primary sponsor: FONDAZIONE IRCCS CA` GRANDA OSPEDALE MAGGIORE POLICLINICO DI MILANO
• Public title: EVALUATION OF CLINICAL RESPONSE TO RITUXIMAB TREATMENT IN PATIENTS WITH ACQUIRED AUTOIMMUNE RECURRENT THROMBOTIC THROMBOCYTOPENIC PURPURA (TTP) - RITUXIMAB IN RECURRENT TTP
• Scientific title: EVALUATION OF CLINICAL RESPONSE TO RITUXIMAB TREATMENT IN PATIENTS WITH ACQUIRED AUTOIMMUNE RECURRENT THROMBOTIC THROMBOCYTOPENIC PURPURA (TTP) - RITUXIMAB IN RECURRENT TTP
• Date of first enrolment: 23/02/2010
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-018794-38
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: TERAPIA STANDARD

Countries of recruitment

Italy

Key inclusion & exclusion 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:
-PREGNANCY
-ONGOING INFECTION
-SEVERE CARDIAC DISEASE
-HISTORY OF HYPERSENSITIVITY TO RITUXIMAB


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

Intervention(s)

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

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

Primary Outcome(s)

Main Objective: PREVENTION OF DISEASE RECURRENCES

Primary end point(s): RECURRENCE RATE AT THREE YEARS

Secondary Objective: -INHIBITION OF ANTI-ADAMTS13 AUTOANTIBODIES
-CORRELATION OF ADAMTS13 ACTIVITY WITH CLINICAL RESPONSE
-CORRELATION OF LYMPHOCYTE DEPLETION AND CLINICAL RESPONSE

Secondary ID(s)

RTXTTP2010