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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	EUCTR
Last refreshed on:	2 October 2017
Main ID:	EUCTR2008-005773-35-IT
Date of registration:	15/01/2013
Prospective Registration:	Yes
Primary sponsor:	AZIENDA OSPEDALIERA DI PADOVA
Public title:	AUTOLOUGUS STEM CELLS TRANSPLANTATION AFTER LINFOCYTE DEPLETION AS A NEW THERAPY FOR THE AGGRESSIVE AND DRUG RESISTANT FORMS OF MULTIPLE SLEROSIS IN THE ADULTS AND CHILDREN. - AUTOLOUGUS STEM CELLS TRANSPLANTATION IN SM
Scientific title:	AUTOLOUGUS STEM CELLS TRANSPLANTATION AFTER LINFOCYTE DEPLETION AS A NEW THERAPY FOR THE AGGRESSIVE AND DRUG RESISTANT FORMS OF MULTIPLE SLEROSIS IN THE ADULTS AND CHILDREN. - AUTOLOUGUS STEM CELLS TRANSPLANTATION IN SM
Date of first enrolment:
Target sample size:
Recruitment status:	NA
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-005773-35
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: Placebo: Other: Number of treatment arms in the trial: 1
Phase:	Human pharmacology (Phase I): yes Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment
Italy

Contacts

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Affiliation:

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Key inclusion & exclusion criteria

Inclusion criteria:
AGE: 12-40 YY
DIAGNOSIS OF MULTIPLE SCLEROSIS ACCORDING TO INTERNATIONAL CRITERIA
EDSS: 3-5.5
RAPID PROGRESSION, CLINICAL AND NEURORADIOLOGICAL, OF THE DISEASE IN THE PREVIOUS YEAR, DESPITE AT LEAST 6 MONTHS OF CONVENTIONAL THERAPIES
Are the trial subjects under 18? yes
Number of subjects for this age range: 0
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:
PRIMARY AND SECONDARY PROGRESSIVE MS
RECENT RELAPSE (WITHIN 30 DAYS)
ONGOING IMMUNOMODULATORY TREATMENT
IMMUNOSUPPRESSIVE THERAPY IN THE PREVIOUS 2 MONTHS
OTHER SYSTEMIC OR INFECTIOUS DISEASES
SEVERE MENTAL DISEASES
PREGNANCY AND BREAST-FEEDING

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

Health Condition(s) or Problem(s) studied

MULTIPLE SCLEROSIS
MedDRA version: 15.1 Level: LLT Classification code 10028053 Term: MS System Organ Class: 100000004852

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Intervention(s)

Trade Name: ENDOXAN BAXTER
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Cyclophosphamide
Concentration unit: mg/kg milligram(s)/kilogram
Concentration number: 40-

Trade Name: FLUDARA
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Fludarabine
Concentration unit: mg/m2 milligram(s)/square meter
Concentration number: 30-

Trade Name: THYMOGLOBULINE
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: Antithymocyte immunoglobulin (rabbit)
Concentration unit: mg/kg milligram(s)/kilogram
Concentration number: 2.5-

Trade Name: MABTHERA
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Rituximab
Concentration unit: mg/m2 milligram(s)/square meter
Concentration number: 375.5-

Primary Outcome(s)

Main Objective: SAFETY AND EFFICACY OF THE TREATMENT

Primary end point(s): SAFETY AND EFFICACY OF THE TREATMENT

Secondary Objective: NEW CLINICAL, IMAGING AND IMMUNOPATHOLOGICAL INFORMATION OF DESEASE.

Secondary Outcome(s)

Secondary ID(s)

2008-005773-35

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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