World Health Organization site
Skip Navigation Links

Main
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: 21 October 2013
Main ID:  EUCTR2010-023560-40-SE
Date of registration: 21/12/2010
Prospective Registration: Yes
Primary sponsor: Uppsala l?ns landsting
Public title: Blood stem cell transplantation for patients with relapsiong-remitting multiple sclerosis, in whom standard treatment has failed.
Scientific title: Haematopoetic Stem Cell Therapy for Patients with Inflammatory Multiple Sclerosis Failing Alternate Approved Therapy: A Randomized Study - MIST
Date of first enrolment: 23/03/2011
Target sample size: 120
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-023560-40
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: yes Single blind: yes Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no  
Phase: 
Countries of recruitment
Brazil Canada Sweden United States
Contacts
Name:    
Address: 
Telephone:
Email:
Affiliation: 
Name:    
Address: 
Telephone:
Email:
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria:
1. Age between 18 -55, inclusive.
2. Diagnosis of MS using McDonald criteria of clinically definite MS.
3. An EDSS of 2.0 to 6.0.
4. Inflammatory disease despite treatment with standard disease modifying therapy including at least 6 months of interferon or copaxone.
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:
1. Any illness that in the opinion of the investigators would jeopardize the ability of the patient to tolerate aggressive chemotherapy.
2. More than six cycles prior therapy with mitoxantrone.
3. Prior history of malignancy except localized basal cell, squameous skin cancer or carcinoma in situ of the cervix. Other malignancies for whoich the patient is judged to be cured, such as haed and neck cancer, or breast cancer wil lbe considered on an individual basis.
4. Positive pregnancy test.
5. Inability or unwillingness to pursue effective means of birth control....



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Relapsing-remitting multiple sclerosis
MedDRA version: 13.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Intervention(s)

Trade Name: Tysabri
Pharmaceutical Form:
INN or Proposed INN: NATALIZUMAB
CAS Number: 189261-10-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-

Trade Name: Sendoxan
Pharmaceutical Form: Powder for solution for injection
CAS Number: 6055192
Other descriptive name: CYCLOPHOSPHAMIDE MONOHYDRATE

Trade Name: Thymoglobuline
Pharmaceutical Form: Powder for infusion*
CAS Number: 0
Other descriptive name: RABBIT HUMAN T LYMPHOCYTE IMMUNOGLOBULIN

Trade Name: Neupogen
Pharmaceutical Form: Solution for injection

Trade Name: Solu-Medrol
Pharmaceutical Form: Powder and solvent for dispersion for injection

Primary Outcome(s)
Main Objective: To assess the efficacy of autologous HSCT versus the FDA approved
standard of care, natalizumab, for inflammatory MS failing alternate
approved therapy.
(The original protocol from Northwestern University, Chicago, includes
interferon, glatiramer acetate and mitoxantrone as comparators as well; we
will only use natalizumab.)
Primary end point(s): Disease progression, defined as a 1-point increase in the EDSS on consecutive evaluations at least 6 months apart and not due to a non-MS disease process. Patients will be followed for 5 years after randomization.
Secondary Objective:
Secondary Outcome(s)
Secondary end point(s): Number of relapses
Ambulation index
25 foot timed walk
9 hole PEG test
PASAT-3 second and PASAT-2 second
MRI enhancing lesions and T1 and T2 burden of disease per CombiRx MRI protocol
SF-36 and MSQOL
Scripps NRS
Survival
Secondary ID(s)
STU00010022
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history