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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: 4 March 2013
Main ID:  EUCTR2011-001442-15-AT
Date of registration: 27/07/2011
Prospective Registration: Yes
Primary sponsor: Novartis Pharma Services AG
Public title: A study to evaluate disease control and safety in patients with RRMS switching from natalizumab to fingolimod
Scientific title: A 32-week, patient- and rater-blinded, randomized, multi-center, parallel-group study to evaluate disease control and safety in patients with relapsing remitting multiple sclerosis transferred from previous treatment with natalizumab to fingolimod (FTY720)
Date of first enrolment: 21/09/2011
Target sample size: 600
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-001442-15
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 3  
Phase: 
Countries of recruitment
Australia Austria Czech Republic Denmark Finland France Germany Greece
Hungary Israel Italy Norway Spain Sweden Switzerland United Kingdom
Contacts
Name: Drug Regulatory Affairs   
Address:  Stella-Klein-Löw-Weg 17 1020 Wien Austria
Telephone: +431866570
Email: austria.dra@novartis.com
Affiliation:  Novartis Pharma GmbH
Name: Drug Regulatory Affairs   
Address:  Stella-Klein-Löw-Weg 17 1020 Wien Austria
Telephone: +431866570
Email: austria.dra@novartis.com
Affiliation:  Novartis Pharma GmbH
Key inclusion & exclusion criteria
Inclusion criteria:
Must have relapsing remitting multiple sclerosis and must be on treatment with natalizumab for at least 6 months prior to screening where discontinuation of treatment is considered for the following reasons:
- Treatment duration for more than 2 years
- Positive JCV antibody status
- Pretreatment with immunosuppressive agents
- Adverse events, including hypersensitivity reactions
- Presence of anti-natalizumab neutralizing antibodies
- Any other valid medical reason
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 588
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12

Exclusion criteria:
Patients with a type of MS that is not relapsing, Patients with history of chronic immune disease, crohns disease, certain cancers or uncontrolled diabetes, patients with certain eye disorders, patients who are on certain immunosuppressive medications or heart medications, patients with certain heart conditions, patients with certain lung conditions.
Other protocol-defined inclusion/exclusion criteria may apply



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
relapsing remitting multiple sclerosis
MedDRA version: 15.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Intervention(s)

Trade Name: Gilenya
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: fingolimod
CAS Number: 162359-56-0
Current Sponsor code: FTY720
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Primary Outcome(s)
Main Objective: To evaluate disease control during different lengths of treatment transition from natalizumab to fingolimod from the last natalizumab infusion through 8 weeks of fingolimod treatment.
Primary end point(s): To evaluate disease control through MRI
Secondary Objective: To evaluate disease control during different lengths of treatment transition from natalizumab to the initiation of fingolimod treatment.
To evaluate disease control after different lengths of treatment transition from natalizumab during the first 8 weeks of fingolimod treatment.
Timepoint(s) of evaluation of this end point: 16, 20 or 24 weeks as applicable per arm
Secondary Outcome(s)
Secondary end point(s): To evaluate disease control through MRI
Timepoint(s) of evaluation of this end point: 8, 12 or 16 weeks as applicable per arm
Secondary ID(s)
2011-001442-15-DE
FTY720D2324
Source(s) of Monetary Support
Novartis Pharma Services AG
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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