A study to evaluate disease control and safety in patients with RRMS switching from natalizumab to fingolimod

• Register: EUCTR
• Last refreshed on: 27 January 2014
• Main ID: EUCTR2011-001442-15-DE
• Date of registration: 26/05/2011
• 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: 26/08/2011
• Target sample size: 142
• 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

Countries of recruitment

Australia, Austria, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Israel, Italy, Norway, Spain, Sweden, Switzerland, United Kingdom

Contacts

• Name: Medizinischer Infoservice
• Affiliation: Novartis Pharma GmbH

• Name: Medizinischer Infoservice
• 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 142
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

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.
In protocol v02, the following is added for patients in the screening ECG:

resting HR < 45 bpm



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

Health Condition(s) or Problem(s) studied

relapsing remitting multiple sclerosis
MedDRA version: 14.1 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
Product Name: Gilenya
Product Code: FTY720
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)

CFTY720D2324

Source(s) of Monetary Support

Novartis Pharma Services AG