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

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)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-001442-15-DE

Enrollment

142

Registered

2011-05-26

Start date

2011-08-26

Completion date

Unknown

Last updated

2014-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
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.;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. ;Primary end point(s): To evaluate disease control through MRI;Timepoint(s) of evaluation of this end point: 16, 20 or 24 weeks as applicable per arm	—

Measure

Time frame

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.;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. ;Primary end point(s): To evaluate disease control through MRI;Timepoint(s) of evaluation of this end point: 16, 20 or 24 weeks as applicable per arm

—

Secondary

Measure	Time frame
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	—

Countries

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

Contacts

Public ContactMedizinischer Infoservice

Novartis Pharma GmbH

infoservice.novartis@novartis.com004901802232300

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026