Long-term Safety and Tolerability of 0.5 mg Fingolimod in Patients Wit

A Single Arm, Open-label, Multicenter Study Evaluating the Long-term Safety and Tolerability of 0.5 mg Fingolimod (FTY720) Administered Orally Once Daily in Patients With Relapsing Forms of Multiple Sclerosis

CompletedPhase 3Relapsing MSNCT012013562010-020515-37

What it found

Results posted, not judged

Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.

What was tested

Treatment tested

Results by group

Parts I and II: Number of Participants With Adverse Events, Serious Adverse Event, and Death

Baseline (Part I) to Month 6 Follow-up (Part II), up to 8 years

GroupValueIntervalNumber analysed
Fingolimod 0.5 mg/Day2125 Participants4083
Fingolimod 0.5 mg/Day515 Participants4083
Fingolimod 0.5 mg/Day16 Participants4083

Fingolimod 0.5 mg/Day

2125

Fingolimod 0.5 mg/Day

515

Fingolimod 0.5 mg/Day

16

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Fingolimod 0.5 mg/Day4083515 (12.6%)16

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • Parts I and II: Number of Participants With Adverse Events, Serious Adverse Event, and Death

    Baseline (Part I) to Month 6 Follow-up (Part II), up to 8 years

    Safety

  • For Part 1 : Long-term safety will be assessed based on adverse events

    Safety

Other measures (11)

  • Part I: Aggregate Annualized Relapse Rates (ARR) From First Dose of Fingolimod

    Month 0 (Core Baseline) to End of Follow-up Visit (an average of 162 months)

    Relapses

  • Part I: Number of Participants With Relapses (Confirmed and Unconfirmed) From First Dose of Fingolimod

    Month 0 (Core Baseline) to End of Follow-up Visit (an average of 162 months)

    Disability progressionRelapsesBladder, bowel and sexual function

  • Part I: Annualized Rates of New or Newly Enlarging T2 Lesions (ARneT2) Compared With First Dose of Fingolimod

    Month 0 (Core Baseline) to End of Study (an average of Month 156)

    MRI lesions

  • Part I: Change From First Dose of Fingolimod in Total T2 Lesions Volume

    Month 3 to End of Study (Study Completion Visit)

    MRI lesions

  • Part I: Change From First Dose of Fingolimod in Total T1 Hypointense Lesions Volume

    Month 3 to End of Study (Study Completion Visit)

    MRI lesions

  • Part I: Percent Brain Volume Change (PBVC) Relative to First Dose of Fingolimod

    Month 3 to Month 156

    Brain volume loss

  • Part I: Annualized Rate of Brain Atrophy (ARBA) Relative to First Dose of Fingolimod

    Month 3 to Month 156

    Brain volume loss

  • Part I: Number of Participants With Confirmed 6-month Disability Progression After First Dose of Fingolimod

    Month 12 to Month 156

    Disability progressionRelapses

  • Part I: Number of Participants With Categorized Change From First Dose of Fingolimod in Expanded Disability Status Scale (EDSS) Overall Score

    Month 3 to Month 6 Follow-up

    Disability progressionBladder, bowel and sexual function

  • Part I: Change From First Dose of Fingolimod in Expanded Disability Status Scale (EDSS)

    Month 0 (Core Baseline) to End of Follow-up Visit (an average of 162 months)

    Disability progressionBladder, bowel and sexual function

Who could take part

Relapsing MS · 18 and over

Show the full criteria

Inclusion criteria

Key Inclusion Criteria: - Patients who have completed selected ongoing or planned trials with FTY720. Key Exclusion Criteria: * Premature permanent discontinuation of a previous fingolimod study. * Pregnant or nursing (lactating) women. * Women of child-bearing potential, UNLESS they are using two birth control methods, at least 1 of which must be hormonal contraception, tubal sterilization, partner's vasectomy or intrauterine device. * Chronic disease of the immune system, other than multiple sclerosis, which may require immunosuppressive treatment. * Diabetic patients with moderate or severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy and uncontrolled diabetic patients with HbA1c > 8%. * Active systemic bacterial, viral or fungal infections, or known to have AIDS, Hepatitis B, Hepatitis C infection or have positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests. * Previous treatment with cladribine, cyclophosphamide or mitoxantrone. * Treatment with immunoglobulins and/or monoclonal antibodies (including Natalizumab) in the past 3 months during the previous fingolimod study: * Any of the following cardiovascular conditions that have developed during the previous fingolimod study: * Myocardial infarction within the past 6 months prior to entry in the extension study or with current unstable ischemic heart disease; * Cardiac failure (Class III, according to New York Heart Association Classification) or any severe cardiac disease as determined by the investigator; * Arrhythmia requiring current treatment with Class III antiarrhythmic drugs (e.g., amiodarone, bretylium, sotalol, ibutilide, azimilide, dofetilide) * History or presence of a third degree AV block * Proven history of sick sinus syndrome or sino-atrial heart block * Known history of angina pectoris due to coronary spasm or Raynaud's phenomenon * Any of the following pulmonary conditions during the previous fingolimod study: * Severe respiratory disease or pulmonary fibrosis diagnosed (during the previous fingolimod study) * Active tuberculosis * Alcohol abuse, chronic liver disease during the previous fingolimod study. The patient must have participated in a previous fingolimod trial to be eligible to participate in this trial.

Exclusion criteria

Not separately supplied in the registry.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

The purpose of this study was to collect long-term safety and tolerability, long-term efficacy, and health outcome data in all patients currently ongoing in the fingolimod multiple sclerosis clinical development program. This study combined all currently ongoing Phase II and III fingolimod extension studies as well as ongoing and newly planned studies into one single long-term extension protocol that provided patients with continuous treatment until fingolimod was registered, commercially available, and reimbursed in the respective countries.

Papers

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History

    1. Started

      Sept 2010

    2. Main results due

      Oct 2018

    3. Finished

      Oct 2018

    4. Results posted

      Nov 2019

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