Disease Control and Safety in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) Switching From Natalizumab to Fingolimod

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01499667
• Date of registration: 18/08/2011
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• Public title: Disease Control and Safety in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) Switching From Natalizumab to Fingolimod TOFIINGO
• 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: September 2011
• Target sample size: 142
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01499667
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Australia, Austria, Czech Republic, Finland, Germany, Greece, Hungary, Israel, Italy, Spain, Switzerland

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion criteria

Inclusion Criteria:

Patients must:

- Have relapsing remitting multiple sclerosis

- Have been on treatment with natalizumab for at least 6 months prior to screening and
discontinuation is an option.

Exclusion Criteria:

Patients with:

- History of chronic immune disease

- Crohn's disease

- Certain cancers

- Uncontrolled diabetes

- Certain eye disorders

- Negative for varicella-zoster virus IgG antibodies

- Certain hepatic conditions

- Low white blood cell count

- On certain immunosuppressive medications or heart medications

- Resting heart rate less than 45 bpm.

- Certain heart conditions or certain lung conditions

- Inability to undergo MRI scans

Other protocol-defined inclusion/exclusion criteria may apply



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Relapsing Remitting Multiple Sclerosis (RRMS)

Intervention(s)

Drug: Fingolimod

Drug: Placebo

Primary Outcome(s)

Number of Active (New or Newly Enlarging) T2 Lesions From the Last Natalizumab Infusion (Baseline) Through 8 Weeks of Fingolimod Treatment [Time Frame: Number of active T2 lesions from last natalizumab dose through 8 weeks of fingolimod treatment]

Secondary Outcome(s)

Number of Active (New or Newly Enlarging) T2 Lesions During the 24 Weeks After the Last Natalizumab Infusion (Baseline) [Time Frame: Baseline up to 24 weeks]

Number of Active (New or Newly Enlarging) T2 Lesions From the Last Natalizumab Infusion (Baseline) up to the Initiation of Fingolimod Treatment [Time Frame: 8, 12 and 16 weeks (number of active T2 lesions during the washout period only)]

Change From Baseline in Expanded Disability Status Scale (EDSS) by Washout Group [Time Frame: Baseline to week 16 and week 32]

Cumulative Number of Gadolinium-enhancing T1 Lesions From the Last Natalizumab Infusion [Time Frame: 8 weeks and 24 weeks]

Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) and Death During Washout Period [Time Frame: Baseline to maximum of 16 weeks]

Number of Active (New or Newly Enlarging) T2 Lesions During the First 8 Weeks of Fingolimod Treatment [Time Frame: Number of active T2 lesions during 8 wks of fingolimod treatment]

Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) and Death During Fingolimod Treatment [Time Frame: Baseline to maximum of 16 weeks]

Secondary ID(s)

2011-001442-15

CFTY720D2324

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 04/04/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01499667