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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01499667
First received: August 18, 2011
Last updated: January 15, 2013
Last verified: January 2013
History of Changes
  Purpose

This study will evaluate disease control during different lengths of treatment transition from natalizumab to fingolimod.


Condition Intervention Phase
Relapsing Remitting Multiple Sclerosis (RRMS)
 Drug: Fingolimod
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Number of active (new or newly enlarging) T2 lesions [ Time Frame: From the last natalizumab infusion (Baseline) up to 8 weeks of FTY treatment ] [ Designated as safety issue: No ]
    Active lesions will be measured on brain MRI scans, performed at week 8, 12, 16, 20 and 24, compared to the prior scan. The primary variable will be analyzed by fitting a negative binomial regression model adjusted for washout group.


Secondary Outcome Measures:
  • Number of active (new or newly enlarging) T2 lesions from the last natalizumab infusion (baseline) up to the initiation of fingolimod treatment [ Time Frame: Baseline to week 8, week 12, week 16 ] [ Designated as safety issue: No ]
    Lesions will be measured by MRIs and the number of active (new or newly enlarging) T2 lesions will be calculated from baseline to beginning of treatment.

  • Number of active (new or newly enlarging) T2 lesions during the first 8 weeks of fingolimod treatment [ Time Frame: At first 8 weeks of study drug treatment ] [ Designated as safety issue: No ]
    Lesions will be measured by MRIs and the number of active (new or newly enlarging) T2 lesions will be calculated for first 8 weeks of fingolimod treatment.

  • 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 ] [ Designated as safety issue: No ]
    Lesions will be measured by MRIs and the number of active (new or newly enlarging) T2 lesions will be calculated for 24 weeks from baseline.

  • Rate of Multiple Sclerosis (MS) relapse [ Time Frame: Baseline to 8 weeks and 24 weeks (after stopping natalizumab) ] [ Designated as safety issue: No ]
    MS relapse is defined as appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event. The abnormality must be present for at least 24 hours and occur in the absence of fever (<37.5C) or infection.

  • Cumulative number of gadolinium-enhancing T1 lesions from the last natalizumab infusion (baseline) [ Time Frame: Baseline to 8 weeks and 24 weeks (after stopping natalizumab) ] [ Designated as safety issue: No ]
    Gadolinium-enhancing lesions will be measured on post-contrast T1-weighted brain MRI scans


Enrollment: 158
Study Start Date: September 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 8-week washout + Fingolimod (FTY) for 24 weeks
8-week washout (8 weeks no treatment) followed by 24 weeks of treatment with fingolimod 0.5 mg capsules for oral administration once daily.
 Drug: Fingolimod
Fingolimod 0.5 mg capsules for oral administration once daily
Experimental: 12-week washout + Fingolimod (FTY) for 20 weeks
12-week washout (8 weeks no treatment and 4 weeks placebo) followed by 20 weeks of treatment with fingolimod 0.5 mg capsules for oral administration once daily.
 Drug: Fingolimod
Fingolimod 0.5 mg capsules for oral administration once daily
Drug: Placebo
Matching Placebo in capsules for oral administration once daily.
Experimental: 16-week washout + Fingolimod (FTY) for 16 weeks
16-week washout (8 weeks no treatment and 8 weeks placebo) followed by 16 weeks of treatment with fingolimod 0.5 mg capsules for oral administration once daily.
 Drug: Fingolimod
Fingolimod 0.5 mg capsules for oral administration once daily
Drug: Placebo
Matching Placebo in capsules for oral administration once daily.

Detailed Description:

At the randomization visit, the Washout Phase starts, and eligible patients will be randomized 1:1:1 to one of three treatment groups:

  • 8-week washout (8 weeks no treatment) followed by 24 weeks of treatment with fingolimod,
  • 12-week washout (8 weeks no treatment and 4 weeks placebo) followed by 20 weeks of treatment with fingolimod, or
  • 16-week washout (8 weeks no treatment and 8 weeks placebo) followed by 16 weeks of treatment with fingolimod.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • Certain heart conditions or certain lung conditions
  • Inability to undergo MRI scans

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01499667

  Show 44 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01499667     History of Changes
Other Study ID Numbers: CFTY720D2324, 2011-001442-15
Study First Received: August 18, 2011
Last Updated: January 15, 2013
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:
Relapsing remitting multiple sclerosis
multiple sclerosis (MS)
safety
tolerability
 health outcomes
fingolimod
disease control
MRI

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
 Immune System Diseases
Pathologic Processes
Fingolimod
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013