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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01499667




Registration number
NCT01499667
Ethics application status
Date submitted
18/08/2011
Date registered
26/12/2011
Date last updated
8/08/2014

Titles & IDs
Public title
Disease Control and Safety in Patients With Relapsing Remitting Multiple Sclerosis (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)
Secondary ID [1] 0 0
2011-001442-15
Secondary ID [2] 0 0
CFTY720D2324
Universal Trial Number (UTN)
Trial acronym
TOFIINGO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsing Remitting Multiple Sclerosis (RRMS) 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Fingolimod
Treatment: Drugs - Placebo

Experimental: 8-week washout + Fingolimod (FTY720) - 8-week washout (8 weeks no treatment) followed by 24 weeks of treatment with fingolimod 0.5mg once a day

Experimental: 12-week washout + Fingolimod (FTY720) - 12-week washout (8 weeks no treatment and 4 weeks placebo) followed by 20 weeks of treatment with fingolimod 0.5mg once a day

Experimental: 16-week washout + Fingolimod (FTY720) - 16-week washout (8 weeks no treatment and 8 weeks placebo) followed by 16 weeks of treatment with fingolimod 0.5mg once a day


Treatment: Drugs: Fingolimod
Fingolimod 0.5 mg capsules for oral administration once daily

Treatment: Drugs: Placebo
Matching placebo in capsules for oral administration once daily.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Active (New or Newly Enlarging) T2 Lesions From the Last Natalizumab Infusion (Baseline) Through 8 Weeks of Fingolimod Treatment
Timepoint [1] 0 0
Number of active T2 lesions from last natalizumab dose through 8 weeks of fingolimod treatment
Secondary outcome [1] 0 0
Number of Active (New or Newly Enlarging) T2 Lesions From the Last Natalizumab Infusion (Baseline) up to the Initiation of Fingolimod Treatment
Timepoint [1] 0 0
8, 12 and 16 weeks (number of active T2 lesions during the washout period only)
Secondary outcome [2] 0 0
Number of Active (New or Newly Enlarging) T2 Lesions During the First 8 Weeks of Fingolimod Treatment
Timepoint [2] 0 0
Number of active T2 lesions during 8 wks of fingolimod treatment
Secondary outcome [3] 0 0
Number of Active (New or Newly Enlarging) T2 Lesions During the 24 Weeks After the Last Natalizumab Infusion (Baseline)
Timepoint [3] 0 0
Baseline up to 24 weeks
Secondary outcome [4] 0 0
Change From Baseline in Expanded Disability Status Scale (EDSS) by Washout Group
Timepoint [4] 0 0
Baseline to week 16 and week 32
Secondary outcome [5] 0 0
Cumulative Number of Gadolinium-enhancing T1 Lesions From the Last Natalizumab Infusion
Timepoint [5] 0 0
8 weeks and 24 weeks
Secondary outcome [6] 0 0
Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) and Death During Washout Period
Timepoint [6] 0 0
Baseline to maximum of 16 weeks
Secondary outcome [7] 0 0
Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) and Death During Fingolimod Treatment
Timepoint [7] 0 0
Baseline to maximum of 16 weeks

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2012
Sample size
Target
Accrual to date
Final
142
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Box Hill
Recruitment hospital [2] 0 0
Novartis Investigative Site - Heidelberg
Recruitment postcode(s) [1] 0 0
3128 - Box Hill
Recruitment postcode(s) [2] 0 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Vienna
Country [2] 0 0
Czech Republic
State/province [2] 0 0
Prague 5
Country [3] 0 0
Czech Republic
State/province [3] 0 0
Praha 2
Country [4] 0 0
Czech Republic
State/province [4] 0 0
Teplice
Country [5] 0 0
Finland
State/province [5] 0 0
Helsinki
Country [6] 0 0
Germany
State/province [6] 0 0
Baden-Wuerttemberg
Country [7] 0 0
Germany
State/province [7] 0 0
Bad Mergentheim
Country [8] 0 0
Germany
State/province [8] 0 0
Berlin
Country [9] 0 0
Germany
State/province [9] 0 0
Bielefeld
Country [10] 0 0
Germany
State/province [10] 0 0
Bochum
Country [11] 0 0
Germany
State/province [11] 0 0
Celle
Country [12] 0 0
Germany
State/province [12] 0 0
Erbach
Country [13] 0 0
Germany
State/province [13] 0 0
Erfurt
Country [14] 0 0
Germany
State/province [14] 0 0
Hamburg
Country [15] 0 0
Germany
State/province [15] 0 0
Itzehoe
Country [16] 0 0
Germany
State/province [16] 0 0
Kandel
Country [17] 0 0
Germany
State/province [17] 0 0
Krefeld
Country [18] 0 0
Germany
State/province [18] 0 0
Leipzig
Country [19] 0 0
Germany
State/province [19] 0 0
Münster
Country [20] 0 0
Germany
State/province [20] 0 0
Neuburg
Country [21] 0 0
Germany
State/province [21] 0 0
Neuruppin
Country [22] 0 0
Germany
State/province [22] 0 0
Rüdersdorf
Country [23] 0 0
Germany
State/province [23] 0 0
Siegen
Country [24] 0 0
Germany
State/province [24] 0 0
Ulm
Country [25] 0 0
Greece
State/province [25] 0 0
GR
Country [26] 0 0
Greece
State/province [26] 0 0
Athens
Country [27] 0 0
Hungary
State/province [27] 0 0
Budapest
Country [28] 0 0
Israel
State/province [28] 0 0
Ashkelon
Country [29] 0 0
Israel
State/province [29] 0 0
Jerusalem
Country [30] 0 0
Italy
State/province [30] 0 0
MI
Country [31] 0 0
Italy
State/province [31] 0 0
PA
Country [32] 0 0
Spain
State/province [32] 0 0
Andalucia
Country [33] 0 0
Spain
State/province [33] 0 0
Catalunya
Country [34] 0 0
Spain
State/province [34] 0 0
Barcelona
Country [35] 0 0
Spain
State/province [35] 0 0
Madrid
Country [36] 0 0
Switzerland
State/province [36] 0 0
Basel

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01499667