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Long-term Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00662649
First received: April 17, 2008
Last updated: June 9, 2012
Last verified: June 2012
Results First Received: June 9, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Multiple Sclerosis
Interventions: Drug: Fingolimod 0.5 mg
Drug: Fingolimod 1.25 mg

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Of the 1272 patients randomly assigned to treatment in the Core study (ClinicalTrials.gov ID NCT00289978), 1033 completed the 24-month double-blind treatment phase and were eligible to enter the Extension study. A total of 920 of the 1033 patients entered the Extension study and received treatment.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Fingolimod 1.25 mg Patients continued the same dose to which they had been randomized in the core study, fingolimod 1.25 mg/day, in this extension study.
Fingolimod 0.5 mg Patients continued the same dose to which they had been randomized in the core study, fingolimod 0.5 mg/day, in this extension study.
Placebo Patients randomized to placebo in the Core study who were subsequently re-randomized to fingolimod(either 1.25 or 0.5 mg/day) in the Extension study.
Placebo-fingolimod 1.25 mg Patients randomized to placebo in the core study were re randomized to fingolimod 1.25 mg/day in this extension study.
Placebo-fingolimod 0.5 Patients randomized to placebo in the core study were re randomized to fingolimod 0.5 mg/day in this extension study.

Participant Flow for 2 periods

Period 1:   Core Study (24 Months)
    Fingolimod 1.25 mg   Fingolimod 0.5 mg   Placebo   Placebo-fingolimod 1.25 mg   Placebo-fingolimod 0.5
STARTED   429   425   418   0 [1]   0 [1] 
Intent to Treat (ITT)   429   425   418   0   0 
COMPLETED   332   369   332   0   0 
NOT COMPLETED   97   56   86   0   0 
Withdrawal by Subject                31                17                28                0                0 
Adverse Event                22                13                18                0                0 
Unsatisfactory therapeutic effect                13                6                25                0                0 
Abnormal laboratory value(s)                20                9                1                0                0 
Lost to Follow-up                3                5                7                0                0 
Protocol Violation                5                5                4                0                0 
Abnormal test procedure result(s)                2                1                1                0                0 
Death                1                0                2                0                0 
[1] This reporting group is used only in extension study.

Period 2:   Extension Study (Month 24 to 60)
    Fingolimod 1.25 mg   Fingolimod 0.5 mg   Placebo   Placebo-fingolimod 1.25 mg   Placebo-fingolimod 0.5
STARTED   289   331   0 [1]   145   155 
Extension Intent to Treat Population   287   330   0   145   154 
From Beginning of Core at Month 24   289   331   0   145   155 
From Beginning of Core at Month 30   276   324   0   136   152 
From Beginning of Core at Month 36   270   311   0   130   145 
From Beginning of Core at Month 42   254   301   0   120   136 
From Beginning of Core at Month 48   125   152   0   58   67 
From Beginning of Core at Month 54   31   32   0   11   13 
COMPLETED   245 [2]   290   0   112   126 
NOT COMPLETED   44   41   0   33   29 
Abnormal laboratory value(s)                10                5                0                8                3 
Abnormal test procedure result(s)                3                1                0                1                3 
Administrative problems                0                0                0                1                0 
Adverse Event                6                9                0                6                10 
Lost to Follow-up                2                0                0                1                1 
Protocol Violation                1                1                0                0                0 
Subject withdrew consent                19                23                0                15                9 
Subject no longer requires study drug                0                1                0                0                0 
Unsatisfactory therapeutic effect                3                1                0                1                3 
[1] This reporting group is used only for core study
[2] "completed" refers to patients that completed extension study in different time points.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Fingolimod 1.25 mg Patients continued the same dose to which they had been randomized in the core study, fingolimod 1.25 mg/day, in this extension study.
Fingolimod 0.5 mg Patients continued the same dose to which they had been randomized in the core study, fingolimod 0.5 mg/day, in this extension study.
Placebo-fingolimod 1.25 mg Patients randomized to placebo in the core study were re randomized to fingolimod 1.25 mg/day in this extension study.
Placebo-fingolimod 0.5 mg Patients randomized to placebo in the core study were re randomized to fingolimod 0.5 mg/day in this extension study.
Total Total of all reporting groups

Baseline Measures
   Fingolimod 1.25 mg   Fingolimod 0.5 mg   Placebo-fingolimod 1.25 mg   Placebo-fingolimod 0.5 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 289   331   145   155   920 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 37.2  (8.87)   36.5  (8.60)   36.6  (9.21)   38.1  (8.26)   37.0  (8.73) 
[1] All demographic measurements are based on extension randomized/safety population.
Gender 
[Units: Participants]
         
Female   204   234   107   106   651 
Male   85   97   38   49   269 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Annualized Aggregate Relapse Rate (ARR) During Months 0 to End of Study(Core [CFTY720D2301/NCT00289978] and Extension Study)   [ Time Frame: Months 0 to end of study (maximum up to 60 months) ]

2.  Primary:   Time to First Confirmed Relapse up to End of Study: Kaplan-Meier Estimate of Percentage of Patients Relapse-free   [ Time Frame: Core baseline to end of study (maximum up to 60 months) ]

3.  Primary:   Annualized Aggregate Relapse Rate (ARR) During Months 0-24 (Core Study) and Months 24-48 (Extension Study)   [ Time Frame: Months 0-24 (core study) and Months 24-48 (extension study) ]

4.  Primary:   Change (Expressed as Ratio) in the Annualized Aggregate Relapse Rate (ARR) From Months 0-24 (Core Study) to Months 24-48 (Extension Study)   [ Time Frame: Months 0-24 (core study) and Months 24-48 (extension study) ]

5.  Secondary:   Change in Mean Number of New or Newly Enlarged T2 Magnetic Resonance Imaging (MRI) Lesions During Months 0-24 (Core Study) and Months 24-48 (Extension Study)   [ Time Frame: Months 0-24 (core study) and Months 24-48 (extension study) ]

6.  Secondary:   Percentage of Patients Free of New or Newly Enlarged T2 Magnetic Resonance Imaging (MRI) Lesions During Months 0-24 (Core Study) and Months 24-48 (Extension Study)   [ Time Frame: Months 0-24 (core study) and Months 24-48 (extension study) ]

7.  Secondary:   Percent Change in Brain Volume From Month 0 to Month 24 (Core Study) and From Month 24 to Month 48 (Extension Study)   [ Time Frame: Months 0-24 (core study) and Months 24-48 (extension study) ]

8.  Secondary:   Percent Change in Brain Volume From Month 0 End of Study (Core and Extension Study)   [ Time Frame: Months 0 to end of study (maximum up to 60 months) ]

9.  Secondary:   Time to First 3-month Confirmed Disability Progression up to End of Study Based on Expanded Disability Status Scale (EDSS): Kaplan-Meier Estimate of Percentage of Patients Free of Disability Progression   [ Time Frame: Core baseline to end of study (maximum up to 60 months) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862 778-8300



Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00662649     History of Changes
Other Study ID Numbers: CFTY720D2301E1
2007-004122-24 ( EudraCT Number )
Study First Received: April 17, 2008
Results First Received: June 9, 2012
Last Updated: June 9, 2012
Health Authority: Sweden: Regional Ethical Review Board