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Evaluation of Patient Retention of Fingolimod vs. Currently Approved Disease Modifying Therapy in Patients With Relapsing Remitting Multiple Sclerosis. (PREFERMS)

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ClinicalTrials.gov Identifier: NCT01623596
Recruitment Status : Completed
First Posted : June 20, 2012
Results First Posted : January 12, 2018
Last Update Posted : January 12, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Relapsing Remitting Multiple Sclerosis
Interventions: Drug: Fingolimod
Drug: Disease Modifying therapy

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

62 Fingolimod arm participants discontinued: 57 discontinued before treatment switch, and 5 discontinued after treatment switch

100 MS-DMT arm participants discontinued before treatment switch: 57 discontinued before treatment switch, and 43 discontinued after treatment switch


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

Patient disposition was summarized on the Randomized Set.

Randomized Set (RS): consists of all participants who were assigned randomization numbers.


Reporting Groups
  Description
Fingolimod fingolimod 0.5 mg once a day
Disease Modifying Therapy 2 classes - Interferon Beta preparation (Exctavia, Betaseron, Rebif, Avonex) or glatiramer acetate (Copaxone)

Participant Flow:   Overall Study
    Fingolimod   Disease Modifying Therapy
STARTED   436   439 
On Randomized Treatment   352   125 
On Switched Treatment   22   214 
COMPLETED   374   339 
NOT COMPLETED   62   100 
Abnormal laboratory values                2                0 
Administrative problems                9                13 
Adverse Event                20                29 
Death                0                2 
Lost to Follow-up                12                16 
Withdrawal by Subject                13                31 
Patient no longer requires study drug                1                0 
Protocol Violation                0                6 
Lack of Efficacy                5                3 



  Baseline Characteristics

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.
Randomized set (RS): consists of all patients who were assigned randomization numbers. The participants in this set were called randomized participants. This set was used to summarize participant disposition, demographic and baseline characteristics, and protocol deviation information. Participants were grouped according to randomized treatment.

Reporting Groups
  Description
Fingolimod fingolimod 0.5 mg once a day
Disease Modifying Therapy (MS_DMT) 2 classes - Interferon Beta preparation (Exctavia, Betaseron, Rebif, Avonex) or glatiramer acetate (Copaxone)
Total Total of all reporting groups

Baseline Measures
   Fingolimod   Disease Modifying Therapy (MS_DMT)   Total 
Overall Participants Analyzed 
[Units: Participants]
 436   439   875 
Age 
[Units: Years]
Mean (Standard Deviation)
 41.5  (10.84)   41.9  (10.39)   41.7  (10.61) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      311  71.3%      329  74.9%      640  73.1% 
Male      125  28.7%      110  25.1%      235  26.9% 


  Outcome Measures

1.  Primary:   Participant Retention Rate Over 12 Months   [ Time Frame: at 12 months ]

2.  Secondary:   Primary and Secondary Reasons for Discontinuation From Randomized Treatment: Randomized Set   [ Time Frame: at 12 months ]

3.  Secondary:   Change From Baseline of Symbol Digit Modalities Test (SDMT) Scores (Oral Test) by Visit (Randomized Treatment / Randomized Phase)   [ Time Frame: baseline, 6 months, 12 months, and Last assessment which is either at Month 12 or at early discontinuation ]

4.  Secondary:   Change From Baseline of Symbol Digit Modalities Test (SDMT) Scores (Written Test) by Visit (Randomized Treatment / Randomized Phase)   [ Time Frame: baseline, 6 months, 12 months, Last assessment which is either at Month 12 or at early discontinuation ]

5.  Secondary:   Percent Change From in Brain Volume From Month 12 to Last Visit (Randomized)   [ Time Frame: 12 months, and Last assessment which is either at Month 12 or at early discontinuation ]

6.  Secondary:   Number of Satisfied Participants Per Medication Satisfaction Questionnaire (MSQ) Score   [ Time Frame: Baseline, 1 month, 3 months, 6 months, 9 months, at 12 months & Last assessment during randomized phase which is either at Month 12 or at early discontinuation ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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

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 ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01623596     History of Changes
Other Study ID Numbers: CFTY720DUS09
First Submitted: June 18, 2012
First Posted: June 20, 2012
Results First Submitted: July 13, 2016
Results First Posted: January 12, 2018
Last Update Posted: January 12, 2018