RESOunD: REbif Satisfaction On Discontinuing Oral Dimethyl Fumarate

Study Overview
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Brief Summary
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This is a Phase IV, prospective, open-label, multi-center trial to assess the treatment satisfaction in patients with relapsing forms of Multiple Sclerosis (MS) who are currently being treated with, but are considering discontinuing treatment with Tecfidera™.

Official Title
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RESOunD: REbif Satisfaction On Discontinuing Oral Dimethyl Fumarate. A 24-week, Prospective, Open-label, Multicenter Trial Evaluating Treatment Satisfaction in Subjects With Relapsing Forms of Multiple Sclerosis Following Treatment Change From Tecfidera™ to Rebif® 44 mcg Subcutaneously (sc) Three Times Weekly (Tiw)

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Drug: Rebif®


Participation Criteria
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Eligibility Criteria
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Key inclusion Criteria: Diagnosis of relapsing form of MS Have declared a desire/plan to discontinue treatment with Tecfidera due to tolerability issues and/or lack of efficacy Expanded Disability Status Scale (EDSS) score 0 to 5.0 inclusive Other protocol defined inclusion criteria could apply Key exclusion Criteria: Pregnant or lactating Significant renal or hepatic impairment or other significant disease that would compromise adherence and completion of the trial Other protocol defined exclusion criteria could apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rebif® via Rebidose® auto-injector<br> | Drug: Rebif®<br>* Rebif® will be administered subcutaneously three times a week at a dose of 8.8 to 44 microgram (mcg) in initial titration schedule (5 weeks), followed by Rebif® 44 mcg subcutaneously three times a week by using Rebif® Rebidose® auto-injector device till Week 24.<br>* Other names: interferon-beta-1a;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Treatment Satisfaction Score Determined by the Global Satisfaction Sub-scale of the Treatment Satisfaction Questionnaire for Medication (TSQM [Version II]) at Week 24 | The TSQM (Version II) is a validated tool that measures patient satisfaction with medical treatments using a 100-point scale. Global satisfaction sub-scale of TSQM was to be used to measure overall satisfaction with medication using a 100-point scale. Subject were to respond about their satisfaction or dissatisfaction with medication they are taking on a scale ranging from 0 to 100, where higher scores indicated greater satisfaction. | Baseline, Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Patient-Determined Disease Steps Questionnaire (PDDS) Score at Week 24 | PDDS questionnaire was to be used to assess the walking ability of subjects. Subjects were to describe their walking ability on scale ranging from 0 to 8, where 0 indicated normal walking and 8 indicated subject's condition as bedridden. Lesser score indicated better walking ability. | Baseline, Week 24 | 
| Change From Baseline in Multiple Sclerosis Quality of Life-54 (MSQoL-54) Score at Week 24 | The MSQOL-54 is a multidimensional health-related quality of life measure that combines both generic and MS-specific items into a single instrument. MSQoL-54 is a 54 item questionnaire which covers 12 sub-scales along with two summary scores, and two additional single-item measures. The 12 sub-scales are: physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall quality of life, and sexual function. The 2 summary scores are the physical health composite summary and the mental health composite summary. The 2 additional single item measures are satisfaction with sexual function and change in health. Each of the 12 sub-scale scores, the 2 summary scores and 2 single item measures were to be converted into an overall Total Score ranging from 0-100, where higher scores indicated better health status. | Baseline, Week 24 | 
| Change From Baseline in TSQM (Version II) - Total Score at Week 12 and Week 24 | The TSQM (Version II) is an 11-item validated tool that measures patient satisfaction with medical treatments using a 100-point scale. Total TSQM score was the average of individual sub-scale scores (effectiveness, side effects, convenience and global satisfaction) and ranged from 0 to 100, where higher scores indicated greater satisfaction. | Baseline, Week 12 and Week 24 | 
| Change From Baseline in TSQM (Version II) - Medication Effectiveness, Side Effects, and Convenience Subscale Scores at Week 24 | The TSQM (Version II) is a validated tool that measures patient satisfaction with medical treatments using a 100-point scale. Effectiveness, side effects and convenience sub-scales of TSQM were to be used to measure overall satisfaction with medication. Subject were to respond about their satisfaction or dissatisfaction with medication they are taking in terms of effectiveness, side effects and convenience, each sub-scale ranging on a scale of 0 to 100, where higher scores indicated greater satisfaction. | Baseline, Week 24 | 
| Change From Baseline in TSQM (Version II) - Global Satisfaction, Medication Effectiveness, Side Effects, and Convenience Subscale Scores at Week 12 | The TSQM (Version II) is a validated tool that measures patient satisfaction with medical treatments using a 100-point scale. Effectiveness, side effects, convenience and global satisfaction sub-scales of TSQM were to be used to measure overall satisfaction with medication. Subject were to respond about their satisfaction or dissatisfaction with medication they are taking in terms of effectiveness, side effects, convenience and global satisfaction, each sub-scale ranging on a scale of 0 to 100, where higher scores indicated greater satisfaction. | Baseline, Week 12 | 
| Change From Baseline in Work Productivity and Activity Impairment- General Health (WPAI-GH) Questionnaire Score at Week 24 | WPAI-GH questionnaire is a subject reported quantitative assessment of general health conditions on productivity. The Total WPAI-GH score assessment was to be done on an 11-point scale ranging 0 to 10, with 0 indicating that health problems had no effect on work and 10 indicating that health problems completely prevented from working. | Baseline, Week 24 | 
| Change From Baseline in Number of Combined Unique Active (CUA) Lesions, New Time or Enlarging Constant 2 (T2) Lesions, and New Gadolinium Enhanced (Gd+) Time Constant 1 (T1) Lesions at Week 24 |  | Baseline, Week 24 | 
| Annualized Relapse Rate (ARR) | A relapse is defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting for at least 24 hours, and accompanied by new objective neurologic findings. Episodes indicated by neurologist as relapse in the subjects chart were to be recorded. | Week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Sclerosis, Rebif ®, Tecfidera ™, treatment change