Back to resultsRESOunD: REbif Satisfaction On Discontinuing Oral Dimethyl Fumarate (RESOunD)
Primary Purpose
Multiple Sclerosis
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Rebif®
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, Rebif ®, Tecfidera ™, treatment change
Eligibility Criteria
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
Sites / Locations
- Call EMD Serono Medical Information for information on recruiting sites
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Rebif® via Rebidose® auto-injector
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02117050
Brief Title
RESOunD: REbif Satisfaction On Discontinuing Oral Dimethyl Fumarate
Acronym
RESOunD
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Terminated
Why Stopped
recruitment challenges
Study Start Date
June 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EMD Serono
4. Oversight
5. Study Description
Brief Summary
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™.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple Sclerosis, Rebif ®, Tecfidera ™, treatment change
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rebif® via Rebidose® auto-injector
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Rebif®
Other Intervention Name(s)
interferon-beta-1a
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Baseline, Week 24
Secondary Outcome Measure Information:
Title
Change From Baseline in Patient-Determined Disease Steps Questionnaire (PDDS) Score at Week 24
Description
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.
Time Frame
Baseline, Week 24
Title
Change From Baseline in Multiple Sclerosis Quality of Life-54 (MSQoL-54) Score at Week 24
Description
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.
Time Frame
Baseline, Week 24
Title
Change From Baseline in TSQM (Version II) - Total Score at Week 12 and Week 24
Description
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.
Time Frame
Baseline, Week 12 and Week 24
Title
Change From Baseline in TSQM (Version II) - Medication Effectiveness, Side Effects, and Convenience Subscale Scores at Week 24
Description
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.
Time Frame
Baseline, Week 24
Title
Change From Baseline in TSQM (Version II) - Global Satisfaction, Medication Effectiveness, Side Effects, and Convenience Subscale Scores at Week 12
Description
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.
Time Frame
Baseline, Week 12
Title
Change From Baseline in Work Productivity and Activity Impairment- General Health (WPAI-GH) Questionnaire Score at Week 24
Description
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.
Time Frame
Baseline, Week 24
Title
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
Time Frame
Baseline, Week 24
Title
Annualized Relapse Rate (ARR)
Description
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.
Time Frame
Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Responsible, MD
Organizational Affiliation
EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany
Official's Role
Study Director
Facility Information:
Facility Name
Call EMD Serono Medical Information for information on recruiting sites
City
Boston
State/Province
Massachusetts
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.narcoms.org/pdds
Description
The North American Research Committee on Multiple Sclerosis - Information about the PDDS Questionaire
Learn more about this trial
RESOunD: REbif Satisfaction On Discontinuing Oral Dimethyl Fumarate
We'll reach out to this number within 24 hrs