Trial Outcomes & Findings for RESOunD: REbif Satisfaction On Discontinuing Oral Dimethyl Fumarate (NCT NCT02117050)
NCT ID: NCT02117050
Last Updated: 2017-01-23
Results Overview
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.
TERMINATED
PHASE4
1 participants
Baseline, Week 24
2017-01-23
Participant Flow
The study was prematurely terminated due to enrollment issues. Only 1 subject was enrolled in this study, but did not receive any dose.
Participant milestones
| Measure |
Rebif® Via Rebidose® Auto-injector
Rebif® was to 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.
|
|---|---|
|
Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Rebif® Via Rebidose® Auto-injector
Rebif® was to 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.
|
|---|---|
|
Overall Study
Subject Enrolled but not Dosed
|
1
|
Baseline Characteristics
RESOunD: REbif Satisfaction On Discontinuing Oral Dimethyl Fumarate
Baseline characteristics by cohort
| Measure |
Rebif® Via Rebidose® Auto-injector
n=1 Participants
Rebif® was to be administered subcutaneously three times a week at a dose of 8.8 to 44 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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Sex/Gender, Customized
Prefers not to identify
|
1 subject
n=93 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 24Population: The study enrolled only 1 subject who did not receive any dose. Thus, the data for primary endpoint was not collected.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 24Population: The study enrolled only 1 subject who did not receive any dose. Thus, the data for secondary endpoint was not collected.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 24Population: The study enrolled only 1 subject who did not receive any dose. Thus, the data for secondary endpoint was not collected.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 12 and Week 24Population: The study enrolled only 1 subject who did not receive any dose. Thus, the data for secondary endpoint was not collected.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 24Population: The study enrolled only 1 subject who did not receive any dose. Thus, the data for secondary endpoint was not collected.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 12Population: The study enrolled only 1 subject who did not receive any dose. Thus, the data for secondary endpoint was not collected.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 24Population: The study enrolled only 1 subject who did not receive any dose. Thus, the data for secondary endpoint was not collected.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 24Population: The study enrolled only 1 subject who did not receive any dose. Thus, the data for secondary endpoint was not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 24Population: The study enrolled only 1 subject who did not receive any dose. Thus, the data for secondary endpoint was not collected.
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.
Outcome measures
Outcome data not reported
Adverse Events
Rebif® Via Rebidose® Auto-injector
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Merck KGaA Communication Center
Merck Serono, a division of Merck KGaA
Results disclosure agreements
- Principal investigator is a sponsor employee The study as a whole will be published prior to any individual investigator publications. It is required that copies of all papers, abstracts, articles, etc. that contain study data are to be forward to the Sponsor for review 30 days prior to submission for publication.
- Publication restrictions are in place
Restriction type: OTHER