Multiple SclerosisPhase 4RESOunDNCT02117050
RESOunD: REbif Satisfaction On Discontinuing Oral Dimethyl Fumarate
A Phase 4 study testing Rebif® in people with Multiple Sclerosis, run by EMD Serono at 1 site in United States.
Trial 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™. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Rebif®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Apr 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Call EMD Serono Medical Information for information on recruiting sites
Boston, Massachusetts
About this study
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)
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™.
- Conditions
- Multiple Sclerosis
- Being tested
- Rebif®
- Keywords
- Multiple Sclerosis, Rebif ®, Tecfidera ™, treatment change
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rebif®Drug
Also called interferon-beta-1a
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.
| Study group | Role | What they receive |
|---|---|---|
| Rebif® via Rebidose® auto-injector | Experimental | Not described Receives: Drug: Rebif® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 24
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2014 (estimated)
- Study startJun 2014
- Primary completionApr 2015
- Study completionApr 2015
Why it stopped: recruitment challenges
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMD Serono
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, MD, Study director, EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02117050
- Sponsor's protocol ID
- EMR200136-586
- Acronym
- RESOunD
- Status last verified
- Nov 2016
- First submitted
- 15 Apr 2014
- Last updated
- 23 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02117050
- Acronym / sponsor ID
- RESOunD / EMR200136-586
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Rebif ®, Tecfidera ™, treatment change
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment challenges
- Enrolment
- 1 participants (actual)
- Lead sponsor
- EMD SeronoIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 17 Apr 2014 (estimated)
- Results
- Posted 23 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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™.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rebif® via Rebidose® auto-injector | Experimental | Drug: Rebif® |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rebif®Also: interferon-beta-1aRebif® 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. | Drug | Rebif® via Rebidose® auto-injector |
Primary outcome
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
Time frame: Baseline, 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.
8 secondary outcomes
Change From Baseline in Patient-Determined Disease Steps Questionnaire (PDDS) Score at Week 24
Time frame: Baseline, Week 24
Change From Baseline in Multiple Sclerosis Quality of Life-54 (MSQoL-54) Score at Week 24
Time frame: Baseline, Week 24
Change From Baseline in TSQM (Version II) - Total Score at Week 12 and Week 24
Time frame: Baseline, Week 12 and Week 24
Change From Baseline in TSQM (Version II) - Medication Effectiveness, Side Effects, and Convenience Subscale Scores at Week 24
Time frame: Baseline, Week 24
Change From Baseline in TSQM (Version II) - Global Satisfaction, Medication Effectiveness, Side Effects, and Convenience Subscale Scores at Week 12
Time frame: Baseline, Week 12
Change From Baseline in Work Productivity and Activity Impairment- General Health (WPAI-GH) Questionnaire Score at Week 24
Time frame: 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
Time frame: Baseline, Week 24
Annualized Relapse Rate (ARR)
Time frame: Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- The North American Research Committee on Multiple Sclerosis - Information about the PDDS QuestionaireLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Responsible, MD study director
EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rebif® in people with Multiple Sclerosis, run by EMD Serono at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Baseline, Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2017.