Multiple Sclerosis, Relapsing-RemittingPhase 4NCT02019550
Rebif® Rebidose® Versus Rebiject II® Ease-of-Use
A Phase 4 study testing Rebif Rebidose and Rebiject II in people with Multiple Sclerosis, Relapsing-Remitting, run by EMD Serono at 21 sites in United States.
Trial summary
This is a Phase 4, prospective, open-label, randomized, cross-over, multicenter trial to evaluate ease-of-use with Rebif® Rebidose® and Rebiject II® autoinjectors in subjects with relapsing remitting multiple sclerosis (RRMS). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting
- What is being tested?
- Rebif Rebidose and Rebiject II
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 21 sitesUnited States
- Study dates
- Mar 2014to Jan 2016
- 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
- Male and female subjects, 18 to 65 years of age inclusive, at the time of informed consent signature
- Diagnosis of RRMS
- Receiving Rebif®, 44 microgram subcutaneously three times a week, by manual injection for at least 12 weeks before the screening assessment and previous use of either Rebif® Rebidose® or Rebiject II® devices is acceptable if they have not been using them for the past 12 weeks prior to study entry and if, in the judgment of the investigator, the subjects are not experienced users
- Subject is capable of self-injecting using Rebif® Rebidose® and Rebiject II® injection devices
- Subject is willing and able to comply with the study procedures for the duration of the trial
- Signed, informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization before any trial-related activities are performed
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- Female subjects of childbearing potential must have a negative pregnancy test at screening to be included in the trial and must be willing to avoid pregnancy by using a highly effective method of contraception
- Outpatient status at the time of screening
- Stable disease status without a history of surgical procedure or hospitalization within 30 days prior to Study Day 1, and with no surgical intervention planned for the duration of the study
Who cannot join
- Received MS therapy other than Rebif® within the 12 weeks before screening or at any time during the trial
- Inadequate liver function and bone marrow reserve as defined in the protocol
- Current complete transverse myelitis, bilateral optic neuritis, or neuromyelitis optica
- History of injection-site necrosis within 12 months before study entry
- History of alcohol or drug abuse in the past year
- Any autoimmune disorder, except for thyroid disease stable on medication
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- Subject having moderate to severe renal impairment, in the Investigator's opinion.
- Diagnosis of primary progressive, secondary progressive, or progressive relapsing MS
- Participation in another clinical trial within the past 30 days or an interventional trial for MS in the past 12 weeks
- Use of high-dose steroids within 14 days of screening
- Currently experiencing moderate to severe active inflammatory skin disease at sites of expected Rebif® injections
- History of clinically significant lipoatrophy at sites of expected Rebif® injections, in the investigator's opinion
- Current major depression or suicidal ideation or suicide attempt in the past year
- Experiencing spasticity which in the opinion of the Investigator, could interfere with self-injections
- Pregnant or lactating
- Inability to self-inject or visual impairment which, in the opinion of the Investigator, is severe enough, even with correction, to impede the subject's participation in this study
- Upper extremity deficit which, in the opinion of the Investigator, is severe enough to impede the subject's participation in this study
- Cognitive deficit which, in the opinion of the Investigator, is severe enough to impede the subject's participation in this study
- Subject-reported reason that he/she cannot complete the 8-week study
- Any other medical condition, which in the opinion of the Investigator makes the subject unsuitable for this study
- Known hypersensitivity to the trial treatment
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Research Site
Atlanta, Georgia, 30327
Research site
Cullman, Alabama, 35058
Research Site
Dayton, Ohio, 45417
Research Site
Dover, Delaware, 19901
Research site
Fort Collins, Colorado, 80528
Research site
Foxborough, Massachusetts, 02035
Research site
Golden Valley, Minnesota, 55422
Research Site
Greensburg, Pennsylvania, 15601
Research Site
Hickory, North Carolina, 28602
Research Site
Indianapolis, Indiana, 46256
Research Site
Knoxville, Tennessee, 37934
Research site
Mansfield, Texas, 76063
Research Site
Miami, Florida, 33136
Research Site
Newport Beach, California, 92663
Research Site
Oklahoma City, Oklahoma, 73104
Research Site
Patchogue, New York, 11772
Research site
Spartanburg, South Carolina, 29307
Research Site
Stratford, New Jersey, 08084
Research site
Sunrise, Florida, 33351
Research Site
Tuscon, Arizona, 85718
Research Site
Winston-Salem, North Carolina, 27103
About this study
Official title: A Phase IV, Randomized, Prospective, US-based, Multicenter, Cross-over Study Evaluating Subject Ease-of-use With Rebif® Rebidose® and Rebiject II® Autoinjectors in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) Treated With REBIF® 44 mcg Subcutaneously Three Times a Week
This is a Phase 4, prospective, open-label, randomized, cross-over, multicenter trial to evaluate ease-of-use with Rebif® Rebidose® and Rebiject II® autoinjectors in subjects with relapsing remitting multiple sclerosis (RRMS). Subjects will participate in the study for up to 10 weeks (including screening and treatment periods). The treatment period will last 8 weeks and include 12 self-injections using the Rebif® Rebidose® device and 12 self-injections using the Rebiject II® device.
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Being tested
- Rebif Rebidose, Rebiject II
- Keywords
- Multiple Sclerosis, Relapsing-Remitting, Rebif®Rebidose®, Rebiject II®
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rebif RebidoseDevice
Rebif 44 mcg will be injected subcutaneously three times a week using Rebif Rebidose self-injector device.
Rebiject IIDevice
Rebif 44 mcg will be injected subcutaneously three times a week using Rebiject II self-injector device.
| Study group | Role | What they receive |
|---|---|---|
| First Rebif Rebidose, Then Rebiject II | Experimental | Subjects will self-inject Rebif at a dose of 44 microgram (mcg) subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 (4 weeks) for the next 4 weeks. Receives: Device: Rebif Rebidose; Device: Rebiject II |
| First Rebiject II, Then Rebif Rebidose | Experimental | Subjects will self-inject Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks. Receives: Device: Rebif Rebidose; Device: Rebiject II |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects Rating Each Device as "Easy/Very Easy to Use" Based on User Trial Questionnaire (UTQ) at Week 4
The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess their overall experience with using the device as "very difficult", "difficult", "neither easy nor difficult", "easy", or "very easy". Percentage of subjects who rated the overall use of device as "easy" or "very easy" were reported. Here results are presented by device sequence.
Measured: Week 4
Percentage of Subjects Rating Each Device as "Easy/Very Easy to Use" Based on User Trial Questionnaire (UTQ) at Week 8
The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess their overall experience with using the device as "very difficult", "difficult", "neither easy nor difficult", "easy", or "very easy". Percentage of subjects who rated the overall use of device as "easy" or "very easy" were reported. Here results are presented by device sequence.
Measured: Week 8
Percentage of Subjects Rating Each Device as "Easy/Very Easy to Use" Based on User Trial Questionnaire (UTQ) up to Week 8
The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess their overall experience with using the device as "very difficult", "difficult", "neither easy nor difficult", "easy", or "very easy". Percentage of subjects who rated the overall use of device as "easy" or "very easy" were reported. Here results are presented by device used.
Measured: Baseline up to Week 8
Secondary outcomes (14)
Number of Subjects Rating Each Device on Level of Satisfaction With Using the Device While Traveling Based on User Trial Questionnaire (UTQ)
The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess their level of satisfaction with using the device while traveling (defined as being away from home overnight). Subjects assessed if they were satisfied with their ability to use the device while traveling overnight as "Strongly disagree", "Disagree", "Neither agree nor disagree", "Agree", "Strongly agree". Here results are presented by device sequence.
Measured: Weeks 4 and 8
Percentage of Subjects Rating Each Device on Amount of Time Needed to Complete the Injection Based on User Trial Questionnaire (UTQ)
The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess their level of satisfaction with respect to the amount of time it took to complete injection with the device. Subjects assessed if they were satisfied as "Strongly disagree", "Disagree", "Neither agree nor disagree", "Agree", "Strongly agree". Here results are presented by device sequence.
Measured: Weeks 4 and 8
Percentage of Subjects Rating Each Device on Number of Steps Involved in Completing the Injection Based on User Trial Questionnaire (UTQ)
The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess their level of satisfaction with respect to number of steps it took to complete an injection with the device. Subjects assessed if they were satisfied as "Strongly disagree", "Disagree", "Neither agree nor disagree", "Agree", "Strongly agree". Here results are presented by device sequence.
Measured: Weeks 4 and 8
Percentage of Subjects Rating Each Device on Ease of Holding Based on User Trial Questionnaire (UTQ)
The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess their overall experience with holding the device as "very difficult", "difficult", "neither easy nor difficult", "easy", or "very easy". Here results are presented by device sequence.
Measured: Weeks 4 and 8
Number of Subjects Rating Each Device on Level of Satisfaction With Using the Device Away From Home Based on User Trial Questionnaire (UTQ)
The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess their level of satisfaction with using the device while away from home. Subjects assessed if they were satisfied with their ability to use the device while away from home as "Strongly disagree", "Disagree", "Neither agree nor disagree", "Agree", "Strongly agree". Here results are presented by device sequence.
Measured: Weeks 4 and 8
Percentage of Subjects Rating Each Device on Level of Convenience of Using the Device Based on User Trial Questionnaire (UTQ)
The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess their level of convenience of using the device as "Extremely inconvenient", "Somewhat inconvenient", "Neutral/no opinion", "Somewhat convenient", or "Extremely convenient". Here results are presented by device sequence.
Measured: Weeks 4 and 8
Percentage of Subjects Rating Each Device on Level of Convenience of Storing the Device Based on User Trial Questionnaire (UTQ)
The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess how convenient it was to store the injection device. Subjects responded as "Strongly disagree", "Disagree", "Neither agree nor disagree", "Agree", "Strongly agree" that the device was convenient to store.
Measured: Weeks 4 and 8
Percentage of Subjects Rating Each Device on Minimization of Safety Hazards Based on User Trial Questionnaire (UTQ)
The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess whether the device features help minimize safety hazards. Subjects responded as "Strongly disagree", "Disagree", "Neither agree nor disagree", "Agree", "Strongly agree". Here results are presented by device sequence.
Measured: Weeks 4 and 8
Percentage of Subjects Rating Each Device on Amount of Needle Anxiety While Using the Device Based on User Trial Questionnaire (UTQ)
The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess their level of anxiety while giving themselves an injection with device. Subjects assessed their anxiety as "Not at all anxious", "A little anxious", "Moderately anxious", "Very anxious", "Extremely anxious". Here results are presented by device sequence.
Measured: Weeks 4 and 8
Percentage of Subjects Rating Each Device on Level of Satisfaction With Information Provided by the Trainer Based on User Trial Questionnaire (UTQ)
The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess whether the trainer provided easily understandable, unbiased and practical information about proper injection. Subjects responded as "Strongly disagree", "Disagree", "Neither agree nor disagree", "Agree", "Strongly agree". Here results are presented by device sequence.
Measured: Weeks 4 and 8
Percentage of Subjects Rating Each Device on Likelihood of Recommending the Device to Others Based on User Trial Questionnaire (UTQ)
The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked they would recommend injection device to others needing REBIF therapy. Subjects responded as "Very unlikely", "Unlikely", "Neutral/no opinion", "Likely", "Very likely". Here results are presented by device sequence.
Measured: Weeks 4 and 8
Percentage of Subjects Rating Each Device on Overall Satisfaction With the Injection Device Based on User Trial Questionnaire (UTQ)
The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess their overall satisfaction with using the device. Subjects responded as "Strongly disagree", "Disagree", "Neither agree nor disagree", "Agree", "Strongly agree" that they were satisfied with the device. Here results are presented by device sequence.
Measured: Weeks 4 and 8
Percentage of Subjects Rating Each Device on Ease of Use Based on User Trial Questionnaire (UTQ)
The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess their overall experience with using the device as "very difficult", "difficult", "neither easy nor difficult", "easy", or "very easy". Percentage of subjects who rated the overall use of device as very difficult", "difficult" or "neither easy nor difficult" were reported. Here results are presented by device sequence.
Measured: Weeks 4 and 8
Change From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Scores to Week 8
The MusiQoL is a validated 31-item questionnaire describing 9 dimensions named according to its constitutive items:activities of daily living (8 items);psychological well-being (4 items);symptoms (3 items);friends relationships (4 items);family relationships (3 items);satisfaction with health care (RHCS 3 items);sentimental and sexual life (2 items);coping (2 items);and rejection (2 items). Each of the questions was answered using a 6-point Likert scale, defined as 1-Never/Not at all, 2-Rarely/A little, 3-Sometimes/Somewhat, 4-Often/A lot, 5-Always/Very much and 6-Not applicable. The scores of each dimension were obtained by computing mean of the item scores of dimension with negatively worded item scores reversed so that higher scores indicated higher health-related QoL. All 9 dimension scores were linearly transformed to a 0-100 scale,where higher score=higher health-related QoL. Global index score was computed as mean of the 9 dimension scores (range 0-100;higher score=higher QoL).
Measured: Baseline, up to Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2013 (estimated)
- Study startMar 2014
- Primary completionJan 2016
- Study completionJan 2016
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMD Serono
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, Study director, EMD Serono, Inc., Rockland MA, a subsidiary of Merck KGaA, Darmstadt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02019550
- Sponsor's protocol ID
- 200136-573
- Status last verified
- Jan 2017
- First submitted
- 18 Dec 2013
- Last updated
- 7 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Wray S, Hayward B, Dangond F, Singer B. Ease of use of two autoinjectors in patients with multiple sclerosis treated with interferon beta-1a subcutaneously three times weekly: results of the randomized, crossover REDEFINE study. Expert Opin Drug Deliv. 2018 Feb;15(2):127-135. doi: 10.1080/17425247.2018.1407755. Epub 2017 Dec 5.
PubMed 29206056
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Randomized, Prospective, US-based, Multicenter, Cross-over Study Evaluating Subject Ease-of-use With Rebif® Rebidose® and Rebiject II® Autoinjectors in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) Treated With REBIF® 44 mcg Subcutaneously Three Times a Week
- ClinicalTrials.gov ID
- NCT02019550
- Acronym / sponsor ID
- 200136-573
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Keywords
- Multiple Sclerosis, Relapsing-Remitting, Rebif®Rebidose®, Rebiject II®
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- EMD SeronoIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 24 Dec 2013 (estimated)
- Results
- Posted 7 Mar 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 4, prospective, open-label, randomized, cross-over, multicenter trial to evaluate ease-of-use with Rebif® Rebidose® and Rebiject II® autoinjectors in subjects with relapsing remitting multiple sclerosis (RRMS). Subjects will participate in the study for up to 10 weeks (including screening and treatment periods). The treatment period will last 8 weeks and include 12 self-injections using the Rebif® Rebidose® device and 12 self-injections using the Rebiject II® device.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First Rebif Rebidose, Then Rebiject II | Experimental | Device: Rebif Rebidose, Device: Rebiject IISubjects will self-inject Rebif at a dose of 44 microgram (mcg) subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 (4 weeks) for the next 4 weeks. |
| First Rebiject II, Then Rebif Rebidose | Experimental | Device: Rebif Rebidose, Device: Rebiject IISubjects will self-inject Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male and female subjects, 18 to 65 years of age inclusive, at the time of informed consent signature
- Diagnosis of RRMS
- Receiving Rebif®, 44 microgram subcutaneously three times a week, by manual injection for at least 12 weeks before the screening assessment and previous use of either Rebif® Rebidose® or Rebiject II® devices is acceptable if they have not been using them for the past 12 weeks prior to study entry and if, in the judgment of the investigator, the subjects are not experienced users
- Subject is capable of self-injecting using Rebif® Rebidose® and Rebiject II® injection devices
- Subject is willing and able to comply with the study procedures for the duration of the trial
Key exclusion criteria (21 listed)
- Received MS therapy other than Rebif® within the 12 weeks before screening or at any time during the trial
- Inadequate liver function and bone marrow reserve as defined in the protocol
- Current complete transverse myelitis, bilateral optic neuritis, or neuromyelitis optica
- History of injection-site necrosis within 12 months before study entry
- History of alcohol or drug abuse in the past year
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 RebidoseRebif 44 mcg will be injected subcutaneously three times a week using Rebif Rebidose self-injector device. | Device | First Rebif Rebidose, Then Rebiject II, First Rebiject II, Then Rebif Rebidose |
| Rebiject IIRebif 44 mcg will be injected subcutaneously three times a week using Rebiject II self-injector device. | Device | First Rebif Rebidose, Then Rebiject II, First Rebiject II, Then Rebif Rebidose |
Primary outcome
Percentage of Subjects Rating Each Device as "Easy/Very Easy to Use" Based on User Trial Questionnaire (UTQ) at Week 4
Time frame: Week 4
The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess their overall experience with using the device as "very difficult", "difficult", "neither easy nor difficult", "easy", or "very easy". Percentage of subjects who rated the overall use of device as "easy" or "very easy" were reported. Here results are presented by device sequence.
Percentage of Subjects Rating Each Device as "Easy/Very Easy to Use" Based on User Trial Questionnaire (UTQ) at Week 8
Time frame: Week 8
The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess their overall experience with using the device as "very difficult", "difficult", "neither easy nor difficult", "easy", or "very easy". Percentage of subjects who rated the overall use of device as "easy" or "very easy" were reported. Here results are presented by device sequence.
Percentage of Subjects Rating Each Device as "Easy/Very Easy to Use" Based on User Trial Questionnaire (UTQ) up to Week 8
Time frame: Baseline up to Week 8
The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess their overall experience with using the device as "very difficult", "difficult", "neither easy nor difficult", "easy", or "very easy". Percentage of subjects who rated the overall use of device as "easy" or "very easy" were reported. Here results are presented by device used.
14 secondary outcomes
Number of Subjects Rating Each Device on Level of Satisfaction With Using the Device While Traveling Based on User Trial Questionnaire (UTQ)
Time frame: Weeks 4 and 8
Percentage of Subjects Rating Each Device on Amount of Time Needed to Complete the Injection Based on User Trial Questionnaire (UTQ)
Time frame: Weeks 4 and 8
Percentage of Subjects Rating Each Device on Number of Steps Involved in Completing the Injection Based on User Trial Questionnaire (UTQ)
Time frame: Weeks 4 and 8
Percentage of Subjects Rating Each Device on Ease of Holding Based on User Trial Questionnaire (UTQ)
Time frame: Weeks 4 and 8
Number of Subjects Rating Each Device on Level of Satisfaction With Using the Device Away From Home Based on User Trial Questionnaire (UTQ)
Time frame: Weeks 4 and 8
Percentage of Subjects Rating Each Device on Level of Convenience of Using the Device Based on User Trial Questionnaire (UTQ)
Time frame: Weeks 4 and 8
Percentage of Subjects Rating Each Device on Level of Convenience of Storing the Device Based on User Trial Questionnaire (UTQ)
Time frame: Weeks 4 and 8
Percentage of Subjects Rating Each Device on Minimization of Safety Hazards Based on User Trial Questionnaire (UTQ)
Time frame: Weeks 4 and 8
Percentage of Subjects Rating Each Device on Amount of Needle Anxiety While Using the Device Based on User Trial Questionnaire (UTQ)
Time frame: Weeks 4 and 8
Percentage of Subjects Rating Each Device on Level of Satisfaction With Information Provided by the Trainer Based on User Trial Questionnaire (UTQ)
Time frame: Weeks 4 and 8
Percentage of Subjects Rating Each Device on Likelihood of Recommending the Device to Others Based on User Trial Questionnaire (UTQ)
Time frame: Weeks 4 and 8
Percentage of Subjects Rating Each Device on Overall Satisfaction With the Injection Device Based on User Trial Questionnaire (UTQ)
Time frame: Weeks 4 and 8
Percentage of Subjects Rating Each Device on Ease of Use Based on User Trial Questionnaire (UTQ)
Time frame: Weeks 4 and 8
Change From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Scores to Week 8
Time frame: Baseline, up to Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29206056Wray S, Hayward B, Dangond F, Singer B. Ease of use of two autoinjectors in patients with multiple sclerosis treated with interferon beta-1a subcutaneously three times weekly: results of the randomized, crossover REDEFINE study. Expert Opin Drug Deliv. 2018 Feb;15(2):127-135. doi: 10.1080/17425247.2018.1407755. Epub 2017 Dec 5.
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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 study director
EMD Serono, Inc., Rockland MA, a subsidiary of Merck KGaA, Darmstadt, Germany
21 sites 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 Rebidose and Rebiject II in people with Multiple Sclerosis, Relapsing-Remitting, run by EMD Serono at 21 sites 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 9 inclusion and 21 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: finished, as of the sponsor's last update on 7 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites 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 7 Mar 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?
Percentage of Subjects Rating Each Device as "Easy/Very Easy to Use" Based on User Trial Questionnaire (UTQ) at Week 4 (time frame: Week 4). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02019550, which also lists 1 linked publication.
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 7 Mar 2017.