Multiple SclerosisPhase 3PerformsNCT01036165
A Multicenter, Open-label, RebiSmart™ Autoinjector Ease of Use Study
A Phase 3 study testing RebiSmart™ in people with Multiple Sclerosis, run by EMD Serono at 1 site in United States.
Trial summary
The purpose of this study is to test the RebiSmart™ for ease of use multiple domains related to subject's acceptability and satisfaction reliability of the correct function for self-injection of Rebif® 44 mcg sc tiw in subjects with RMS. 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?
- RebiSmart™
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Aug 2010
- Phase
- Phase 3
- 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, 18-65 years of age, inclusive, at the time of informed consent signature
- RMS diagnosed according to the McDonald criteria
- Currently receiving Rebif® 44mcg sc tiw using manual injections and/or Rebiject II autoinjector for greater than or equal to twelve weeks
- Capable of self-injecting using the RebiSmart™ autoinjector. Self- injecting is defined as being able to make 2 of the 3 weekly injections without assistance.
- Be willing and able to comply with the study procedures for the duration of the trial
- Have given written informed consent and signed Health Insurance Portability and Accountability Act (HIPAA) Authorization before any study- related activities are carried out
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- Female subjects must not be either pregnant or breast-feeding and must lack childbearing potential, as defined by either:
- Being post-menopausal or surgically sterile, or using a highly effective method of contraception (defined as a method that results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly, and includes for instance, implants, injectables, combined oral contraceptives*, some intrauterine devices, sexual abstinence or vasectomised partner)
- Female subjects of childbearing potential must have a negative pregnancy test at Screening and Study Day 1 to be included in the trial. A urine pregnancy test will also be done at the Week 12/Exit visit
- Note for subjects using a hormonal contraceptive method: No formal drug interaction studies have been carried out with Rebif®. As interferons have been reported to exert an inhibitory activity on hepatic microsomal enzymes, it is unlikely that the clearance of oral contraceptives would increase and result in decreased efficacy. In over 10,000 patient years of clinical trial experience with Rebif®, there has never been any indication of an interaction with oral contraceptives.
Who cannot join
- Have used any other injectable medications (e.g. for pain) on a regular basis during the week prior to Screening or throughout the duration of the trial (the administration of a single injection for treatment or prophylaxis of a condition unrelated to MS or Rebif® therapy (e.g., influenza or pneumococcus vaccination) will be acceptable)
- Have received MS therapy other than Rebif® within twelve weeks prior to Screening or at any time during the trial (e.g., other disease modifying drugs, Rebif® New Formulation, combination therapy, immunomodulatory and/or immunosuppressive agents, including but not limited to any other interferon (Avonex/Betaseron/Extavia), glatiramer acetate (Copolymer I), cyclophosphamide, cyclosporine, methotrexate, linomide, azathioprine, mitoxantrone, teriflunomide, laquinimod, cladribine, fingolimod (FTY720), total lymphoid irradiation, anti-lymphocyte monoclonal antibody treatment (e.g. natalizumab, alemtuzumab/Campath, anti-CD4), Intravenous immunoglobulin (IVIg), cytokines or anti-cytokine therapy) and telbivudine
- Have inadequate liver function, defined by a alanine aminotransferase (ALT) > 2.5x upper limit of normal (ULN), or alkaline phosphatase > 2.5x ULN, or total bilirubin > 2.5x ULN
- Have inadequate bone marrow reserve, defined as a total white blood cell count < 3.0x 109/L, platelet count < 75x109/L, hemoglobin < 100g/L
- Have complete transverse myelitis or simultaneous-onset bilateral optic neuritis
- Have a history of alcohol or drug abuse
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- Have thyroid dysfunction
- Have moderate to severe renal impairment
- Have a major medical or psychiatric illness that in the opinion of the investigator creates undue risk to the subject or could affect compliance with the study protocol
- Have a history of seizures not adequately controlled by treatment
- Have serious or acute cardiac disease, such as uncontrolled dysrhythmias, uncontrolled angina pectoris, cardiomyopathy, or uncontrolled congestive heart failure
- Have, in the opinion of the investigator, major visual, physical or cognitive impairment that would preclude the subject from self-injecting with the RebiSmart™ autoinjector
- Have a known hypersensitivity or allergy to interferon-beta or any of the excipients
- Have participated in another clinical trial within the past thirty days
- Are pregnant or attempting to conceive
- Have previously used a RebiSmart™ autoinjector
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Twelve-week, Phase IIIb, Open-label, Single-arm, Multicenter Trial to Evaluate Ease of Use of an Electronic Autoinjector (RebiSmart™) for Self-injection in Subjects With Relapsing Multiple Sclerosis (RMS) Treated With Rebif® 44mcg Subcutaneously (sc) Three Times a Week (Tiw)
The purpose of this study is to test the RebiSmart™ for
- ease of use
- multiple domains related to subject's acceptability and satisfaction
- reliability of the correct function for self-injection of Rebif® 44 mcg sc tiw in subjects with RMS.
- Conditions
- Multiple Sclerosis
- Being tested
- RebiSmart™
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RebiSmart™Device
The RebiSmart™ autoinjector contains Rebif® 132 mcg multidose cartridges for sc injection.
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary Endpoint is the Proportion of RMS Subjects Rating the RebiSmart™ Autoinjector as 'Easy to Use' or 'Very Easy to Use' for Self-injection in a User Trial Questionnaire.
Data from the User Trial Questionnaire-B, Question 13 (Overall, how do you rate your experience with using the injection device). Mean and confidence intervals refer to proportion of subjects responding positively to question. Missing values were replaced with worst case response.
Measured: at 12 Weeks
Secondary outcomes (1)
Multiple Secondary Endpoints Will be Assessed, Based on Questions From the User Trial Questionnaire Related to the RebiSmart™ Autoinjector Use-related Outcomes.
The User Trial Questionnaire B was administered at Week 6 and Week 12 to assess the ease of use, functional reliability, overall satisfaction, satisfaction with device attributes, convenience, safety and portability of the Rebismart. Means and confidence intervals refer to the proportion of subjects responding positively, based on the number of non-missing values for each question. Secondary endpoints presented for decriptive purposes only thus no statistical analysis performed.
Measured: at Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionAug 2010
- Study completionAug 2010
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 3
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMD Serono
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Fernando Dangond, MD, Study director, EMD Serono
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01036165
- Sponsor's protocol ID
- 29652
- Acronym
- Performs
- Status last verified
- Aug 2013
- First submitted
- 18 Dec 2009
- Last updated
- 8 Aug 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Twelve-week, Phase IIIb, Open-label, Single-arm, Multicenter Trial to Evaluate Ease of Use of an Electronic Autoinjector (RebiSmart™) for Self-injection in Subjects With Relapsing Multiple Sclerosis (RMS) Treated With Rebif® 44mcg Subcutaneously (sc) Three Times a Week (Tiw)
- ClinicalTrials.gov ID
- NCT01036165
- Acronym / sponsor ID
- Performs / 29652
- Conditions
- Multiple Sclerosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- EMD SeronoIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 21 Dec 2009 (estimated)
- Results
- Posted 22 Dec 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test the RebiSmart™ for
- ease of use
- multiple domains related to subject's acceptability and satisfaction
- reliability of the correct function for self-injection of Rebif® 44 mcg sc tiw in subjects with RMS.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male and female subjects, 18-65 years of age, inclusive, at the time of informed consent signature
- RMS diagnosed according to the McDonald criteria
- Currently receiving Rebif® 44mcg sc tiw using manual injections and/or Rebiject II autoinjector for greater than or equal to twelve weeks
- Capable of self-injecting using the RebiSmart™ autoinjector. Self- injecting is defined as being able to make 2 of the 3 weekly injections without assistance.
- Be willing and able to comply with the study procedures for the duration of the trial
Key exclusion criteria (16 listed)
- Have used any other injectable medications (e.g. for pain) on a regular basis during the week prior to Screening or throughout the duration of the trial (the administration of a single injection for treatment or prophylaxis of a condition unrelated to MS or Rebif® therapy (e.g., influenza or pneumococcus vaccination) will be acceptable)
- Have received MS therapy other than Rebif® within twelve weeks prior to Screening or at any time during the trial (e.g., other disease modifying drugs, Rebif® New Formulation, combination therapy, immunomodulatory and/or immunosuppressive agents, including but not limited to any other interferon (Avonex/Betaseron/Extavia), glatiramer acetate (Copolymer I), cyclophosphamide, cyclosporine, methotrexate, linomide, azathioprine, mitoxantrone, teriflunomide, laquinimod, cladribine, fingolimod (FTY720), total lymphoid irradiation, anti-lymphocyte monoclonal antibody treatment (e.g. natalizumab, alemtuzumab/Campath, anti-CD4), Intravenous immunoglobulin (IVIg), cytokines or anti-cytokine therapy) and telbivudine
- Have inadequate liver function, defined by a alanine aminotransferase (ALT) > 2.5x upper limit of normal (ULN), or alkaline phosphatase > 2.5x ULN, or total bilirubin > 2.5x ULN
- Have inadequate bone marrow reserve, defined as a total white blood cell count < 3.0x 109/L, platelet count < 75x109/L, hemoglobin < 100g/L
- Have complete transverse myelitis or simultaneous-onset bilateral optic neuritis
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 |
|---|---|---|
| RebiSmart™The RebiSmart™ autoinjector contains Rebif® 132 mcg multidose cartridges for sc injection. | Device | – |
Primary outcome
The Primary Endpoint is the Proportion of RMS Subjects Rating the RebiSmart™ Autoinjector as 'Easy to Use' or 'Very Easy to Use' for Self-injection in a User Trial Questionnaire.
Time frame: at 12 Weeks
Data from the User Trial Questionnaire-B, Question 13 (Overall, how do you rate your experience with using the injection device). Mean and confidence intervals refer to proportion of subjects responding positively to question. Missing values were replaced with worst case response.
1 secondary outcome
Multiple Secondary Endpoints Will be Assessed, Based on Questions From the User Trial Questionnaire Related to the RebiSmart™ Autoinjector Use-related Outcomes.
Time frame: at Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Fernando Dangond, MD study director
EMD Serono
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing RebiSmart™ 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 10 inclusion and 16 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 8 Aug 2013. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 22 Dec 2010). 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?
The Primary Endpoint is the Proportion of RMS Subjects Rating the RebiSmart™ Autoinjector as 'Easy to Use' or 'Very Easy to Use' for Self-injection in a User Trial Questionnaire. (time frame: at 12 Weeks). 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 8 Aug 2013.