Multiple Sclerosis, Relapsing-remittingPhase 3NCT00292253
Tolerability of Rebif® Injection With and Without the Use of Rebiject™Mini in Relapsing-Remitting Multiple Sclerosis Subjects
A Phase 3 study testing Rebif® via Rebiject™Mini and Rebif® via manual injections in people with Multiple Sclerosis, Relapsing-remitting, run by EMD Serono.
Trial summary
This is a randomized, multicenter, parallel-group, open-label study comparing the tolerability of Rebif® injections (44 microgram [mcg] administered subcutaneously three times a week) with and without Rebiject™Mini, an auto-injection device in relapsing-remitting multiple sclerosis (MS) subjects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Relapsing-remitting
- What is being tested?
- Rebif® via Rebiject™Mini and Rebif® via manual injections
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,883 participants
- Where
- No sites listed yet
- Study dates
- Jan 2001to Dec 2002
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Greater than or equal to 18 years of age
- Has relapsing-remitting MS
- Are willing and able to comply with the protocol for the duration of the study
Who cannot join
- Has significant leukopenia/lymphopenia (white blood cell count less than (<) 0.5 times the lower limit of normal)
- Has elevated liver function tests (aspartate aminotransferase [AST], Alanine transaminase [ALT], or alkaline phosphatase greater than (>) 2 times the upper limit of normal or total bilirubin > 1.5 times the upper limit of normal)
- Has an allergy to human serum albumin or mannitol
- Had treatment with an investigational product or procedure within 3 months
- Has the presence of systemic disease or abnormal laboratory findings that might interfere with subject safety, compliance or evaluation of the condition under study
- Has concomitant use of Avonex®, Betaseron®, Copaxone®, or Novantrone®
About this study
Official title: A Randomized, Multicenter, Parallel Group, Open-label Study Comparing the Tolerability of Rebif® Injection With and Without the Use of Rebiject™Mini in Relapsing Remitting MS Patients
This is a randomized, multicenter, parallel-group, open-label study comparing the tolerability of Rebif® injections (44 microgram [mcg] administered subcutaneously three times a week) with and without Rebiject™Mini, an auto-injection device in relapsing-remitting multiple sclerosis (MS) subjects. Subjects will be randomly assigned to either one of the two Rebif® groups in a 1:1 ratio on Study Day 1 stratified by center. Subjects will receive a minimum of 3 months of treatment with Rebif® 44 mcg three times a week and will be asked to assess their injection site reactions on a weekly basis. Clinic visit will occur at 1 and 3 months after the initiation of treatment.
- Conditions
- Multiple Sclerosis, Relapsing-remitting
- Being tested
- Rebif® via Rebiject™Mini, Rebif® via manual injections
- Keywords
- MS
- 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® via Rebiject™MiniDevice
Rebif® will be administered subcutaneously at a dose 44 mcg three times a week with Rebiject™Mini, an auto-injection device for 3 months.
Rebif® via manual injectionsDevice
Rebif® will be administered subcutaneously at a dose 44 mcg three times a week with manual injections for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Rebif® with Rebiject™Mini | Experimental | Not described Receives: Device: Rebif® via Rebiject™Mini |
| Rebif® without Rebiject™Mini | Active comparator | Not described Receives: Device: Rebif® via manual injections |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects with moderate to severe (Grade 3-5) injection site reactions based on physician assessment
Measured: Month 3
Secondary outcomes (3)
Number of subjects with any injection site reactions based on physician assessment
Measured: Month 3
Percentage of moderate to severe (Grade 3-5) injection site reactions reported per subject based on subject reports
Measured: Baseline up to Month 3
Percentage of injection site reactions reported per subject based on subject reports
Measured: Baseline up to Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2006 (estimated)
- Study startJan 2001
- Primary completionDec 2002
- Study completionDec 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,883 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMD Serono
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Serono International SA
- Responsible party
- Sponsor
- Investigators
- Maria Lopez-Bresnahan, M.D., Study director, Merck Serono International SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00292253
- Sponsor's protocol ID
- 22982
- Status last verified
- Aug 2013
- First submitted
- 13 Feb 2006
- Last updated
- 6 Aug 2013
- Results posted
- No
Publications
Mikol D, Lopez-Bresnahan M, Taraskiewicz S, Chang P, Rangnow J; Rebiject Study Group. A randomized, multicentre, open-label, parallel-group trial of the tolerability of interferon beta-1a (Rebif) administered by autoinjection or manual injection in relapsing-remitting multiple sclerosis. Mult Scler. 2005 Oct;11(5):585-91. doi: 10.1191/1352458505ms1197oa.
PubMed 16193898
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Parallel Group, Open-label Study Comparing the Tolerability of Rebif® Injection With and Without the Use of Rebiject™Mini in Relapsing Remitting MS Patients
- ClinicalTrials.gov ID
- NCT00292253
- Acronym / sponsor ID
- 22982
- Conditions
- Multiple Sclerosis, Relapsing-remitting
- Keywords
- MS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,883 participants (actual)
- Lead sponsor
- EMD SeronoIndustry (pharma, biotech, devices)
- Collaborators
- Merck Serono International SA
- Study start
- Jan 2001
- Primary completion
- Dec 2002 (actual)
- Study completion
- Dec 2002 (actual)
- First posted
- 15 Feb 2006 (estimated)
- Results
- Not posted in the source record
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 randomized, multicenter, parallel-group, open-label study comparing the tolerability of Rebif® injections (44 microgram [mcg] administered subcutaneously three times a week) with and without Rebiject™Mini, an auto-injection device in relapsing-remitting multiple sclerosis (MS) subjects. Subjects will be randomly assigned to either one of the two Rebif® groups in a 1:1 ratio on Study Day 1 stratified by center. Subjects will receive a minimum of 3 months of treatment with Rebif® 44 mcg three times a week and will be asked to assess their injection site reactions on a weekly basis. Clinic visit will occur at 1 and 3 months after the initiation of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rebif® with Rebiject™Mini | Experimental | Device: Rebif® via Rebiject™Mini |
| Rebif® without Rebiject™Mini | Active comparator | Device: Rebif® via manual injections |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Greater than or equal to 18 years of age
- Has relapsing-remitting MS
- Are willing and able to comply with the protocol for the duration of the study
Key exclusion criteria (6 listed)
- Has significant leukopenia/lymphopenia (white blood cell count less than (<) 0.5 times the lower limit of normal)
- Has elevated liver function tests (aspartate aminotransferase [AST], Alanine transaminase [ALT], or alkaline phosphatase greater than (>) 2 times the upper limit of normal or total bilirubin > 1.5 times the upper limit of normal)
- Has an allergy to human serum albumin or mannitol
- Had treatment with an investigational product or procedure within 3 months
- Has the presence of systemic disease or abnormal laboratory findings that might interfere with subject safety, compliance or evaluation of the condition under study
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® via Rebiject™MiniRebif® will be administered subcutaneously at a dose 44 mcg three times a week with Rebiject™Mini, an auto-injection device for 3 months. | Device | Rebif® with Rebiject™Mini |
| Rebif® via manual injectionsRebif® will be administered subcutaneously at a dose 44 mcg three times a week with manual injections for 3 months. | Device | Rebif® without Rebiject™Mini |
Primary outcome
Percentage of subjects with moderate to severe (Grade 3-5) injection site reactions based on physician assessment
Time frame: Month 3
3 secondary outcomes
Number of subjects with any injection site reactions based on physician assessment
Time frame: Month 3
Percentage of moderate to severe (Grade 3-5) injection site reactions reported per subject based on subject reports
Time frame: Baseline up to Month 3
Percentage of injection site reactions reported per subject based on subject reports
Time frame: Baseline up to Month 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2013.
- Results publication: PubMed 16193898Mikol D, Lopez-Bresnahan M, Taraskiewicz S, Chang P, Rangnow J; Rebiject Study Group. A randomized, multicentre, open-label, parallel-group trial of the tolerability of interferon beta-1a (Rebif) administered by autoinjection or manual injection in relapsing-remitting multiple sclerosis. Mult Scler. 2005 Oct;11(5):585-91. doi: 10.1191/1352458505ms1197oa.
- Published in Multiple Sclerosis 2005;11:585-591Link provided by the sponsor.
- Full FDA approved prescribing information can be found hereLink provided by the sponsor.
Related trials for Multiple Sclerosis, Relapsing-remitting
Active, not recruiting
Myrosinase Bioactivated Gglucoraphanin for the Treatment of Neurodegenerative Diseases (GRA-MYR-ND)
PARKINSON DISEASE (Disorder), Multiple Sclerosis (MS) - Relapsing-remitting
Recruiting
Wearable Focal Vibration Therapy on Upper Extremity Function of People With Multiple Sclerosis: A Pilot Study
Multiple Sclerosis (MS) - Relapsing-remitting, Upper Extremity Dysfunction
Not yet recruiting
Treatment of Memory Retrieval Impairments in MS With HDtDCS to the LIFG in a Placebo Controlled Trial
Multiple Sclerosis, Relapsing-remitting Multiple Sclerosis (RRMS)
Recruiting
Monthly Monitoring of Plasma NfL in Treated Relapsing-remitting Multiple Sclerosis to Detect Persistent Infraclinical Disease Activity
Multiple Sclerosis (MS) - Relapsing-remitting
Active, not recruitingPhase 4
Safety and Efficacy Study of Fingolimod in Taiwanese Adults (≥ 20years) With Relapsing Remitting Multiple Sclerosis
Multiple Sclerosis
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.
Maria Lopez-Bresnahan, M.D. study director
Merck Serono International SA
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rebif® via Rebiject™Mini and Rebif® via manual injections in people with Multiple Sclerosis, Relapsing-remitting, run by EMD Serono.
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 3 inclusion and 6 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 6 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 with moderate to severe (Grade 3-5) injection site reactions based on physician assessment (time frame: Month 3). 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 NCT00292253, 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 6 Aug 2013.