Multiple Sclerosis, Relapsing-remitting
Conditions
Keywords
MS
Brief 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. 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.
Interventions
DEVICERebif® via Rebiject™Mini
Rebif® will be administered subcutaneously at a dose 44 mcg three times a week with Rebiject™Mini, an auto-injection device for 3 months.
DEVICERebif® via manual injections
Rebif® will be administered subcutaneously at a dose 44 mcg three times a week with manual injections for 3 months.
Sponsors
Merck Serono International SA
EMD Serono
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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®
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of subjects with moderate to severe (Grade 3-5) injection site reactions based on physician assessment | Month 3 |
Secondary
| Measure | Time frame |
|---|---|
| Number of subjects with any injection site reactions based on physician assessment | Month 3 |
| Percentage of moderate to severe (Grade 3-5) injection site reactions reported per subject based on subject reports | Baseline up to Month 3 |
| Percentage of injection site reactions reported per subject based on subject reports | Baseline up to Month 3 |
Outcome results
None listed