Clinical trial NCT00292253: Tolerability of Rebif® Injection With and Without the Use of Rebiject™Mini in Relapsing-Remitting Multiple Sclerosis Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Sclerosis, Relapsing-remitting
Keywords: MS
Lead sponsor: EMD Serono
Sponsor class: INDUSTRY
Collaborators: name: Merck Serono International SA
First posted: 2006-02-15
Enrollment: 1883
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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®

Primary outcomes:
measure: Percentage of subjects with moderate to severe (Grade 3-5) injection site reactions based on physician assessment
timeFrame: Month 3
Secondary outcomes:
measure: Number of subjects with any injection site reactions based on physician assessment
timeFrame: Month 3
measure: Percentage of moderate to severe (Grade 3-5) injection site reactions reported per subject based on subject reports
timeFrame: Baseline up to Month 3
measure: Percentage of injection site reactions reported per subject based on subject reports
timeFrame: Baseline up to Month 3
Other outcomes:
Locations:
Study officials:
affiliation: Merck Serono International SA
name: Maria Lopez-Bresnahan, M.D.
role: STUDY_DIRECTOR
References:
citation: 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.