Tolerability of Rebif® Injection With and Without the Use of Rebiject™Mini in Relapsing-Remitting Multiple Sclerosis Subjects

EMD Serono1,883 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,883

Conditions

Multiple Sclerosis, Relapsing-remitting

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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®

Outcomes

Primary Outcomes

Percentage of subjects with moderate to severe (Grade 3-5) injection site reactions based on physician assessment

Time frame: Month 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