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

Phase 3

Completed

• Conditions: Multiple Sclerosis, Relapsing-remitting
• Interventions: Device: Rebif® via Rebiject™Mini; Device: Rebif® via manual injections

• Registration Number: NCT00292253
• Lead Sponsor: EMD Serono

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-01
• Primary Completion: 2002-12
• Study Completion: 2002-12
• Study First Submitted: 2006-02-13
• Study First Submitted QC: 2006-02-13
• Study First Posted: 2006-02-15
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-04
• Last Update Posted: 2013-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1883

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®

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rebif® with Rebiject™Mini	Rebif® via Rebiject™Mini	-
Rebif® without Rebiject™Mini	Rebif® via manual injections	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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