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

August 4, 2013 updated by: EMD Serono

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1883

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rebif® with Rebiject™Mini
Device: Rebif® 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.
Active Comparator: Rebif® without Rebiject™Mini
Device: Rebif® via manual injections
Rebif® will be administered subcutaneously at a dose 44 mcg three times a week with manual injections for 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of subjects with moderate to severe (Grade 3-5) injection site reactions based on physician assessment
Time Frame: Month 3
Month 3

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of subjects with any injection site reactions based on physician assessment
Time Frame: Month 3
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
Baseline up to Month 3
Percentage of injection site reactions reported per subject based on subject reports
Time Frame: Baseline up to Month 3
Baseline up to Month 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EMD Serono

Collaborators

Merck Serono International SA

Investigators

  • Study Director: Maria Lopez-Bresnahan, M.D., Merck Serono International SA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2001

Primary Completion (Actual)

December 1, 2002

Study Completion (Actual)

December 1, 2002

Study Registration Dates

First Submitted

February 13, 2006

First Submitted That Met QC Criteria

February 13, 2006

First Posted (Estimate)

February 15, 2006

Study Record Updates

Last Update Posted (Estimate)

August 6, 2013

Last Update Submitted That Met QC Criteria

August 4, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22982

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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