Back to resultsTolerability of Rebif® Injection With and Without the Use of Rebiject™Mini in Relapsing-Remitting Multiple Sclerosis Subjects
Primary Purpose
Multiple Sclerosis, Relapsing-remitting
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Rebif® via Rebiject™Mini
Rebif® via manual injections
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis, Relapsing-remitting focused on measuring MS
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®
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Rebif® with Rebiject™Mini
Rebif® without Rebiject™Mini
Arm Description
Outcomes
Primary Outcome Measures
Percentage of subjects with moderate to severe (Grade 3-5) injection site reactions based on physician assessment
Secondary Outcome Measures
Number of subjects with any injection site reactions based on physician assessment
Percentage of moderate to severe (Grade 3-5) injection site reactions reported per subject based on subject reports
Percentage of injection site reactions reported per subject based on subject reports
Full Information
NCT ID
NCT00292253
First Posted
February 13, 2006
Last Updated
August 4, 2013
Sponsor
EMD Serono
Collaborators
Merck Serono International SA
1. Study Identification
Unique Protocol Identification Number
NCT00292253
Brief Title
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
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
January 2001 (undefined)
Primary Completion Date
December 2002 (Actual)
Study Completion Date
December 2002 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EMD Serono
Collaborators
Merck Serono International SA
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Relapsing-remitting
Keywords
MS
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1883 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rebif® with Rebiject™Mini
Arm Type
Experimental
Arm Title
Rebif® without Rebiject™Mini
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Rebif® via Rebiject™Mini
Intervention Description
Rebif® will be administered subcutaneously at a dose 44 mcg three times a week with Rebiject™Mini, an auto-injection device for 3 months.
Intervention Type
Device
Intervention Name(s)
Rebif® via manual injections
Intervention Description
Rebif® will be administered subcutaneously at a dose 44 mcg three times a week with manual injections for 3 months.
Primary Outcome Measure Information:
Title
Percentage of subjects with moderate to severe (Grade 3-5) injection site reactions based on physician assessment
Time Frame
Month 3
Secondary Outcome Measure Information:
Title
Number of subjects with any injection site reactions based on physician assessment
Time Frame
Month 3
Title
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
Title
Percentage of injection site reactions reported per subject based on subject reports
Time Frame
Baseline up to Month 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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®
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Lopez-Bresnahan, M.D.
Organizational Affiliation
Merck Serono International SA
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
16193898
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.
Results Reference
result
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/16193898?dopt=Abstract
Description
Published in Multiple Sclerosis 2005;11:585-591
URL
http://www.mslifelines.com
Description
Full FDA approved prescribing information can be found here
Learn more about this trial
Tolerability of Rebif® Injection With and Without the Use of Rebiject™Mini in Relapsing-Remitting Multiple Sclerosis Subjects
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