NCT00292253

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,883

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2001

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2001

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2002

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

February 13, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 15, 2006

Completed
Last Updated

August 6, 2013

Status Verified

August 1, 2013

Enrollment Period

1.9 years

First QC Date

February 13, 2006

Last Update Submit

August 4, 2013

Conditions

Multiple Sclerosis, Relapsing-remitting

Keywords

MS

Outcome Measures

Primary Outcomes (1)

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

    Month 3

Secondary Outcomes (3)

  • 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

Study Arms (2)

Rebif® with Rebiject™Mini

EXPERIMENTAL
Device: Rebif® via Rebiject™Mini

Rebif® without Rebiject™Mini

ACTIVE COMPARATOR
Device: Rebif® via manual injections

Interventions

Rebif® via Rebiject™MiniDEVICE

Rebif® will be administered subcutaneously at a dose 44 mcg three times a week with Rebiject™Mini, an auto-injection device for 3 months.

Rebif® with Rebiject™Mini
Rebif® via manual injectionsDEVICE

Rebif® will be administered subcutaneously at a dose 44 mcg three times a week with manual injections for 3 months.

Rebif® without Rebiject™Mini

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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®

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 16193898RESULT

Related Links

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Condition Hierarchy (Ancestors)

Multiple SclerosisDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Maria Lopez-Bresnahan, M.D.

    Merck Serono International SA

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2006

First Posted

February 15, 2006

Study Start

January 1, 2001

Primary Completion

December 1, 2002

Study Completion

December 1, 2002

Last Updated

August 6, 2013

Record last verified: 2013-08