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

This study has been completed.
Sponsor:
Collaborator:
Serono International S.A.
Information provided by (Responsible Party):
EMD Serono
ClinicalTrials.gov Identifier:
NCT00292253
First received: February 13, 2006
Last updated: August 4, 2013
Last verified: August 2013

February 13, 2006
August 4, 2013
January 2001
December 2002   (final data collection date for primary outcome measure)
Percentage of subjects with moderate to severe (Grade 3-5) injection site reactions based on physician assessment [ Time Frame: Month 3 ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00292253 on ClinicalTrials.gov Archive Site
  • Number of subjects with any injection site reactions based on physician assessment [ Time Frame: Month 3 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Percentage of injection site reactions reported per subject based on subject reports [ Time Frame: Baseline up to Month 3 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
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Tolerability of Rebif® Injection With and Without the Use of Rebiject™Mini in Relapsing-Remitting Multiple Sclerosis Subjects
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Sclerosis, Relapsing-remitting
  • 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.
  • 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.
  • Experimental: Rebif® with Rebiject™Mini
    Intervention: Device: Rebif® via Rebiject™Mini
  • Active Comparator: Rebif® without Rebiject™Mini
    Intervention: Device: Rebif® via manual injections
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1883
December 2002
December 2002   (final data collection date for primary outcome measure)

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®
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00292253
22982
Not Provided
EMD Serono
EMD Serono
Serono International S.A.
Study Director: Maria Lopez-Bresnahan, M.D. Serono International S.A.
EMD Serono
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP