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

This study has been completed.
Sponsor:
Information provided by:
EMD Serono
ClinicalTrials.gov Identifier:
NCT00292253
First received: February 13, 2006
Last updated: July 9, 2009
Last verified: March 2009
History of Changes

February 13, 2006
July 9, 2009
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Complete list of historical versions of study NCT00292253 on ClinicalTrials.gov Archive Site
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Tolerability of Rebif® Injection With and Without the Use of Rebiject™ Mini in Relapsing Remitting Multiple Sclerosis Patients
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A randomized, multicenter, parallel-group open-label study comparing the tolerability of Rebif® injections (44 mcg administered subcutaneously three times a week) with and without Rebiject™Mini, an auto-injection device in relapsing-remitting MS patients. Patients were randomly assigned to either one of the two Rebif® groups in a 1:1 ratio on Study Day 1 stratified by centre. Patients were to receive a minimum of three months of treatment with Rebif® 44 mcg tiw and were asked to assess their injection site reactions on a weekly basis. Clinic visit occurred one and three months after the initiation of treatment
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Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Sclerosis, Relapsing-Remitting
  • Device: Rebiject™ Mini
  • Procedure: manual injections
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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
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Inclusion Criteria:

  • ≥18 years of age
  • Relapsing-remitting MS
  • Willing and able to comply with the protocol for the duration of the study

Exclusion Criteria:

  • Had significant leukopenia/lymphopenia (white blood cell count < 0.5 times the lower limit of normal)
  • Had elevated liver function tests (AST, ALT, or alkaline phosphatase > 2 times the upper limit of normal or total bilirubin > 1.5 times the upper limit of normal)
  • Had an allergy to human serum albumin or mannitol
  • Had treatment with an investigational product or procedure within 3 months
  • Had the presence of systemic disease or abnormal laboratory findings that might interfere with patient safety, compliance or evaluation of the condition under study
  • Had concomitant use of Avonex®, Betaseron®, Copaxone®, Novantrone® or Rebif®
Both
18 Years and older
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Contact information is only displayed when the study is recruiting subjects
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NCT00292253
22982
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EMD Serono
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Study Director: Maria Lopez-Bresnahan, M.D. EMD Serono
EMD Serono
March 2009

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