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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
  Purpose

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


Condition Intervention Phase
Multiple Sclerosis, Relapsing-Remitting
 Device: Rebiject™ Mini
Procedure: manual injections
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by EMD Serono:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

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®
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00292253

Sponsors and Collaborators
EMD Serono
Investigators
Study Director: Maria Lopez-Bresnahan, M.D. EMD Serono
  More Information

Additional Information:
Published in Multiple Sclerosis 2005;11:585-591  This link exits the ClinicalTrials.gov site
Full FDA approved prescribing information can be found here  This link exits the ClinicalTrials.gov site

Publications:

ClinicalTrials.gov Identifier: NCT00292253     History of Changes
Other Study ID Numbers: 22982
Study First Received: February 13, 2006
Last Updated: July 9, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by EMD Serono:
MS

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013