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Completed

NCT Number: NCT00292253

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

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.

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Key information

Conditions

Multiple Sclerosis, Relapsing-Remitting Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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®

Treatment and study plan

Rebif® via Rebiject™Mini

Device

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® via manual injections

Device

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

Primary outcomes

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

    Time frame: Month 3

Secondary outcomes

  1. Number of subjects with any injection site reactions based on physician assessment

    Time frame: Month 3

  2. 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

  3. Percentage of injection site reactions reported per subject based on subject reports

    Time frame: Baseline up to Month 3

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Sponsors and collaborators

Lead sponsor

EMD Serono

Industry

Collaborators

  • Merck Serono International SA

Registry information

Official study 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

Important dates

Study start
2001
Primary completion
2002
Study completion
2002
First posted
Feb 15, 2006
Registry last updated
Aug 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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