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:
Merck Serono International SA
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
  Purpose

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.


Condition Intervention Phase
Multiple Sclerosis, Relapsing-remitting
Device: Rebif® via Rebiject™Mini
Device: Rebif® via manual injections
Phase 3

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

Resource links provided by NLM:


Further study details as provided by EMD Serono:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 1883
Study Start Date: January 2001
Study Completion Date: December 2002
Primary Completion Date: December 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rebif® with Rebiject™Mini 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.
Active Comparator: Rebif® without Rebiject™Mini 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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®
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00292253

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

Additional Information:
Publications:
Responsible Party: EMD Serono
ClinicalTrials.gov Identifier: NCT00292253     History of Changes
Other Study ID Numbers: 22982
Study First Received: February 13, 2006
Last Updated: August 4, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by EMD Serono:
MS

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Interferon beta 1a
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 01, 2014