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Tolerability of Rebif® (Interferon-beta 1-A) Therapy in Korean Patients With Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01074346
Recruitment Status : Completed
First Posted : February 24, 2010
Last Update Posted : February 19, 2014
Sponsor:
Information provided by (Responsible Party):
Merck KGaA, Darmstadt, Germany

Study Description
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Brief Summary:
This is an observational study to assess the tolerability of Rebif treatment in Korean multiple sclerosis (MS) subjects.

Condition or disease Intervention/treatment
Multiple Sclerosis Drug: Interferon-β-1a

Detailed Description:

The present observational study is being conducted to assess the safety information from a target of 100 Korean subjects with MS treated with Rebif. Various parameters like subjects' background (age, sex, BMI), MS history, MS status (MS type, Expanded Disability Status Score [EDSS] and others), MS Treatment Concern Questionnaire (MSTCQ), Rebif treatment status, concomitant disease modifying agents (DMA) therapy and Rebif related adverse events will be collected. Subjects will be followed for 12 months. Proportion of subjects with moderate to severe (Grade 3-5) injection site reactions after 3, 6, 12 months of Rebif treatment will be determined. Secondary outcomes like annual relapse rate, change in EDSS, changes in MSTCQ, time to first relapse and incidence of side effects associated with Rebif therapy will also be determined and presented descriptively.

OBJECTIVES

Primary objectives

  • To assess the tolerability of Rebif treatment in Korean MS subjects in a non-interventional setting Secondary Objectives
  • To evaluate subject's satisfaction, clinical data and disease characteristics of the population of MS subjects undergoing Rebif treatment.
Study Design
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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Multi-center, Observational Study to Assess the Tolerability of Interferon-beta 1-A (Rebif®) Therapy for Korean Patients With Multiple Sclerosis
Study Start Date : August 2008
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

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Groups and Cohorts
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Intervention Details:
  • Drug: Interferon-β-1a
    Interferon-β-1a according to the standard practice
    Other Name: Rebif®

Outcome Measures
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Primary Outcome Measures :
  1. Proportion of subjects with moderate to severe (grade 3-5) injection site reactions based on pain, bruising and/or transient (<24 hours) erythema; inflammation alone and with induration; necrosis at injection site; plastic surgery required for necrosis [ Time Frame: After 3, 6 and 12 months of Rebif treatment ]

Secondary Outcome Measures :
  1. Annual relapse rate [ Time Frame: Baseline to 12 months observation period ]
  2. Change in EDSS [ Time Frame: Baseline to 12 months observation period ]
  3. Change in MSTCQ [ Time Frame: Baseline to 12 months observation period ]
  4. Time to first relapse [ Time Frame: Baseline to 12 months observation period ]
  5. Incidence of side effects associated with Rebif therapy [ Time Frame: Baseline to 12 months observation period ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects with MS undergoing treatment with Rebif in Korea.
Criteria

Inclusion Criteria:

  • Subjects, who are eligible for Rebif treatment according to the indication in the national label of Rebif in Korean subjects with MS. The national labels approved by Korean Regulatory Authority are:

    1. Subjects with relapsing MS with two or more acute exacerbations in the previous two years
    2. Subjects with secondary progressive MS with ongoing relapsing activity
  • Subjects who sign the informed consent form.

Exclusion Criteria:

  • Initiation of treatment in pregnancy.
  • Subjects with a history of hypersensitivity to natural or recombinant interferon-ß, or to any excipients.
  • Subjects with current severe depression and/or suicidal ideation.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01074346


Locations
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Korea, Republic of
Samsung Medical Center
Seoul, 50 Ilwon-dong, Gangnam-gu, Korea, Republic of
Sponsors and Collaborators
Merck KGaA, Darmstadt, Germany
More Information
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Responsible Party: Merck KGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier: NCT01074346    
Other Study ID Numbers: EMR 701068-511
First Posted: February 24, 2010    Key Record Dates
Last Update Posted: February 19, 2014
Last Verified: February 2014
Keywords provided by Merck KGaA, Darmstadt, Germany:
Multiple sclerosis
Interferon-beta 1-a
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
 Interferons
Interferon-beta
Interferon beta-1a
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic