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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01074346
First received: February 22, 2010
Last updated: February 16, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention
Multiple Sclerosis
Drug: Interferon-β-1a

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Annual relapse rate [ Time Frame: Baseline to 12 months observation period ] [ Designated as safety issue: No ]
  • Change in EDSS [ Time Frame: Baseline to 12 months observation period ] [ Designated as safety issue: No ]
  • Change in MSTCQ [ Time Frame: Baseline to 12 months observation period ] [ Designated as safety issue: No ]
  • Time to first relapse [ Time Frame: Baseline to 12 months observation period ] [ Designated as safety issue: No ]
  • Incidence of side effects associated with Rebif therapy [ Time Frame: Baseline to 12 months observation period ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: August 2008
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Interferon-β-1a
    Interferon-β-1a according to the standard practice
    Other Name: Rebif®
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.
  Eligibility

Genders Eligible for Study:   Both
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
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: NCT01074346

Locations
Korea, Republic of
Samsung Medical Center
Seoul, 50 Ilwon-dong, Gangnam-gu, Korea, Republic of
Sponsors and Collaborators
Merck KGaA
  More Information

No publications provided

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01074346     History of Changes
Other Study ID Numbers: EMR 701068-511
Study First Received: February 22, 2010
Last Updated: February 16, 2014
Health Authority: Korea: Food and Drug Administration

Keywords provided by Merck KGaA:
Multiple sclerosis
Interferon-beta 1-a

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
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
Interferons
Interferon-beta
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 29, 2014