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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

Tracking Information
First Submitted Date February 22, 2010
First Posted Date February 24, 2010
Last Update Posted Date February 19, 2014
Study Start Date August 2008
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 22, 2010)
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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 22, 2010)
  • Annual relapse rate [ Time Frame: Baseline to 12 months observation period ]
  • Change in EDSS [ Time Frame: Baseline to 12 months observation period ]
  • Change in MSTCQ [ Time Frame: Baseline to 12 months observation period ]
  • Time to first relapse [ Time Frame: Baseline to 12 months observation period ]
  • Incidence of side effects associated with Rebif therapy [ Time Frame: Baseline to 12 months observation period ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Tolerability of Rebif® (Interferon-beta 1-A) Therapy in Korean Patients With Multiple Sclerosis
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
Brief Summary This is an observational study to assess the tolerability of Rebif treatment in Korean multiple sclerosis (MS) subjects.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Subjects with MS undergoing treatment with Rebif in Korea.
Condition Multiple Sclerosis
Intervention Drug: Interferon-β-1a
Interferon-β-1a according to the standard practice
Other Name: Rebif®
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 16, 2014)
60
Original Estimated Enrollment
 (submitted: February 22, 2010)
100
Actual Study Completion Date November 2011
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT01074346
Other Study ID Numbers EMR 701068-511
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Merck KGaA, Darmstadt, Germany
Study Sponsor Merck KGaA, Darmstadt, Germany
Collaborators Not Provided
Investigators Not Provided
PRS Account Merck KGaA, Darmstadt, Germany
Verification Date February 2014