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

• ClinicalTrials.gov Identifier: NCT01074346
• Recruitment Status: Completed
• First Posted: February 24, 2010
• Last Update Posted: February 19, 2014
• Sponsor: Merck KGaA, Darmstadt, Germany
• 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

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

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

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