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

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01074346
• Other study ID #: EMR 701068-511
• Status: Completed
• Phase: N/A
• First received: February 22, 2010
• Last updated: February 16, 2014
• Start date: August 2008
• Est. completion date: November 2011

Study information

• Verified date: February 2014
• Source: Merck KGaA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Interferon-ß-1a
Interferon-ß-1a according to the standard practice

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul, 50 Ilwon-dong, Gangnam-gu

Sponsors (1)

Lead Sponsor	Collaborator
Merck KGaA

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		After 3, 6 and 12 months of Rebif treatment	Yes
Secondary	Annual relapse rate		Baseline to 12 months observation period	No
Secondary	Change in EDSS		Baseline to 12 months observation period	No
Secondary	Change in MSTCQ		Baseline to 12 months observation period	No
Secondary	Time to first relapse		Baseline to 12 months observation period	No
Secondary	Incidence of side effects associated with Rebif therapy		Baseline to 12 months observation period	Yes