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

Merck KGaA (EMD Serono)

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Drug: Interferon-β-1a

Study type: Observational

Funder types: Industry

Identifiers

NCT01074346

EMR 701068-511

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: All

Volunteers: No Healthy Volunteers

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.