Clinical trial NCT01074346: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Multiple sclerosis
Interferon-beta 1-a
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
First posted: 2010-02-24
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects with MS undergoing treatment with Rebif in Korea.

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.

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.

Primary outcomes:
measure: 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
timeFrame: After 3, 6 and 12 months of Rebif treatment
Secondary outcomes:
measure: Annual relapse rate
timeFrame: Baseline to 12 months observation period
measure: Change in EDSS
timeFrame: Baseline to 12 months observation period
measure: Change in MSTCQ
timeFrame: Baseline to 12 months observation period
measure: Time to first relapse
timeFrame: Baseline to 12 months observation period
measure: Incidence of side effects associated with Rebif therapy
timeFrame: Baseline to 12 months observation period
Other outcomes:
Locations:
city: Seoul, 50 Ilwon-dong, Gangnam-gu
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References: