DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Merck KGaA
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Sclerosis

Intervention: Interferon-β-1a (Drug)

Phase: N/A

Status: Completed

Sponsored by: Merck KGaA

Summary

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

Clinical Details

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 design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: 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

Secondary outcome:

Annual relapse rate

Change in EDSS

Change in MSTCQ

Time to first relapse

Incidence of side effects associated with Rebif therapy

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

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Samsung Medical Center, Seoul, 50 Ilwon-dong, Gangnam-gu, Korea, Republic of
Additional Information

Starting date: August 2008
Last updated: February 16, 2014

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017