Post-Authorization Observational Study to Evaluate Cognition and Fatigue in Relapsing-remitting Multiple Sclerosis (RRMS) Patients Treated With Rebif®

NCT ID: NCT01075880

Last Updated: 2013-09-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2013-06-30

Brief Summary

The study is planned to evaluate the cognitive functions in subjects with RRMS treated with interferon beta-1a, and its relationship to the fatigue and neurological dysfunction status.

Detailed Description

Besides the motor and sensory dysfunctions, the progression of cognitive decline is a frequent manifestation of RRMS. Fatigue is another important symptom of MS, and can negatively affect subject's Quality of life (QoL) and socio-economic functioning, including the ability to work, independent of the direct effects of disability. This is a phase IV observational, non-interventional, prospective, multicentric study to evaluate cognition in RRMS subjects treated with Rebif and its relationship to the fatigue and neurological dysfunction status. The study plans to enroll 300 subjects, across 14 centres in Czech Republic, who will be prescribed with Rebif according to its summary of product characteristics (SmPC). Assessment of cognitive and fatigue status will be done at baseline and follow-up visits at Months 3, 6, 12, 24. Subjects will be selected using the convenience method following the non-probability sampling.

OBJECTIVES

Primary Objective:

• To assess changes of cognition [measured by Paced Auditory Serial Addition Test (PASAT)] in RRMS subjects treated with Rebif

Secondary Objectives:

• To assess changes of fatigue [measured by Fatigue Descriptive Scale (FDS)] in RRMS subjects treated with Rebif
• To assess a correlation between cognition, fatigue and neurological status in RRMS subjects treated with Rebif
• To assess a relationship between Rebif dosage [22 mcg vs 44 mcg thrice a week (tiw)] and cognition (PASAT)
• To assess a relationship between Rebif dosage (22 mcg vs 44 mcg tiw) and fatigue (FDS)
• To assess adherence to Rebif treatment
• To explore the use of antidepressive and antifatigue medicaments

Conditions

Multiple Sclerosis, Relapsing-Remitting

Keywords

Multiple Sclerosis, Relapsing-Remitting; Rebif; Interferon beta-1a

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Rebif (Interferon beta-1a)

The treatment to be administered is interferon beta-1a on prescription, used as per SmPC, i.e. both doses 22 and 44 mcg s.c. tiw, and the titration pack 8.8 mcg and 22 mcg s.c. tiw when initiating the therapy.

Intervention Type: DRUG

Other Intervention Names

Rebif

Eligibility Criteria

Inclusion Criteria

• Subjects diagnosed with RRMS
• Subjects eligible for treatment with Rebif as per SmPC, the Czech local guidelines and the actual Health insurance policy.
• Subjects 18-65 years of age
• Subjects with EDSS score < 4
• Subjects who are willing and able to give informed consent

Exclusion Criteria

• Treatment with Rebif for more than 24 months prior the informed consent form has been obtained.
• Subjects with history of hypersensitivity to natural or recombinant interferon-β, or to any excipients
• Female subject who is pregnant or breast feeding and/or planning to become pregnant
• Subjects with current severe depression and/or suicidal ideation
• Any contraindication for Rebif therapy as per SmPC
• Subjects with severe disability and/or any neurologic or psychiatric condition that may interfere with test performance
• Prior treatment with interferon beta-1a i.m. or interferon beta-1b or glatiramer acetate.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck spol.s.r.o., Czech Republic

INDUSTRY

Sponsor Role: collaborator

Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Responsible

Role: STUDY_DIRECTOR

Merck spol.s.r.o., Czech Republic

Locations

Neurologicka klinika FNBB

Brno, , Czechia

Neurologicka klinika, Fakultní nemocnice U Sv. Anny

Brno, , Czechia

Neurologicke oddeleni KN.

České Budějovice, , Czechia

Neurologicka klinika Fakultní nemocnice

Hradec Králové, , Czechia

Neurologicka klinika Fakultní nemocnice

Motol, , Czechia

Neurologicka klinika, Fakultní nemocnice

Olomouc, , Czechia

Neurologicka klinika Fakultní nemocnice

Ostrava, , Czechia

Neurologicke oddeleni KN

Pardubice, , Czechia

Neurologicka klinika Fakultní nemocnice

Pilsen, , Czechia

Neurologicka klinika FNKV

Prague, , Czechia

Neurologicka klinika, Fakultní Thomayerovy nemocnice

Prague, , Czechia

Neurologicke oddeleni NsP

Teplice, , Czechia

Neurologicke oddeleni, Baťova nemocnice

Zlín, , Czechia

Countries

Czechia

Other Identifiers

EMR 701068-519

Identifier Type: -

Identifier Source: org_study_id