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

September 5, 2013 updated by: Merck KGaA, Darmstadt, Germany

Post-Authorization Observational Study to Evaluate Cognition and Fatigue in RRMS Patients Treated With Rebif

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Brno, Czech Republic
        • Neurologicka klinika FNBB
      • Brno, Czech Republic
        • Neurologicka klinika, Fakultní nemocnice U Sv. Anny
      • Ceske Budejovice, Czech Republic
        • Neurologicke oddeleni KN.
      • Hradec Kralove, Czech Republic
        • Neurologicka klinika Fakultní nemocnice
      • Motol, Czech Republic
        • Neurologicka klinika Fakultní nemocnice
      • Olomouc, Czech Republic
        • Neurologicka klinika, Fakultní nemocnice
      • Ostrava, Czech Republic
        • Neurologicka klinika Fakultní nemocnice
      • Pardubice, Czech Republic
        • Neurologicke oddeleni KN
      • Plzeň, Czech Republic
        • Neurologicka klinika Fakultní nemocnice
      • Praha, Czech Republic
        • Neurologicka klinika FNKV
      • Praha, Czech Republic
        • Neurologicka klinika, Fakultní Thomayerovy nemocnice
      • Teplice, Czech Republic
        • Neurologicke oddeleni NsP
      • Zlín, Czech Republic
        • Neurologicke oddeleni, Baťova nemocnice

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects with RRMS prescribed with Rebif across 14 centres in Czech Republic.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of subjects with decreased/increased/stable cognition status (PASAT)
Time Frame: Baseline vs Month 6 - 12 - 24
Baseline vs Month 6 - 12 - 24

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of subjects with decreased/increased/stable fatigue (FDS)
Time Frame: Baseline vs Month 6- 12 - 24
Baseline vs Month 6- 12 - 24
Relationship between the cognition status, the fatigue status and the EDSS status
Time Frame: Baseline, Month 6- 12 - 24
Baseline, Month 6- 12 - 24
Relationship between the Rebif dosage used with cognition and fatigue status
Time Frame: Baseline, Month 6- 12 - 24
Baseline, Month 6- 12 - 24
Proportion of relapse-free subjects
Time Frame: Month 3 - 6 - 12 - 24
Month 3 - 6 - 12 - 24
Proportion of subjects with defined EDSS changes (decrease; no change; increase of 0.5 - 1.0; 1.5 - 2.0; 2.5 - 3.0; 3.0 or more points, respectively)
Time Frame: Month 6 - 12 - 24
Month 6 - 12 - 24
Proportion of subjects without either relapse, EDSS progression, cognition status decrease and fatigue increase
Time Frame: Month 6 - 12- 24
Month 6 - 12- 24
Number of Rebif doses not taken since the last study visit, and the reason of dose not taken
Time Frame: Month 3 - 6 - 12 - 24
Month 3 - 6 - 12 - 24
Proportion of subjects using the antidepressive or antifatigue medication
Time Frame: Baseline, Month 3 - 6 - 12 - 24
Baseline, Month 3 - 6 - 12 - 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck KGaA, Darmstadt, Germany

Collaborators

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

Investigators

  • Study Director: Medical Responsible, Merck spol.s.r.o., Czech Republic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (ACTUAL)

June 1, 2013

Study Completion (ACTUAL)

June 1, 2013

Study Registration Dates

First Submitted

February 24, 2010

First Submitted That Met QC Criteria

February 24, 2010

First Posted (ESTIMATE)

February 25, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

September 6, 2013

Last Update Submitted That Met QC Criteria

September 5, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMR 701068-519

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Multiple Sclerosis, Relapsing-Remitting

Clinical Trials on Rebif (Interferon beta-1a)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bangladesh

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe