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

This study has been completed.
Sponsor:
Collaborator:
Merck spol.s.r.o., Czech Republic
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01075880
First received: February 24, 2010
Last updated: September 5, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Multiple Sclerosis, Relapsing-Remitting
Drug: Rebif (Interferon beta-1a)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-Authorization Observational Study to Evaluate Cognition and Fatigue in RRMS Patients Treated With Rebif

Resource links provided by NLM:


Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • Percentage of subjects with decreased/increased/stable cognition status (PASAT) [ Time Frame: Baseline vs Month 6 - 12 - 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of subjects with decreased/increased/stable fatigue (FDS) [ Time Frame: Baseline vs Month 6- 12 - 24 ] [ Designated as safety issue: No ]
  • Relationship between the cognition status, the fatigue status and the EDSS status [ Time Frame: Baseline, Month 6- 12 - 24 ] [ Designated as safety issue: No ]
  • Relationship between the Rebif dosage used with cognition and fatigue status [ Time Frame: Baseline, Month 6- 12 - 24 ] [ Designated as safety issue: No ]
  • Proportion of relapse-free subjects [ Time Frame: Month 3 - 6 - 12 - 24 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Proportion of subjects without either relapse, EDSS progression, cognition status decrease and fatigue increase [ Time Frame: Month 6 - 12- 24 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Proportion of subjects using the antidepressive or antifatigue medication [ Time Frame: Baseline, Month 3 - 6 - 12 - 24 ] [ Designated as safety issue: No ]

Enrollment: 300
Study Start Date: May 2009
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: 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.
    Other Name: Rebif
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
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01075880

Locations
Czech Republic
Neurologicka klinika FNBB
Brno, Czech Republic
Neurologicka klinika, Fakultní nemocnice U Sv. Anny
Brno, Czech Republic
Neurologicke oddeleni KN.
Ceske Budejovice, Czech Republic
Neurologicka klinika Fakultní nemocnice
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
Neurologicke oddeleni KN
Pardubice, Czech Republic
Neurologicka klinika Fakultní nemocnice
Plzeň, Czech Republic
Neurologicka klinika FNKV
Praha, Czech Republic
Neurologicka klinika, Fakultní Thomayerovy nemocnice
Praha, Czech Republic
Neurologicke oddeleni NsP
Teplice, Czech Republic
Neurologicke oddeleni, Baťova nemocnice
Zlín, Czech Republic
Sponsors and Collaborators
Merck KGaA
Merck spol.s.r.o., Czech Republic
Investigators
Study Director: Medical Responsible Merck spol.s.r.o., Czech Republic
  More Information

No publications provided

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01075880     History of Changes
Other Study ID Numbers: EMR 701068-519
Study First Received: February 24, 2010
Last Updated: September 5, 2013
Health Authority: Czech Republic: State Institute for Drug Control

Keywords provided by Merck KGaA:
Multiple Sclerosis, Relapsing-Remitting
Rebif
Interferon beta-1a

Additional relevant MeSH terms:
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Interferon beta 1a
Interferons
Interferon-beta
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on September 18, 2014