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

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ClinicalTrials.gov Identifier: NCT01075880
Recruitment Status : Completed
First Posted : February 25, 2010
Last Update Posted : September 6, 2013
Sponsor:
Collaborator:
Merck spol.s.r.o., Czech Republic
Information provided by (Responsible Party):
Merck KGaA, Darmstadt, Germany

Study Description
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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.

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

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 Design
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Study Type : Observational
Actual Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-Authorization Observational Study to Evaluate Cognition and Fatigue in RRMS Patients Treated With Rebif
Study Start Date : May 2009
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

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Groups and Cohorts
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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

Outcome Measures
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Primary Outcome Measures :
  1. Percentage of subjects with decreased/increased/stable cognition status (PASAT) [ Time Frame: Baseline vs Month 6 - 12 - 24 ]

Secondary Outcome Measures :
  1. Percentage of subjects with decreased/increased/stable fatigue (FDS) [ Time Frame: Baseline vs Month 6- 12 - 24 ]
  2. Relationship between the cognition status, the fatigue status and the EDSS status [ Time Frame: Baseline, Month 6- 12 - 24 ]
  3. Relationship between the Rebif dosage used with cognition and fatigue status [ Time Frame: Baseline, Month 6- 12 - 24 ]
  4. Proportion of relapse-free subjects [ Time Frame: Month 3 - 6 - 12 - 24 ]
  5. 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 ]
  6. Proportion of subjects without either relapse, EDSS progression, cognition status decrease and fatigue increase [ Time Frame: Month 6 - 12- 24 ]
  7. 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 ]
  8. Proportion of subjects using the antidepressive or antifatigue medication [ Time Frame: Baseline, Month 3 - 6 - 12 - 24 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01075880


Locations
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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, Darmstadt, Germany
Merck spol.s.r.o., Czech Republic
Investigators
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Study Director: Medical Responsible Merck spol.s.r.o., Czech Republic
More Information
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Responsible Party: Merck KGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier: NCT01075880    
Other Study ID Numbers: EMR 701068-519
First Posted: February 25, 2010    Key Record Dates
Last Update Posted: September 6, 2013
Last Verified: September 2013
Keywords provided by Merck KGaA, Darmstadt, Germany:
Multiple Sclerosis, Relapsing-Remitting
Rebif
Interferon beta-1a
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Fatigue
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
 Immune System Diseases
Interferons
Interferon-beta
Interferon beta-1a
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic