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Multiple Sclerosis, Relapsing-RemittingSKORENCT01075880

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

An observational study of Multiple Sclerosis, Relapsing-Remitting, run by Merck KGaA, Darmstadt, Germany at 13 sites in Czechia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Multiple Sclerosis, Relapsing-Remitting
What is being tested?
Rebif (Interferon beta-1a)
How many people
300 participants
Where
13 sitesCzechia
Study dates
May 2009to Jun 2013
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

Czechia13 sites

  • Neurologicka klinika FNBB

    Brno

  • Neurologicka klinika, Fakultní nemocnice U Sv. Anny

    Brno

  • Neurologicke oddeleni KN.

    České Budějovice

  • Neurologicka klinika Fakultní nemocnice

    Hradec Králové

  • Neurologicka klinika Fakultní nemocnice

    Motol

  • Neurologicka klinika, Fakultní nemocnice

    Olomouc

  • Neurologicka klinika Fakultní nemocnice

    Ostrava

  • Neurologicke oddeleni KN

    Pardubice

  • Neurologicka klinika Fakultní nemocnice

    Pilsen

  • Neurologicka klinika FNKV

    Prague

  • Neurologicka klinika, Fakultní Thomayerovy nemocnice

    Prague

  • Neurologicke oddeleni NsP

    Teplice

  • Neurologicke oddeleni, Baťova nemocnice

    Zlín

Other trials in Czechia

About this study

Official title: 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.

Read the 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
Being tested
Rebif (Interferon beta-1a)
Keywords
Multiple Sclerosis, Relapsing-Remitting, Rebif, Interferon beta-1a
Medical subject headings
Multiple Sclerosis, Relapsing-Remitting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rebif (Interferon beta-1a)Drug

    Also called Rebif

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of subjects with decreased/increased/stable cognition status (PASAT)

    Measured: Baseline vs Month 6 - 12 - 24

Secondary outcomes (8)

  1. Percentage of subjects with decreased/increased/stable fatigue (FDS)

    Measured: Baseline vs Month 6- 12 - 24

  2. Relationship between the cognition status, the fatigue status and the EDSS status

    Measured: Baseline, Month 6- 12 - 24

  3. Relationship between the Rebif dosage used with cognition and fatigue status

    Measured: Baseline, Month 6- 12 - 24

  4. Proportion of relapse-free subjects

    Measured: 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)

    Measured: Month 6 - 12 - 24

  6. Proportion of subjects without either relapse, EDSS progression, cognition status decrease and fatigue increase

    Measured: Month 6 - 12- 24

  7. Number of Rebif doses not taken since the last study visit, and the reason of dose not taken

    Measured: Month 3 - 6 - 12 - 24

  8. Proportion of subjects using the antidepressive or antifatigue medication

    Measured: Baseline, Month 3 - 6 - 12 - 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2010 (estimated)
  2. Study startMay 2009
  3. Primary completionJun 2013
  4. Study completionJun 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01075880
Sponsor's protocol ID
EMR 701068-519
Acronym
SKORE
Status last verified
Sep 2013
First submitted
24 Feb 2010
Last updated
6 Sep 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Multiple Sclerosis, Relapsing-Remitting, run by Merck KGaA, Darmstadt, Germany at 13 sites in Czechia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of subjects with decreased/increased/stable cognition status (PASAT) (time frame: Baseline vs Month 6 - 12 - 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01075880.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2013; AzTrials last refreshed its copy on 27 Oct 2026.

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