Clinical trial NCT01075880: Post-Authorization Observational Study to Evaluate Cognition and Fatigue in Relapsing-remitting Multiple Sclerosis (RRMS) Patients Treated With Rebif®
Official title: Post-Authorization Observational Study to Evaluate Cognition and Fatigue in RRMS Patients Treated With Rebif
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis, Relapsing-Remitting
Keywords: Multiple Sclerosis, Relapsing-Remitting
Rebif
Interferon beta-1a
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
Collaborators: name: Merck spol.s.r.o., Czech Republic
First posted: 2010-02-25
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with RRMS prescribed with Rebif across 14 centres in Czech Republic.

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

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.

Primary outcomes:
measure: Percentage of subjects with decreased/increased/stable cognition status (PASAT)
timeFrame: Baseline vs Month 6 - 12 - 24
Secondary outcomes:
measure: Percentage of subjects with decreased/increased/stable fatigue (FDS)
timeFrame: Baseline vs Month 6- 12 - 24
measure: Relationship between the cognition status, the fatigue status and the EDSS status
timeFrame: Baseline, Month 6- 12 - 24
measure: Relationship between the Rebif dosage used with cognition and fatigue status
timeFrame: Baseline, Month 6- 12 - 24
measure: Proportion of relapse-free subjects
timeFrame: Month 3 - 6 - 12 - 24
measure: 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)
timeFrame: Month 6 - 12 - 24
measure: Proportion of subjects without either relapse, EDSS progression, cognition status decrease and fatigue increase
timeFrame: Month 6 - 12- 24
measure: Number of Rebif doses not taken since the last study visit, and the reason of dose not taken
timeFrame: Month 3 - 6 - 12 - 24
measure: Proportion of subjects using the antidepressive or antifatigue medication
timeFrame: Baseline, Month 3 - 6 - 12 - 24
Other outcomes:
Locations:
city: Brno
country: Czech Republic
facility: Neurologicka klinika FNBB
city: Brno
country: Czech Republic
facility: Neurologicka klinika, Fakultní nemocnice U Sv. Anny
city: Ceske Budejovice
country: Czech Republic
facility: Neurologicke oddeleni KN.
city: Hradec Kralove
country: Czech Republic
facility: Neurologicka klinika Fakultní nemocnice
city: Motol
country: Czech Republic
facility: Neurologicka klinika Fakultní nemocnice
city: Olomouc
country: Czech Republic
facility: Neurologicka klinika, Fakultní nemocnice
city: Ostrava
country: Czech Republic
facility: Neurologicka klinika Fakultní nemocnice
city: Pardubice
country: Czech Republic
facility: Neurologicke oddeleni KN
city: Plzeň
country: Czech Republic
facility: Neurologicka klinika Fakultní nemocnice
city: Praha
country: Czech Republic
facility: Neurologicka klinika FNKV
city: Praha
country: Czech Republic
facility: Neurologicka klinika, Fakultní Thomayerovy nemocnice
city: Teplice
country: Czech Republic
facility: Neurologicke oddeleni NsP
city: Zlín
country: Czech Republic
facility: Neurologicke oddeleni, Baťova nemocnice
Study officials:
affiliation: Merck spol.s.r.o., Czech Republic
name: Medical Responsible
role: STUDY_DIRECTOR
References: