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| Name | Class |
|---|---|
| Merck spol.s.r.o., Czech Republic | INDUSTRY |
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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.
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:
Secondary Objectives:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rebif (Interferon beta-1a) | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects with decreased/increased/stable cognition status (PASAT) | Baseline vs Month 6 - 12 - 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects with decreased/increased/stable fatigue (FDS) | Baseline vs Month 6- 12 - 24 | |
| Relationship between the cognition status, the fatigue status and the EDSS status | Baseline, Month 6- 12 - 24 |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects with RRMS prescribed with Rebif across 14 centres in Czech Republic.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck spol.s.r.o., Czech Republic | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neurologicka klinika FNBB | Brno | Czechia | ||||
| Neurologicka klinika, Fakultní nemocnice U Sv. Anny |
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| Relationship between the Rebif dosage used with cognition and fatigue status | Baseline, Month 6- 12 - 24 |
| Proportion of relapse-free subjects | 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) | Month 6 - 12 - 24 |
| Proportion of subjects without either relapse, EDSS progression, cognition status decrease and fatigue increase | Month 6 - 12- 24 |
| Number of Rebif doses not taken since the last study visit, and the reason of dose not taken | Month 3 - 6 - 12 - 24 |
| Proportion of subjects using the antidepressive or antifatigue medication | Baseline, Month 3 - 6 - 12 - 24 |
| Brno |
| Czechia |
| Neurologicke oddeleni KN. | České Budějovice | Czechia |
| Neurologicka klinika Fakultní nemocnice | Hradec Králové | Czechia |
| Neurologicka klinika Fakultní nemocnice | Motol | Czechia |
| Neurologicka klinika, Fakultní nemocnice | Olomouc | Czechia |
| Neurologicka klinika Fakultní nemocnice | Ostrava | Czechia |
| Neurologicke oddeleni KN | Pardubice | Czechia |
| Neurologicka klinika Fakultní nemocnice | Pilsen | Czechia |
| Neurologicka klinika FNKV | Prague | Czechia |
| Neurologicka klinika, Fakultní Thomayerovy nemocnice | Prague | Czechia |
| Neurologicke oddeleni NsP | Teplice | Czechia |
| Neurologicke oddeleni, Baťova nemocnice | Zlín | Czechia |
| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000068556 | Interferon beta-1a |
| ID | Term |
|---|---|
| D016899 | Interferon-beta |
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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