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

Study Overview
=================
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

Official Title
-----------------
Post-Authorization Observational Study to Evaluate Cognition and Fatigue in RRMS Patients Treated With Rebif

Conditions
-----------------
Multiple Sclerosis, Relapsing-Remitting

Intervention / Treatment
-----------------
* Drug: Rebif (Interferon beta-1a)


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects with decreased/increased/stable cognition status (PASAT) |  | Baseline vs Month 6 - 12 - 24 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple Sclerosis, Relapsing-Remitting, Rebif, Interferon beta-1a