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

Multiple Sclerosis, Relapsing-Remitting Clinical Trial

— SKORE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01075880
• Other study ID #: EMR 701068-519
• Status: Completed
• Phase: N/A
• First received: February 24, 2010
• Last updated: September 5, 2013
• Start date: May 2009
• Est. completion date: June 2013

Study information

• Verified date: September 2013
• Source: Merck KGaA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: State Institute for Drug Control
• Study type: Observational

Clinical 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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-ß, 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Intervention

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.

Locations

Country	Name	City	State
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	Plzen
Czech Republic	Neurologicka klinika FNKV	Praha
Czech Republic	Neurologicka klinika, Fakultní Thomayerovy nemocnice	Praha
Czech Republic	Neurologicke oddeleni NsP	Teplice
Czech Republic	Neurologicke oddeleni, Batova nemocnice	Zlín

Sponsors (2)

Lead Sponsor	Collaborator
Merck KGaA	Merck spol.s.r.o., Czech Republic

Country where clinical trial is conducted

Czech Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of subjects with decreased/increased/stable cognition status (PASAT)		Baseline vs Month 6 - 12 - 24	No
Secondary	Percentage of subjects with decreased/increased/stable fatigue (FDS)		Baseline vs Month 6- 12 - 24	No
Secondary	Relationship between the cognition status, the fatigue status and the EDSS status		Baseline, Month 6- 12 - 24	No
Secondary	Relationship between the Rebif dosage used with cognition and fatigue status		Baseline, Month 6- 12 - 24	No
Secondary	Proportion of relapse-free subjects		Month 3 - 6 - 12 - 24	No
Secondary	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	No
Secondary	Proportion of subjects without either relapse, EDSS progression, cognition status decrease and fatigue increase		Month 6 - 12- 24	No
Secondary	Number of Rebif doses not taken since the last study visit, and the reason of dose not taken		Month 3 - 6 - 12 - 24	No
Secondary	Proportion of subjects using the antidepressive or antifatigue medication		Baseline, Month 3 - 6 - 12 - 24	No