NCT01075880

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 300 (actual)
• Sponsor: Merck KGaA, Darmstadt, Germany · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• Multiple Sclerosis, Relapsing-Remitting

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-05-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2010-02-25
• Last updated: 2013-09-06

Locations

13 sites across 1 country: Czechia