Evaluation of Quality of Life (QoL) in Subjects With Highly Active Relapsing Multiple Sclerosis (MS) (CLARIFY MS)

Phase 4

Completed

• Conditions: Multiple Sclerosis
• Interventions: Drug: Mavenclad®

• Registration Number: NCT03369665
• Lead Sponsor: Merck KGaA, Darmstadt, Germany

Brief Summary

The main purpose of the study was to assess the health-related quality of life (HRQoL) through the Multiple Sclerosis Quality of Life-54 Questionnaire (MSQoL-54) scale in highly-active relapsing multiple sclerosis (RMS) particpants treated with Mavenclad® for 2 years (24 months).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-06
• Study First Submitted QC: 2017-12-06
• Study First Posted: 2017-12-12
• Study Start: 2018-06-20
• Primary Completion: 2021-11-12
• Study Completion: 2021-11-12
• Status Verified: 2022-11
• Results First Submitted: 2022-11-09
• Results First Submitted QC: 2022-11-09
• Last Update Submitted: 2022-11-09
• Results First Posted: 2023-09-14
• Last Update Posted: 2023-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 485

Inclusion Criteria

• Highly active RMS as defined by:
• One relapse in the previous year and at least 1 T1 Gadolinium (Gd)+ lesion or 9 or more T2 lesions, while on therapy with other disease modifying drugs (DMDs).
• Two or more relapses in the previous year, whether on DMD treatment or not.
• Expanded Disability Status Scale (EDSS) score less than equals to (<=) 5.0.
• Other protocol defined inclusion criteria could apply.

Exclusion Criteria

• Positive hepatitis C or hepatitis B surface antigen test and/or core antibody test for immunoglobulin G (IgG) and/or immunoglobulin M (IgM).
• Current or previous history of immune deficiency disorders including a positive human immunodeficiency virus (HIV) result.
• Currently receiving immunosuppressive or myelosuppressive therapy with, for example, monoclonal antibodies, methotrexate, cyclophosphamide, cyclosporine or azathioprine, or chronic use of corticosteroids.
• History of tuberculosis, presence of active tuberculosis, or latent tuberculosis
• Presence of Progressive Multifocal Leukoencephalopathy (PML) in Magnetic Resonance Imaging (MRI).
• Active malignancy.
• Other protocol defined exclusion criteria could apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mavenclad®	Mavenclad®	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Multiple Sclerosis Quality of Life-54 Questionnaire (MSQoL-54) Physical Health Composite Summary and Mental Health Composite Summary Scores at Month 24	Baseline, Month 24	The MSQOL-54 was a multidimensional health-related QOL measure that combines both generic and MS-specific items into a single instrument. This 54-item instrument generates 12 sub-scales along with two summary scores, and two additional single-item measures. Sub-scales are: physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall quality of life, and sexual function. The two summary scores physical health and mental health are derived from a weighted combination of scale scores. Each composite summary score has a range from 0-100 where higher scores indicate better QOL. A positive change from baseline indicates improvement.

Secondary Outcome Measures

Name	Time	Method
Treatment Global Satisfaction Determined by Treatment Satisfaction Questionnaire Medication Version 1.4 (TSQM v1.4) Scale at Month 6	At Month 6	TSQM version 1.4 was a global satisfaction scale used to assess the overall level of participant's satisfaction or dissatisfaction with their medications. It comprises of 14 items assessing the following 4 domains: effectiveness (questions: 1-3), side effects (questions: 4-8), convenience (questions: 9-11), global satisfaction (questions:12-14). Global Satisfaction- Question 12 scored as 1 (not at all confident) to 5 (extremely confident); question 13 scored as 1 (not at all certain) to 5 (extremely certain); and question 14 scored as 1 (extremely dissatisfied) to 7 (extremely satisfied). The scores of the domain were added together and an algorithm was used to create a score of 0 to 100. Higher scores indicated greater satisfaction.

Trial Locations

Locations (90)

Kepler Universitätsklinikum; 🇦🇹 Linz, Austria

Paracelsus Medical University Salzburg; 🇦🇹 Salzburg, Austria

Eva Maida; 🇦🇹 Wien, Austria

Cliniques Univ. St.-Luc; 🇧🇪 Brussels, Belgium

UZ Antwerpen; 🇧🇪 Edegem, Belgium

Clinique Saint Pierre; 🇧🇪 Ottignies, Belgium

FN u sv. Anny Brno; 🇨🇿 Brno, Czechia

FN Hradec Kralove; 🇨🇿 Chocen, Czechia

Nemocnice Jihlava, p.o.; 🇨🇿 Jihlava, Czechia

Fakultni nemocnice Olomouc; 🇨🇿 Olomouc, Czechia

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