A Quality of Life Study for People with Relapsing Multiple Sclerosis

Phase 1

• Conditions: Relapsing multiple sclerosis; MedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2017-002632-17-SK
• Lead Sponsor: Merck KGaA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-04-17
• Last Update Posted: 15 November 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 445

Inclusion Criteria

• Male or female subjects = 18 years old;
• 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;
• EDSS score =5.0

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 445
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Positive test for hepatitis C or positive tests for hepatitis B infection:
either hepatitis B surface antigen (HBsAg) positive, or positive hepatitis B core antibody (total anti-HBcAb) confirmed by a positive viral polymerase chain reaction (PCR)
• Current or previous history of immune deficiency disorders including a positive human immunodeficiency virus (HIV) result
• Currently receiving immunosuppressive or myelosuppressive therapy with, (e.g., monoclonal antibodies, methotrexate, cyclophosphamide, cyclosporine, mitoxantrone or azathioprine), or chronic use of corticosteroids
• History of tuberculosis, presence of active tuberculosis, or latent tuberculosis
• Presence of signs of progressive multifocal leukoencephalopathy (PML) detected by MRI, clinical and/or biomarker evaluations or other (than MS) major Central Nervous System disease clinically diagnosed or evidenced in screening MRI
• Active malignancy and history of malignancy
• Hypersensitivity to Mavenclad® or to any of the excipients listed in the SmPC
• Presence or suspect of PML or other (than MS) major Central Nervous System disease clinically diagnosed or evidences in screening MRI
• Moderate or severe renal impairment (creatinine clearance <60 mL/min)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the health related quality of life (HRQoL) through the MSQOL-54 scale in relapsing multiple sclerosis subjects treated with Mavenclad® for 2 years (24 months);Secondary Objective: To assess treatment satisfaction through the TSQM v1.4 questionnaire in highly active RMS relapsing multiple sclerosis subjects at 6 months of treatment;Primary end point(s): Changes in MSQoL-54 at 24 months compared to baseline, i.e., the changes in the physical and mental health composite scores;Timepoint(s) of evaluation of this end point: at 24 months compared to baseline

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Treatment global satisfaction assessed by TSQM v1.4 at 6 months;Timepoint(s) of evaluation of this end point: at 6 months