A Quality of Life Study for People with Relapsing Multiple Sclerosis

• Register: EUCTR
• Last refreshed on: 30 June 2019
• Main ID: EUCTR2017-002632-17-GB
• Date of registration: 06/02/2018
• Prospective Registration: Yes
• Primary sponsor: Merck KGaA
• Public title: A Quality of Life Study for People with Relapsing Multiple Sclerosis
• Scientific title: A 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad®
• Date of first enrolment: 25/07/2018
• Target sample size: 445
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-002632-17
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no; Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Austria, Belgium, Czech Republic, Denmark, Finland, France, Greece, Hungary, Italy, Lithuania, Netherlands, Norway, Poland, Portugal, Slovakia, Spain, Sweden, United Kingdom

Contacts

• Name: Communication Center Merck KGaA
• Affiliation: Merck KGaA

• Name: Communication Center Merck KGaA
• Affiliation: Merck KGaA

Key inclusion & exclusion criteria

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)


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Relapsing multiple sclerosis
MedDRA version: 20.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Intervention(s)

Trade Name: Mavenclad®
Product Name: Cladribine
Pharmaceutical Form: Tablet
INN or Proposed INN: CLADRIBINE
CAS Number: 4291-63-8
Current Sponsor code: EMD280922
Other descriptive name: 2-chloro-2'-deoxyadenosine (2-CdA)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: at 24 months compared to baseline

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)

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

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

Secondary Outcome(s)

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

Secondary ID(s)

2017-002632-17-LT

MS700568_0021

Source(s) of Monetary Support

Merck KGaA

Ethics review

Status: Approved
Approval date:
Contact: