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

• Register: ClinicalTrials.gov
• Last refreshed on: 27 September 2021
• Main ID: NCT03369665
• Date of registration: 06/12/2017
• Prospective Registration: Yes
• Primary sponsor: Merck KGaA, Darmstadt, Germany
• Public title: Evaluation of Quality of Life (QoL) in Subjects With Highly Active Relapsing Multiple Sclerosis (MS) (CLARIFY MS)
• 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® (CLARIFY MS)
• Date of first enrolment: June 20, 2018
• Target sample size: 485
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT03369665
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

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

Contacts

• Name: Medical Responsible
• Affiliation: Merck KGaA, Darmstadt, Germany

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: Mavenclad®

Primary Outcome(s)

Change From Baseline in Multiple Sclerosis Quality of Life-54 Questionnaire (MSQoL-54) Scale Score at Month 24 [Time Frame: Baseline, Month 24]

Secondary Outcome(s)

Treatment Satisfaction Assessed by Treatment Satisfaction Questionnaire Medication Version 1.4 (TSQM v1.4) Scale at Month 6 [Time Frame: Month 6]

Secondary ID(s)

2017-002632-17

MS700568_0021

Source(s) of Monetary Support

Please refer to primary and secondary sponsors