Status:
COMPLETED
Evaluation of Quality of Life (QoL) in Subjects With Highly Active Relapsing Multiple Sclerosis (MS) (CLARIFY MS)
Lead Sponsor:
Merck KGaA, Darmstadt, Germany
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 multi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 12 2021
Estimated Enrollment :
485 Patients enrolled
Trial Details
Trial ID
NCT03369665
Start Date
June 20 2018
End Date
November 12 2021
Last Update
September 14 2023
Active Locations (92)
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1
Kepler Universitätsklinikum
Linz, Austria, 4021
2
Paracelsus Medical University Salzburg
Salzburg, Austria
3
Eva Maida
Vienna, Austria
4
Cliniques Univ. St.-Luc
Brussels, Belgium, 1200