Phase 4
Completed N=482
Evaluation of Quality of Life (QoL) in Subjects With Highly Active Relapsing Multiple Sclerosis (MS) (CLARIFY MS)
Source: ClinicalTrials.gov NCT03369665 ↗Enrolled (actual)
482
Serious AEs
5.4%
Results posted
Sep 2023
Primary outcomePrimary: 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 — 4.86; 4.80 Score on a Scale
◆ Published Evidence
Established
▲ Trending
21citations · ~7 / year
Improvements in quality of life over 2 years with cladribine tablets in people with relapsing multiple sclerosis: The CLARIFY-MS study.
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).
Linked Publications (2)
-
Improvements in quality of life over 2 years with cladribine tablets in people with relapsing multiple sclerosis: The CLARIFY-MS study.
-
Stability in Cognition and Employment in People with Relapsing Multiple Sclerosis Treated with Cladribine Tablets: Two-year Phase IV CLARIFY-MS Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
4.86; 4.80 | — |
| SECONDARY Treatment Global Satisfaction Determined by Treatment Satisfaction Questionnaire Medication Version 1.4 (TSQM v1.4) Scale at Month 6 |
72.02 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT03369665) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.