EUCTR2017-002632-17-NO
Active, not recruiting
Phase 1
A 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad®
DrugsMavenclad®
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Merck KGaA
- Enrollment
- 482
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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
Outcomes
Primary Outcomes
Not specified
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