Evaluation of the Onset of Action in Highly Active Multiple Sclerosis (MS)
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|ClinicalTrials.gov Identifier: NCT03364036|
Recruitment Status : Active, not recruiting
First Posted : December 6, 2017
Last Update Posted : December 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Drug: Mavenclad®||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||270 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A 2-year Prospective Study to Evaluate the Onset of Action of Mavenclad® in Subjects With Highly Active Relapsing Multiple Sclerosis|
|Actual Study Start Date :||May 28, 2018|
|Estimated Primary Completion Date :||January 16, 2020|
|Estimated Study Completion Date :||July 16, 2021|
Subjects will receive Mavenclad® 3.5 milligram per kilogram (mg/kg) of body weight over 2 years, administered as 1 treatment course of 1.75 mg/kg per year.
Other Name: Cladribine
- Change From Baseline in Counts of Combined Unique Active (CUA) Magnetic Resonance Imaging (MRI) Lesions at Month 6 [ Time Frame: Baseline, Month 6 ]
- Change From Baseline in Counts of Immune Cell Subsets at Month 3, 6, 12, 15, 18 and 24 [ Time Frame: Baseline, Month 3, 6, 12, 15, 18 and 24 ]Immune cell subsets will be analyzed by flow cytometry analysis.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03364036
|Study Director:||Medical Responsible||Merck KGaA, Darmstadt, Germany|