The primary objective of this study is to determine whether DAC HYP, when compared to placebo, is effective in reducing the rate of relapses between baseline and Week 52. The secondary objectives are to determine whether DAC HYP is effective in reducing the number of new gadolinium (Gd)-enhancing lesions, reducing the number of new or newly-enlarging T2 hyperintense lesions, reducing the proportion of participants with relapses, and improving quality of life.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
621
SC injection
Placebo SC injection
Adjusted Annualized Relapse Rate Between Baseline and Week 52
Relapses are defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the examining neurologist. The annualized relapse rate was calculated as the total number of relapses that occurred during the study divided by the total number of subject-years followed in the study.
Time frame: Baseline through Week 52
Adjusted Mean Number of New Gadolinium (Gd)-Enhancing Lesions Between Week 8 and Week 24
Gd-enhancing lesions are detected when Gd leaks into a perivascular space due to local breakdown of the blood-brain barrier, indicating the presence of active inflammation. For participants with missing data the last valid nonbaseline measurement was carried forward if the participant was missing only 1 or 2 consecutive postbaseline scans. Otherwise the mean based on treatment group and visit was used as the imputed value. Estimated from a negative binomial model adjusted for the baseline number of Gd-enhancing lesions.
Time frame: Week 8 through Week 24
Adjusted Mean Number of New or Newly-enlarging T2 Hyperintense Lesions at Week 52
Lesions detected on T2-weighted sequences represent a range of histopathology related to MS, including edema, inflammation, demyelination, gliosis, and axon loss.
Time frame: Week 52
Proportion of Participants Who Relapsed at Week 52
Estimated cumulative proportion of participants relapsed at Week 52, based on the Kaplan-Meier product limit method. Only relapses confirmed by the Independent Neurology Evaluation Committee were included in the analysis.
Time frame: Week 52
Mean Change From Baseline in Multiple Sclerosis Impact Scale (MSIS)-29 Physical Impact Score at Week 52
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Research Site
Brno, Czechia
Research Site
Olomouc, Czechia
Research Site
Pilsen, Czechia
Research Site
Teplice, Czechia
Research Site
Erlangen, Germany
Research Site
Marburg, Germany
Research Site
Osnabrück, Germany
Research Site
Regensburg, Germany
Research Site
Rostock, Germany
Research Site
Budapest, Hungary
...and 46 more locations
The 29-item Multiple Sclerosis Impact Scale (MSIS-29) is a disease specific patient-reported outcome measure that has been developed and validated to examine the physical and psychological impact of MS from a patient's perspective; it measures 20 physical items and 9 psychological items. Responses use a 5 point Likert scale range from 1 to 5. All questions are to be answered. The total score is the sum of points for all 29 questions, with a minimum score of 29, and a maximum score of 145. A lower total score indicates less physically-related impact while a higher total score indicates greater physically-related impact on a subject's functioning.
Time frame: Baseline and Week 52