A Phase III Multicenter, Randomized, Double-Blind, Double-Dummy Study to Evaluate Safety and Efficacy of Ocrelizumab in Comparison with Fingolimod in Children and Adolescents with Relapsing-Remitting Multiple Sclerosis

Conditions

Relapsing-Remitting Multiple Sclerosis

Brief summary

1. Protocol-defined annualized relapse rate (ARR) (non-inferiority)

Detailed description

1. Number of new or enlarging T2 lesions as detected by brain MRI during the double-blind period, 2. Number of T1 gadolinium (Gd) lesions at Week 12, 3. Protocol-defined ARR during the double-blind period (superiority), 4. Incidence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0), 5. Change from baseline in targeted vital signs and clinical significant abnormalities in electrocardiogram (ECG) parameters, 6. Change from baseline in targeted clinical laboratory test results, 7. Concentrations of ocrelizumab at indicated time points, 8. Levels of CD19 B-cell count in blood, 9. Prevalence of anti-drug antibodies (ADAs) against ocrelizumab at baseline, 10. Incidence of ADAs against ocrelizumab during the study

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Interventions

DRUGOcrevus 300 mg concentrate for solution for infusion

DRUGPlacebo for FINGOLIMOD

DRUGGilenya 0.25 mg hard capsules

DRUGMethylprednisolon acis 1000 mg Pulver und Lösungsmittel zur Herstellung einer Injektions- bzw. Infusionslösung

DRUGGilenya 0.5 mg hard capsules

DRUGReisetabletten AL Dimenhydrinat 50 mg pro Tablette

DRUGPlacebo for Ocrelizumab

DRUGMethylprednisolon acis 250 mg Pulver und Lösungsmittel zur Herstellung einer Injektions- bzw. Infusionslösung

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
1. Protocol-defined annualized relapse rate (ARR) (non-inferiority)	—

Secondary

Measure	Time frame
1. Number of new or enlarging T2 lesions as detected by brain MRI during the double-blind period, 2. Number of T1 gadolinium (Gd) lesions at Week 12, 3. Protocol-defined ARR during the double-blind period (superiority), 4. Incidence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0), 5. Change from baseline in targeted vital signs and clinical significant abnormalities in electrocardiogram (ECG) parameters, 6. Change from baseline in targeted clinical laboratory test results, 7. Concentrations of ocrelizumab at indicated time points, 8. Levels of CD19 B-cell count in blood, 9. Prevalence of anti-drug antibodies (ADAs) against ocrelizumab at baseline, 10. Incidence of ADAs against ocrelizumab during the study	—

Measure

Time frame

1. Number of new or enlarging T2 lesions as detected by brain MRI during the double-blind period, 2. Number of T1 gadolinium (Gd) lesions at Week 12, 3. Protocol-defined ARR during the double-blind period (superiority), 4. Incidence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0), 5. Change from baseline in targeted vital signs and clinical significant abnormalities in electrocardiogram (ECG) parameters, 6. Change from baseline in targeted clinical laboratory test results, 7. Concentrations of ocrelizumab at indicated time points, 8. Levels of CD19 B-cell count in blood, 9. Prevalence of anti-drug antibodies (ADAs) against ocrelizumab at baseline, 10. Incidence of ADAs against ocrelizumab during the study

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Countries

Austria, Belgium, Bulgaria, Croatia, Denmark, Estonia, France, Germany, Greece, Hungary, Italy, Latvia, Netherlands, Poland, Portugal, Romania, Spain

Outcome results

None listed