drugset / Trial / NCT03870763
Study to Evaluate the Efficacy and Safety of Dimethyl Fumarate (Tecfidera) and Peginterferon Beta-1a (Plegridy) for the Treatment of Relapsing-Remitting Multiple Sclerosis in Pediatric Participants
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The main objective of the study is to evaluate the efficacy of dimethyl fumarate (Tecfidera) and peginterferon beta-1a (Plegridy), both compared with placebo, in pediatric participants with RRMS. The other objectives of this study are to evaluate the safety and tolerability of dimethyl fumarate and peginterferon beta-1a and to assess the effect of dimethyl fumarate and peginterferon beta-1a, both compared with placebo, on additional clinical and radiological measures of disease activity.
Timeline
- Start
- 2019-03-19
- Primary completion
- 2022-07-21
- Completion
- 2022-07-21
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | dimethyl fumarate | Unknown | 240 mg | Oral |
| Subject | peginterferon beta-1a | Protein / enzyme biologic | 125 ug | Subcutaneous |