drugset / Trial / NCT03177083
Evaluate Safety/Tolerability in Portuguese Participants With RRMS Transitioning From Current Therapy
RandomizedParallel-groupOpen-labelTreatment
Summary
The primary objective of the study is to evaluate safety and tolerability as defined by the frequency of the adverse events (AEs) of flu-like symptoms (FLS) \[chills, pyrexia, myalgia, and asthenia\], injection site reactions (ISRs), and injection site reaction pain (ISR-P), over 24 weeks of treatment (the active comparator period) with PLEGRIDY 125 microgram (μg) subcutaneous (SC) every 2 weeks versus current SC IFN-β therapy in participants with Relapsing Remitting Multiple Sclerosis (RRMS).
Timeline
- Start
- 2017-01-30
- Primary completion
- 2020-10-26
- Completion
- 2020-10-26
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Interferon beta-1a | Protein / enzyme biologic | — | Subcutaneous |
| Comparator | Interferon beta-1b | Protein / enzyme biologic | — | Subcutaneous |
| Comparator | peginterferon beta-1a | Protein / enzyme biologic | 125 ug | Subcutaneous |