drugset / Trial / NCT02064816

A Study of Rebif® in Subjects With Relapsing Multiple Sclerosis

NCT02064816 ↗

Phase 4 Completed 200 enrolled Merck KGaA, Darmstadt, Germany
RandomizedParallel-groupOpen-labelTreatment

Summary

This is an open-label, multi-center, 12-week, randomized, controlled, parallel group, Phase 4 study to assess whether the morning administration of interferon beta 1a (Rebif®) leads to a lower severity of flu-like symptoms (FLS) as compared to the evening administration, in subjects with relapsing multiple sclerosis (RMS).

Timeline

Start
2014-05-31
Primary completion
2016-04-30
Completion
2016-04-30

Outcome

Missed primary endpoint

registry p = 0.277763; Mean Difference (Final Values) 0.6 (95% CI -0.46 to 1.56) NCT02064816 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Interferon beta-1a Protein / enzyme biologic 44 ug Subcutaneous