Study design
The GWIIRT (ClinicalTrials.gov Identifier: NCT02506192) is a Phase 2 randomized, placebo-controlled, double-blind, parallel group, clinical trial. The prednisone arm received a low-dose (10 mg qd) of MR-prednisone for 8 weeks. The placebo arm received matching placebo tablets. The treatment phase was followed by a washout period of 8 weeks. The study goal was to determine if prednisone treatment induces a statistically significant change from baseline in physical HRQOL. Horizon Therapeutics Plc supplied the MR-prednisone (Rayos