Polymyalgia Rheumatica Clinical Trial
Official title:
A Randomised, Multi-centre, Double-blind, Active-controlled, Parallel Group Study to Assess the Efficacy and Safety of Modified Release Prednisone (Lodotra®) Compared to Immediate Release Prednisone (Prednisone IR) in Subjects Suffering From Polymyalgia Rheumatica (PMR).
The study compares the efficacy and safety of modified release prednisone versus immediate release prednisone in patients suffering from polymyalgia rheumatica.
The study consists of a screening phase, followed by a 4 week double-blind phase. During the
double-blind phase, the patients will be randomised in a 1:1 ratio to either Lodotra® or
immediate release prednisone (prednisone IR) plus respective placebo.
After completion of the double-blind phase, patients will be re-randomised in a 1:1 ratio to
open-label Lodotra® or prednisone IR for 48 weeks. During the open-label phase, the dose of
study medication will be tapered based on titration criteria.
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