A Multi-centre, Randomised, Double-blinded, Placebo Controlled 16-week Study to Compare Hydrocortisone and Placebo in Patients With Giant Cell Arteritis (GCA) or Polymyalgia Rheumatica (PMR) Experiencing Symptoms of Adrenal Insufficiency After Glucocorticoid Treatment

What this Trial Is About

Researchers are studying patients who have polymyalgia rheumatica (PMR) or giant cell arteritis (GCA) and experience symptoms of adrenal insufficiency after stopping glucocorticoid (prednisolone) treatment. The study addresses concerns about relative adrenal insufficiency that may occur after long-term steroid use, which can cause fatigue and other symptoms often referred to as "steroid withdrawal syndrome." This randomized controlled trial aims to provide evidence-based guidance on managing this condition, which affects many patients. Participants will be randomly assigned to receive either oral hydrocortisone tablets (10 mg twice daily) or placebo tablets for 16 weeks. Some patients with certain test results indicating better adrenal function will only undergo baseline exams, while those with pronounced adrenal insufficiency will receive open hydrocortisone replacement following standard care. This study is double-blinded and includes multiple groups based on symptom scores and cortisol test levels. During the study, participants will undergo various assessments including symptom questionnaires, blood pressure checks, body composition scans, muscle function tests, and quality of life evaluations at baseline and after 16 weeks. Daily symptom reporting via a mobile app will also be collected. Researchers will measure adrenal insufficiency symptoms as the primary outcome, along with other health and physical activity measures. The total study duration for treatment is 16 weeks.

Hydrocortisone and Placebo in Patients With Symptoms of Adrenal Insufficiency After Cessation of Glucocorticoid Treatment