A Trial of Prednisolone in Combination With SPI-62 in Participants With Polymyalgia Rheumatica (PMR)

Ki vehet részt

• Written informed consent
• Diagnosis of PMR according to European League Against Rheumatism and American College of Rheumatology classification criteria confirmed by a rheumatologist
• Absence of PMR relapse based on symptoms and acute phase markers
• Daily oral prednisolone 10, 12.5, 15, 17.5, or 20 mg dose that will have been stable for at least 7 days prior to Day 1

Ki nem vehet részt

• Use of medications for treatment of PMR other than oral prednisolone within specified intervals prior to Day 1 and during the treatment period
• Use of other medications likely to interfere with trial assessments
• Any current or prior medical condition, medical or surgical therapies, or clinical trial participation expected to interfere with the conduct of the trial or the evaluation of its results
• Any autoimmune disease (e.g., late-onset rheumatoid arthritis) other than PMR
• Any contraindication for prednisolone administration
• A diagnosis or any clinical features of giant cell arteritis
• History or diagnosis of endogenous hypercortisolism