A Randomized Multi-Center, Double-Blind, Placebo-Controlled Study of a New Modified-Release Tablet Formulation of Prednisone (Lodotra®) in Patients With Rheumatoid Arthritis
A Randomized Multi-Center, Double-Blind, Placebo-Controlled Study of a New Modified-Release Tablet Formulation of Prednisone (Lodotra®) in Patients With Rheumatoid Arthritis
The purpose of the study is to compare the safety and efficacy, with regards to the signs and symptoms, of MR prednisone (Lodotra®) versus placebo in combination with standard Disease Modifying Anti-Rheumatic Drug (DMARD) treatment in patients with active rheumatoid arthritis.
Study with completed results acquired from Horizon in 2024.
Inclusion Criteria:
Exclusion Criteria:
Suffering from another disease, which requires glucocorticoid treatment during the study period
Synovectomy within 4 months prior to study start
Use of glucocorticoids:
Use of biologicals such as: tumor necrosis factor α (TNFα) inhibitors and other compounds within 5 serum half lives prior to screening visit
Pregnancy or nursing
Bialystok, 15-296, Poland
Lublin, 20-954, Poland
Poznan, 61-833, Poland
Torun, 87-100, Poland
Lincolnshire, DN33 2BA, United Kingdom