Randomized Phase 3 Trial Comparing Low Dose Prednisone and Methotrexate Combination Versus Standard Dose Prednisone in Treating Active Cardiac Sarcoidosis

What this Trial Is About

Researchers are evaluating treatment options for patients diagnosed with acute active clinically manifest cardiac sarcoidosis who have not yet received treatment. This phase 3 randomized controlled trial compares a low dose combination of Prednisone or Prednisolone and Methotrexate to standard dose Prednisone or Prednisolone. The study aims to assess whether the combination therapy is as effective as the standard dose while potentially offering better quality of life and fewer side effects. Participants will be randomly assigned to one of two groups. Outside Japan, one group receives Prednisone at 0.5 mgkgday for 6 months up to 30 mg daily, while the other gets Methotrexate once weekly starting at 15 mg, increasing to 20 mg if tolerated plus Folic Acid daily and Prednisone tapered over 3 months. In Japan, dosing regimens vary slightly but follow similar principles. Baseline tests include blood work, FDG-PET scans with myocardial perfusion imaging, ECG, echocardiogram, optional cardiac MRI, and quality of life questionnaires. Treatment lasts 6 months with scheduled visits at 4, 8 methotrexate group only, 12 weeks, and a final 6-month visit. During the study, participants undergo assessments for medication side effects, safety blood tests, and quality of life evaluations at multiple visits. At 6 months, comprehensive evaluations including imaging, biomarker analysis, device interrogation, muscle strength, skin and neuropsychiatric assessments will be completed. After this, further care is managed by the participants physician. The study measures heart function, medication effects, quality of life, and toxicity related to glucocorticoid use to understand the impact of these treatment strategies.

Cardiac Sarcoidosis Randomized Trial