Comparing Short-term Glucocorticoid Alone Versus Combined with Mycophenolate Mofetil for Treating IgG4-Related Disease

What this Trial Is About

Researchers are evaluating the treatment of IgG4-related Disease by comparing short-term glucocorticoid monotherapy with short-term glucocorticoid combined with Mycophenolate mofetil MMF. This 72-week prospective, randomized controlled study at a single center aims to understand the differences in relapse rates and other clinical outcomes between these two treatment approaches. Participants receive oral prednison starting at 0.6-0.8 mgkg per day, which is tapered and stopped within six months. One group receives only prednison, while the other group receives prednison plus oral Mycophenolate mofetil 0.75g twice daily for six months. The study monitors patients over 72 weeks to assess treatment effects. During the study, participants undergo regular evaluations including assessments of disease recurrence, changes in the IgG4-related disease Responder Index, serum IgG4 levels, adverse events, and Physician Global Assessment scores. The primary outcome is the difference in relapse rates between the two groups over 72 weeks. Safety and remission rates are also assessed, with ongoing monitoring throughout the study period.

Short-term Glucocorticoid Combined with MMF for IgG4-RD