Actively Recruiting
Comparison of Short-term Glucocorticoid Monotherapy and Short-term Glucocorticoid Combined with Mycophenolate Mofetil in the Treatment of IgG4 Related Disease
Led by Wen Zhang · Updated on 2024-10-29
63
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
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 mg/kg 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.
CONDITIONS
Brief Title
Short-term Glucocorticoid Combined with MMF for IgG4-RD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 80 years
- Diagnosis meeting the 2020 Japanese comprehensive criteria or 2019 ACR/EULAR classification criteria for IgG4-Related Disease
- Active IgG4-Related Disease with at least one organ showing a disease activity score of 2 or higher
- No prior medication or recurrence after stopping treatment
You will not qualify if you...
- Presence of other autoimmune diseases as the main diagnosis
- Pregnant or breastfeeding women
- Patients with malignant tumors
- Active bacterial, fungal, viral, or mycobacterial infections
- Severe complications of important organs with expected survival less than 6 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive short-term glucocorticoid monotherapy or short-term glucocorticoid combined with Mycophenolate mofetil for IgG4-Related Disease.
Regular visits during treatment period
Duration - Up to 72 weeks from start of treatment
Participants are monitored for disease recurrence and other outcomes after treatment ends.
Visits scheduled periodically during follow-up
Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100050
Actively Recruiting
Research Team
L
Linyi Peng, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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