Treatment Strategies for IgG4-RD Patients With Internal Organ Involvement
Efficacy of Mycophenolate Mofetil Versus Leflunomide as Maintenance Treatment for IgG4-RD Patients With Internal Organ Involvement
Peking Union Medical College Hospital
60 participants
Jul 1, 2022
INTERVENTIONAL
Conditions
Summary
This study has been designed as a 18-month, open-label randomized controlled clinical trial. The study aims to compare the efficacy and safety of two treatment strategies in active IgG4-RD patients with internal organ involvement during maintenance remission period: low dose mycophenolate mofetil group and leflunomide group.
Eligibility
Inclusion Criteria1
- \. Fulfillment of the 2019 American College of Rheumatology/European League against Rheumatology (ACR/EULAR) IgG4-related disease classification criteria; 2. Newly-onset or relapsed patients who requires initiation or continuation of glucocorticoids treatment.
Exclusion Criteria1
- \. Patients who were diagnosed as other autoimmune diseases; 2. Patients who were diagnosed as malignant diseases; 3. Pregnant and lactating women； 4. Active infection: HIV, HCV, HBV, TB； 5. Severe irreversible damage of organ function; 6. Receipt of any biologic therapy or immunosuppressive agent other than GCs.
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Interventions
Patients are treated with glucocorticoids and mycophenolate mofetil in remission induction period (6 months), during which glucocorticoids are tapered regularly and discontinued in 6 months.
Patients are treated with low dose mycophenolate (1-1.5g/day) during remission maintenance period for 12 months.
Patients are treated with leflunomide (20 mg/day) during remission maintenance period for 12 months.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05789017