IgG4 Related Disease
Conditions
Brief summary
For patients with active proliferative IgG4-RD, we plan to conduct a 52-week prospective randomized controlled trial to compare the efficacy and safety of 5mg lenalidomide plus prednisone, 10mg lenalidomide plus prednisone, and prednisone alone, so as to find new treatment measures for patients with proliferative IgG4-RD.
Interventions
DRUG5mg lenalidomide
Lenalidomide 5mg/d combined with prednisone, prednisone at an initial dose of 0.6-0.8mg/kg/d for 2-4 weeks, then reduced by 5mg every 1-2 weeks until discontinued (within 24 weeks)
DRUG10mg lenalidomide
Lenalidomide 10mg/ day combined with prednisone, prednisone at an initial dose of 0.6-0.8mg/kg/ day for 2-4 weeks, then reduced by 5mg every 1-2 weeks until discontinued (within 24 weeks)
DRUGPrednisone monotherapy
The initial dose of prednisone was 0.6-0.8mg/kg/ day for 2-4 weeks, followed by 5mg every 1-2 weeks until withdrawal (within 24 weeks).
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Patients aged between 18 and 75 years who meet the 2019 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification criteria for IgG4-RD； 2. Patients with active disease: For patients with initial treatment or relapse after drug withdrawal, active disease is defined as having an IgG4-RD Response Index (RI) of at least 2 points in at least one organ at the time of screening; for those experiencing relapse while on treatment, active disease is defined as having an IgG4-RD RI of at least 3 points in at least one organ at the time of screening； 3. Patients with the clinical subtype of proliferative IgG4-RD； 4. Patients who have no plans for pregnancy within the next 18 months and who agree to use reliable contraceptive measures during the study period；
Exclusion criteria
1. IgG4-RD patients with only fibrotic features; 2. Absolute neutrophil count \<1.5×10\^9 /L or platelet count \<100×10\^9/L; 3. Creatinine clearance less than 60 ml/ min; 4. Liver function Child-Pugh grade B or above; 5. Chronic active infection requiring systemic treatment; 6. Diagnosed with malignant tumor in the past five years; 7. Patients with a history of thrombosis; 8. Using biological agents within six months; 9. Known to be allergic to lenalidomide or thalidomide; 10. Pregnant or lactating women; 11. Patients with any other medical conditions or for specific reasons judged by the investigator to be ineligible to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence rate at 52 weeks | From enrollment to the end of treatment at 52 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IgG4 - RD RI change | At 4, 12, 24, 36, 52 weeks | — |
| Change of IgG4-RD damage index (DI) | At 4, 12, 24, 36, 52 weeks | — |
| Treatment response rate | At 4, 12, 24, 36, 52 weeks | — |
| Changes of serum IgG4 levels | At 4, 12, 24, 36, 52 weeks | — |
| security | At 4, 12, 24, 36, 52 weeks | Use CTCAE V5.0 to record adverse events |
| physician's overall assessment of disease activity | At 4, 12, 24, 36, 52 weeks | — |
Countries
China
Outcome results
None listed