Autoimmune Diseases
Conditions
Keywords
Immunoglobulin G4-Related Disease, treatment strategies, iguratimod, leflunomide, relapse
Brief summary
This study has been designed as a 12-month, open-label randomized controlled clinical trial. The study aims to compare the efficacy and safety of two treatment strategies in IgG4-RD patients with superficial organ involvement: prednisone plus iguratimod and prednisone plus leflunomide.
Detailed description
60 IgG4-RD patients with superficial organ involvement are enrolled in this study and randomly divided into two groups at a 1:1 ratio: Patients in Group I are treated with prednisone (≤20 mg qd, or equivalent glucocorticoid, taper to ≤5mg in 3 months) and iguratimod (25 mg bid). Patients in Group II are treated with prednisone (≤20 mg qd, or equivalent glucocorticoid, taper to ≤5mg in 3 months ) and leflunomide (10-20 mg qd).All patients will be followed up for 12 months, and clinical evaluations, laboratory tests, image examinations and IgG4-RD responder index (RI) will be recorded during follow up. The primary endpoint is the difference of relapse rate between two groups at 12 months. The secondary endpoints are relapse time, response rate and side effects.
Interventions
DRUGglucocorticoid plus iguratimod
Patients in Group I are treated with prednisone (≤20 mg qd, or equivalent glucocorticoid, taper to ≦ 5mg in 3 months) and iguratimod (25 mg bid).
DRUGglucocorticoid plus leflunomide
Patients in Group II are treated with prednisone (≤20 mg qd, or equivalent glucocorticoid, taper to ≦ 5mg in 3 months ) and leflunomide (10-20 mg qd).
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\. 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; 3. The addition of glucocorticoids was started at lower than 10 mg/d.
Exclusion criteria
* 1\. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The difference of relapse rate of IgG4-RD among 2 groups in 12 months. | 12 months | The definition of relapse: elevation of IgG4-RD Responder Index ≥ 2 points; new organ involvement or recurrence, with or without elevation of serum IgG4 levels. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The difference of the time at baseline to first relapse among 2 groups | 12 months | The difference of relapse time in 2 groups |
| The difference of the response rate of the treatment among the 2 groups. | 12 months | Complete response rate; Partial response rate; No response |
| Side effects | 12 months | Any side effects caused by treatments for IgG4-RD. |
Countries
China
Contacts
CONTACTYunyun Fei, MD
PRINCIPAL_INVESTIGATORWen Zhang, MD
Peking Union Medical College Hospital
Outcome results
None listed