Status:
UNKNOWN
Belimumab Treatment for IgG4-related Disease
Lead Sponsor:
Peking Union Medical College Hospital
Conditions:
IgG4-related Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
Even though glucocorticoid is the current first line medication for IgG4-RD, it is well accepted in the field that excessive dosage of GC, especially accumulative dosage, is associated with increasing...
Detailed Description
IgG4-RD is associated with substantial morbidity and mortality, but there is no established therapy other than GCs for an acute flare. Up to date, no randomized prospective controlled studies have bee...
Eligibility Criteria
Inclusion
- Male or female adults, ≥ 18 years of age at time of informed consent.
- Written informed consent.
- Fulfillment of the 2019 ACR/EULAR classification criteria, involving at least one of the following organs: pancreas, lacrimal glands, salivary glands, bile ducts/biliary, orbits, lungs, retroperitoneum, aorta, kidneys, or thyroid gland.
- New onset or experiencing an IgG4-RD flare that requires initiation or continuation of GC treatment at the time of informed consent. This GC therapy can either be newly initiated or be increased from a maintenance dose of ≤ 10 mg/day of prednisone or equivalent.
Exclusion
- Severe organ dysfunction.
- Severe infection.
- Having known immunodeficiency disorder.
- History of malignancy within the last 10 years.
- Receipt of any biologic therapy, including B cell-depleting therapy (eg, rituximab, ocrelizumab, obinutuzumab, ofatumumab, inebilizumab) or other biologic immunomodulatory agent (abatacept) in the 6 months prior to screening.
- Non-biologic DMARDs or immunosuppressive agent other than GCs (eg, Leflunomide, Cyclophosphamide, azathioprine, mycophenolate mofetil, methotrexate, others) have been used withing 12 weeks before screening.
- Being pregnant, lactating, or planning to become pregnant within 6 months of the test.
- Positive test for hepatitis B or HIV infection. Positive test for hepatitis B include detection of hepatitis B surface antigen (HBsAg) or HBV-DNA.
- Chest image ,PPD or TB-ELISPOT results show active tuberculosis.
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04660565
Start Date
January 1 2021
End Date
December 1 2023
Last Update
January 8 2021
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100032