IgG4-Related Disease Clinical Trials

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A Prospective Study on the Effect of Minimal Residual Disease Detected by Fibroblast Activation Protein PET / CT on the Recurrence of IgG4-related Disease

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study intends to use the new technology of fibroblast activation protein PET / CT to study whether the tiny residual lesions detected by 68Ga-FAPI PET / CT are related to the recurrence of IgG4-RD in patients with IgG4-RD who have been clinically evaluated for complete remission after treatment.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• age 18-75 years old ;

• Meet the 2019 ACR / EURLAR IgG4-RD diagnostic criteria ;

• The disease was stable for more than 1 year, and the clinical evaluation of the disease was complete remission \* ;

• Glucocorticoid dosage ≤ prednisone 7.5mg / d × 6 months or more, or combined with an immunosuppressive therapy ( mycophenolate mofetil ) Ester ≤ 1.0g / d, leflunomide ≤ 20mg / d, methotrexate ≤ 15mg / w, azathioprine ≤ 100mg / d, iguratimod ≤ 25mg Bid )

Locations
Other Locations
China
Peking Union Medical College Hospital
RECRUITING
Beijing
Contact Information
Primary
Yaping Luo, MD
luoyaping@live.com
86-010-69154716
Time Frame
Start Date: 2025-05-10
Estimated Completion Date: 2027-12-01
Participants
Target number of participants: 46
Treatments
Other: A(68Ga-FAPI PET / CT negative patients)
Group A (MRD-negative) will receive no intervention and enter treatment withdrawal with observational follow-up.
Other: B(68Ga-FAPI PET / CT positive patients)
Group B (68Ga-FAPI PET/CT positive, indicating MRD-positive status). Group B (MRD-positive) patients will be randomized 1:1 into either the experimental subgroup B1 (continuing low-dose glucocorticoids with or without immunosuppressant maintenance therapy) or the control subgroup B2 (treatment withdrawal with observational follow-up).
Related Therapeutic Areas
IgG4-Related Disease
Sponsors
Leads: Luo Yaping
Collaborators: Peking Union Medical College Hospital

This content was sourced from clinicaltrials.gov

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