Status:
UNKNOWN
Treatment Strategies in IgG4-RD Patients With Re-elevation of Serum IgG4 Level During Maintenance Remission Period
Lead Sponsor:
Peking Union Medical College Hospital
Collaborating Sponsors:
Beijing Friendship Hospital
Tongji Hospital
Conditions:
Autoimmune Diseases
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
This study has been designed as a 52-week, randomized double blind placebo controlled multicenter clinical trial. The study aims to compare the efficacy and safety of two treatment strategies in IgG4-...
Detailed Description
108 IgG4-RD patients with re-elevation of serum IgG4 level to ≥30% of baseline serum IgG4 level during maintenance remission period are to be enrolled in this study after screening period, and then do...
Eligibility Criteria
Inclusion
- 1\. Fulfillment of the 2019 American College of Rheumatology/European League against Rheumatology (ACR/EULAR) IgG4-related disease classification criteria or the 2020 revised comprehensive diagnostic (RCD) criteria for IgG4-RD.
- 2\. Age between 18 and 70 years.
- 3\. Elevation of baseline serum IgG4 level (\>1400mg/L).
- 4\. Major organ involvement, including but not limited to autoimmune pancreatitis, retroperitoneal fibrosis, sclerosing cholangitis, IgG4-related Castleman disease, and involvement of the lungs, kidney, nasal sinus, and central nervous system.
- 5\. Re-elevation of serum IgG4 level to ≥30% of baseline serum IgG4 level during maintenance remission period, with no evidence of relapse.
- 6\. Written informed consent signed.
- 7\. Agreed to take highly effective contraceptive procedures from signing of informed consent till 6 months after the end of last visit.
Exclusion
- 1\. Patients with an IgG4-RD Responder Index ≥ 2 points of any organ system.
- 2\. IgG4-RD patients without major organ involvement.
- 3\. Patients with severe or active infections, including but not limited to HIV, HCV, HBV, TB.
- 4\. Patients with malignancies or a history of malignancies within 5 years, except:
- Patients with adenocarcinoma in situ (AIS) of the cervix who have received curative treatment for at least 12 months before screening.
- Patients with cutaneous basal or squamous cell carcinoma who have received curative treatment.
- Patients with prostate cancer, who have received radical prostatectomy or definitive radiotherapy for over 3 years, with no sign of relapse or ongoing treatment
- 5\. Patients with immunodeficiency diseases.
- 6\. Patients with severe cardiovascular, respiratory, endocrine, gastrointestinal, hematological, neuropsychological, or constitutional comorbidities; or at risk of unacceptable complications, or having confounding factors in safety and explanation of results according to the evaluations from investigators.
- 7\. Patients with other rheumatic diseases, including but not limited to rheumatoid arthritis, systemic lupus erythematosus, systemic vasculitis, sarcoidosis; or other mimickers of IgG4-RD, including but not limited to Rosai-Dorfman disease, Castleman disease.
- 8\. Participating in any other clinical trials with drug interventions.
- 9\. A history of alcohol or drug abuse, possibly harming patient's safety, compliance, or evaluation of study's safety or other necessary aspects according to the evaluations from investigators.
- 10\. Women during pregnancy, lactation, or planning of pregnancy within 6 months of the last visit of the study.
- 11\. Meeting any of the following blood test finding on screening:
- Hemoglobin level \< 7.5g/dL.
- neutrophil count \< 1.0×10\^9/L.
- Platelet count \< 100×10\^9/L.
- Alanine aminotransferase (ALT) \> 2 × upper limit number (ULN).
- Aspartate aminotransferase (AST) \> 2 × ULN.
- Total Bilirubin (TBil) \> 2 × ULN.
- Estimated glomerular filtration rate (eGFR) \< 30ml/(min·1.73m\^2), calculated using the Modification of Diet in Renal Disease (MDRD) study equation by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
Key Trial Info
Start Date :
August 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT05974683
Start Date
August 1 2023
End Date
December 1 2025
Last Update
August 3 2023
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, China