Comparison of the Effects of Cyclophosphamide and Mycophenolate Mofetil Treatment Against Immunoglobulin G4-Related Disease: A Retrospective Cohort Study.
Xuan Luo, Yu Peng, Panpan Zhang...
https://pubmed.ncbi.nlm.nih.gov/32733900Actively Recruiting
Age: 18Years - 75Years
All Genders
ID01670695
Cohort Study of Patients With IgG4-Related Disease
Led by Peking Union Medical College Hospital · Updated on 2017-04-11
1000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating IgG4-related disease (IgG4-RD), a condition marked by infiltration of tissues with IgG4-positive plasma cells, tissue fibrosis, and raised IgG4 levels in the blood. This observational cohort study aims to understand the disease course and how patients respond to treatment. The study includes patients with various manifestations of IgG4-RD, such as sclerosing pancreatitis, cholangitis, inflammatory pseudotumors, and others. Participants in this study will receive standard care for IgG4-RD and will be followed for at least six months. The study will gather detailed information on clinical symptoms, laboratory test results, and imaging findings to better characterize the disease and treatment effects. There are no experimental treatments; all patients continue with their usual care. During the study, participants will undergo regular assessments including clinical evaluations and laboratory tests focusing on IgG4 levels and disease activity. The primary outcome is the clinical response measured at six months. The study will monitor participants over time to observe changes in their condition and treatment outcomes, helping to improve understanding of IgG4-RD.
CONDITIONS
Brief Title
A Prospective Cohort Study of IgG4RD in China
Who Can Participate
Age: 18Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Male or female
- Age between 18 and 75 years old with informed consent
- Diagnosis of IgG4-related disease involving one or more organs such as sclerosing pancreatitis, cholangitis, inflammatory pseudotumors, retroperitoneal or mediastinal fibrosis, interstitial nephritis, hypophysitis, sclerosing dacryoadenitis, sialadenitis, inflammatory aortic aneurysm, or lymphadenopathy
- Elevated serum IgG4 levels greater than 1.35 g/L
- Tissue biopsy showing fibrosis and/or lymphocytic and polyclonal plasma cell infiltration, including IgG4+ plasma cells when tested
- Exclusion of other diseases that could explain symptoms
You will not qualify if you...
- Females who are planning to become pregnant soon or have childbearing potential
- Having severe, uncontrolled, or unstable medical conditions
- Current diagnosis of cancer
AI-Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
Duration - At least 6 months
Participants diagnosed with IgG4-related disease are observed to document clinical presentation, laboratory findings, and imaging studies while receiving standard care.
Regular follow-up visits during the monitoring period
Trial Site Locations
Total: 1 location
1
Deptment of Rheumatology, Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100032
Actively Recruiting
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Research Team
H
Hua Chen, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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