IgG4 Related Disease
Conditions
Brief summary
The goal of this clinical trial is to learn if tripterygium wilfordii added to prednisone can treat active IgG4-related disease (IgG4-RD) in adults 45 to 80 years of age. Women in the study must be postmenopausal. The main questions it aims to answer are: * Does adding tripterygium wilfordii to prednisone lower the chance that IgG4-RD comes back at 12 months compared with prednisone alone? * Does the combination improve remission, disease activity scores, blood tests, quality of life, and remain acceptably safe? Researchers will compare prednisone alone to prednisone plus tripterygium glycoside tablets to see if the combination reduces relapse. Participants will: * Be assigned by chance to prednisone alone or prednisone plus tripterygium glycoside tablets 20 mg three times a day * Start prednisone at 0.6 to 0.8 mg/kg per day and taper it off within 6 months * Attend clinic visits at the start of the study and at 1, 3, 6, 9, and 12 months for exams, blood tests, disease scores, and imaging when needed * Report symptoms and any side effects during the 12-month follow-up
Interventions
DRUGPrednisone
Oral prednisone started at 0.6-0.8 mg/kg/day for 4 weeks, then tapered by 5 mg weekly to 15 mg/day, then by 1.25-2.5 mg weekly, and discontinued within 6 months. Used in both study arms.
Tripterygium glycoside tablets 20 mg orally three times daily, given together with the prednisone taper in the experimental arm. This is an approved Chinese herbal extract used off-label for IgG4-related disease in this trial.
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* Age greater than 45 years and less than 80 years; women must be postmenopausal * Diagnosis of IgG4-related disease meeting the 2020 Revised Comprehensive Diagnostic Criteria (Japan) or the 2019 ACR/EULAR classification criteria * Active IgG4-RD, defined as an IgG4-RD Responder Index score of 2 or higher in at least one organ at enrollment * Treatment-naive or relapsed after discontinuation of prior therapy
Exclusion criteria
* Organ-threatening or otherwise unsuitable clinical phenotypes as judged by the investigator, including neurologic involvement and IgG4-related sclerosing cholangitis * Baseline liver-function abnormality (ALT greater than 2 times the upper limit of normal), renal insufficiency (CKD stage 3 or higher, GFR less than 60 mL/min), or heart failure * Another autoimmune disease as the primary diagnosis * Malignancy * Active bacterial, fungal, viral, or mycobacterial infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relapse rate | 12 months after randomization | Proportion of participants with IgG4-RD relapse. Relapse is defined as new or worsening disease activity after improvement, based on clinical assessment, laboratory tests, and/or imaging, and reflected by an increase in the IgG4-RD Responder Index that requires treatment intensification. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical remission rate | Month 6 and Month 12 | — |
| Relapse rate | 6 months after randomization | Proportion of participants with IgG4-RD relapse, using the same definition as the primary outcome. |
| Change from baseline in IgG4-RD Responder Index (RI) | Baseline and Months 1, 3, 6, 9, and 12 | According to IgG4-RD responder index-2018 |
| Change from baseline in serum laboratory markers | Baseline and Months 1, 3, 6, 9, and 12 | Serum IgG4、Total IgE and IgG |
| Physician Global Assessment (PGA) | Baseline and Months 1, 3, 6, 9, and 12 | Physician-rated overall disease status. Change from baseline will be compared between groups. |
| Patient Global Assessment (PGA) | Baseline and Months 1, 3, 6, 9, and 12 | Patient-rated overall disease status. Change from baseline will be compared between groups. |
| EQ-5D-5L | Baseline and Months 1, 3, 6, 9, and 12 | Health-related quality of life measured by the EQ-5D-5L questionnaire, including the descriptive system and the visual analogue scale. |
| Incidence of treatment-emergent adverse events | From first dose through Month 12 | Number and percentage of participants with adverse events and serious adverse events, including laboratory abnormalities related to study treatment (for example, liver enzyme elevation, cytopenia, infection, and glucocorticoid-related events). |
Countries
China
Contacts
CONTACTLinyi Peng
Outcome results
None listed