Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
40 participants
OBSERVATIONAL
2022-11-10
2025-12-31
Brief Summary
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Detailed Description
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2\) Investigators observe the diagnosis and treatment of IgG4-RD patients, and only provide patients with clinically appropriate diagnosis and treatment proposals.
It does not interfere with the choice of treatment plan for patients with the study drug of tropib or cyclophosphamide. If the patient chooses the hormone combined with tofatib or the hormone combined with cyclophosphamide as the main treatment drug, and at the same time meets the inclusion and exclusion criteria of this study, the patient can be included in this clinical observation study and become a subject. The experimental group was treated with glucocorticoid combined with tofatib, and the control group was treated with glucocorticoid combined with cyclophosphamide. It is planned that 20 people in each group will be treated for 6 months. After the study, the number of subjects in each group shall be at least 20 according to the actual situation. In the final statistical analysis, ensure that the sample size of the two groups participating in the statistical analysis is controlled at about 1:1.
3\) The primary end point of this study was to compare the remission rate of the two groups after treatment; The secondary end point was to compare the response rate, recurrence rate and adverse event rate of the two groups after treatment.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Glucocorticosteroids combined with Cyclophosphamide Group
Glucocorticoid: 0.5-1.0 mg/kg/d prednisone (or other glucocorticoids of equivalent dose) for 1 month (visit V2-V3), then reduced by 5 mg every 2 weeks, and maintained at 5-10 mg/day to visit V8.
Cyclophosphamide: intravenous infusion, once a month, 0.5-1g/m2 each time, 6 times in total, until the end of visit V7.
tofacitinib
All subjects were treated immediately after non randomized enrollment. The treatment scheme of the experimental group: glucocorticoid+tropitib; the treatment scheme of the control group: glucocorticoid+cyclophosphamide.
Glucocorticoids combined with tofacitinib Group
Glucocorticoid: 0.5-1.0 mg/kg/d prednisone (or other glucocorticoids of equivalent dose) for 1 month (visit V2-V3), then reduced by 5 mg every 2 weeks, and maintained at 5-10 mg/day to visit V8.
Tofacitinib: oral, twice a day, 5mg each time, lasting for 6 months, until the end of visit V8.
tofacitinib
All subjects were treated immediately after non randomized enrollment. The treatment scheme of the experimental group: glucocorticoid+tropitib; the treatment scheme of the control group: glucocorticoid+cyclophosphamide.
Interventions
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tofacitinib
All subjects were treated immediately after non randomized enrollment. The treatment scheme of the experimental group: glucocorticoid+tropitib; the treatment scheme of the control group: glucocorticoid+cyclophosphamide.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2\. Only Mikulicz disease, no other internal organs involved;
3\. People with history of thrombotic disease or high risk of thrombosis;
4\. Have a history of malignant tumor;
5\. Active infection;
6\. Pregnant or lactating women;
18 Years
75 Years
ALL
No
Sponsors
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Changhai Hospital
OTHER
Responsible Party
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Principal Investigators
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Gao Jie, doctor
Role: STUDY_CHAIR
Changhai Hospital
Locations
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Shanghai Changhai Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CHEC2022-175
Identifier Type: -
Identifier Source: org_study_id
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