Tofatib Treatment for IgG4-related Disease

Clinical Study on the Efficacy and Safety of Tofatib and Cyclophosphamide in the Treatment of Active IgG4 Related Diseases

Sponsors

Lead Sponsor: Changhai Hospital

Source Changhai Hospital
Brief Summary

Compared with cyclophosphamide, the efficacy and safety of tofacitinib in the treatment of active IgG4-related diseases were evaluated.

Detailed Description

This study is a prospective, single center, non randomized, controlled, open label clinical observation study to evaluate the efficacy and safety of tropitib versus cyclophosphamide in inducing remission in IgG4-RD patients. 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.

Overall Status Recruiting
Start Date 2022-11-10
Completion Date 2025-12-31
Primary Completion Date 2024-12-31
Study Type Observational
Primary Outcome
Measure Time Frame
Disease remission rate at 1 month, 3 months and 6 months of treatment (%) 1 month, 3 months and 6 months of treatment
Secondary Outcome
Measure Time Frame
Response rate at 1 month, 3 months and 6 months after treatment (%) 1 month, 3 months and 6 months after treatment
Disease recurrence rate at 3 and 6 months after treatment (%) 3 and 6 months after treatment
Changes in physician's overall assessment (PGA) from baseline at 1 month, 3 months and 6 months of treatment 1 month, 3 months and 6 months of treatment
Enrollment 40
Condition
Intervention

Intervention Type: Drug

Intervention Name: tofacitinib

Description: 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 Name: cyclophosphamide

Eligibility

Sampling Method:

Non-Probability Sample

Criteria:

Inclusion Criteria: - It meets the 2019 ACR/EULAR classification diagnostic criteria for IgG4 related diseases, and is an active IgG4-RD, defined as an IgG4-RD RI score ≥ 3 points when screening Exclusion Criteria: - 1. IgG4 related diseases endangering organ function or life; 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;

Gender:

All

Minimum Age:

18 Years

Maximum Age:

75 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Gao Jie, doctor Study Chair Changhai Hospital
Overall Contact

Last Name: Gao Jie, doctor

Phone: 13585561861

Email: [email protected]

Location
Facility: Status: Contact: Shanghai Changhai Hospital Gao Jie, doctor 13585561861 [email protected]
Location Countries

China

Verification Date

2022-11-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Arm Group

Label: Glucocorticosteroids combined with Cyclophosphamide Group

Description: 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.

Label: Glucocorticoids combined with tofacitinib Group

Description: 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.

Patient Data No
Study Design Info

Observational Model: Case-Control

Time Perspective: Prospective

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