Compared with cyclophosphamide, the efficacy and safety of tofacitinib in the treatment of active IgG4-related diseases were evaluated.
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.
Study Type
OBSERVATIONAL
Enrollment
40
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.
Shanghai Changhai Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGDisease remission rate at 1 month, 3 months and 6 months of treatment (%)
Definition of disease remission: including ① complete remission (CR) (main efficacy index), partial remission (PR), continuous complete remission (CCR) and no change (NC).
Time frame: 1 month, 3 months and 6 months of treatment
Response rate at 1 month, 3 months and 6 months after treatment (%)
Defined as IgG4-RD RI score decrease ≥ 1 point
Time frame: 1 month, 3 months and 6 months after treatment
Disease recurrence rate at 3 and 6 months after treatment (%)
There are two types of disease recurrence, clinical recurrence and serological recurrence. Clinical recurrence was defined as recurrence of clinical symptoms or deterioration of imaging findings, with or without elevated serum IgG4 levels; Serological relapse was defined as an increase in serum IgG4 level and an increase in IgG4-RD RI score of ≥ 1 point after treatment, without recurrence of clinical symptoms or deterioration of imaging manifestations. The isolated increase of serum IgG4 concentration only constitutes serological recurrence. The date of recurrence is the date of onset of symptoms, or the date of new or deteriorated physical examination, laboratory examination or radiological examination results.
Time frame: 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
First, the doctor evaluated the overall situation of IgG4 - RD subjects and marked them at the corresponding position of the straight line in the form of a vertical vertical line "l". The straight line is a 100mm scale, where the 0 end of the straight line represents very good, and the 100mm end represents very poor.
Time frame: 1 month, 3 months and 6 months of treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.