Idiopathic Orbital Inflammation
Conditions
Interventions
trial group:Intravenous infusion of TCZ with the dose of 8 mg/kg (maximum dose not exceeding 800 mg), diluted in 0.9% saline to a total volume of 100 ml, with an infusion time of over 1 hour.
Sponsors
Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Patients with refractory and relapsed IOI; 2. Older than 18 years old, less than 65 years old, gender is not limited; 3. Patients who have not received any biologics therapy within 3 months and have not received hormone pulse therapy within 1 month; 4. Inflammation is in the onset phase (CAS score = 3) ; 5. Patient signed informed consent form and is willing to follow up at the time specified in the trial.
Exclusion criteria
Exclusion criteria: 1. Patients with specific orbital inflammation with a definite diagnosis; 2. Severe cardiac, hepatic and renal insufficiency (myocardial ischemia or myocardial infarction, arrhythmia and cardiac insufficiency; ALT and AST = upper limit of normal values× 5 times; Absolute neutrophil count< 0.5×10^9//L; platelet count < 50; Creatinine = upper limit of normal; eGFR < 60 ml/min/1.73 m2) ; 3. Hematopoietic system disorders, malignant tumors, active infections; 4. Allergy; 5. Pregnancy or lactation; 6. Those who may not cooperate with the experiment, such as patients with schizophrenia;
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Duration of Response;Recurrence rate;Vision;Intraocular pressure;Exophthalmos;Quality of life;Visual analogue scale; | — |
Primary
| Measure | Time frame |
|---|---|
| 1-year efficacy rate; | — |
Countries
CHINA
Contacts
Public ContactSONG XIN
Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed