Adult-onset still's disease
Conditions
Interventions
experimental group:deferasirox
control group:placebo
Sponsors
South Hospital of Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. The diagnostic criteria were in accordance with Yamaguchi standard; 2. Patients who voluntarily joined the experimental study and signed the informed consent; 3. Patients who were over 18 years old at the time of enrollment and over 15 years old at the time of onset; 4. Patients with refractory and active AOSD (meeting the following 34 items at the same time): (1) There was no remission after more than 1 week treatment with glucocorticoid >= 0.5mg/kg/d; (2) Fever and at least one of the following systemic symptoms, including: rash, sore throat, arthritis, myalgia, lymphadenopathy, hepatomegaly, splenomegaly, serositis, pulmonary infiltration. (3) Serological indicators: ferritin >= 500ng / ml (necessary) and ESR >= 20 mm / h or CRP >= 10 mg / L (at least one).
Exclusion criteria
Exclusion criteria: 1. Patients who used biologics or did not wash out at baseline (tolfatib within 1 week; enalapril within 2 weeks; adalimumab or toluzumab within 6 weeks; infliximab within 8 weeks; rituximab within 6 months); 2. Patients who meet the hlh-2004 standard of the international organization cell association; 3. Patients with various acute or chronic systemic infections (including tuberculosis, HIV, hepatitis B or hepatitis C); 4. Patients with malignant tumor, serious cardiovascular disease, digestive system disease (GPT >= 5 times normal upper limit) and kidney disease (serum creatinine >= 1.5 times normal upper limit); 5. Pregnancy and lactation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compete and partial remission rate defined using Pouchot score;Compete and partial remission rate defined using Pouchot score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Prednisone dose;Incidence of Macrophage activation syndrome defined using 2004-HLH;iron metabolism; | — |
Countries
China
Contacts
Public ContactHaiting Wang
South Hospital of Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Outcome results
None listed