refractory active systemic juvenile idiopathic arthritis
Conditions
Interventions
Control group:Oral Tofacitinib
Experimental group:Oral Upadacitinib
Sponsors
Children's Hospital of Chongqing Medical University
Eligibility
Sex/Gender
All
Age
2 Years to 16 Years
Inclusion criteria
Inclusion criteria: 1. Informed Consent: The subject and/or legally authorized representative must be able to understand and agree to comply with all protocol requirements, and voluntarily sign an informed consent form approved by an independent ethics committee/institutional review board, indicating the date, prior to the initiation of any screening or study-specific procedures (and assent forms for minors as required by applicable regulations). 2. Demographics and Laboratory Assessments: (1) Male or female subjects, aged >=2 weeks and 10 kg at screening. (3)Laboratory test values at screening, prior to the first dose of the study drug, must meet the following criteria: 1) aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =3.0×10^9/L; 3) absolute neutrophil count (ANC) >=2.0×10^9/L; 4) platelet count (PLT) >=100.0×10^9/L; 5) absolute lymphocyte count (ALC) >=0.75×10^9/L; 6) hemoglobin (Hb) >=90 g/L. 3. Disease/Condition Activity: (1) Subjects must have been diagnosed with sJIA at least 6 weeks prior to screening according to the 2001 ILAR criteria or the 2018 PRINTO criteria, with an age of onset between >=2 years and =4 weeks, etanercept: >=2 weeks, adalimumab, infliximab, certolizumab, golimumab, abatacept, and ekizumab: >= 4 weeks. (3) If concomitant methotrexate (MTX) treatment at baseline, oral or subcutaneous injection is allowed, the recommended dose is 10~15 mg/m^2 per week, and stable dosin
Exclusion criteria
Exclusion criteria: 1.Subjects with uncontrolled severe systemic diseases and/or suspected, impending, or active MAS within 3 months prior to baseline. 2.Previously received oral JAK inhibitor treatment, including investigational drug upadacitinib (for example, marketed upadacitinib [Rinvoq®], tofacitinib [Xeljanz®], ruxolitinib [Jakavi®]), baricitinib [Olumiant®], peficitinib [Smyraf®], abrocitinib [Cibinqo®], and filgotinib [Jyseleca®]). 3.Laboratory test results during the screening period prior to the first administration of the study drug showed the following: (1) serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) >2.0× the upper limit of normal (ULN) based on age and sex; (2) abnormal renal function deemed by the investigator to make the subject unsuitable for participation in this study; (3) total white blood cell count (WBC) <3.0×10^9/L; (4) absolute neutrophil count (ANC) <2.0×10^9/L; (5) platelet count (PLT) <100.0×10^9/L; (6) absolute lymphocyte count (ALC) <0.75×10^9/L; (7) hemoglobin (Hb) <90 g/L. 4.One or more episodes of shingles; (1) herpes zoster with one or more episodes; (2) one or more episodes of disseminated herpes simplex (including eczematous herpetic infections); (3) human immunodeficiency virus (HIV) infection, defined as a confirmed positive result for HIV antibody (Ab) testing; (4) active tuberculosis (TB), untreated latent TB, or TB that cannot be ruled out by chest X-ray, PPD test, T-spot, or other examinations; (5) active infections requiring intravenous anti-infective treatment within 30 days prior to the baseline visit (assessment of active infection must be confirmed by the investigator), or active infections requiring oral/intramuscular anti-infective treatment within 14 days prior to the baseline visit; (6) chronic recurrent infections and/or active viral infections that, in the investigator’s clinical assessment, make the participant unsuitable for this study; (7) clinically significant infections occurring less than 4 weeks before baseline; (8) participants with the following hepatitis B virus (HBV) evidence: hepatitis B surface antigen (HBSAg) positive or for hepatitis B core antibody (HBcAb) positive participants (and for hepatitis B surface antibody (HBSAb) positive participants, if required locally), detectable HBV DNA by qualitative polymerase chain reaction (PCR); (9) participants with the following hepatitis C virus (HCV) evidence: detectable HCV RNA in any participant with anti-HCV Ab. 5.The subject has any of the following medical conditions or disorders: (1) History of allergic reactions to the study drug components (including excipients) and/or other similar products, or significant allergies; (2) recent (within the past 6 months) occurrence of cerebrovascular accidents, myocardial infarction, coronary artery stent implantation, or coronary artery bypass graft surgery, or any conditions that the investigator believes may put the subject at higher risk for major cardiovascular events; (3) history of gastrointestinal perforation (excluding those caused by appendicitis or mechanical injury) or diverticulitis, or a significantly increased risk of GI perforation as judged by the investigator; (4) diseases that may affect drug absorption, including but not limited to short bowel syndrome or gastric bypass surgery (history of gastric banding/gastric sleeve surgery not excluded); (5) history of malignant tumors. 6.Subjects who test positive for pregnancy at baseline before t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion achieving sJIA ACR 30 response at Week 12;Safety assessment; | — |
Secondary
| Measure | Time frame |
|---|---|
| sJIA ACR 30/50/70 response at each observation time point; | — |
Countries
China
Contacts
Public ContactXuemei Tang
Children's Hospital of Chongqing Medical University
Outcome results
None listed