juvenile idiopathic arthritis
Conditions
Interventions
1:rhTNFR-Ig
Sponsors
The Children's Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
2 Years to 17 Years
Inclusion criteria
Inclusion criteria: (1) Age: 2-17 years old (both ends included); (2) Meet the classification criteria of pJIA and ERA by the International League of Associations for Rheumatology (ILAR); (3) Children with pJIA and ERA whose initial treatment is still moderately active after 3 months of MTX or still low activity after 6 months of MTX; (4) MTX medication needs to meet one of the following conditions: MTX-free time before taking MTX or baseline visit >= 4 weeks; MTX medication time before baseline >= 12 weeks, and stable dose (10-15mg/m2) for 8 weeks , and taking folic acid; (5) Children who did not take oral corticosteroids, or the hormones have been discontinued for 4 weeks; (6) Children who did not receive NSAID; or are taking 1 NSAID, but the stable dose (the dose = 2 weeks before the baseline visit; (7) For girls with fertility potential, use contraception during treatment and for at least 3 months after the last dose.
Exclusion criteria
Exclusion criteria: Excluded when meets any item of the following General standards: (1) Sitting in a wheelchair or bed; (2) Suffering from other autoimmune or rheumatic diseases other than JIA; (3) The recent surgery has not fully recovered or the screening visit was less than 6 weeks from the end of the operation or the operation is planned within the first 12 weeks of the study. Safety standards: (1) Major medical or surgical diseases; (2) At risk of sepsis or sepsis; (3) There is primary immunodeficiency disease or severe secondary immunodeficiency disease is not corrected; (4) Accompanied by serious infectious diseases, including but not limited to active tuberculosis, latent tuberculosis infection, active viral hepatitis, etc.; (5) Hepatitis B surface antigen or hepatitis C antibody positive; (6) Chronic viral or autoimmune hepatitis; (7) severe gastrointestinal disease or previous medical history, such as ulcer, perforation or inflammatory bowel disease, Crohn's disease, ulcerative colitis, etc.; (8) There is a history of MAS within 3 months before the screening visit; (9) Evidence of active malignant disease or diagnosis of malignant tumor ; (10) Poorly controlled diabetes; (11) Severe heart disease (such as congenital heart disease, heart valve disease, constrictive pericarditis, myocarditis) or lung disease (asthma, cystic fibrosis); (12) Previous history of demyelinating syndrome or multiple sclerosis. Past or combined treatment: (1) Children who participated in other research clinical trials within 30 days before the baseline visit, or at least 5 drug half-lives or efficacy periods of the study drug; (2) Received intra-articular, intramuscular, intravenous, or long-acting CS treatment within 28 days before the baseline visit; (3) Have received cDMARDs (except MTX) within 6 weeks before the baseline visit, including but not limited to: hydroxychloroquine, chloroquine, azathioprine, D-penicillamine, sulfasalazine, thalidomide Amine etc.; (4) Within 12 weeks before the baseline visit, within 14 days after receiving leflunomide treatment or eluting with standard cholestyramine or activated carbon; (5) Received cyclophosphamide treatment within 90 days before the baseline visit; (6) Etoposide treatment within 90 days before baseline visit; (7) Received growth hormone therapy within 4 weeks before the baseline visit; (8) Received androgen (eg testosterone) treatment within 4 weeks before the baseline visit; (9) Received statin therapy within 90 days before the baseline visit; (10) Immune globulin was given intravenously within 28 days before the baseline visit; (11) Patients who have previously received cell depletion therapy, including experimental drugs (such as anti-CD19 and anti-CD20); (12) Have received stem cell transplantation at any time in the past; (13) Received live or attenuated vaccination within 4 weeks before the baseline visit, or plan to receive live or attenuated vaccination during study drug administration or within 3 months after the last study drug administration. Laboratory indicators: (1) Peripheral blood leukocyte count 1.5 times the upper limit of reference value; (5) Serum ALT> 2 times the upper limit of reference value.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| cJADAS;Joint imaging; | — |
Secondary
| Measure | Time frame |
|---|---|
| blood rutine;C reactive protein;ESR;Liver and kidney function; | — |
Countries
China
Contacts
Public ContactMeiping Lu
Children's Hospital of Zhejiang University School of Medicine
Outcome results
None listed