A long-term, open-label follow-up study of Tofacitinib for Treatment of juvenile idiopathic arthritis (JIA)

Pfizer Inc0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年10月17日

试验速览

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•Pediatric subjects with JIA aged from 2 to less than 18 years who met entry criteria for the qualifying/index study and in the opinion of the investigator have sufficient evidence of JIA disease activity to warrant use of tofacitinib as a DMARD. Subjects turning 18 years of age during participation in the qualifying/index study or subsequently will be eligible for participation in this study.
•Subjects must have previously completed participation in a qualifying study of tofacitinib for the treatment of JIA. Subjects who have required earlier discontinuation of treatment in a qualifying study for reasons other than tofacitinib related serious adverse events may be eligible.

•Subjects presenting with any of the following will not be included in the study:
•For subjects who enroll outside the 14 day window of the EOS Visit of their qualifying/index study:
•Blood dyscrasias, including:
•a. Hgb <10 g/dL or Hct <33%;
•b. WBC <3.0 x 109/L;
•c. Neutrophil count <1.2 x 109/L;
•d. Platelet count <100 x 109/L;
•e. Lymphocyte count of <0.75 x 109/L.
•Estimated glomerular filtration rate [GFR] <40 mL/min/1.73 m2 calculated using
•Bedside Schwartz formula at the Screening Visit.
•Persistent oligoarthritis and undifferentiated JIA.

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