ong-Term Safety Study Of Tofacitinib In Patients With Juvenile Idiopathic Arthritis

Phase 2

Conditions: Health Condition 1: M082- Juvenile rheumatoid arthritis withsystemic onset

Registration Number: CTRI/2022/04/041752

Lead Sponsor: Pfizer Inc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective of this study is to determine the long term safety and tolerability of tofacitinib for treatment of the signs and symptoms of JIA.Timepoint: Up to 120 weeks

Secondary Outcome Measures

Name	Time	Method
The secondary objective of this study is to evaluate the persistence of efficacy of tofacitinib for treatment of the signs and symptoms of JIA.Timepoint: Up to 120 weeks