A study of Baricitinib in children and young adults with Juvenile Idiopathic Arthritis (jia)

INTERVENTION: Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: BARICITINIB Current Sponsor code: LY3009104 Other descriptive name: BARICITINIB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 4‐ Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use Trade Name: Olumiant Product Name: Olumiant Product Code: ly3009104 Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: BARICITINIB Current Sponsor code: LY3009104 Other descriptive name: BARICITINIB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2‐ Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use Product Name: Olumiant Product Code: ly3009104 Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: BARICITINIB Current Sponsor code: LY3009104 Other descriptive name: BARICITINIB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1‐ Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use Product Name: Olumiant Product Code: LY3009104 Pharmaceutical Form: Suspension for oral suspension INN or Proposed INN: BARICITINIB Other descriptive name: BARICITINIB CONDITION: Systemic Juvenile Idiopathic Arthritis (sJIA) ; MedDRA version: 20.0 Level: LLT Classification code 10079454 Term: Systemic juvenile idiopathic arthritis System Organ Class: 100000004859 Therapeutic area: Diseases [C] ‐ Musculoskeletal Diseases [C05] PRIMARY OUTCOME: ; Secondary Objective: To evaluate the efficacy of baricitinib in children with sJIA.; To assess the safety of baricitinib compared to placebo in patients with sJIA.; Main Objective: To evaluate the efficacy of baricitinib compared to placebo in children with sJIA Primary end point(s): ‐Time to disease flare (defined as recurrence of fever lasting for 2 or more consecutive days, and/ or worsening of =30% in at least 3 of the 6 Pediatric American College of Rheumatology (PediACR) core criteria for JIA and an improvement of =30% in no more than 1 of the criteria) from the initiation of the double blind withdrawal period to the end of the double blind withdrawal period. Timepoint(s) of evaluation of this end point: 32 weeks SECONDARY OUTCOME: ; Secondary end point(s): Open Label Lead in Period: ; Changes from baseline in each of the 6 individual components of the PediACR Core Set variables as follows, with the addition of absence of spiking fever, as follows: ; ‐Number of active joints ; ‐Number of joints with limited range of motion ; ‐Physician's Global Assessment of Disease Activity ; ‐Parent's Global Assessment of Well‐Being ; ‐Physical function as measured by the CHAQ ; ‐Acute‐phase reactant hsCRP and erythrocyte sedimentation rate (ESR) ; ‐ Proportion of patients without spiking fever ; Adapted PediACR 30/50/70/90/100 response rates at the end of the Open label lead in period. ; Proportion of patients with inactive disease. ; Proportion of patients with minimal disease activity. ; ; Double Blind Withdrawal period: ; Changes from the beginning of the OLLI period to the end of the DBW period (due to disease flare or completion) in each of the 6 individual components of the PediACR Core set, plus absence of spiking fever. ; Adapted PediACR 30/50/70/90/100 response rates at the end of the DBW period. ; Proportion of patients with disease flare. ; Proportion of patients with inactive disease ; Adverse events including serious AE's.; Timepoint(s) of evaluation of this end point: 24 weeks (Open label lead in period) and 32 weeks (Double Blind Withdrawal period) INCLUSION CRITERIA: [1] Patients are at least 1 year and less than 18 years of age; full date of birth will be collected except in countries in which it is not allowed. [2] Have a diagnosis of sJIA as defined by International League of Associations for Rheumatology (ILAR) criteria (Petty et al. 2004), with onset before the age of 16 years: Arthritis in 1 or more joints with or preceded by fever of at least 2 weeks’ duration that is documented to be daily (quotidian) fever for at least 3 days, and accompanied by 1 or more of the following: o Evanescent (nonfixed) erythematous rash o Generalized lymph node enlargement o Hepatomegaly and/or splenomegaly o Serositis [4] If participating in the PoC period, must have ? a diagnosis of sJIA as defined by the ILAR criteria ? at least 2 joints wit