臨床研究等提出・公開システム

Open-Label, Randomized Study With a Tocilizumab Reference Arm to Evaluate Safety, Efficacy and Pharmacokinetics of Baricitinib in Children From 1 to Less Than 18 Years of Age With Systemic Juvenile Idiopathic Arthritis.

I4V-MC-JAHU

Masaki Takeshi

Eli Lilly Japan K.K.

5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo

LTG_CallCenter@lists.lilly.com

Trial Guide Call Center

Eli Lilly Japan K.K.

5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo

+81-120-023-812

LTG_CallCenter@lists.lilly.com

recruiting

Dec. 15, 2019

Interventional

Allocation:Randomized Interventional Model:Parallel Assignment Masking:None (Open Label) Primary Purpose:Treatment

treatment purpose

3

-Participants must have a diagnosis of systemic Juvenile Idiopathic Arthritis (sJIA) as defined by International League of Associations for Rheumatology (ILAR) criteria with onset before the age of 16 years.
-Participants must have at least 2 active joints at screening and baseline.
-Cohort 1 (IL-6 inhibitor therapy naive): Participants who are at least 1 year and less than 18 years of age, except in countries that restrict use of tocilizumab in participants less than 2 years of age
-Cohort 2 (open-label baricitinib): Participants who are at least 1 year and less than 18 years of age

-Participants must not have polyarticular JIA (positive or negative for rheumatoid factor), extended oligoarticular JIA, enthesitis-related JIA, or juvenile psoriatic arthritis.
-Participants must not have persistent oligoarticular arthritis as defined by the ILAR criteria.
-Participants must not have a history or presence of any autoimmune inflammatory condition other than JIA.
-Participants must not have active anterior uveitis or are receiving concurrent treatment for anterior uveitis.
-Participants must not have active fibromyalgia or other chronic pain conditions that, in the investigator's opinion, would make it difficult to appropriately assess disease activity for the purposes of this study.
-Participants must not have biologic features of Macrophage Activation Syndrome (MAS) over the past 12 weeks.
-Participants must not have a current or recent (<4 weeks prior to baseline) clinically serious infection.
-Participants must not have a positive test for hepatitis B virus.
-Participants must not have evidence of active tuberculosis (TB) or untreated latent TB.

Both

Systemic Juvenile Idiopathic Arthritis

Drug: Baricitinib
Administered orally
Other Names:
LY3009104
Drug: Tocilizumab
Administered SC

-Percentage of Participants Achieving Adapted Pediatric American College of Rheumatology 30 Responder Index (PediACR30) Response Criteria at Week 12 [Time Frame: Week 12]
o Percentage of Participants Achieving Adapted PediACR30 Response Criteria

-Percentage of Participants Achieving Adapted PediACR30 Response Criteria at Week 24 [Time Frame: Week 24]
o Percentage of Participants Achieving Adapted PediACR30 Response Criteria
-Percentage of Participants with Inactive Disease [Time Frame: Week 12]
o Percentage of Participants with Inactive Disease
-Percentage of Participants with Minimal Disease Activity [Time Frame: Week 12]
o Percentage of Participants with Minimal Disease Activity
-Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS)-27 [Time Frame: Baseline, Week 24]
o Change from Baseline in JADAS-27
-Change from Baseline in Arthritis-Related Pain Severity as Measured by the Childhood Health Assessment Questionnaire (CHAQ) Pain Visual Analog Scale (VAS) Item [Time Frame: Baseline, Week 24]
o Change from Baseline in Arthritis-Related Pain Severity as Measured by the CHAQ Pain VAS Item
-Pharmacokinetics (PK): Maximum Plasma Baricitinib Concentration at Steady-State (Cmax, ss) [Time Frame: Baseline through Week 24]
o PK: Cmax, ss of Baricitinib
-PK: Area Under the Baricitinib Concentration-Time Curve at Steady-State (AUC, ss) [Time Frame: Baseline through Week 24]
o PK: AUC, ss of Baricitinib

+81-72-683-1221

Aug. 01, 2019