A Study of Baricitinib (LY3009104) in Participants From 1 Year to Less Than 18 Years Old With sJIA
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|ClinicalTrials.gov Identifier: NCT04088396|
Recruitment Status : Recruiting
First Posted : September 12, 2019
Last Update Posted : April 18, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Systemic Juvenile Idiopathic Arthritis||Drug: Baricitinib Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||103 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients From 1 Year to Less Than 18 Years Old With Systemic Juvenile Idiopathic Arthritis|
|Actual Study Start Date :||February 12, 2020|
|Estimated Primary Completion Date :||August 7, 2023|
|Estimated Study Completion Date :||August 7, 2023|
Baricitinib given orally.
Other Name: LY3009104
Placebo Comparator: Placebo
Placebo given orally.
- Time to Disease Flare [ Time Frame: Week 24 to End of Double Blind Withdrawal (DBW) Period (Disease Flare or up to Week 56) ]Time to Disease Flare
- Percentage of Participants Achieving Pediatric American College of Rheumatology 30 Responder Index (PedACR30) [ Time Frame: Baseline through End of DBW Period (Disease Flare or up to Week 56) ]Percentage of Participants Achieving PedACR30
- Percentage of Participants with Inactive Disease [ Time Frame: Baseline through End of DBW Period (Disease Flare or up to Week 56) ]Percentage of Participants with Inactive Disease
- Percentage of Participants with Minimal Disease Activity [ Time Frame: Baseline through End of DBW Period (Disease Flare or up to Week 56) ]Percentage of Participants with Minimal Disease Activity
- Percentage of Participants in Remission [ Time Frame: Baseline through End of DBW Period (Disease Flare or up to Week 56) ]Percentage of Participants in Remission
- Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS)-27 [ Time Frame: Baseline, End of DBW Period (Disease Flare or up to Week 56) ]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, End of DBW Period (Disease Flare or up to Week 56) ]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 End of DBW Period (Disease Flare or up to Week 56) ]PK: Cmax, ss of Baricitinib
- PK: Area Under the Baricitinib Concentration-Time Curve at Steady-State (AUC, ss) [ Time Frame: Baseline through End of DBW Period (Disease Flare or up to Week 56) ]PK: AUC, ss of Baricitinib
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|Ages Eligible for Study:||1 Year to 17 Years (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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).
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04088396
|Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or||1-317-615-4559||ClinicalTrials.firstname.lastname@example.org|
|Study Director:||Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)||Eli Lilly and Company|
|Responsible Party:||Eli Lilly and Company|
|Other Study ID Numbers:||
I4V-MC-JAHU ( Other Identifier: Eli Lilly and Company )
2017-004495-60 ( EudraCT Number )
|First Posted:||September 12, 2019 Key Record Dates|
|Last Update Posted:||April 18, 2023|
|Last Verified:||April 1, 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.|
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
|Time Frame:||Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.|
|Access Criteria:||A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
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