Trial · NCT03773978

A Study of Baricitinib in Participants From 2 Years to Less Than 18 Years Old With Juvenile Idiopathic Arthritis

NCT03773978, Phase 3, Completed, Eli Lilly and Company; results first posted 2022-10-07

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Study of Baricitinib in Participants From 2 Years to Less Than 18 Years Old With Juvenile Idiopathic Arthritis. Trials, record NCT03773978. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03773978

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study of Baricitinib in Participants From 2 Years to Less Than 18 Years Old With Juvenile Idiopathic Arthritis
NCT number: NCT03773978
Status: Completed
Phases: Phase 3
Enrollment: 220 participants, actual
Lead sponsor: Eli Lilly and Company
Conditions: Juvenile Idiopathic Arthritis
Interventions: Baricitinib, Placebo
First posted: 2018-12-12
Last updated: 2022-10-07
Other registries' IDs: eudract:2017-004518-24
Results first posted: 2022-10-07

Source ClinicalTrials.gov

Registered outcomes19

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Time to Disease Flare	Week 12 to Week 44	A disease flare is defined as a worsening of 30% or more in at least three of the six core Paediatric American College of Rheumatology (PedACR) criteria for juvenile rheumatoid arthritis (JIA) and an improvement of 30% or more in no more than one of the criteria. The six PedACR criteria are: 1) the number of active joints, 2) the number of joints with limited range of motion, 3) physician's global assessment of disease activity, 4) parent's global assessment of the participant's overall well-being, 5) physical function as measured by the Childhood Health Assessment Questionnaire (CHAQ) and 6) acute-phase reactant (high-sensitivity C-reactive protein \[hsCRP\] and erythrocyte sedimentation rate \[ESR\]), the ESR measure is only used as an acute phase reactant in the core criteria.
Secondary	Percentage of Participants Achieving PedACR30 Responder Index	Week 16, 20, 24, 28, 32, 36, 40 and 44	The PedACR30 response is defined as at least 30% improvement from baseline in 3 of any 6 variables in the core set, with no more than 1 of the remaining variables worsening by \>30%. The 6 core response variables included in the PedACR criteria are: Number of active joints (defined as a joint that is swollen or in the absence of swelling has loss of passive motion accompanied by either pain on motion or joint tenderness) in 73 joints, Number of joints with limited range of motion in 69 joints, Physician's Global Assessment of Disease Activity (21-circle visual analogue scale \[VAS\]), Parent's Global Assessment of Patient's Overall Well-being, Physical function as assessed by the CHAQ and Acute-phase reactant (hsCRP and ESR). When PedACR response is analyzed as secondary endpoint, ESR measure is only used as acute-phase reactant in the core criteria.
Secondary	Percentage of Participants Achieving PedACR50 Responder Index	Week 16, 20, 24, 28, 32, 36, 40 and 44	The PedACR50 response is defined as at least 50% improvement from baseline in 3 of any 6 variables in the core set, with no more than 1 of the remaining variables worsening by \> 30%. The 6 core response variables included in the PedACR criteria are: Number of active joints (defined as a joint that is swollen or in the absence of swelling has loss of passive motion accompanied by either pain on motion or joint tenderness) in 73 joints, Number of joints with limited range of motion in 69 joints, Physician's Global Assessment of Disease Activity (21-circle VAS), Parent's Global Assessment of Patient's Overall Well-being, Physical function as assessed by the CHAQ and Acute-phase reactant (hsCRP and ESR). When PedACR response is analyzed as secondary endpoint, ESR measure is only used as acute-phase reactant in the core criteria.
Secondary	Percentage of Participants Achieving PedACR70 Responder Index	Week 16, 20, 24, 28, 32, 36, 40 and 44	The PedACR70 response is defined as at least 70% improvement from baseline in 3 of any 6 variables in the core set, with no more than 1 of the remaining variables worsening by \> 30%. The 6 core response variables included in the PedACR criteria are: Number of active joints (defined as a joint that is swollen or in the absence of swelling has loss of passive motion accompanied by either pain on motion or joint tenderness) in 73 joints, Number of joints with limited range of motion in 69 joints, Physician's Global Assessment of Disease Activity (21-circle VAS), Parent's Global Assessment of Patient's Overall Well-being, Physical function as assessed by the CHAQ and Acute-phase reactant (hsCRP and ESR). When PedACR response is analyzed as secondary endpoint, ESR measure is only used as acute-phase reactant in the core criteria.
Secondary	Percentage of Participants Achieving PedACR90 Responder Index	Week 16, 20, 24, 28, 32, 36, 40 and 44	The PedACR90 response is defined as at least 90% improvement from baseline in 3 of any 6 variables in the core set, with no more than 1 of the remaining variables worsening by \> 30%. The 6 core response variables included in the PedACR criteria are: Number of active joints (defined as a joint that is swollen or in the absence of swelling has loss of passive motion accompanied by either pain on motion or joint tenderness) in 73 joints, Number of joints with limited range of motion in 69 joints, Physician's Global Assessment of Disease Activity (21-circle VAS), Parent's Global Assessment of Patient's Overall Well-being, Physical function as assessed by the CHAQ and Acute-phase reactant (hsCRP and ESR). When PedACR response is analyzed as secondary endpoint, ESR measure is only used as acute-phase reactant in the core criteria.
Secondary	Percentage of Participants Achieving PedACR100 Responder Index	Week 16, 20, 24, 28, 32, 36, 40 and 44	The PedACR100 response is defined as at least 100% improvement from baseline in 3 of any 6 variables in the core set, with no more than 1 of the remaining variables worsening by \> 30%. The 6 core response variables included in the PedACR criteria are: Number of active joints (defined as a joint that is swollen or in the absence of swelling has loss of passive motion accompanied by either pain on motion or joint tenderness) in 73 joints, Number of joints with limited range of motion in 69 joints, Physician's Global Assessment of Disease Activity (21-circle VAS), Parent's Global Assessment of Patient's Overall Well-being, Physical function as assessed by the CHAQ and Acute-phase reactant (hsCRP and ESR). When PedACR response is analyzed as secondary endpoint, ESR measure is only used as acute-phase reactant in the core criteria.
Secondary	Percentage of Participants With Inactive Disease	Week 16, 20, 24, 28, 32, 36, 40 and 44	Inactive disease is defined as the presence of all of the following: 1. No joints with active arthritis based on Juvenile Arthritis Disease Activity Score (JADAS) - 27 score, 2. No fever, rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to JIA as assessed by the investigator, 3. No active uveitis as assessed by the investigator, 4. Normal ESR or hsCRP (i.e., within normal limits in the local laboratory or, if elevated, not attributable to JIA), 5. Physician's Global Assessment of Disease Activity indicating no active disease (Score ranges are 0 to 100 and best possible score on scale is 0) and 6. Duration of morning stiffness ≤15 minutes.
Secondary	Percentage of Participants With Minimal Disease Activity	Week 16, 20, 24, 28, 32, 36, 40 and 44	Minimal disease activity is calculated based on the scores from the 1. Physician's Global Assessment of Disease Activity 2. Parent's Global Assessment of Well-Being and 3. the number of swollen joints. If the physician's global assessment of disease activity is ≤3.5 (score range: 0-100), the parent's global rating of patient's overall well-being is ≤2.5 (score range: 0-100), and the swollen joint count is ≤1 (score range: 0-73), then the participant reaches minimal disease activity. if not, minimal disease activity is not reached.
Secondary	Percentage of Participants in Remission	Week 28, 32, 36, 40 and 44	Remission is defined as inactive disease for at least 24 consecutive weeks. Inactive disease is defined as the presence of all of the following: 1) No joints with active arthritis based on Juvenile Arthritis Disease Activity Score (JADAS)-27 score, 2) No fever, rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to JIA as assessed by the investigator, 3) No active uveitis as assessed by the investigator, 4) Normal ESR or hsCRP (i.e., within normal limits in the local laboratory or, if elevated, not attributable to JIA), 5) Physician's Global Assessment of Disease Activity indicating no active disease (best possible score on scale \[0\]) and 6) Duration of morning stiffness ≤15 minutes.
Secondary	Change From Baseline in Juvenile Arthritis Disease Activity Score-27 (JADAS-27) Score	Baseline, Week 44	The JADAS-27 score is based on 4 components: 1) Physician's global assessment of disease activity on a 0-100 mm VAS, 2) Parent's global assessment of overall well-being on a 0-100 mm VAS, 3) normalized ESR and 4) number of joints (maximum of 27) with active arthritis (cervical spine, elbows, wrists, metacarpophalangeal joints \[from first to third\], proximal interphalangeal joints, hips, knees, and ankles). The scores for the each of the first 3 components range from 0 -10; the score for the final component ranges from 0-27. The overall JADAS-27 score is sum of the 4 components and it ranges from 0-57. A higher score indicates more disease activity. Least square (LS) mean was calculated using Analysis of covariance (ANCOVA) model which includes treatment, baseline, prior biologic JIA therapy, combined JIA category and predose exposure ESR category value as fixed factors.

1 to 10 of 19Source ClinicalTrials.gov

See all 19 registered outcomes

Outcomes19

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Time to Disease Flare	Week 12 to Week 44	DBW Population: All randomized participants from the DBW period who had data for time to disease flare at given time point.	Weeks	MEDIAN
SECONDARY	Percentage of Participants Achieving PedACR30 Responder Index	Week 16, 20, 24, 28, 32, 36, 40 and 44	DBW Population: All randomized participants from the DBW period who had data for PedACR30 at given time point.	Percentage of participants	NUMBER
SECONDARY	Percentage of Participants Achieving PedACR50 Responder Index	Week 16, 20, 24, 28, 32, 36, 40 and 44	DBW Population: All randomized participants from the DBW period who had data for PedACR50 at given time point.	Percentage of participants	NUMBER
SECONDARY	Percentage of Participants Achieving PedACR70 Responder Index	Week 16, 20, 24, 28, 32, 36, 40 and 44	DBW Population: All randomized participants from the DBW period who had data for PedACR70 at given time point.	Percentage of participants	NUMBER
SECONDARY	Percentage of Participants Achieving PedACR90 Responder Index	Week 16, 20, 24, 28, 32, 36, 40 and 44	DBW Population: All randomized participants from the DBW period who had data for PedACR90 at given time point.	Percentage of participants	NUMBER
SECONDARY	Percentage of Participants Achieving PedACR100 Responder Index	Week 16, 20, 24, 28, 32, 36, 40 and 44	DBW Population: All randomized participants from the DBW period who had data for PedACR100 at given time point.	Percentage of participants	NUMBER
SECONDARY	Percentage of Participants With Inactive Disease	Week 16, 20, 24, 28, 32, 36, 40 and 44	DBW Population: All randomized participants from the DBW period who had data for inactive disease at given time point.	Percentage of participants	NUMBER
SECONDARY	Percentage of Participants With Minimal Disease Activity	Week 16, 20, 24, 28, 32, 36, 40 and 44	DBW Population: All randomized participants from the DBW period who had data for minimum disease activity at given time point.	Percentage of participants	NUMBER
SECONDARY	Percentage of Participants in Remission	Week 28, 32, 36, 40 and 44	DBW Population: All randomized participants from the DBW period who had data for remission at given time point.	Percentage of participants	NUMBER
SECONDARY	Change From Baseline in Juvenile Arthritis Disease Activity Score-27 (JADAS-27) Score	Baseline, Week 44	DBW Population: All randomized participants from the DBW period who had data for at least one post-baseline JADAS-27 score at given time point.	score on a scale	LEAST_SQUARES_MEAN

1 to 10 of 19Source ClinicalTrials.gov

See all 19 outcomes

Results by group203

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Time to Disease Flare	Baricitinib		NA	95% Confidence Interval NA to NA	Weeks
Time to Disease Flare	Placebo		27.14	95% Confidence Interval 15.29 to NA	Weeks
Percentage of Participants Achieving PedACR30 Responder Index	Baricitinib	At week 16	92.7	95% Confidence Interval 87 to 98.3	Percentage of participants
Percentage of Participants Achieving PedACR30 Responder Index	Placebo	At week 16	81.5	95% Confidence Interval 73 to 89.9	Percentage of participants
Percentage of Participants Achieving PedACR30 Responder Index	Baricitinib	At week 20	87.8	95% Confidence Interval 80.7 to 94.9	Percentage of participants
Percentage of Participants Achieving PedACR30 Responder Index	Placebo	At week 20	64.2	95% Confidence Interval 53.8 to 74.6	Percentage of participants
Percentage of Participants Achieving PedACR30 Responder Index	Baricitinib	At week 24	85.4	95% Confidence Interval 77.7 to 93.0	Percentage of participants
Percentage of Participants Achieving PedACR30 Responder Index	Placebo	At week 24	55.6	95% Confidence Interval 44.7 to 66.4	Percentage of participants
Percentage of Participants Achieving PedACR30 Responder Index	Baricitinib	At week 28	78	95% Confidence Interval 69.1 to 87	Percentage of participants
Percentage of Participants Achieving PedACR30 Responder Index	Placebo	At week 28	51.9	95% Confidence Interval 41 to 62.7	Percentage of participants

1 to 10 of 203Source ClinicalTrials.gov

See all 203 results by group

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
PK/Safety and OLLI Period	STARTED	Baricitinib	220
PK/Safety and OLLI Period	STARTED	Placebo	0
PK/Safety and OLLI Period	PK/Safety Period	Baricitinib	29
PK/Safety and OLLI Period	PK/Safety Period	Placebo	0
PK/Safety and OLLI Period	OLLI Period	Baricitinib	219
PK/Safety and OLLI Period	OLLI Period	Placebo	0
PK/Safety and OLLI Period	Received at Least One Dose of Study Drug	Baricitinib	220
PK/Safety and OLLI Period	Received at Least One Dose of Study Drug	Placebo	0
PK/Safety and OLLI Period	COMPLETED	Baricitinib	163
PK/Safety and OLLI Period	COMPLETED	Placebo	0

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events51

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Nasopharyngitis	Infections and infestations	Baricitinib PK and OLLI	19	220	20
other	Nasopharyngitis	Infections and infestations	Placebo DBW	3	81	3
other	Nasopharyngitis	Infections and infestations	Baricitinib DBW	6	82	7
other	Upper respiratory tract infection	Infections and infestations	Baricitinib PK and OLLI	11	220	12
other	Upper respiratory tract infection	Infections and infestations	Placebo DBW	1	81	1
other	Upper respiratory tract infection	Infections and infestations	Baricitinib DBW	9	82	10
other	Arthralgia	Musculoskeletal and connective tissue disorders	Baricitinib PK and OLLI	11	220	15
other	Arthralgia	Musculoskeletal and connective tissue disorders	Placebo DBW	3	81	4
other	Arthralgia	Musculoskeletal and connective tissue disorders	Baricitinib DBW	6	82	6
other	Headache	Nervous system disorders	Baricitinib PK and OLLI	14	220	16

1 to 10 of 51Source ClinicalTrials.gov

See all 51 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Baricitinib PK and OLLI	0	220
Total, all-cause mortality	Placebo DBW	0	81
Total, all-cause mortality	Baricitinib DBW	0	82
Total, other adverse events	Baricitinib PK and OLLI	48	220
Total, other adverse events	Placebo DBW	10	81
Total, other adverse events	Baricitinib DBW	26	82
Total, serious adverse events	Baricitinib PK and OLLI	6	220
Total, serious adverse events	Placebo DBW	3	81
Total, serious adverse events	Baricitinib DBW	4	82

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
37423231	DERIVED	PubMed
40915298	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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