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Clinical Trial Results:
A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients from 2 Years to Less Than 18 Years Old with Juvenile Idiopathic Arthritis (JIA)

Summary
EudraCT number	2017-004518-24
Trial protocol	GB DK CZ DE AT ES PL FR BE IT
Global end of trial date	26 Jan 2022

Results information
Results version number	v2(current)
This version publication date	15 Dec 2022
First version publication date	09 Aug 2022
Other versions	v1
Version creation reason	Correction of full data set Correction of full data set

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

I4V-MC-JAHV

ISRCTN number

US NCT number

NCT03773978

WHO universal trial number (UTN)

Other trial identifiers

Trial Number: 16276

Sponsor organisation name

Eli Lilly and Company

Sponsor organisation address

Lilly Corporate Center, Indianapolis, IN, United States, 46285

Public contact

Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐CTLilly,

Scientific contact

Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐285‐4559,

Is trial part of an agreed paediatric investigation plan (PIP)

Yes

EMA paediatric investigation plan number(s)

EMEA-001220-PIP01-11

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

26 Jan 2022

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

26 Jan 2022

Was the trial ended prematurely?

Main objective of the trial

The reason for this study is to see if the study drug baricitinib given orally is safe and effective in participants with JIA from 2 years to less than 18 years old.

Protection of trial subjects

This study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.

Background therapy

Evidence for comparator

Actual start date of recruitment

17 Dec 2018

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Argentina: 20

Country: Number of subjects enrolled

Czechia: 12

Country: Number of subjects enrolled

Japan: 25

Country: Number of subjects enrolled

United Kingdom: 11

Country: Number of subjects enrolled

India: 6

Country: Number of subjects enrolled

Spain: 14

Country: Number of subjects enrolled

Russian Federation: 8

Country: Number of subjects enrolled

Austria: 2

Country: Number of subjects enrolled

Turkey: 3

Country: Number of subjects enrolled

Belgium: 7

Country: Number of subjects enrolled

China: 18

Country: Number of subjects enrolled

Brazil: 2

Country: Number of subjects enrolled

Poland: 7

Country: Number of subjects enrolled

Denmark: 1

Country: Number of subjects enrolled

Italy: 11

Country: Number of subjects enrolled

Mexico: 21

Country: Number of subjects enrolled

Israel: 15

Country: Number of subjects enrolled

France: 10

Country: Number of subjects enrolled

Australia: 1

Country: Number of subjects enrolled

Germany: 26

Worldwide total number of subjects

220

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

175

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

Top of page

Recruitment details

Overall, 220 participants were enrolled: 29 started with the Pharmacokinetics (PK)/Safety period (2 weeks), and one participant was discontinued due to protocol deviation. 191 participants entered into the Open-label lead-in period (OLLI) period, and during week 2, 28 participants from the PK/Safety population entered into the OLLI period.

Screening details

Participants entered the PK/Safety period (2 weeks) in staggered enrollment of 4 age groups (12 to <18, 9 to <12, 6 to <9, and 2 to <6 years). Upon the safety comparability assessment, Other participants were enrolled directly into OLLI period (12 weeks) followed by a double-blind randomised withdrawal placebo-controlled period (12 to 44 weeks).

Period 1 title

PK/Safety and OLLI Period

Is this the baseline period?

Yes

Allocation method

Non-randomised - controlled

Blinding used

Not blinded

Baricitinib

Arm description

Baricitinib was administered once daily (QD) as a 4-milligram (mg) for adolescent participants (12 to <18 years of age) and children ≥9 years of age; and 2 mg for children <9 years of age. Participants <6 years of age received an oral suspension. Participants ≥6 to <12 years old had the option of receiving an oral suspension. Participants >12 years old were supplied tablets.

Arm type

Experimental

Investigational medicinal product name

Baricitinib

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Baricitinib was administered once daily (OD) as a 4-mg for adolescent participants (12 to <18 years of age) and children ≥9 years of age; and 2 mg for children <9 years of age. Participants <6 years of age received an oral suspension. Participants ≥6 to <12 years old had the option of receiving an oral suspension. Participants >12 years old were supplied tablets.

Investigational medicinal product name

Baricitinib

Investigational medicinal product code

Other name

Pharmaceutical forms

Oral suspension

Routes of administration

Oral use

Dosage and administration details

Baricitinib was administered once daily (OD) as a 4-mg for children ≥9 years of age; and 2 mg for children <9 years of age. Participants <6 years of age received an oral suspension. Participants ≥6 to <12 years old had the option of receiving an oral suspension.

Number of subjects in period 1	Baricitinib
Started	220
PK/Safety Period	29 ^[1]
OLLI Period	219
Received at Least One Dose of Study Drug	220
Completed	163
Not completed	57
Consent withdrawn by subject	3
Investigational product was not delivered to site	1
Because of an unexplainable flare disease	1
Adverse event, non-fatal	1
Failure to Meet Randomization Criteria	39
Due to epidemic or pandemic	6
Participant transitioned to JAHX	1
Lost to follow-up	1
Protocol deviation	4

Notes
[1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: PK/Safety Period: One participant was discontinued from this period due to protocol violation. OLLI Population: 191 participants entered into the Open-label lead-in period (OLLI) period, and during week 2, 28 participants from PK/Safety population entered into the OLLI period.

Period 2 title

DBW Period

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Assessor

Are arms mutually exclusive

Yes

Baricitinib

Arm description

Baricitinib was administered once daily (QD) as a 4-mg for adolescent participants (12 to <18 years of age) and children ≥9 years of age; and 2 mg for children <9 years of age. Participants <6 years of age received an oral suspension. Participants ≥6 to <12 years old had the option of receiving an oral suspension. Participants >12 years old were supplied tablets.

Arm type

Experimental

Investigational medicinal product name

Baricitinib

Investigational medicinal product code

Other name

Pharmaceutical forms

Oral suspension, Tablet

Routes of administration

Oral use

Dosage and administration details

Baricitinib was administered once daily (QD) as a 4-mg oral tablet for adolescent participants (12 to <18 years of age) and children ≥9 years of age; and 2 mg for children <9 years of age. Participants <6 years of age received an oral suspension. Participants ≥6 to <12 years old had the option of receiving an oral suspension. Participants >12 years old were supplied tablets. The oral suspension dose was administered as 4-mg, 2-mg, 1-mg, and 0.5-mg as needed.

Placebo

Arm description

Placebo matched to baricitinib was administered to participants during the DBW period.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet, Oral suspension

Routes of administration

Oral use

Dosage and administration details

Placebo matched to baricitinib was administered to participants during the DBW period.

Number of subjects in period 2	Baricitinib	Placebo
Started	82	81
DBW Population	82	81
Completed	56	32
Not completed	26	49
Study team decision	1	-
Consent withdrawn by subject	2	1
Failure to Meet Continuation Criteria	16	40
Adverse event, non-fatal	2	2
Due to epidemic or pandemic	5	6

Baseline characteristics

Top of page

Reporting group title

Baricitinib

Reporting group description

Reporting group values	Baricitinib	Total
Number of subjects	220	220
Age categorical
Units: Subjects
>=2 to <6 years	6	6
>=6 to <9 years	9	9
>=9 to <12 years	30	30
>=12 to <18 years	175	175
Age continuous
Units: years
arithmetic mean (standard deviation)	13.3 ± 3.0	-
Gender categorical
Units: Subjects
Female	152	152
Male	68	68
Ethnicity
Units: Subjects
Hispanic or Latino	43	43
Not Hispanic or Latino	133	133
Unknown or Not Reported	44	44
Race
Units: Subjects
American Indian or Alaska Native	7	7
Asian	48	48
Native Hawaiian or Other Pacific Islander	0	0
Black or African American	5	5
White	152	152
More than one race	2	2
Unknown or Not Reported	6	6
Region of Enrollment
Units: Subjects
Argentina	20	20
Czechia	12	12
Japan	25	25
United Kingdom	11	11
India	6	6
Spain	14	14
Russia	8	8
Austria	2	2
Turkey	3	3
Belgium	7	7
China	18	18
Brazil	2	2
Poland	7	7
Denmark	1	1
Italy	11	11
Mexico	21	21
Israel	15	15
France	10	10
Australia	1	1
Germany	26	26

End points

Top of page

Reporting group title

Baricitinib

Reporting group description

Reporting group title

Baricitinib

Reporting group description

Reporting group title

Placebo

Reporting group description

Placebo matched to baricitinib was administered to participants during the DBW period.

Subject analysis set title

12 to <18 Years 4-mg QD

Subject analysis set type

Intention-to-treat

Subject analysis set description

Participants aged 12 to <18 years were given 4-mg baricitinib once day.

Subject analysis set title

9 to <12 Years 4-mg QD

Subject analysis set type

Intention-to-treat

Subject analysis set description

Participants aged 9 to <12 years were given 4-mg baricitinib once day.

Subject analysis set title

6 to <9 Years 2-mg QD

Subject analysis set type

Intention-to-treat

Subject analysis set description

Participants aged 6 to <9 years were given 2-mg baricitinib once day.

Subject analysis set title

2 to <6 Years 2-mg QD

Subject analysis set type

Intention-to-treat

Subject analysis set description

Participants aged 2 to <6 years were given 2-mg baricitinib once day.

Primary: Time to Disease Flare

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End point title

Time to Disease Flare

End point description

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 (pts) 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. Analysis Population Description(APD) included DBW Population: All randomized participants from the DBW period who had data for time to disease flare at given time point. 9999=Data Not Available (N/A).

End point type

Primary

End point timeframe

Week 12 to Week 44

End point values	Baricitinib	Placebo
Number of subjects analysed	82 ^[1]	81 ^[2]
Units: Weeks
median (confidence interval 95%)	9999 (9999 to 9999)	27.14 (15.29 to 9999)

Notes
[1] - Median, upper and lower limits of 95% CI not estimable due to small number of pts with event.
[2] - Median,upper and lower limits of 95% CI not estimable due to small number of pts with event.

Statistical analysis 1

Comparison groups

Baricitinib v Placebo

Number of subjects included in analysis

163

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Logrank

Parameter type

Hazard ratio (HR)

Point estimate

0.241

Confidence interval

level

95%

sides

2-sided

lower limit

0.128

upper limit

0.453

Secondary: Percentage of Participants Achieving PedACR30 Responder Index

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End point title

Percentage of Participants Achieving PedACR30 Responder Index

End point description

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. APD included DBW Population: All randomized participants from the DBW period who had data for PedACR30 at given time point.

End point type

Secondary

End point timeframe

Week 16, 20, 24, 28, 32, 36, 40 and 44

End point values	Baricitinib	Placebo
Number of subjects analysed	82	81
Units: Percentage of participants
number (confidence interval 95%)
At week 16	92.7 (87 to 98.3)	81.5 (73 to 89.9)
At week 20	87.8 (80.7 to 94.9)	64.2 (53.8 to 74.6)
At week 24	85.4 (77.7 to 93)	55.6 (44.7 to 66.4)
At week 28	78 (69.1 to 87)	51.9 (41 to 62.7)
At week 32	74.4 (64.9 to 83.8)	49.4 (38.5 to 60.3)
At week 36	72 (62.2 to 81.7)	44.4 (33.6 to 55.3)
At week 40	69.5 (59.5 to 79.5)	38.3 (27.7 to 48.9)
At week 44	67.1 (56.9 to 77.2)	38.3 (27.7 to 48.9)

Statistical Analysis 1

Statistical analysis description

at week 16

Comparison groups

Baricitinib v Placebo

Number of subjects included in analysis

163

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.052

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

2.72

Confidence interval

level

95%

sides

2-sided

lower limit

0.99

upper limit

7.46

Statistical analysis 2

Statistical analysis description

at week 20

Comparison groups

Baricitinib v Placebo

Number of subjects included in analysis

163

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.002

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

3.64

Confidence interval

level

95%

sides

2-sided

lower limit

1.6

upper limit

8.28

Statistical Analysis 3

Statistical analysis description

at week 24

Comparison groups

Baricitinib v Placebo

Number of subjects included in analysis

163

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

4.34

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

9.41

Statistical Analysis 4

Statistical analysis description

at week 28

Comparison groups

Placebo v Baricitinib

Number of subjects included in analysis

163

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.001

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

3.37

Confidence interval

level

95%

sides

2-sided

lower limit

1.62

upper limit

7.01

Statistical Analysis 5

Statistical analysis description

at week 32

Comparison groups

Placebo v Baricitinib

Number of subjects included in analysis

163

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.002

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

1.48

upper limit

6.07

Statistical Analysis 6

Statistical analysis description

at week 36

Comparison groups

Placebo v Baricitinib

Number of subjects included in analysis

163

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

3.25

Confidence interval

level

95%

sides

2-sided

lower limit

1.62

upper limit

6.52

Statistical Analysis 7

Statistical analysis description

at week 40

Comparison groups

Baricitinib v Placebo

Number of subjects included in analysis

163

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

3.7

Confidence interval

level

95%

sides

2-sided

lower limit

1.85

upper limit

7.41

Statistical Analysis 8

Statistical analysis description

at week 44

Comparison groups

Baricitinib v Placebo

Number of subjects included in analysis

163

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

3.27

Confidence interval

level

95%

sides

2-sided

lower limit

1.65

upper limit

6.5

Secondary: Percentage of Participants Achieving PedACR50 Responder Index

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End point title

Percentage of Participants Achieving PedACR50 Responder Index

End point description

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. APD included DBW Population: All randomized participants from the DBW period who had data for PedACR50 at given time point.

End point type

Secondary

End point timeframe

Week 16, 20, 24, 28, 32, 36, 40 and 44

End point values	Baricitinib	Placebo
Number of subjects analysed	82	81
Units: Percentage of participants
number (confidence interval 95%)
At week 16	79.3 (70.5 to 88)	75.3 (65.9 to 84.7)
At week 20	81.7 (73.3 to 90.1)	58 (47.3 to 68.8)
At week 24	81.7 (73.3 to 90.1)	49.4 (38.5 to 60.3)
At week 28	75.6 (66.3 to 84.9)	50.6 (39.7 to 61.5)
At week 32	72 (62.2 to 81.7)	46.9 (36 to 57.8)
At week 36	68.3 (58.2 to 78.4)	43.2 (32.4 to 54)
At week 40	68.3 (58.2 to 78.4)	38.3 (27.7 to 48.9)
At week 44	63.4 (53 to 73.8)	37 (26.5 to 47.6)

Statistical analysis 1

Statistical analysis description

at week 16

Comparison groups

Baricitinib v Placebo

Number of subjects included in analysis

163

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.568

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Confidence interval

level

95%

sides

2-sided

lower limit

0.59

upper limit

2.65

Statistical analysis 2

Statistical analysis description

at week 20

Comparison groups

Placebo v Baricitinib

Number of subjects included in analysis

163

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.004

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

2.92

Confidence interval

level

95%

sides

2-sided

lower limit

1.4

upper limit

6.09

Statistical Analysis 3

Statistical analysis description

at week 24

Comparison groups

Baricitinib v Placebo

Number of subjects included in analysis

163

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

4.38

Confidence interval

level

95%

sides

2-sided

lower limit

2.1

upper limit

9.15

Statistical Analysis 4

Statistical analysis description

at week 28

Comparison groups

Baricitinib v Placebo

Number of subjects included in analysis

163

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.002

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

3.09

Confidence interval

level

95%

sides

2-sided

lower limit

1.51

upper limit

6.32

Statistical Analysis 5

Statistical analysis description

at week 32

Comparison groups

Placebo v Baricitinib

Number of subjects included in analysis

163

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.003

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

2.99

Confidence interval

level

95%

sides

2-sided

lower limit

1.47

upper limit

6.11

Statistical Analysis 6

Statistical analysis description

at week 36

Comparison groups

Baricitinib v Placebo

Number of subjects included in analysis

163

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.003

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

2.84

Confidence interval

level

95%

sides

2-sided

lower limit

1.44

upper limit

5.6

Statistical Analysis 7

Statistical analysis description

at week 40

Comparison groups

Placebo v Baricitinib

Number of subjects included in analysis

163

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

3.49

Confidence interval

level

95%

sides

2-sided

lower limit

1.74

upper limit

6.97

Statistical Analysis 8

Statistical analysis description

at week 44

Comparison groups

Placebo v Baricitinib

Number of subjects included in analysis

163

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.002

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

2.87

Confidence interval

level

95%

sides

2-sided

lower limit

1.46

upper limit

5.66

Secondary: Percentage of Participants Achieving PedACR70 Responder Index

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End point title

Percentage of Participants Achieving PedACR70 Responder Index

End point description

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. APD included DBW Population: All randomized participants from the DBW period who had data for PedACR70 at given time point.

End point type

Secondary

End point timeframe

Week 16, 20, 24, 28, 32, 36, 40 and 44

End point values	Baricitinib	Placebo
Number of subjects analysed	82	81
Units: Percentage of participants
number (confidence interval 95%)
At week 16	54.9 (44.1 to 65.6)	54.3 (43.5 to 65.2)
At week 20	68.3 (58.2 to 78.4)	45.7 (34.8 to 56.5)
At week 24	59.8 (49.1 to 70.4)	37 (26.5 to 47.6)
At week 28	67.1 (56.9 to 77.2)	39.5 (28.9 to 50.2)
At week 32	57.3 (46.6 to 68)	35.8 (25.4 to 46.2)
At week 36	61 (50.4 to 71.5)	35.8 (25.4 to 46.2)
At week 40	57.3 (46.6 to 68)	30.9 (20.8 to 40.9)
At week 44	53.7 (42.9 to 64.5)	35.8 (25.4 to 46.2)

Statistical analysis 1

Statistical analysis description

at week 16

Comparison groups

Baricitinib v Placebo

Number of subjects included in analysis

163

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.972

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

0.99

Confidence interval

level

95%

sides

2-sided

lower limit

0.52

upper limit

1.87

Statistical analysis 2

Statistical analysis description

at week 20

Comparison groups

Baricitinib v Placebo

Number of subjects included in analysis

163

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.008

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

2.47

Confidence interval

level

95%

sides

2-sided

lower limit

1.27

upper limit

4.81

Statistical Analysis 3

Statistical analysis description

at week 24

Comparison groups

Baricitinib v Placebo

Number of subjects included in analysis

163

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.005

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

2.57

Confidence interval

level

95%

sides

2-sided

lower limit

1.33

upper limit

4.97

Statistical Analysis 4

Statistical analysis description

at week 28

Comparison groups

Baricitinib v Placebo

Number of subjects included in analysis

163

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

3.06

Confidence interval

level

95%

sides

2-sided

lower limit

1.57

upper limit

5.94

Statistical Analysis 5

Statistical analysis description

at week 32

Comparison groups

Baricitinib v Placebo

Number of subjects included in analysis

163

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.009

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

2.42

Confidence interval

level

95%

sides

2-sided

lower limit

1.25

upper limit

4.71

Statistical Analysis 6

Statistical analysis description

at week 36

Comparison groups

Baricitinib v Placebo

Number of subjects included in analysis

163

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.003

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

2.8

Confidence interval

level

95%

sides

2-sided

lower limit

1.43

upper limit

5.47

Statistical Analysis 7

Statistical analysis description

at week 40

Comparison groups

Baricitinib v Placebo

Number of subjects included in analysis

163

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.002

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

2.93

Confidence interval

level

95%

sides

2-sided

lower limit

1.47

upper limit

5.83

Statistical Analysis 8

Statistical analysis description

at week 44

Comparison groups

Baricitinib v Placebo

Number of subjects included in analysis

163

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.052

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

1.93

Confidence interval

level

95%

sides

2-sided

lower limit

0.99

upper limit

3.74

Secondary: Percentage of Participants Achieving PedACR90 Responder Index

Top of page

End point title

Percentage of Participants Achieving PedACR90 Responder Index

End point description

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. APD included DBW Population: All randomized participants from the DBW period who had data for PedACR90 at given time point.

End point type

Secondary

End point timeframe

Week 16, 20, 24, 28, 32, 36, 40 and 44

End point values	Baricitinib	Placebo
Number of subjects analysed	82	81
Units: Percentage of participants
number (confidence interval 95%)
At week 16	29.3 (19.4 to 39.1)	23.5 (14.2 to 32.7)
At week 20	42.7 (32 to 53.4)	24.7 (15.3 to 34.1)
At week 24	37.8 (27.3 to 48.3)	21 (12.1 to 29.9)
At week 28	42.7 (32 to 53.4)	25.9 (16.4 to 35.5)
At week 32	43.9 (33.2 to 54.6)	27.2 (17.5 to 36.8)
At week 36	39 (28.5 to 49.6)	27.2 (17.5 to 36.8)
At week 40	40.2 (29.6 to 50.9)	23.5 (14.2 to 32.7)
At week 44	42.7 (32 to 53.4)	23.5 (14.2 to 32.7)

Statistical analysis 1

Statistical analysis description

at week 16

Comparison groups

Placebo v Baricitinib

Number of subjects included in analysis

163

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.409

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

1.35

Confidence interval

level

95%

sides

2-sided

lower limit

0.66

upper limit

2.75

Statistical analysis 2

Statistical analysis description

at week 20

Comparison groups

Placebo v Baricitinib

Number of subjects included in analysis

163

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.03

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

2.13

Confidence interval

level

95%

sides

2-sided

lower limit

1.07

upper limit

4.23

Statistical Analysis 3

Statistical analysis description

at week 24

Comparison groups

Baricitinib v Placebo

Number of subjects included in analysis

163

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.022

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

2.36

Confidence interval

level

95%

sides

2-sided

lower limit

1.13

upper limit

4.92

Statistical Analysis 4

Statistical analysis description

at week 28

Comparison groups

Baricitinib v Placebo

Number of subjects included in analysis

163

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.04

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

2.05

Confidence interval

level

95%

sides

2-sided

lower limit

1.03

upper limit

4.08

Statistical Analysis 5

Statistical analysis description

at week 32

Comparison groups

Baricitinib v Placebo

Number of subjects included in analysis

163

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.032

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

2.13

Confidence interval

level

95%

sides

2-sided

lower limit

1.07

upper limit

4.24

Statistical Analysis 6

Statistical analysis description

at week 36

Comparison groups

Baricitinib v Placebo

Number of subjects included in analysis

163

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.132

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

1.71

Confidence interval

level

95%

sides

2-sided

lower limit

0.85

upper limit

3.42

Statistical Analysis 7

Statistical analysis description

at week 40

Comparison groups

Baricitinib v Placebo

Number of subjects included in analysis

163

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.05

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

2.02

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

4.1

Statistical Analysis 8

Statistical analysis description

at week 44

Comparison groups

Placebo v Baricitinib

Number of subjects included in analysis

163

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.019

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

2.32

Confidence interval

level

95%

sides

2-sided

lower limit

1.15

upper limit

4.71

Secondary: Percentage of Participants Achieving PedACR100 Responder Index

Top of page

End point title

Percentage of Participants Achieving PedACR100 Responder Index

End point description

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. APD included DBW Population: All randomized participants from the DBW period who had data for PedACR100 at given time point.

End point type

Secondary

End point timeframe

Week 16, 20, 24, 28, 32, 36, 40 and 44

End point values	Baricitinib	Placebo
Number of subjects analysed	82	81
Units: Percentage of participants
number (confidence interval 95%)
At week 16	14.6 (7 to 22.3)	17.3 (9 to 25.5)
At week 20	24.4 (15.1 to 33.7)	19.8 (11.1 to 28.4)
At week 24	18.3 (9.9 to 26.7)	16 (8.1 to 24)
At week 28	26.8 (17.2 to 36.4)	19.8 (11.1 to 28.4)
At week 32	28 (18.3 to 37.8)	21 (12.1 to 29.9)
At week 36	29.3 (19.4 to 39.1)	17.3 (9 to 25.5)
At week 40	29.3 (19.4 to 39.1)	17.3 (9 to 25.5)
At week 44	29.3 (19.4 to 39.1)	16 (8.1 to 24)

Statistical analysis 1

Statistical analysis description

at week 16

Comparison groups

Baricitinib v Placebo

Number of subjects included in analysis

163

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.62

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

0.8

Confidence interval

level

95%

sides

2-sided

lower limit

0.33

upper limit

1.92

Statistical analysis 2

Statistical analysis description

at week 20

Comparison groups

Baricitinib v Placebo

Number of subjects included in analysis

163

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.492

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

1.3

Confidence interval

level

95%

sides

2-sided

lower limit

0.61

upper limit

2.78

Statistical Analysis 3

Statistical analysis description

at week 24

Comparison groups

Baricitinib v Placebo

Number of subjects included in analysis

163

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.715

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

1.17

Confidence interval

level

95%

sides

2-sided

lower limit

0.5

upper limit

2.75

Statistical Analysis 4

Statistical analysis description

at week 28

Comparison groups

Placebo v Baricitinib

Number of subjects included in analysis

163

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.384

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

1.4

Confidence interval

level

95%

sides

2-sided

lower limit

0.66

upper limit

2.99

Statistical Analysis 5

Statistical analysis description

at week 32

Comparison groups

Baricitinib v Placebo

Number of subjects included in analysis

163

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.311

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

1.47

Confidence interval

level

95%

sides

2-sided

lower limit

0.7

upper limit

3.1

Statistical Analysis 6

Statistical analysis description

at week 36

Comparison groups

Baricitinib v Placebo

Number of subjects included in analysis

163

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.231

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

1.58

Confidence interval

level

95%

sides

2-sided

lower limit

0.75

upper limit

3.34

Statistical Analysis 7

Statistical analysis description

at week 40

Comparison groups

Baricitinib v Placebo

Number of subjects included in analysis

163

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.129

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

1.82

Confidence interval

level

95%

sides

2-sided

lower limit

0.84

upper limit

3.95

Statistical Analysis 8

Statistical analysis description

at week 44

Comparison groups

Baricitinib v Placebo

Number of subjects included in analysis

163

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.043

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

2.23

Confidence interval

level

95%

sides

2-sided

lower limit

1.02

upper limit

4.84

Secondary: Percentage of Participants With Inactive Disease

Top of page

End point title

Percentage of Participants With Inactive Disease

End point description

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. APD included DBW Population: All randomized participants from the DBW period who had data for inactive disease at given time point.

End point type

Secondary

End point timeframe

Week 16, 20, 24, 28, 32, 36, 40 and 44

End point values	Baricitinib	Placebo
Number of subjects analysed	82	81
Units: Percentage of participants
number (confidence interval 95%)
At week 16	12.2 (5.1 to 19.5)	11.1 (4.3 to 18.0)
At week 20	13.4 (6.0 to 20.8)	17.3 (9 to 25.5)
At week 24	17.1 (8.9 to 25.2)	17.3 (9.0 to 25.5)
At week 28	20.7 (12 to 29.5)	13.6 (6.1 to 21.0)
At week 32	22.0 (13.0 to 30.9)	13.6 (6.1 to 21.0)
At week 36	23.2 (14.0 to 32.3)	16.0 (8.1 to 24)
At week 40	20.7 (12.0 to 29.5)	12.3 (5.2 to 19.5)
At week 44	23.2 (14.0 to 32.3)	13.6 (6.1 to 21.0)

Statistical analysis 1

Statistical analysis description

at week 16

Comparison groups

Baricitinib v Placebo

Number of subjects included in analysis

163

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.853

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

1.1

Confidence interval

level

95%

sides

2-sided

lower limit

0.4

upper limit

2.98

Statistical analysis 2

Statistical analysis description

at week 20

Comparison groups

Baricitinib v Placebo

Number of subjects included in analysis

163

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.432

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

0.7

Confidence interval

level

95%

sides

2-sided

lower limit

0.29

upper limit

1.71

Statistical Analysis 3

Statistical analysis description

at week 24

Comparison groups

Baricitinib v Placebo

Number of subjects included in analysis

163

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.96

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

0.95

Confidence interval

level

95%

sides

2-sided

lower limit

0.41

upper limit

2.31

Statistical Analysis 4

Statistical analysis description

at week 28

Comparison groups

Baricitinib v Placebo

Number of subjects included in analysis

163

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.215

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

1.71

Confidence interval

level

95%

sides

2-sided

lower limit

0.73

upper limit

4.01

Statistical Analysis 5

Statistical analysis description

at week 32

Comparison groups

Baricitinib v Placebo

Number of subjects included in analysis

163

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.173

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

1.8

Confidence interval

level

95%

sides

2-sided

lower limit

0.77

upper limit

4.22

Statistical Analysis 6

Statistical analysis description

at week 36

Comparison groups

Baricitinib v Placebo

Number of subjects included in analysis

163

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.367

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

1.46

Confidence interval

level

95%

sides

2-sided

lower limit

0.64

upper limit

3.33

Statistical Analysis 7

Statistical analysis description

at week 40

Comparison groups

Baricitinib v Placebo

Number of subjects included in analysis

163

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.162

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

1.9

Confidence interval

level

95%

sides

2-sided

lower limit

0.77

upper limit

4.67

Statistical Analysis 8

Statistical analysis description

at week 44

Comparison groups

Baricitinib v Placebo

Number of subjects included in analysis

163

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.113

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

1.96

Confidence interval

level

95%

sides

2-sided

lower limit

0.85

upper limit

4.5

Secondary: Percentage of Participants in Remission

Top of page

End point title

Percentage of Participants in Remission

End point description

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. APD included DBW Population: All randomized participants from the DBW period who had data for remission at given time point.

End point type

Secondary

End point timeframe

Week 28, 32, 36, 40 and 44

End point values	Baricitinib	Placebo
Number of subjects analysed	82	81
Units: Percentage of participants
number (confidence interval 95%)
At week 28	0 (0 to 0)	0 (0 to 0)
At week 32	0 (0 to 0)	1.2 (0 to 3.6)
At week 36	1.2 (0 to 3.6)	4.9 (0.2 to 9.7)
At week 40	2.4 (0 to 5.8)	3.7 (0 to 7.8)
At week 44	3.7 (0 to 7.7)	3.7 (0 to 7.8)

No statistical analyses for this end point

Secondary: Percentage of Participants With Minimal Disease Activity

Top of page

End point title

Percentage of Participants With Minimal Disease Activity

End point description

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. APD included DBW Population: All randomized participants from the DBW period who had data for minimum disease activity at given time point.

End point type

Secondary

End point timeframe

Week 16, 20, 24, 28, 32, 36, 40 and 44

End point values	Baricitinib	Placebo
Number of subjects analysed	82	81
Units: Percentage of participants
number (confidence interval 95%)
At week 16	36.6 (26.2 to 47)	40.7 (30 to 51.4)
At week 20	46.3 (35.5 to 57.1)	33.3 (23.1 to 43.6)
At week 24	43.9 (33.2 to 54.6)	34.6 (24.2 to 44.9)
At week 28	45.1 (34.4 to 55.9)	33.3 (23.1 to 43.6)
At week 32	43.9 (33.2 to 54.6)	32.1 (21.9 to 42.3)
At week 36	40.2 (29.6 to 50.9)	33.3 (23.1 to 43.6)
At week 40	43.9 (33.2 to 54.6)	32.1 (21.9 to 42.3)
At week 44	43.9 (33.2 to 54.6)	27.2 (17.5 to 36.8)

Statistical analysis 1

Statistical analysis description

at week 16

Comparison groups

Baricitinib v Placebo

Number of subjects included in analysis

163

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.511

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

0.8

Confidence interval

level

95%

sides

2-sided

lower limit

0.42

upper limit

1.55

Statistical analysis 2

Statistical analysis description

at week 20

Comparison groups

Baricitinib v Placebo

Number of subjects included in analysis

163

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.145

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

1.64

Confidence interval

level

95%

sides

2-sided

lower limit

0.84

upper limit

3.2

Statistical analysis 3

Statistical analysis description

at week 24

Comparison groups

Baricitinib v Placebo

Number of subjects included in analysis

163

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.349

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

1.38

Confidence interval

level

95%

sides

2-sided

lower limit

0.7

upper limit

2.72

Statistical Analysis 4

Statistical analysis description

at week 28

Comparison groups

Baricitinib v Placebo

Number of subjects included in analysis

163

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.167

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

1.63

Confidence interval

level

95%

sides

2-sided

lower limit

0.82

upper limit

3.25

Statistical Analysis 5

Statistical analysis description

at week 32

Comparison groups

Baricitinib v Placebo

Number of subjects included in analysis

163

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.212

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

1.55

Confidence interval

level

95%

sides

2-sided

lower limit

0.78

upper limit

3.07

Statistical Analysis 6

Statistical analysis description

at week 36

Comparison groups

Baricitinib v Placebo

Number of subjects included in analysis

163

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.577

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

1.21

Confidence interval

level

95%

sides

2-sided

lower limit

0.62

upper limit

2.39

Statistical Analysis 7

Statistical analysis description

at week 40

Comparison groups

Baricitinib v Placebo

Number of subjects included in analysis

163

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.225

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

1.51

Confidence interval

level

95%

sides

2-sided

lower limit

0.78

upper limit

2.95

Statistical Analysis 8

Statistical analysis description

at week 44

Comparison groups

Baricitinib v Placebo

Number of subjects included in analysis

163

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.055

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

1.96

Confidence interval

level

95%

sides

2-sided

lower limit

0.98

upper limit

3.9

Secondary: Change From Baseline in Juvenile Arthritis Disease Activity Score-27 (JADAS-27) Score

Top of page

End point title

Change From Baseline in Juvenile Arthritis Disease Activity Score-27 (JADAS-27) Score

End point description

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). Scores for the each of the first 3 components range from 0 -10; score for the final component ranges from 0-27. 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. APD included DBW Population: All randomized participants who had at least 1 post-baseline JADAS-27 score at given time point.

End point type

Secondary

End point timeframe

Baseline, Week 44

End point values	Baricitinib	Placebo
Number of subjects analysed	82	79
Units: score on a scale
least squares mean (standard deviation)	-14.24 ± 1.006	-9.91 ± 1.013

Statistical analysis 1

Comparison groups

Baricitinib v Placebo

Number of subjects included in analysis

161

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.001

Method

ANCOVA

Parameter type

LS Mean difference

Point estimate

-4.33

Confidence interval

level

95%

sides

2-sided

lower limit

-6.95

upper limit

-1.7

Variability estimate

Standard error of the mean

Dispersion value

1.328

Secondary: Change From Baseline in Psoriasis Area and Severity Index (PASI) Score

Top of page

End point title

Change From Baseline in Psoriasis Area and Severity Index (PASI) Score

End point description

PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk and legs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area * area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). LS mean was calculated using ANCOVA model which includes treatment, baseline, prior biologic JIA therapy, combined JIA category and predose exposure ESR category value as fixed factors. APD included DBW Population: All randomized participants from the DBW period who had at least 1 post-baseline juvenile psoriatic arthritis (JPsA) were included in this population.

End point type

Secondary

End point timeframe

Baseline, Week 44

End point values	Baricitinib	Placebo
Number of subjects analysed	4	3
Units: score on a scale
least squares mean (standard error)	-1.14 ± 0.291	-0.79 ± 0.354

Statistical analysis 1

Comparison groups

Baricitinib v Placebo

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.574

Method

ANCOVA

Parameter type

LS Mean difference

Point estimate

-0.35

Confidence interval

level

95%

sides

2-sided

lower limit

-2.62

upper limit

1.91

Variability estimate

Standard error of the mean

Dispersion value

0.526

Secondary: Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Index

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End point title

Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Index

End point description

The SPARCC index assesses 16 sites for enthesitis using a score of "0" for no activity or "1" for activity. Sites assessed include Medial epicondyle (left/right [L/R]), Lateral epicondyle (L/R), Supraspinatus insertion into greater tuberosity of humerus (L/R), Greater trochanter (L/R), Quadriceps insertion into superior border of patella (L/R), Patellar ligament insertion into inferior pole of patella or tibial tubercle (L/R), Achilles tendon insertion into calcaneum (L/R), and Plantar fascia insertion into calcaneum (L/R). The SPARCC is the sum of all site scores (range 0 to 16). Higher scores indicate more severe enthesitis. LS mean was calculated using ANCOVA model which includes treatment, baseline, prior biologic JIA therapy, combined JIA category and predose exposure ESR category value as fixed factors. APD included DBW Population: All randomized participants who had at least 1 post-baseline enthesitis-related juvenile idiopathic arthritis (ERA) or JPsA at given time point.

End point type

Secondary

End point timeframe

Baseline, Week 44

End point values	Baricitinib	Placebo
Number of subjects analysed	19	22
Units: score on a scale
arithmetic mean (standard error)	-1.51 ± 0.276	-1.95 ± 0.241

Statistical analysis 1

Comparison groups

Baricitinib v Placebo

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.208

Method

Regression, Logistic

Parameter type

LS Mean difference

Point estimate

0.45

Confidence interval

level

95%

sides

2-sided

lower limit

-0.26

upper limit

1.15

Variability estimate

Standard error of the mean

Dispersion value

0.348

Secondary: Change From Baseline in Juvenile Spondyloarthritis Disease Activity (JSpADA) Index

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End point title

Change From Baseline in Juvenile Spondyloarthritis Disease Activity (JSpADA) Index

End point description

The JSpADA index is used to evaluate the disease activity of juvenile spondyloarthritis. The JSpADA index scores will be determined by following 8 components: active joint count, active enthesitis count, pain over the past week, CRP level related to juvenile spondyloarthritis activity, morning stiffness greater than 15 minutes, clinical sacroiliitis, uveitis and back mobility. All items are transformed to values of 0, 0.5, or 1, and the total score ranges from 0 to 8, where higher scores indicate more disease activity. LS mean was calculated using ANCOVA model which includes treatment, baseline, prior biologic JIA therapy, combined JIA category and predose exposure ESR category value as fixed factors. APD included DBW Population: All randomized participants from the DBW period who had at least 1 post-baseline ERA or JPsA were included in this population.

End point type

Secondary

End point timeframe

Baseline, Week 44

End point values	Baricitinib	Placebo
Number of subjects analysed	15	18
Units: score on a scale
least squares mean (standard error)	-2.56 ± 0.347	-1.47 ± 0.296

Statistical analysis 1

Comparison groups

Baricitinib v Placebo

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.019

Method

ANCOVA

Parameter type

LS Mean difference

Point estimate

-1.08

Confidence interval

level

95%

sides

2-sided

lower limit

-1.98

upper limit

-0.19

Variability estimate

Standard error of the mean

Dispersion value

0.438

Secondary: Pharmacokinetics (PK): Area Under the Baricitinib Concentration-Time Curve During a Dosing Interval at Steady-State (AUCτ,ss)

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End point title

Pharmacokinetics (PK): Area Under the Baricitinib Concentration-Time Curve During a Dosing Interval at Steady-State (AUCτ,ss)

End point description

Area under the concentration-time curve of Baricitinib during a dosing interval at steady state. APD included Safety/PK and OLLI population: All randomized participants from the Safety/PK assessment and OLLI period who had data for AUCτ,ss at given time point.

End point type

Secondary

End point timeframe

For Safety/PK period: Day 1, Day 4, Day 14 (pre dose) and Day 14 (post dose). For OLLI period: Day 1, Day 14, Day 28, Day 56 and 84 (pre dose)

End point values	12 to <18 Years 4-mg QD	9 to <12 Years 4-mg QD	6 to <9 Years 2-mg QD	2 to <6 Years 2-mg QD
Number of subjects analysed	172	29	8	6
Units: hournanogram/millilitre (hng/mL)
geometric mean (geometric coefficient of variation)	386 ± 45	500 ± 57	254 ± 27	410 ± 57

No statistical analyses for this end point

Secondary: PK: Maximum Plasma Baricitinib Concentration at Steady-State (Cmax, ss)

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End point title

PK: Maximum Plasma Baricitinib Concentration at Steady-State (Cmax, ss)

End point description

Maximum Plasma Baricitinib Concentration at Steady-State. APD included Safety/PK and OLLI population: All randomized participants from the Safety/PK and OLLI periods who had data for Cmax, ss at given time point.

End point type

Secondary

End point timeframe

For Safety/PK period: Day 1, Day 4, Day 14 (pre dose) and Day 14 (post dose). For OLLI period: Day 1, Day 14, Day 28, Day 56 and 84 (pre dose)

End point values	12 to <18 Years 4-mg QD	9 to <12 Years 4-mg QD	6 to <9 Years 2-mg QD	2 to <6 Years 2-mg QD
Number of subjects analysed	172	27	8	6
Units: Nanograms per milliliter (ng/mL)
geometric mean (geometric coefficient of variation)	57.7 ± 28	79 ± 33	56.8 ± 22	87.4 ± 38

No statistical analyses for this end point

Secondary: Change From Baseline in Immunoglobulin Levels

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End point title

Change From Baseline in Immunoglobulin Levels

End point description

Change from baseline in Serum Immunoglobulin A, Serum Immunoglobulin G and Serum Immunoglobulin M levels at week 12 are presented. Safety/PK and OLLI population: All randomized participants from the APD included Safety/PK and OLLI periods who had data for immunoglobulin levels at given time point.

End point type

Secondary

End point timeframe

Baseline, Week 12

End point values	Baricitinib
Number of subjects analysed	220 ^[3]
Units: Milligrams per decilitre (mg/dL)
arithmetic mean (standard deviation)
Serum Immunoglobulin A	-15.98 ± 39.501
Serum Immunoglobulin G	-81.46 ± 209.549
Serum Immunoglobulin M	-9.86 ± 26.680

Notes
[3] - Serum Immunoglobulin A, n=185, Serum Immunoglobulin G, n=189, Serum Immunoglobulin M, n=190.

No statistical analyses for this end point

Secondary: Number of Participants With Change of Immunoglobulin G (IgG) Titers

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End point title

Number of Participants With Change of Immunoglobulin G (IgG) Titers

End point description

Number of participants with change of IgG titers eligible for tetanus / diphtheria / acellular pertussis (tDaP) vaccine and pneumococcal conjugate are presented. Participants immunized with tDaP or pneumococcal conjugate vaccine had their IgG antibody titers to the antigens evaluated preimmunization and at 4 and 12 weeks postimmunization. A primary immune response was seen in participants who had never received tDaP or pneumococcal conjugate vaccines previously and secondary/booster responses were assessed if participants previously received the vaccines. For pneumococcal conjugate vaccine, number of participants with >= 2-fold increase from baseline in >=6 pneumococcal serotypes at week 4 and 12 is presented. For tDaP vaccine, number of participants with >= 4-fold increase from baseline in participants with baseline titer >=0.1 IU/mL at week 4 and 12 is presented. APD included Safety/PK and OLLI population: All randomized participants who had data for IgG titers at given time point.

End point type

Secondary

End point timeframe

Pre-Vaccination to 4 and 12 Weeks Post-Vaccination

End point values	Baricitinib
Number of subjects analysed	7
Units: participants
Tetanus toxoid vaccine at week 4 (n=4)	2
Tetanus toxoid vaccine at week 12 (n=3)	2
Diphtheria toxoid vaccine at week 4 (n=4)	2
Diphtheria toxoid vaccine at week 12 (n=3)	1
Pertussis toxin vaccine at week 4 (n=4)	2
Pertussis toxin vaccine at week 12 (n=3)	2
pneumococcal conjugate vaccine at week 4 (n=4)	3
pneumococcal conjugate vaccine at week 12 (n=3)	2

No statistical analyses for this end point

Secondary: Number of Participants With Product Acceptability and Palatability Assessment

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End point title

Number of Participants With Product Acceptability and Palatability Assessment

End point description

The questionnaire for acceptability and palatability assessed the participants ability to swallow tablet, experience on taste, smell and ease of administering and taking suspension. The questionnaire had following Questions: Question(Q) 1) How did you (your child) like the taste of the medicine? Question 2) How did you (your child) like the smell of the medicine? Question 3) How easy was it for you (your child) to take the medicine today? Question 4) How easy was it for you to use the oral syringe to give your child the dose today? and Question 5) How easy was it for you (your child) to swallow the medicine today? Responses: Liked Very Much, Liked, Neither Liked nor Disliked, Disliked, Disliked Very Much, Very Easy, Easy, Neither Easy nor Hard, Difficult (or Hard) and Very Difficult (or Hard). Data is presented as "Question Number-Response-Time point". APD included all randomized participants from the Safety/PK and OLLI period who had data for product acceptability and palatability.

End point type

Secondary

End point timeframe

Baseline and week 12

End point values	Baricitinib
Number of subjects analysed	220
Units: participants
Q1- Liked Very Much : Baseline (n=13)	2
Q1- Liked Very Much : Week 12 (n=10)	6
Q1- Liked : Baseline (n=13)	8
Q1- Liked : Week 12 (n=10)	2
Q1- Neither Liked nor Disliked : Baseline (n=13)	3
Q1- Neither Liked nor Disliked : Week 12 (n=10)	1
Q1- Disliked : Baseline (n=13)	0
Q1- Disliked : Week 12 (n=10)	1
Q1- Disliked Very Much : Baseline (n=13)	0
Q1- Disliked Very Much : Week 12 (n=10)	0
Q2- Liked Very Much : Baseline (n=13)	3
Q2- Liked Very Much : Week 12 (n=10)	2
Q2- Liked : Baseline (n=13)	7
Q2- Liked : Week 12 (n=10)	4
Q2- Neither Liked nor Disliked : Baseline (n=13)	3
Q2- Neither Liked nor Disliked : Week 12 (n=10)	2
Q2- Disliked : Baseline (n=13)	0
Q2- Disliked : Week 12 (n=10)	1
Q2- Disliked Very Much : Baseline (n=13)	0
Q2- Disliked Very Much : Week 12 (n=10)	1
Q3- Very Easy : Baseline (n=13)	8
Q3- Very Easy : Week 12 (n=10)	7
Q3- Easy : Baseline (n=13)	3
Q3- Easy : Week 12 (n=10)	2
Q3- Neither Easy nor Hard : Baseline (n=13)	1
Q3- Neither Easy nor Hard : Week 12 (n=10)	0
Q3- Difficult (or Hard) : Baseline (n=13)	0
Q3- Difficult (or Hard) : Week 12 (n=10)	1
Q3- Very Difficult (or Hard) : Baseline (n=13)	1
Q3- Very Difficult (or Hard) : Week 12 (n=10)	0
Q4- Very Easy : Baseline (n=11)	5
Q4- Very Easy : Week 12 (n=10)	8
Q4- Easy : Baseline (n=11)	6
Q4- Easy : Week 12 (n=10)	2
Q4- Neither Easy nor Hard : Baseline (n=11)	0
Q4- Neither Easy nor Hard : Week 12 (n=10)	0
Q4- Difficult (or Hard) : Baseline (n=11)	0
Q4- Difficult (or Hard) : Week 12 (n=10)	0
Q4- Very Difficult (or Hard) : Baseline (n=11)	0
Q4- Very Difficult (or Hard) : Week 12 (n=10)	0
Q5- Very Easy : Baseline (n=203)	146
Q5- Very Easy : Week 12 (n=159)	120
Q5- Easy : Baseline (n=203)	39
Q5- Easy : Week 12 (n=159)	34
Q5- Neither Easy nor Hard : Baseline (n=203)	14
Q5- Neither Easy nor Hard : Week 12 (n=159)	5
Q5- Difficult (or Hard) : Baseline (n=203)	3
Q5- Difficult (or Hard) : Week 12 (n=159)	0
Q5- Very Difficult (or Hard) : Baseline (n=203)	1
Q5- Very Difficult (or Hard) : Week 1 (n=159)	0

No statistical analyses for this end point

Secondary: Change From Baseline in Arthritis-Related Pain Severity as Measured by the Childhood Health Assessment Questionnaire (CHAQ) Pain Visual Analog Scale (VAS) Item

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End point title

Change From Baseline in Arthritis-Related Pain Severity as Measured by the Childhood Health Assessment Questionnaire (CHAQ) Pain Visual Analog Scale (VAS) Item

End point description

CHAQ assesses the health status and physical function of children with juvenile arthritis over the past week. The CHAQ consists of a Disability Index (DI) and a Discomfort Index. The DI has 30 items grouped into the following 8 domains: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities. The scores of 8 domains were averaged to calculate the CHAQ-DI total score, which ranges from 0 (no or minimal physical dysfunction) to 3 (very severe physical dysfunction). A higher score indicates worse physical function. The discomfort index consisted of Parent's Global Assessment of Well-Being and pain assessment due to illness. Intensity of pain is scored on a VAS scale ranging from 0 to 100 mm, with zero referring to "no pain" and 100 referring to "very severe pain", higher score indicates worse outcome. APD included all randomized participants with at least 1 post-baseline CHAQ Pain VAS Item data. LS mean was calculated using Analysis of covariance (ANCOVA)

End point type

Secondary

End point timeframe

Baseline, Week 44

End point values	Baricitinib	Placebo
Number of subjects analysed	82	79
Units: score on a scale
least squares mean (standard error)	-29.65 ± 3.276	-16.68 ± 3.202

Statistical analysis 1

Comparison groups

Baricitinib v Placebo

Number of subjects included in analysis

161

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.003

Method

ANCOVA

Parameter type

LS Mean difference

Point estimate

-12.97

Confidence interval

level

95%

sides

2-sided

lower limit

-21.39

upper limit

-4.55

Variability estimate

Standard error of the mean

Dispersion value

4.262

Adverse events

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Timeframe for reporting adverse events

Baseline through Follow-up (Up To 341 Days)

Adverse event reporting additional description

All participants who received at least one dose of study drug.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

24.1

Reporting group title

Baricitinib PK and OLLI

Reporting group description

During the PK/safety and OLLI periods, baricitinib was administered once daily (QD) as a 4-mg for adolescent participants (12 to <18 years of age) and children ≥9 years of age; and 2 mg for children <9 years of age. Participants <6 years of age received an oral suspension. Participants ≥6 to <12 years old had the option of receiving an oral suspension. Participants >12 years old were supplied tablets.

Reporting group title

Placebo DBW

Reporting group description

Participants received placebo matched to baricitinib during the DBW period.

Reporting group title

Baricitinib DBW

Reporting group description

During the DBW period, baricitinib was administered QD (once daily) as a 4-mg for adolescent participants (12 to <18 years of age) and children ≥9 years of age; and 2 mg for children <9 years of age. Participants <6 years of age received an oral suspension. Participants ≥6 to <12 years old had the option of receiving an oral suspension. Participants >12 years old were supplied tablets.

Serious adverse events	Baricitinib PK and OLLI	Placebo DBW	Baricitinib DBW
Total subjects affected by serious adverse events
subjects affected / exposed	6 / 220 (2.73%)	3 / 81 (3.70%)	4 / 82 (4.88%)
number of deaths (all causes)	0	0	0
number of deaths resulting from adverse events	0	0	0
Nervous system disorders
headache
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 220 (0.00%)	0 / 81 (0.00%)	1 / 82 (1.22%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
bronchospasm
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 220 (0.00%)	1 / 81 (1.23%)	0 / 82 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
pulmonary embolism
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 220 (0.00%)	0 / 81 (0.00%)	1 / 82 (1.22%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Psychiatric disorders
suicide attempt
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 220 (0.00%)	1 / 81 (1.23%)	0 / 82 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
arthralgia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 220 (0.45%)	0 / 81 (0.00%)	0 / 82 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
joint destruction
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 220 (0.45%)	0 / 81 (0.00%)	0 / 82 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
joint effusion
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 220 (0.45%)	0 / 81 (0.00%)	0 / 82 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
juvenile idiopathic arthritis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 220 (0.45%)	1 / 81 (1.23%)	0 / 82 (0.00%)
occurrences causally related to treatment / all	0 / 1	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
musculoskeletal chest pain
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 220 (0.45%)	0 / 81 (0.00%)	0 / 82 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Infections and infestations
covid-19
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 220 (0.00%)	0 / 81 (0.00%)	1 / 82 (1.22%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
gastroenteritis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 220 (0.00%)	0 / 81 (0.00%)	1 / 82 (1.22%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
decreased appetite
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 220 (0.45%)	0 / 81 (0.00%)	0 / 82 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Baricitinib PK and OLLI	Placebo DBW	Baricitinib DBW
Total subjects affected by non serious adverse events
subjects affected / exposed	48 / 220 (21.82%)	10 / 81 (12.35%)	26 / 82 (31.71%)
Nervous system disorders
headache
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	14 / 220 (6.36%)	3 / 81 (3.70%)	8 / 82 (9.76%)
occurrences all number	16	3	10
Respiratory, thoracic and mediastinal disorders
oropharyngeal pain
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	3 / 220 (1.36%)	1 / 81 (1.23%)	5 / 82 (6.10%)
occurrences all number	3	1	5
Musculoskeletal and connective tissue disorders
arthralgia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	11 / 220 (5.00%)	3 / 81 (3.70%)	6 / 82 (7.32%)
occurrences all number	15	4	6
Infections and infestations
nasopharyngitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	19 / 220 (8.64%)	3 / 81 (3.70%)	6 / 82 (7.32%)
occurrences all number	20	3	7
upper respiratory tract infection
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	11 / 220 (5.00%)	1 / 81 (1.23%)	9 / 82 (10.98%)
occurrences all number	12	1	10

More information

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Were there any global substantial amendments to the protocol? Yes

14 Mar 2019

Protocol (a) - Removed Inclusion Criteria: language regarding same-sex relationships. - Added Exclusion Criteria: exclusion of patients who have hypersensitivity to any ingredient of the investigational product. - Added dose modification for patients receiving OAT3 inhibitors. - Added arterial thromboembolic event (ATE) as an event that will be adjudicated.

15 Apr 2019

Protocol (b) - Added specifications on how baricitinib doses will be administered. - Added list of permitted analgesics in Concomitant JIA Therapies.

07 Nov 2020

Protocol (d) - Exclusion Criteria for hypogammaglobinemia adjusted

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results: A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients from 2 Years to Less Than 18 Years Old with Juvenile Idiopathic Arthritis (JIA)

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Time to Disease Flare

Primary: Time to Disease Flare

Secondary: Percentage of Participants Achieving PedACR30 Responder Index

Secondary: Percentage of Participants Achieving PedACR30 Responder Index

Secondary: Percentage of Participants Achieving PedACR50 Responder Index

Secondary: Percentage of Participants Achieving PedACR50 Responder Index

Secondary: Percentage of Participants Achieving PedACR70 Responder Index

Secondary: Percentage of Participants Achieving PedACR70 Responder Index

Secondary: Percentage of Participants Achieving PedACR90 Responder Index

Secondary: Percentage of Participants Achieving PedACR90 Responder Index

Secondary: Percentage of Participants Achieving PedACR100 Responder Index

Secondary: Percentage of Participants Achieving PedACR100 Responder Index

Secondary: Percentage of Participants With Inactive Disease

Secondary: Percentage of Participants With Inactive Disease

Secondary: Percentage of Participants in Remission

Secondary: Percentage of Participants in Remission

Secondary: Percentage of Participants With Minimal Disease Activity

Secondary: Percentage of Participants With Minimal Disease Activity

Secondary: Change From Baseline in Juvenile Arthritis Disease Activity Score-27 (JADAS-27) Score

Secondary: Change From Baseline in Juvenile Arthritis Disease Activity Score-27 (JADAS-27) Score

Secondary: Change From Baseline in Psoriasis Area and Severity Index (PASI) Score

Secondary: Change From Baseline in Psoriasis Area and Severity Index (PASI) Score

Secondary: Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Index

Secondary: Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Index

Secondary: Change From Baseline in Juvenile Spondyloarthritis Disease Activity (JSpADA) Index

Secondary: Change From Baseline in Juvenile Spondyloarthritis Disease Activity (JSpADA) Index

Secondary: Pharmacokinetics (PK): Area Under the Baricitinib Concentration-Time Curve During a Dosing Interval at Steady-State (AUCτ,ss)

Secondary: Pharmacokinetics (PK): Area Under the Baricitinib Concentration-Time Curve During a Dosing Interval at Steady-State (AUCτ,ss)

Secondary: PK: Maximum Plasma Baricitinib Concentration at Steady-State (Cmax, ss)

Secondary: PK: Maximum Plasma Baricitinib Concentration at Steady-State (Cmax, ss)

Secondary: Change From Baseline in Immunoglobulin Levels

Secondary: Change From Baseline in Immunoglobulin Levels

Secondary: Number of Participants With Change of Immunoglobulin G (IgG) Titers

Secondary: Number of Participants With Change of Immunoglobulin G (IgG) Titers

Secondary: Number of Participants With Product Acceptability and Palatability Assessment

Secondary: Number of Participants With Product Acceptability and Palatability Assessment

Secondary: Change From Baseline in Arthritis-Related Pain Severity as Measured by the Childhood Health Assessment Questionnaire (CHAQ) Pain Visual Analog Scale (VAS) Item

Secondary: Change From Baseline in Arthritis-Related Pain Severity as Measured by the Childhood Health Assessment Questionnaire (CHAQ) Pain Visual Analog Scale (VAS) Item

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients from 2 Years to Less Than 18 Years Old with Juvenile Idiopathic Arthritis (JIA)