Trial Outcomes & Findings for A Study of Baricitinib in Participants From 2 Years to Less Than 18 Years Old With Juvenile Idiopathic Arthritis (NCT NCT03773978)
NCT ID: NCT03773978
Last Updated: 2022-10-07
Results Overview
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.
COMPLETED
PHASE3
220 participants
Week 12 to Week 44
2022-10-07
Participant Flow
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.
Participants entered the PK/Safety period (0 to 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 confirmation of the safety comparability assessment, remaining participants were enrolled directly into the OLLI period (0 to 12 weeks) followed by a double-blind randomised withdrawal placebo-controlled period (DBW) period (12 to 44 weeks) in which participants were randomized to baricitinib or placebo.
Participant milestones
| Measure |
Baricitinib
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.
|
Placebo
Placebo matched to baricitinib was administered to participants during the DBW period.
|
|---|---|---|
|
PK/Safety and OLLI Period
STARTED
|
220
|
0
|
|
PK/Safety and OLLI Period
PK/Safety Period
|
29
|
0
|
|
PK/Safety and OLLI Period
OLLI Period
|
219
|
0
|
|
PK/Safety and OLLI Period
Received at Least One Dose of Study Drug
|
220
|
0
|
|
PK/Safety and OLLI Period
COMPLETED
|
163
|
0
|
|
PK/Safety and OLLI Period
NOT COMPLETED
|
57
|
0
|
|
DBW Period
STARTED
|
82
|
81
|
|
DBW Period
COMPLETED
|
56
|
32
|
|
DBW Period
NOT COMPLETED
|
26
|
49
|
Reasons for withdrawal
| Measure |
Baricitinib
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.
|
Placebo
Placebo matched to baricitinib was administered to participants during the DBW period.
|
|---|---|---|
|
PK/Safety and OLLI Period
Adverse Event
|
1
|
0
|
|
PK/Safety and OLLI Period
Failure to Meet Randomization Criteria
|
39
|
0
|
|
PK/Safety and OLLI Period
Lost to Follow-up
|
1
|
0
|
|
PK/Safety and OLLI Period
Withdrawal by Subject
|
3
|
0
|
|
PK/Safety and OLLI Period
Due to epidemic or pandemic
|
6
|
0
|
|
PK/Safety and OLLI Period
unexplainable flare disease
|
1
|
0
|
|
PK/Safety and OLLI Period
Protocol Violation
|
4
|
0
|
|
PK/Safety and OLLI Period
Participant transitioned to JAHX
|
1
|
0
|
|
PK/Safety and OLLI Period
Investigational product was not delivered to the site
|
1
|
0
|
|
DBW Period
Adverse Event
|
2
|
2
|
|
DBW Period
Failure to Meet Continuation Criteria
|
16
|
40
|
|
DBW Period
Withdrawal by Subject
|
2
|
1
|
|
DBW Period
Due to epidemic or pandemic
|
5
|
6
|
|
DBW Period
Study team decision
|
1
|
0
|
Baseline Characteristics
A Study of Baricitinib in Participants From 2 Years to Less Than 18 Years Old With Juvenile Idiopathic Arthritis
Baseline characteristics by cohort
| Measure |
Baricitinib
n=220 Participants
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.
|
|---|---|
|
Age, Customized
Age · >=2 to <6 years
|
6 Participants
n=5 Participants
|
|
Age, Customized
Age · >=6 to <9 years
|
9 Participants
n=5 Participants
|
|
Age, Customized
Age · >=9 to <12 years
|
30 Participants
n=5 Participants
|
|
Age, Customized
Age · >=12 to <18 years
|
175 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
152 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
68 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
43 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
133 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
44 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
48 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
152 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
Argentina
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
Czechia
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
25 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
India
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
Russia
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
Turkey
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
18 Participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
21 Participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
26 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 12 to Week 44Population: DBW Population: All randomized participants from the DBW period who had data for time to disease flare at given time point.
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.
Outcome measures
| Measure |
Baricitinib
n=82 Participants
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.
|
Placebo
n=81 Participants
Placebo matched to baricitinib was administered to participants during the DBW period.
|
6 to <9 Years 2-mg QD
Participants aged 6 to \<9 years were given 2-mg baricitinib once daily.
|
2 to <6 Years 2-mg QD
Participants aged 2 to \<6 years were given 2-mg baricitinib once daily.
|
|---|---|---|---|---|
|
Time to Disease Flare
|
NA Weeks
Median, upper and lower limits of 95% CI was not estimable due to small number of participants with the event.
|
27.14 Weeks
Interval 15.29 to
Upper limit of 95% CI was not estimable due to small number of participants with the event.
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 16, 20, 24, 28, 32, 36, 40 and 44Population: DBW Population: All randomized participants from the DBW period who had data for PedACR30 at given time point.
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.
Outcome measures
| Measure |
Baricitinib
n=82 Participants
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.
|
Placebo
n=81 Participants
Placebo matched to baricitinib was administered to participants during the DBW period.
|
6 to <9 Years 2-mg QD
Participants aged 6 to \<9 years were given 2-mg baricitinib once daily.
|
2 to <6 Years 2-mg QD
Participants aged 2 to \<6 years were given 2-mg baricitinib once daily.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving PedACR30 Responder Index
At week 16
|
92.7 Percentage of participants
Interval 87.0 to 98.3
|
81.5 Percentage of participants
Interval 73.0 to 89.9
|
—
|
—
|
|
Percentage of Participants Achieving PedACR30 Responder Index
At week 20
|
87.8 Percentage of participants
Interval 80.7 to 94.9
|
64.2 Percentage of participants
Interval 53.8 to 74.6
|
—
|
—
|
|
Percentage of Participants Achieving PedACR30 Responder Index
At week 24
|
85.4 Percentage of participants
Interval 77.7 to 93.0
|
55.6 Percentage of participants
Interval 44.7 to 66.4
|
—
|
—
|
|
Percentage of Participants Achieving PedACR30 Responder Index
At week 28
|
78 Percentage of participants
Interval 69.1 to 87.0
|
51.9 Percentage of participants
Interval 41.0 to 62.7
|
—
|
—
|
|
Percentage of Participants Achieving PedACR30 Responder Index
At week 32
|
74.4 Percentage of participants
Interval 64.9 to 83.8
|
49.4 Percentage of participants
Interval 38.5 to 60.3
|
—
|
—
|
|
Percentage of Participants Achieving PedACR30 Responder Index
At week 36
|
72.0 Percentage of participants
Interval 62.2 to 81.7
|
44.4 Percentage of participants
Interval 33.6 to 55.3
|
—
|
—
|
|
Percentage of Participants Achieving PedACR30 Responder Index
At week 40
|
69.5 Percentage of participants
Interval 59.5 to 79.5
|
38.3 Percentage of participants
Interval 27.7 to 48.9
|
—
|
—
|
|
Percentage of Participants Achieving PedACR30 Responder Index
At week 44
|
67.1 Percentage of participants
Interval 56.9 to 77.2
|
38.3 Percentage of participants
Interval 27.7 to 48.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 16, 20, 24, 28, 32, 36, 40 and 44Population: DBW Population: All randomized participants from the DBW period who had data for PedACR50 at given time point.
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.
Outcome measures
| Measure |
Baricitinib
n=82 Participants
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.
|
Placebo
n=81 Participants
Placebo matched to baricitinib was administered to participants during the DBW period.
|
6 to <9 Years 2-mg QD
Participants aged 6 to \<9 years were given 2-mg baricitinib once daily.
|
2 to <6 Years 2-mg QD
Participants aged 2 to \<6 years were given 2-mg baricitinib once daily.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving PedACR50 Responder Index
At week 16
|
79.3 Percentage of participants
Interval 70.5 to 88.0
|
75.3 Percentage of participants
Interval 65.9 to 84.7
|
—
|
—
|
|
Percentage of Participants Achieving PedACR50 Responder Index
At week 20
|
81.7 Percentage of participants
Interval 73.3 to 90.1
|
58 Percentage of participants
Interval 47.3 to 68.8
|
—
|
—
|
|
Percentage of Participants Achieving PedACR50 Responder Index
At week 24
|
81.7 Percentage of participants
Interval 73.3 to 90.1
|
49.4 Percentage of participants
Interval 38.5 to 60.3
|
—
|
—
|
|
Percentage of Participants Achieving PedACR50 Responder Index
At week 28
|
75.6 Percentage of participants
Interval 66.3 to 84.9
|
50.6 Percentage of participants
Interval 39.7 to 61.5
|
—
|
—
|
|
Percentage of Participants Achieving PedACR50 Responder Index
At week 32
|
72 Percentage of participants
Interval 62.2 to 81.7
|
46.9 Percentage of participants
Interval 36.0 to 57.8
|
—
|
—
|
|
Percentage of Participants Achieving PedACR50 Responder Index
At week 36
|
68.3 Percentage of participants
Interval 58.2 to 78.4
|
43.2 Percentage of participants
Interval 32.4 to 54.0
|
—
|
—
|
|
Percentage of Participants Achieving PedACR50 Responder Index
At week 40
|
68.3 Percentage of participants
Interval 58.2 to 78.4
|
38.3 Percentage of participants
Interval 27.7 to 48.9
|
—
|
—
|
|
Percentage of Participants Achieving PedACR50 Responder Index
At week 44
|
63.4 Percentage of participants
Interval 53.0 to 73.8
|
37 Percentage of participants
Interval 26.5 to 47.6
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 16, 20, 24, 28, 32, 36, 40 and 44Population: DBW Population: All randomized participants from the DBW period who had data for PedACR70 at given time point.
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.
Outcome measures
| Measure |
Baricitinib
n=82 Participants
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.
|
Placebo
n=81 Participants
Placebo matched to baricitinib was administered to participants during the DBW period.
|
6 to <9 Years 2-mg QD
Participants aged 6 to \<9 years were given 2-mg baricitinib once daily.
|
2 to <6 Years 2-mg QD
Participants aged 2 to \<6 years were given 2-mg baricitinib once daily.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving PedACR70 Responder Index
At week 16
|
54.9 Percentage of participants
Interval 44.1 to 65.6
|
54.3 Percentage of participants
Interval 43.5 to 65.2
|
—
|
—
|
|
Percentage of Participants Achieving PedACR70 Responder Index
At week 20
|
68.3 Percentage of participants
Interval 58.2 to 78.4
|
45.7 Percentage of participants
Interval 34.8 to 56.5
|
—
|
—
|
|
Percentage of Participants Achieving PedACR70 Responder Index
At week 24
|
59.8 Percentage of participants
Interval 49.1 to 70.4
|
37.0 Percentage of participants
Interval 26.5 to 47.6
|
—
|
—
|
|
Percentage of Participants Achieving PedACR70 Responder Index
At week 28
|
67.1 Percentage of participants
Interval 56.9 to 77.2
|
39.5 Percentage of participants
Interval 28.9 to 50.2
|
—
|
—
|
|
Percentage of Participants Achieving PedACR70 Responder Index
At week 32
|
57.3 Percentage of participants
Interval 46.6 to 68.0
|
35.8 Percentage of participants
Interval 25.4 to 46.2
|
—
|
—
|
|
Percentage of Participants Achieving PedACR70 Responder Index
At week 36
|
61 Percentage of participants
Interval 50.4 to 71.5
|
35.8 Percentage of participants
Interval 25.4 to 46.2
|
—
|
—
|
|
Percentage of Participants Achieving PedACR70 Responder Index
At week 40
|
57.3 Percentage of participants
Interval 46.6 to 68.0
|
30.9 Percentage of participants
Interval 20.8 to 40.9
|
—
|
—
|
|
Percentage of Participants Achieving PedACR70 Responder Index
At week 44
|
53.7 Percentage of participants
Interval 42.9 to 64.5
|
35.8 Percentage of participants
Interval 25.4 to 46.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 16, 20, 24, 28, 32, 36, 40 and 44Population: DBW Population: All randomized participants from the DBW period who had data for PedACR90 at given time point.
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.
Outcome measures
| Measure |
Baricitinib
n=82 Participants
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.
|
Placebo
n=81 Participants
Placebo matched to baricitinib was administered to participants during the DBW period.
|
6 to <9 Years 2-mg QD
Participants aged 6 to \<9 years were given 2-mg baricitinib once daily.
|
2 to <6 Years 2-mg QD
Participants aged 2 to \<6 years were given 2-mg baricitinib once daily.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving PedACR90 Responder Index
At week 16
|
29.3 Percentage of participants
Interval 19.4 to 39.1
|
23.5 Percentage of participants
Interval 14.2 to 32.7
|
—
|
—
|
|
Percentage of Participants Achieving PedACR90 Responder Index
At week 20
|
42.7 Percentage of participants
Interval 32.0 to 53.4
|
24.7 Percentage of participants
Interval 15.3 to 34.1
|
—
|
—
|
|
Percentage of Participants Achieving PedACR90 Responder Index
At week 24
|
37.8 Percentage of participants
Interval 27.3 to 48.3
|
21 Percentage of participants
Interval 12.1 to 29.9
|
—
|
—
|
|
Percentage of Participants Achieving PedACR90 Responder Index
At week 28
|
42.7 Percentage of participants
Interval 32.0 to 53.4
|
25.9 Percentage of participants
Interval 16.4 to 35.5
|
—
|
—
|
|
Percentage of Participants Achieving PedACR90 Responder Index
At week 32
|
43.9 Percentage of participants
Interval 33.2 to 54.6
|
27.2 Percentage of participants
Interval 17.5 to 36.8
|
—
|
—
|
|
Percentage of Participants Achieving PedACR90 Responder Index
At week 36
|
39 Percentage of participants
Interval 28.5 to 49.6
|
27.2 Percentage of participants
Interval 17.5 to 36.8
|
—
|
—
|
|
Percentage of Participants Achieving PedACR90 Responder Index
At week 40
|
40.2 Percentage of participants
Interval 29.6 to 50.9
|
23.5 Percentage of participants
Interval 14.2 to 32.7
|
—
|
—
|
|
Percentage of Participants Achieving PedACR90 Responder Index
At week 44
|
42.7 Percentage of participants
Interval 32.0 to 53.4
|
23.5 Percentage of participants
Interval 14.2 to 32.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 16, 20, 24, 28, 32, 36, 40 and 44Population: DBW Population: All randomized participants from the DBW period who had data for PedACR100 at given time point.
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.
Outcome measures
| Measure |
Baricitinib
n=82 Participants
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.
|
Placebo
n=81 Participants
Placebo matched to baricitinib was administered to participants during the DBW period.
|
6 to <9 Years 2-mg QD
Participants aged 6 to \<9 years were given 2-mg baricitinib once daily.
|
2 to <6 Years 2-mg QD
Participants aged 2 to \<6 years were given 2-mg baricitinib once daily.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving PedACR100 Responder Index
At week 16
|
14.6 Percentage of participants
Interval 7.0 to 22.3
|
17.3 Percentage of participants
Interval 9.0 to 25.5
|
—
|
—
|
|
Percentage of Participants Achieving PedACR100 Responder Index
At week 20
|
24.4 Percentage of participants
Interval 15.1 to 33.7
|
19.8 Percentage of participants
Interval 11.1 to 28.4
|
—
|
—
|
|
Percentage of Participants Achieving PedACR100 Responder Index
At week 24
|
18.3 Percentage of participants
Interval 9.9 to 26.7
|
16 Percentage of participants
Interval 8.1 to 24.0
|
—
|
—
|
|
Percentage of Participants Achieving PedACR100 Responder Index
At week 28
|
26.8 Percentage of participants
Interval 17.2 to 36.4
|
19.8 Percentage of participants
Interval 11.1 to 28.4
|
—
|
—
|
|
Percentage of Participants Achieving PedACR100 Responder Index
At week 32
|
28 Percentage of participants
Interval 18.3 to 37.8
|
21 Percentage of participants
Interval 12.1 to 29.9
|
—
|
—
|
|
Percentage of Participants Achieving PedACR100 Responder Index
At week 36
|
29.3 Percentage of participants
Interval 19.4 to 39.1
|
21 Percentage of participants
Interval 12.1 to 29.9
|
—
|
—
|
|
Percentage of Participants Achieving PedACR100 Responder Index
At week 40
|
29.3 Percentage of participants
Interval 19.4 to 39.1
|
17.3 Percentage of participants
Interval 9.0 to 25.5
|
—
|
—
|
|
Percentage of Participants Achieving PedACR100 Responder Index
At week 44
|
29.3 Percentage of participants
Interval 19.4 to 39.1
|
16 Percentage of participants
Interval 8.1 to 24.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 16, 20, 24, 28, 32, 36, 40 and 44Population: DBW Population: All randomized participants from the DBW period who had data for inactive disease at given time point.
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.
Outcome measures
| Measure |
Baricitinib
n=82 Participants
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.
|
Placebo
n=81 Participants
Placebo matched to baricitinib was administered to participants during the DBW period.
|
6 to <9 Years 2-mg QD
Participants aged 6 to \<9 years were given 2-mg baricitinib once daily.
|
2 to <6 Years 2-mg QD
Participants aged 2 to \<6 years were given 2-mg baricitinib once daily.
|
|---|---|---|---|---|
|
Percentage of Participants With Inactive Disease
At week 20
|
13.4 Percentage of participants
Interval 6.0 to 20.8
|
17.3 Percentage of participants
Interval 9.0 to 25.5
|
—
|
—
|
|
Percentage of Participants With Inactive Disease
At week 16
|
12.2 Percentage of participants
Interval 5.1 to 19.3
|
11.1 Percentage of participants
Interval 4.3 to 18.0
|
—
|
—
|
|
Percentage of Participants With Inactive Disease
At week 24
|
17.1 Percentage of participants
Interval 8.9 to 25.2
|
17.3 Percentage of participants
Interval 9.0 to 25.5
|
—
|
—
|
|
Percentage of Participants With Inactive Disease
At week 28
|
20.7 Percentage of participants
Interval 12.0 to 29.5
|
13.6 Percentage of participants
Interval 6.1 to 21.0
|
—
|
—
|
|
Percentage of Participants With Inactive Disease
At week 32
|
22.0 Percentage of participants
Interval 13.0 to 30.9
|
13.6 Percentage of participants
Interval 6.1 to 21.0
|
—
|
—
|
|
Percentage of Participants With Inactive Disease
At week 36
|
23.2 Percentage of participants
Interval 14.0 to 32.3
|
16.0 Percentage of participants
Interval 8.1 to 24.0
|
—
|
—
|
|
Percentage of Participants With Inactive Disease
At week 40
|
20.7 Percentage of participants
Interval 12.0 to 29.5
|
12.3 Percentage of participants
Interval 5.2 to 19.5
|
—
|
—
|
|
Percentage of Participants With Inactive Disease
At week 44
|
23.2 Percentage of participants
Interval 14.0 to 32.3
|
13.6 Percentage of participants
Interval 6.1 to 21.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 16, 20, 24, 28, 32, 36, 40 and 44Population: DBW Population: All randomized participants from the DBW period who had data for minimum disease activity at given time point.
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.
Outcome measures
| Measure |
Baricitinib
n=82 Participants
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.
|
Placebo
n=81 Participants
Placebo matched to baricitinib was administered to participants during the DBW period.
|
6 to <9 Years 2-mg QD
Participants aged 6 to \<9 years were given 2-mg baricitinib once daily.
|
2 to <6 Years 2-mg QD
Participants aged 2 to \<6 years were given 2-mg baricitinib once daily.
|
|---|---|---|---|---|
|
Percentage of Participants With Minimal Disease Activity
At week 16
|
36.6 Percentage of participants
Interval 26.2 to 47.0
|
40.7 Percentage of participants
Interval 30.0 to 51.4
|
—
|
—
|
|
Percentage of Participants With Minimal Disease Activity
At week 20
|
46.3 Percentage of participants
Interval 35.5 to 57.1
|
33.3 Percentage of participants
Interval 23.1 to 43.6
|
—
|
—
|
|
Percentage of Participants With Minimal Disease Activity
At week 24
|
43.9 Percentage of participants
Interval 33.2 to 54.6
|
34.6 Percentage of participants
Interval 24.2 to 44.9
|
—
|
—
|
|
Percentage of Participants With Minimal Disease Activity
At week 28
|
45.1 Percentage of participants
Interval 34.4 to 55.9
|
33.3 Percentage of participants
Interval 23.1 to 43.6
|
—
|
—
|
|
Percentage of Participants With Minimal Disease Activity
At week 32
|
43.9 Percentage of participants
Interval 33.2 to 54.6
|
32.1 Percentage of participants
Interval 21.9 to 42.3
|
—
|
—
|
|
Percentage of Participants With Minimal Disease Activity
At week 36
|
40.2 Percentage of participants
Interval 29.6 to 50.9
|
33.3 Percentage of participants
Interval 23.1 to 43.6
|
—
|
—
|
|
Percentage of Participants With Minimal Disease Activity
At week 40
|
43.9 Percentage of participants
Interval 33.2 to 54.6
|
32.1 Percentage of participants
Interval 21.9 to 42.3
|
—
|
—
|
|
Percentage of Participants With Minimal Disease Activity
At week 44
|
43.9 Percentage of participants
Interval 33.2 to 54.6
|
27.2 Percentage of participants
Interval 17.5 to 36.8
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 28, 32, 36, 40 and 44Population: DBW Population: All randomized participants from the DBW period who had data for remission at given time point.
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.
Outcome measures
| Measure |
Baricitinib
n=82 Participants
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.
|
Placebo
n=81 Participants
Placebo matched to baricitinib was administered to participants during the DBW period.
|
6 to <9 Years 2-mg QD
Participants aged 6 to \<9 years were given 2-mg baricitinib once daily.
|
2 to <6 Years 2-mg QD
Participants aged 2 to \<6 years were given 2-mg baricitinib once daily.
|
|---|---|---|---|---|
|
Percentage of Participants in Remission
At week 28
|
0 Percentage of participants
Interval 0.0 to 0.0
|
0 Percentage of participants
Interval 0.0 to 0.0
|
—
|
—
|
|
Percentage of Participants in Remission
At week 32
|
0 Percentage of participants
Interval 0.0 to 0.0
|
1.2 Percentage of participants
Interval 0.0 to 3.6
|
—
|
—
|
|
Percentage of Participants in Remission
At week 36
|
1.2 Percentage of participants
Interval 0.0 to 3.6
|
4.9 Percentage of participants
Interval 0.2 to 9.7
|
—
|
—
|
|
Percentage of Participants in Remission
At week 40
|
2.4 Percentage of participants
Interval 0.0 to 5.8
|
3.7 Percentage of participants
Interval 0.0 to 7.8
|
—
|
—
|
|
Percentage of Participants in Remission
At week 44
|
3.7 Percentage of participants
Interval 0.0 to 7.7
|
3.7 Percentage of participants
Interval 0.0 to 7.8
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 44Population: 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.
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.
Outcome measures
| Measure |
Baricitinib
n=80 Participants
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.
|
Placebo
n=78 Participants
Placebo matched to baricitinib was administered to participants during the DBW period.
|
6 to <9 Years 2-mg QD
Participants aged 6 to \<9 years were given 2-mg baricitinib once daily.
|
2 to <6 Years 2-mg QD
Participants aged 2 to \<6 years were given 2-mg baricitinib once daily.
|
|---|---|---|---|---|
|
Change From Baseline in Juvenile Arthritis Disease Activity Score-27 (JADAS-27) Score
|
-14.24 score on a scale
Standard Error 1.006
|
-9.91 score on a scale
Standard Error 1.013
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 44Population: DBW Population: All randomized participants from the DBW period who had data for at least one post-baseline CHAQ Pain VAS Item at given time point. 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.
CHAQ assesses the health status and physical function of children with juvenile arthritis over the past week. The CHAQ consists of a Disability Index and a Discomfort Index. The disability index consisted of 30 items grouped into the following 8 domains: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities. Each item is scored from 0 to 3 (0 = no difficulty; 1 = some difficulty; 2 = much difficulty and 3 = unable to do or not applicable). The scores of 8 domains were averaged to calculate the CHAQ-Disability Index total score. 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. The intensity of pain is scored on a VAS scale ranging from 0-100 mm, with zero referring to "no pain" and 100 referring to "very severe pain". A higher score indicates a worse outcome.
Outcome measures
| Measure |
Baricitinib
n=82 Participants
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.
|
Placebo
n=79 Participants
Placebo matched to baricitinib was administered to participants during the DBW period.
|
6 to <9 Years 2-mg QD
Participants aged 6 to \<9 years were given 2-mg baricitinib once daily.
|
2 to <6 Years 2-mg QD
Participants aged 2 to \<6 years were given 2-mg baricitinib once daily.
|
|---|---|---|---|---|
|
Change From Baseline in Arthritis-Related Pain Severity as Measured by the Childhood Health Assessment Questionnaire (CHAQ) Pain Visual Analog Scale (VAS) Item
|
-29.65 score on a scale
Standard Error 3.276
|
-16.68 score on a scale
Standard Error 3.202
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 44Population: DBW Population: All randomized participants from the DBW period who had at least one post-baseline juvenile psoriatic arthritis (JPsA) were included in this population.
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.
Outcome measures
| Measure |
Baricitinib
n=4 Participants
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.
|
Placebo
n=3 Participants
Placebo matched to baricitinib was administered to participants during the DBW period.
|
6 to <9 Years 2-mg QD
Participants aged 6 to \<9 years were given 2-mg baricitinib once daily.
|
2 to <6 Years 2-mg QD
Participants aged 2 to \<6 years were given 2-mg baricitinib once daily.
|
|---|---|---|---|---|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Score
|
-1.14 score on a scale
Standard Error 0.291
|
-0.79 score on a scale
Standard Error 0.354
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 44Population: DBW Population: All randomized participants from the DBW period who had enthesitis-related juvenile idiopathic arthritis (ERA) or JPsA were included in this population.
The SPARCC enthesitis is an index used to measure the severity of enthesitis (sites at which tendons and ligaments attach to bones). The SPARCC 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.
Outcome measures
| Measure |
Baricitinib
n=19 Participants
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.
|
Placebo
n=22 Participants
Placebo matched to baricitinib was administered to participants during the DBW period.
|
6 to <9 Years 2-mg QD
Participants aged 6 to \<9 years were given 2-mg baricitinib once daily.
|
2 to <6 Years 2-mg QD
Participants aged 2 to \<6 years were given 2-mg baricitinib once daily.
|
|---|---|---|---|---|
|
Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Index
|
-1.51 score on a scale
Standard Error 0.276
|
-1.95 score on a scale
Standard Error 0.241
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 44Population: DBW Population: All randomized participants from the DBW period who had ERA or JPsA were included in this population.
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.
Outcome measures
| Measure |
Baricitinib
n=15 Participants
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.
|
Placebo
n=18 Participants
Placebo matched to baricitinib was administered to participants during the DBW period.
|
6 to <9 Years 2-mg QD
Participants aged 6 to \<9 years were given 2-mg baricitinib once daily.
|
2 to <6 Years 2-mg QD
Participants aged 2 to \<6 years were given 2-mg baricitinib once daily.
|
|---|---|---|---|---|
|
Change From Baseline in Juvenile Spondyloarthritis Disease Activity (JSpADA) Index
|
-2.56 score on a scale
Standard Error 0.347
|
-1.47 score on a scale
Standard Error 0.296
|
—
|
—
|
SECONDARY outcome
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)Population: 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.
Maximum Plasma Baricitinib Concentration at Steady-State
Outcome measures
| Measure |
Baricitinib
n=172 Participants
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.
|
Placebo
n=27 Participants
Placebo matched to baricitinib was administered to participants during the DBW period.
|
6 to <9 Years 2-mg QD
n=8 Participants
Participants aged 6 to \<9 years were given 2-mg baricitinib once daily.
|
2 to <6 Years 2-mg QD
n=6 Participants
Participants aged 2 to \<6 years were given 2-mg baricitinib once daily.
|
|---|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Plasma Baricitinib Concentration at Steady-State (Cmax, ss)
|
57.7 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 28
|
79 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 33
|
56.8 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 22
|
87.4 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 38
|
SECONDARY outcome
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)Population: 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.
Area under the concentration-time curve of Baricitinib during a dosing interval at steady state.
Outcome measures
| Measure |
Baricitinib
n=172 Participants
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.
|
Placebo
n=29 Participants
Placebo matched to baricitinib was administered to participants during the DBW period.
|
6 to <9 Years 2-mg QD
n=8 Participants
Participants aged 6 to \<9 years were given 2-mg baricitinib once daily.
|
2 to <6 Years 2-mg QD
n=6 Participants
Participants aged 2 to \<6 years were given 2-mg baricitinib once daily.
|
|---|---|---|---|---|
|
PK: Area Under the Baricitinib Concentration-Time Curve During a Dosing Interval at Steady-State (AUCτ,ss)
|
386 hour*nanogram/millilitre (h*ng/mL)
Geometric Coefficient of Variation 45
|
500 hour*nanogram/millilitre (h*ng/mL)
Geometric Coefficient of Variation 57
|
254 hour*nanogram/millilitre (h*ng/mL)
Geometric Coefficient of Variation 27
|
410 hour*nanogram/millilitre (h*ng/mL)
Geometric Coefficient of Variation 57
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Safety/PK and OLLI population: All randomized participants from the Safety/PK and OLLI periods who had data for for at least one post-baseline immunoglobulin levels at given time point.
Change from baseline in Serum Immunoglobulin A, Serum Immunoglobulin G and Serum Immunoglobulin M levels at week 12 are presented.
Outcome measures
| Measure |
Baricitinib
n=220 Participants
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.
|
Placebo
Placebo matched to baricitinib was administered to participants during the DBW period.
|
6 to <9 Years 2-mg QD
Participants aged 6 to \<9 years were given 2-mg baricitinib once daily.
|
2 to <6 Years 2-mg QD
Participants aged 2 to \<6 years were given 2-mg baricitinib once daily.
|
|---|---|---|---|---|
|
Change From Baseline in Immunoglobulin Levels
Serum Immunoglobulin A
|
-15.98 Milligrams per decilitre (mg/dL)
Standard Deviation 39.501
|
—
|
—
|
—
|
|
Change From Baseline in Immunoglobulin Levels
Serum Immunoglobulin G
|
-81.46 Milligrams per decilitre (mg/dL)
Standard Deviation 209.549
|
—
|
—
|
—
|
|
Change From Baseline in Immunoglobulin Levels
Serum Immunoglobulin M
|
-9.86 Milligrams per decilitre (mg/dL)
Standard Deviation 26.680
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-Vaccination to 4 and 12 Weeks Post-VaccinationPopulation: Safety/PK and OLLI population: All randomized participants from the Safety/PK assessment and OLLI period who had data for IgG titers at given time point.
Number of participants with change of IgG titers eligible for tetanus / diphtheria / acellular pertussis (tDaP) vaccine and pneumococcal conjugate are presented. Participants who were 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 assessed in participants who had never received tDaP or pneumococcal conjugate vaccines previously and secondary/booster responses were assessed if the participants had 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.
Outcome measures
| Measure |
Baricitinib
n=7 Participants
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.
|
Placebo
Placebo matched to baricitinib was administered to participants during the DBW period.
|
6 to <9 Years 2-mg QD
Participants aged 6 to \<9 years were given 2-mg baricitinib once daily.
|
2 to <6 Years 2-mg QD
Participants aged 2 to \<6 years were given 2-mg baricitinib once daily.
|
|---|---|---|---|---|
|
Number of Participants With Change of Immunoglobulin G (IgG) Titers
Tetanus toxoid containing vaccine at week 4
|
2 participants
|
—
|
—
|
—
|
|
Number of Participants With Change of Immunoglobulin G (IgG) Titers
Tetanus toxoid containing vaccine at week 12
|
2 participants
|
—
|
—
|
—
|
|
Number of Participants With Change of Immunoglobulin G (IgG) Titers
Diphtheria toxoid containing vaccine at week 4
|
2 participants
|
—
|
—
|
—
|
|
Number of Participants With Change of Immunoglobulin G (IgG) Titers
Diphtheria toxoid containing vaccine at week 12
|
1 participants
|
—
|
—
|
—
|
|
Number of Participants With Change of Immunoglobulin G (IgG) Titers
Pertussis toxin containing vaccine at week 4
|
2 participants
|
—
|
—
|
—
|
|
Number of Participants With Change of Immunoglobulin G (IgG) Titers
Pertussis toxin containing vaccine at week 12
|
2 participants
|
—
|
—
|
—
|
|
Number of Participants With Change of Immunoglobulin G (IgG) Titers
pneumococcal conjugate vaccine at week 4
|
3 participants
|
—
|
—
|
—
|
|
Number of Participants With Change of Immunoglobulin G (IgG) Titers
pneumococcal conjugate vaccine at week 12
|
2 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and week 12Population: Safety/PK and OLLI population: All randomized participants from the Safety/PK assessment and OLLI period who had data for product acceptability and palatability at given time point.
The questionnaire for product acceptability and palatability assessed the participants ability to swallow the tablet, experience relating to the taste, smell and ease of administering and taking the suspension. The questionnaire contained following Questions: Question 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). The number of participants with these responses are presented. Data is presented as "Question Number-Response-Time point".
Outcome measures
| Measure |
Baricitinib
n=220 Participants
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.
|
Placebo
Placebo matched to baricitinib was administered to participants during the DBW period.
|
6 to <9 Years 2-mg QD
Participants aged 6 to \<9 years were given 2-mg baricitinib once daily.
|
2 to <6 Years 2-mg QD
Participants aged 2 to \<6 years were given 2-mg baricitinib once daily.
|
|---|---|---|---|---|
|
Number of Participants With Product Acceptability and Palatability Assessment
Question 1- Liked Very Much: Baseline
|
2 participants
|
—
|
—
|
—
|
|
Number of Participants With Product Acceptability and Palatability Assessment
Question 1- Liked Very Much: Week 12
|
6 participants
|
—
|
—
|
—
|
|
Number of Participants With Product Acceptability and Palatability Assessment
Question 1- Liked: Baseline
|
8 participants
|
—
|
—
|
—
|
|
Number of Participants With Product Acceptability and Palatability Assessment
Question 1- Liked: Week 12
|
2 participants
|
—
|
—
|
—
|
|
Number of Participants With Product Acceptability and Palatability Assessment
Question 1- Neither Liked nor Disliked: Baseline
|
3 participants
|
—
|
—
|
—
|
|
Number of Participants With Product Acceptability and Palatability Assessment
Question 1- Neither Liked nor Disliked: Week 12
|
1 participants
|
—
|
—
|
—
|
|
Number of Participants With Product Acceptability and Palatability Assessment
Question 1- Disliked: Baseline
|
0 participants
|
—
|
—
|
—
|
|
Number of Participants With Product Acceptability and Palatability Assessment
Question 1- Disliked: Week 12
|
1 participants
|
—
|
—
|
—
|
|
Number of Participants With Product Acceptability and Palatability Assessment
Question 1- Disliked Very Much: Baseline
|
0 participants
|
—
|
—
|
—
|
|
Number of Participants With Product Acceptability and Palatability Assessment
Question 1- Disliked Very Much: Week 12
|
0 participants
|
—
|
—
|
—
|
|
Number of Participants With Product Acceptability and Palatability Assessment
Question 2- Liked Very Much: Baseline
|
3 participants
|
—
|
—
|
—
|
|
Number of Participants With Product Acceptability and Palatability Assessment
Question 2- Liked Very Much: Week 12
|
2 participants
|
—
|
—
|
—
|
|
Number of Participants With Product Acceptability and Palatability Assessment
Question 2- Liked: Baseline
|
7 participants
|
—
|
—
|
—
|
|
Number of Participants With Product Acceptability and Palatability Assessment
Question 2- Liked: Week 12
|
4 participants
|
—
|
—
|
—
|
|
Number of Participants With Product Acceptability and Palatability Assessment
Question 2- Neither Liked nor Disliked: Baseline
|
3 participants
|
—
|
—
|
—
|
|
Number of Participants With Product Acceptability and Palatability Assessment
Question 2- Neither Liked nor Disliked: Week 12
|
2 participants
|
—
|
—
|
—
|
|
Number of Participants With Product Acceptability and Palatability Assessment
Question 2- Disliked: Baseline
|
0 participants
|
—
|
—
|
—
|
|
Number of Participants With Product Acceptability and Palatability Assessment
Question 2- Disliked: Week 12
|
1 participants
|
—
|
—
|
—
|
|
Number of Participants With Product Acceptability and Palatability Assessment
Question 2- Disliked Very Much: Baseline
|
0 participants
|
—
|
—
|
—
|
|
Number of Participants With Product Acceptability and Palatability Assessment
Question 2- Disliked Very Much: Week 12
|
1 participants
|
—
|
—
|
—
|
|
Number of Participants With Product Acceptability and Palatability Assessment
Question 3- Very Easy: Baseline
|
8 participants
|
—
|
—
|
—
|
|
Number of Participants With Product Acceptability and Palatability Assessment
Question 3- Very Easy: Week 12
|
7 participants
|
—
|
—
|
—
|
|
Number of Participants With Product Acceptability and Palatability Assessment
Question 3- Easy: Baseline
|
3 participants
|
—
|
—
|
—
|
|
Number of Participants With Product Acceptability and Palatability Assessment
Question 3- Easy: Week 12
|
2 participants
|
—
|
—
|
—
|
|
Number of Participants With Product Acceptability and Palatability Assessment
Question 3- Neither Easy nor Hard: Baseline
|
1 participants
|
—
|
—
|
—
|
|
Number of Participants With Product Acceptability and Palatability Assessment
Question 3- Neither Easy nor Hard: Week 12
|
0 participants
|
—
|
—
|
—
|
|
Number of Participants With Product Acceptability and Palatability Assessment
Question 3- Difficult (or Hard): Baseline
|
0 participants
|
—
|
—
|
—
|
|
Number of Participants With Product Acceptability and Palatability Assessment
Question 3- Difficult (or Hard): Week 12
|
1 participants
|
—
|
—
|
—
|
|
Number of Participants With Product Acceptability and Palatability Assessment
Question 3- Very Difficult (or Hard): Baseline
|
1 participants
|
—
|
—
|
—
|
|
Number of Participants With Product Acceptability and Palatability Assessment
Question 3- Very Difficult (or Hard): Week 12
|
0 participants
|
—
|
—
|
—
|
|
Number of Participants With Product Acceptability and Palatability Assessment
Question 4- Very Easy: Baseline
|
5 participants
|
—
|
—
|
—
|
|
Number of Participants With Product Acceptability and Palatability Assessment
Question 4- Very Easy: Week 12
|
8 participants
|
—
|
—
|
—
|
|
Number of Participants With Product Acceptability and Palatability Assessment
Question 4- Easy: Baseline
|
6 participants
|
—
|
—
|
—
|
|
Number of Participants With Product Acceptability and Palatability Assessment
Question 4- Easy: Week 12
|
2 participants
|
—
|
—
|
—
|
|
Number of Participants With Product Acceptability and Palatability Assessment
Question 4- Neither Easy nor Hard: Baseline
|
0 participants
|
—
|
—
|
—
|
|
Number of Participants With Product Acceptability and Palatability Assessment
Question 4- Neither Easy nor Hard: Week 12
|
0 participants
|
—
|
—
|
—
|
|
Number of Participants With Product Acceptability and Palatability Assessment
Question 4- Difficult (or Hard): Baseline
|
0 participants
|
—
|
—
|
—
|
|
Number of Participants With Product Acceptability and Palatability Assessment
Question 4- Difficult (or Hard): Week 12
|
0 participants
|
—
|
—
|
—
|
|
Number of Participants With Product Acceptability and Palatability Assessment
Question 4- Very Difficult (or Hard): Baseline
|
0 participants
|
—
|
—
|
—
|
|
Number of Participants With Product Acceptability and Palatability Assessment
Question 4- Very Difficult (or Hard): Week 12
|
0 participants
|
—
|
—
|
—
|
|
Number of Participants With Product Acceptability and Palatability Assessment
Question 5- Very Easy: Baseline
|
146 participants
|
—
|
—
|
—
|
|
Number of Participants With Product Acceptability and Palatability Assessment
Question 5- Very Easy: Week 12
|
120 participants
|
—
|
—
|
—
|
|
Number of Participants With Product Acceptability and Palatability Assessment
Question 5- Easy: Baseline
|
39 participants
|
—
|
—
|
—
|
|
Number of Participants With Product Acceptability and Palatability Assessment
Question 5- Easy: Week 12
|
34 participants
|
—
|
—
|
—
|
|
Number of Participants With Product Acceptability and Palatability Assessment
Question 5- Neither Easy nor Hard: Baseline
|
14 participants
|
—
|
—
|
—
|
|
Number of Participants With Product Acceptability and Palatability Assessment
Question 5- Neither Easy nor Hard: Week 12
|
5 participants
|
—
|
—
|
—
|
|
Number of Participants With Product Acceptability and Palatability Assessment
Question 5- Difficult (or Hard): Baseline
|
3 participants
|
—
|
—
|
—
|
|
Number of Participants With Product Acceptability and Palatability Assessment
Question 5- Difficult (or Hard): Week 12
|
0 participants
|
—
|
—
|
—
|
|
Number of Participants With Product Acceptability and Palatability Assessment
Question 5- Very Difficult (or Hard): Baseline
|
1 participants
|
—
|
—
|
—
|
|
Number of Participants With Product Acceptability and Palatability Assessment
Question 5- Very Difficult (or Hard): Week 12
|
0 participants
|
—
|
—
|
—
|
Adverse Events
Baricitinib PK and OLLI
Placebo DBW
Baricitinib DBW
Serious adverse events
| Measure |
Baricitinib PK and OLLI
n=220 participants at risk
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.
|
Placebo DBW
n=81 participants at risk
Participants received placebo matched to baricitinib during the DBW period.
|
Baricitinib DBW
n=82 participants at risk
During the DBW period, 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.
|
|---|---|---|---|
|
Infections and infestations
Covid-19
|
0.00%
0/220 • Baseline through Follow-up (Up To 341 Days)
All participants who received at least one dose of study drug.
|
0.00%
0/81 • Baseline through Follow-up (Up To 341 Days)
All participants who received at least one dose of study drug.
|
1.2%
1/82 • Number of events 1 • Baseline through Follow-up (Up To 341 Days)
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/220 • Baseline through Follow-up (Up To 341 Days)
All participants who received at least one dose of study drug.
|
0.00%
0/81 • Baseline through Follow-up (Up To 341 Days)
All participants who received at least one dose of study drug.
|
1.2%
1/82 • Number of events 1 • Baseline through Follow-up (Up To 341 Days)
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.45%
1/220 • Number of events 1 • Baseline through Follow-up (Up To 341 Days)
All participants who received at least one dose of study drug.
|
0.00%
0/81 • Baseline through Follow-up (Up To 341 Days)
All participants who received at least one dose of study drug.
|
0.00%
0/82 • Baseline through Follow-up (Up To 341 Days)
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.45%
1/220 • Number of events 1 • Baseline through Follow-up (Up To 341 Days)
All participants who received at least one dose of study drug.
|
0.00%
0/81 • Baseline through Follow-up (Up To 341 Days)
All participants who received at least one dose of study drug.
|
0.00%
0/82 • Baseline through Follow-up (Up To 341 Days)
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Joint destruction
|
0.45%
1/220 • Number of events 1 • Baseline through Follow-up (Up To 341 Days)
All participants who received at least one dose of study drug.
|
0.00%
0/81 • Baseline through Follow-up (Up To 341 Days)
All participants who received at least one dose of study drug.
|
0.00%
0/82 • Baseline through Follow-up (Up To 341 Days)
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.45%
1/220 • Number of events 1 • Baseline through Follow-up (Up To 341 Days)
All participants who received at least one dose of study drug.
|
0.00%
0/81 • Baseline through Follow-up (Up To 341 Days)
All participants who received at least one dose of study drug.
|
0.00%
0/82 • Baseline through Follow-up (Up To 341 Days)
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Juvenile idiopathic arthritis
|
0.45%
1/220 • Number of events 1 • Baseline through Follow-up (Up To 341 Days)
All participants who received at least one dose of study drug.
|
1.2%
1/81 • Number of events 1 • Baseline through Follow-up (Up To 341 Days)
All participants who received at least one dose of study drug.
|
0.00%
0/82 • Baseline through Follow-up (Up To 341 Days)
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.45%
1/220 • Number of events 1 • Baseline through Follow-up (Up To 341 Days)
All participants who received at least one dose of study drug.
|
0.00%
0/81 • Baseline through Follow-up (Up To 341 Days)
All participants who received at least one dose of study drug.
|
0.00%
0/82 • Baseline through Follow-up (Up To 341 Days)
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/220 • Baseline through Follow-up (Up To 341 Days)
All participants who received at least one dose of study drug.
|
0.00%
0/81 • Baseline through Follow-up (Up To 341 Days)
All participants who received at least one dose of study drug.
|
1.2%
1/82 • Number of events 1 • Baseline through Follow-up (Up To 341 Days)
All participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/220 • Baseline through Follow-up (Up To 341 Days)
All participants who received at least one dose of study drug.
|
1.2%
1/81 • Number of events 1 • Baseline through Follow-up (Up To 341 Days)
All participants who received at least one dose of study drug.
|
0.00%
0/82 • Baseline through Follow-up (Up To 341 Days)
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/220 • Baseline through Follow-up (Up To 341 Days)
All participants who received at least one dose of study drug.
|
1.2%
1/81 • Number of events 1 • Baseline through Follow-up (Up To 341 Days)
All participants who received at least one dose of study drug.
|
0.00%
0/82 • Baseline through Follow-up (Up To 341 Days)
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/220 • Baseline through Follow-up (Up To 341 Days)
All participants who received at least one dose of study drug.
|
0.00%
0/81 • Baseline through Follow-up (Up To 341 Days)
All participants who received at least one dose of study drug.
|
1.2%
1/82 • Number of events 1 • Baseline through Follow-up (Up To 341 Days)
All participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Baricitinib PK and OLLI
n=220 participants at risk
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.
|
Placebo DBW
n=81 participants at risk
Participants received placebo matched to baricitinib during the DBW period.
|
Baricitinib DBW
n=82 participants at risk
During the DBW period, 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.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.4%
3/220 • Number of events 3 • Baseline through Follow-up (Up To 341 Days)
All participants who received at least one dose of study drug.
|
1.2%
1/81 • Number of events 1 • Baseline through Follow-up (Up To 341 Days)
All participants who received at least one dose of study drug.
|
6.1%
5/82 • Number of events 5 • Baseline through Follow-up (Up To 341 Days)
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
8.6%
19/220 • Number of events 20 • Baseline through Follow-up (Up To 341 Days)
All participants who received at least one dose of study drug.
|
3.7%
3/81 • Number of events 3 • Baseline through Follow-up (Up To 341 Days)
All participants who received at least one dose of study drug.
|
7.3%
6/82 • Number of events 7 • Baseline through Follow-up (Up To 341 Days)
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.0%
11/220 • Number of events 12 • Baseline through Follow-up (Up To 341 Days)
All participants who received at least one dose of study drug.
|
1.2%
1/81 • Number of events 1 • Baseline through Follow-up (Up To 341 Days)
All participants who received at least one dose of study drug.
|
11.0%
9/82 • Number of events 10 • Baseline through Follow-up (Up To 341 Days)
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.0%
11/220 • Number of events 15 • Baseline through Follow-up (Up To 341 Days)
All participants who received at least one dose of study drug.
|
3.7%
3/81 • Number of events 4 • Baseline through Follow-up (Up To 341 Days)
All participants who received at least one dose of study drug.
|
7.3%
6/82 • Number of events 6 • Baseline through Follow-up (Up To 341 Days)
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
6.4%
14/220 • Number of events 16 • Baseline through Follow-up (Up To 341 Days)
All participants who received at least one dose of study drug.
|
3.7%
3/81 • Number of events 3 • Baseline through Follow-up (Up To 341 Days)
All participants who received at least one dose of study drug.
|
9.8%
8/82 • Number of events 10 • Baseline through Follow-up (Up To 341 Days)
All participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60