Trial Outcomes & Findings for Active Juvenile Idiopathic Arthritis (JIA) Compassionate Use (NCT NCT00775437)

Results Overview

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. If an AE meets any of the following criteria, it is considered a serious adverse event (SAE): Results in death, is life-threatening, results in hospitalization or the prolongation of hospitalization, is a congenital anomaly or a persistent or significant disability/incapacity, or is an important medical event requiring medical or surgical intervention to prevent a serious outcome. A treatment-emergent AE (TEAE) is defined as any AE with onset or worsening reported by a participant from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration (total of 32.5 months).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

32 participants

Primary outcome timeframe

TEAEs were collected from first dose of study drug until 70 days after the last dose of study drug and before start of commercial adalimumab or other biologics (32.5 months).

Results posted on

2016-01-26

Participant Flow

Participants were enrolled at 14 investigative sites in the Czech Republic, France, Germany, and the United States.

Participants age 2 to \< 4 years or ≥ 4 years and under 15 kg with moderately to severely active polyarticular or polyarticular-course JIA with a parent/guardian to administer injections. The screening visit occurred between Day -28 and Day 0.

Participant milestones

Participant milestones
Measure	Adalimumab Adalimumab 24 mg/m\^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
Overall Study STARTED	32
Overall Study COMPLETED	26
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Adalimumab Adalimumab 24 mg/m\^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
Overall Study Loss of efficacy	2
Overall Study Withdrawal by Subject	3
Overall Study Lost to Follow-up	1

Baseline Characteristics

Active Juvenile Idiopathic Arthritis (JIA) Compassionate Use

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Adalimumab n=32 Participants Adalimumab 24 mg/m\^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
Age, Continuous	3.04 years STANDARD_DEVIATION 0.723 • n=5 Participants
Age, Customized < 4 years	28 participants n=5 Participants
Age, Customized ≥ 4 years	4 participants n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: TEAEs were collected from first dose of study drug until 70 days after the last dose of study drug and before start of commercial adalimumab or other biologics (32.5 months).

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. If an AE meets any of the following criteria, it is considered a serious adverse event (SAE): Results in death, is life-threatening, results in hospitalization or the prolongation of hospitalization, is a congenital anomaly or a persistent or significant disability/incapacity, or is an important medical event requiring medical or surgical intervention to prevent a serious outcome. A treatment-emergent AE (TEAE) is defined as any AE with onset or worsening reported by a participant from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration (total of 32.5 months).

Outcome measures

Outcome measures
Measure	Adalimumab n=32 Participants Adalimumab 24 mg/m\^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Any Treatment-emergent AE	29 participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Any Treatment-emergent SAE	5 participants

SECONDARY outcome

Timeframe: Weeks 0, 12, and 24

Population: All participants who had samples for pharmacokinetic analysis

Adalimumab concentrations in serum were determined using a validated enzyme-linked immunoadsorbent assay (ELISA) method. The lower limit of quantitation (LLOQ) for adalimumab is 3.13 ng/mL.

Outcome measures

Outcome measures
Measure	Adalimumab n=15 Participants Adalimumab 24 mg/m\^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
Mean Serum Adalimumab Trough Concentrations at Week 0, Week 12, and Week 24 Week 0	0 µg/mL Standard Deviation 0
Mean Serum Adalimumab Trough Concentrations at Week 0, Week 12, and Week 24 Week 12	6.97 µg/mL Standard Deviation 5.69
Mean Serum Adalimumab Trough Concentrations at Week 0, Week 12, and Week 24 Week 24	7.78 µg/mL Standard Deviation 5.85

SECONDARY outcome

Timeframe: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.

Outcome measures

Outcome measures
Measure	Adalimumab n=31 Participants Adalimumab 24 mg/m\^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
Hemoglobin: Mean Change From Baseline to Each Visit Week 12 (n=29)	6.7 g/L Standard Deviation 7.32
Hemoglobin: Mean Change From Baseline to Each Visit Week 24 (n=29)	6.7 g/L Standard Deviation 9.76
Hemoglobin: Mean Change From Baseline to Each Visit Week 36 (n=25)	5.5 g/L Standard Deviation 9.31
Hemoglobin: Mean Change From Baseline to Each Visit Week 48 (n=24)	5.3 g/L Standard Deviation 10.68
Hemoglobin: Mean Change From Baseline to Each Visit Week 60 (n=21)	6 g/L Standard Deviation 10.96
Hemoglobin: Mean Change From Baseline to Each Visit Week 72 (n=17)	9.5 g/L Standard Deviation 10.65
Hemoglobin: Mean Change From Baseline to Each Visit Week 84 (n=16)	10.5 g/L Standard Deviation 13.69
Hemoglobin: Mean Change From Baseline to Each Visit Week 96 (n=11)	8.6 g/L Standard Deviation 9.99
Hemoglobin: Mean Change From Baseline to Each Visit Week 108 (n=9)	7.7 g/L Standard Deviation 8.08
Hemoglobin: Mean Change From Baseline to Each Visit Week 120 (n=3)	4.7 g/L Standard Deviation 2.89

SECONDARY outcome

Timeframe: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.

Outcome measures

Outcome measures
Measure	Adalimumab n=31 Participants Adalimumab 24 mg/m\^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
Hematocrit: Mean Change From Baseline to Each Visit Week 12 (n=29)	0.018 Fraction Standard Deviation 0.0206
Hematocrit: Mean Change From Baseline to Each Visit Week 24 (n=29)	0.016 Fraction Standard Deviation 0.0289
Hematocrit: Mean Change From Baseline to Each Visit Week 36 (n=25)	0.017 Fraction Standard Deviation 0.0292
Hematocrit: Mean Change From Baseline to Each Visit Week 48 (n=24)	0.011 Fraction Standard Deviation 0.0288
Hematocrit: Mean Change From Baseline to Each Visit Week 60 (n=21)	0.009 Fraction Standard Deviation 0.0275
Hematocrit: Mean Change From Baseline to Each Visit Week 72 (n=17)	0.024 Fraction Standard Deviation 0.0264
Hematocrit: Mean Change From Baseline to Each Visit Week 84 (n=16)	0.026 Fraction Standard Deviation 0.0366
Hematocrit: Mean Change From Baseline to Each Visit Week 96 (n=11)	0.023 Fraction Standard Deviation 0.0319
Hematocrit: Mean Change From Baseline to Each Visit Week 108 (n=9)	0.018 Fraction Standard Deviation 0.0273
Hematocrit: Mean Change From Baseline to Each Visit Week 120 (n=3)	0.008 Fraction Standard Deviation 0.0082

SECONDARY outcome

Timeframe: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.

Outcome measures

Outcome measures
Measure	Adalimumab n=31 Participants Adalimumab 24 mg/m\^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
Red Blood Cell (RBC) Count: Mean Change From Baseline to Each Visit Week 12 (n=29)	0.15 x10˄12/L Standard Deviation 0.231
Red Blood Cell (RBC) Count: Mean Change From Baseline to Each Visit Week 24 (n=29)	0.08 x10˄12/L Standard Deviation 0.308
Red Blood Cell (RBC) Count: Mean Change From Baseline to Each Visit Week 36 (n=25)	0.098 x10˄12/L Standard Deviation 0.277
Red Blood Cell (RBC) Count: Mean Change From Baseline to Each Visit Week 48 (n=24)	0.05 x10˄12/L Standard Deviation 0.213
Red Blood Cell (RBC) Count: Mean Change From Baseline to Each Visit Week 60 (n=21)	0.07 x10˄12/L Standard Deviation 0.296
Red Blood Cell (RBC) Count: Mean Change From Baseline to Each Visit Week 72 (n=17)	0.1 x10˄12/L Standard Deviation 0.187
Red Blood Cell (RBC) Count: Mean Change From Baseline to Each Visit Week 84 (n=16)	0.06 x10˄12/L Standard Deviation 0.228
Red Blood Cell (RBC) Count: Mean Change From Baseline to Each Visit Week 96 (n=11)	0.08 x10˄12/L Standard Deviation 0.343
Red Blood Cell (RBC) Count: Mean Change From Baseline to Each Visit Week 108 (n=9)	0.1 x10˄12/L Standard Deviation 0.32
Red Blood Cell (RBC) Count: Mean Change From Baseline to Each Visit Week 120 (n=3)	0.03 x10˄12/L Standard Deviation 0.153

SECONDARY outcome

Timeframe: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.

Outcome measures

Outcome measures
Measure	Adalimumab n=31 Participants Adalimumab 24 mg/m\^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
Platelets: Mean Change From Baseline to Each Visit Week 12 (n=29)	-35 x10˄9/L Standard Deviation 145.44
Platelets: Mean Change From Baseline to Each Visit Week 24 (n=29)	-57.7 x10˄9/L Standard Deviation 140.82
Platelets: Mean Change From Baseline to Each Visit Week 36 (n=25)	-75.2 x10˄9/L Standard Deviation 148.51
Platelets: Mean Change From Baseline to Each Visit Week 48 (n=23)	-21 x10˄9/L Standard Deviation 174.17
Platelets: Mean Change From Baseline to Each Visit Week 60 (n=21)	-46.7 x10˄9/L Standard Deviation 125.71
Platelets: Mean Change From Baseline to Each Visit Week 72 (n=17)	-51.1 x10˄9/L Standard Deviation 111.11
Platelets: Mean Change From Baseline to Each Visit Week 84 (n=15)	-58.5 x10˄9/L Standard Deviation 127.29
Platelets: Mean Change From Baseline to Each Visit Week 96 (n=11)	-49.2 x10˄9/L Standard Deviation 142.73
Platelets: Mean Change From Baseline to Each Visit Week 108 (n=9)	-30.4 x10˄9/L Standard Deviation 137.84
Platelets: Mean Change From Baseline to Each Visit Week 120 (n=3)	20 x10˄9/L Standard Deviation 185.95

SECONDARY outcome

Timeframe: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.

Outcome measures

Outcome measures
Measure	Adalimumab n=31 Participants Adalimumab 24 mg/m\^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
White Blood Cell (WBC) Count: Mean Change From Baseline to Each Visit Week 12 (n=29)	0.19 x10^9/L Standard Deviation 3.959
White Blood Cell (WBC) Count: Mean Change From Baseline to Each Visit Week 24 (n=29)	-0.25 x10^9/L Standard Deviation 3.756
White Blood Cell (WBC) Count: Mean Change From Baseline to Each Visit Week 36 (n=25)	-0.42 x10^9/L Standard Deviation 4.632
White Blood Cell (WBC) Count: Mean Change From Baseline to Each Visit Week 48 (n=24)	0.3 x10^9/L Standard Deviation 4.804
White Blood Cell (WBC) Count: Mean Change From Baseline to Each Visit Week 60 (n=21)	0.25 x10^9/L Standard Deviation 2.183
White Blood Cell (WBC) Count: Mean Change From Baseline to Each Visit Week 72 (n=17)	0.66 x10^9/L Standard Deviation 3.225
White Blood Cell (WBC) Count: Mean Change From Baseline to Each Visit Week 84 (n=16)	0.18 x10^9/L Standard Deviation 2.944
White Blood Cell (WBC) Count: Mean Change From Baseline to Each Visit Week 96 (n=11)	0.55 x10^9/L Standard Deviation 2.757
White Blood Cell (WBC) Count: Mean Change From Baseline to Each Visit Week 108 (n=9)	-0.76 x10^9/L Standard Deviation 4.166
White Blood Cell (WBC) Count: Mean Change From Baseline to Each Visit Week 120 (n=3)	1.8 x10^9/L Standard Deviation 3.651

SECONDARY outcome

Timeframe: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.

Outcome measures

Outcome measures
Measure	Adalimumab n=31 Participants Adalimumab 24 mg/m\^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
Neutrophils: Mean Change From Baseline to Each Visit Week 12 (n=29)	-0.138 x10˄9/L Standard Deviation 2.9819
Neutrophils: Mean Change From Baseline to Each Visit Week 24 (n=29)	-0.619 x10˄9/L Standard Deviation 3.0082
Neutrophils: Mean Change From Baseline to Each Visit Week 36 (n=25)	-0.586 x10˄9/L Standard Deviation 3.7363
Neutrophils: Mean Change From Baseline to Each Visit Week 48 (n=24)	0.065 x10˄9/L Standard Deviation 3.4433
Neutrophils: Mean Change From Baseline to Each Visit Week 60 (n=21)	0.222 x10˄9/L Standard Deviation 2.0937
Neutrophils: Mean Change From Baseline to Each Visit Week 72 (n=17)	-0.169 x10˄9/L Standard Deviation 2.6167
Neutrophils: Mean Change From Baseline to Each Visit Week 84 (n=16)	-0.206 x10˄9/L Standard Deviation 2.0077
Neutrophils: Mean Change From Baseline to Each Visit Week 96 (n=11)	0.293 x10˄9/L Standard Deviation 2.511
Neutrophils: Mean Change From Baseline to Each Visit Week 108 (n=9)	-0.39 x10˄9/L Standard Deviation 3.1702
Neutrophils: Mean Change From Baseline to Each Visit Week 120 (n=3)	2.47 x10˄9/L Standard Deviation 3.2658

SECONDARY outcome

Timeframe: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.

Outcome measures

Outcome measures
Measure	Adalimumab n=31 Participants Adalimumab 24 mg/m\^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
Lymphocytes: Mean Change From Baseline to Each Visit Week 12 (n=29)	0.371 x10˄9/L Standard Deviation 2.3523
Lymphocytes: Mean Change From Baseline to Each Visit Week 24 (n=29)	0.292 x10˄9/L Standard Deviation 1.9345
Lymphocytes: Mean Change From Baseline to Each Visit Week 36 (n=25)	0.176 x10˄9/L Standard Deviation 1.962
Lymphocytes: Mean Change From Baseline to Each Visit Week 48 (n=24)	0.186 x10˄9/L Standard Deviation 1.9584
Lymphocytes: Mean Change From Baseline to Each Visit Week 60 (n=21)	-0.034 x10˄9/L Standard Deviation 1.6129
Lymphocytes: Mean Change From Baseline to Each Visit Week 72 (n=17)	0.636 x10˄9/L Standard Deviation 1.7404
Lymphocytes: Mean Change From Baseline to Each Visit Week 84 (n=16)	0.306 x10˄9/L Standard Deviation 1.5143
Lymphocytes: Mean Change From Baseline to Each Visit Week 96 (n=11)	0.006 x10˄9/L Standard Deviation 1.9402
Lymphocytes: Mean Change From Baseline to Each Visit Week 108 (n=9)	-0.46 x10˄9/L Standard Deviation 2.4315
Lymphocytes: Mean Change From Baseline to Each Visit Week 120 (n=3)	-0.67 x10˄9/L Standard Deviation 1.8041

SECONDARY outcome

Timeframe: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.

Outcome measures

Outcome measures
Measure	Adalimumab n=31 Participants Adalimumab 24 mg/m\^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
Monocytes: Mean Change From Baseline to Each Visit Week 12 (n=29)	-0.032 x10^9/L Standard Deviation 0.3051
Monocytes: Mean Change From Baseline to Each Visit Week 24 (n=29)	0.081 x10^9/L Standard Deviation 0.4547
Monocytes: Mean Change From Baseline to Each Visit Week 36 (n=25)	0.028 x10^9/L Standard Deviation 0.2978
Monocytes: Mean Change From Baseline to Each Visit Week 48 (n=24)	-0.006 x10^9/L Standard Deviation 0.2718
Monocytes: Mean Change From Baseline to Each Visit Week 60 (n=21)	0.08 x10^9/L Standard Deviation 0.1831
Monocytes: Mean Change From Baseline to Each Visit Week 72 (n=17)	0.113 x10^9/L Standard Deviation 0.2054
Monocytes: Mean Change From Baseline to Each Visit Week 84 (n=16)	0.061 x10^9/L Standard Deviation 0.2594
Monocytes: Mean Change From Baseline to Each Visit Week 96 (n=11)	0.089 x10^9/L Standard Deviation 0.2295
Monocytes: Mean Change From Baseline to Each Visit Week 108 (n=9)	0.096 x10^9/L Standard Deviation 0.3248
Monocytes: Mean Change From Baseline to Each Visit Week 120 (n=3)	0.057 x10^9/L Standard Deviation 0.0777

SECONDARY outcome

Timeframe: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.

Outcome measures

Outcome measures
Measure	Adalimumab n=31 Participants Adalimumab 24 mg/m\^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
Eosinophils: Mean Change From Baseline to Each Visit Week 12 (n=29)	-0.004 x10^9/L Standard Deviation 0.1771
Eosinophils: Mean Change From Baseline to Each Visit Week 24 (n=29)	-0.006 x10^9/L Standard Deviation 0.1545
Eosinophils: Mean Change From Baseline to Each Visit Week 36 (n=25)	-0.052 x10^9/L Standard Deviation 0.1374
Eosinophils: Mean Change From Baseline to Each Visit Week 48 (n=24)	0.056 x10^9/L Standard Deviation 0.2773
Eosinophils: Mean Change From Baseline to Each Visit Week 60 (n=21)	-0.015 x10^9/L Standard Deviation 0.1363
Eosinophils: Mean Change From Baseline to Each Visit Week 72 (n=17)	0.069 x10^9/L Standard Deviation 0.1886
Eosinophils: Mean Change From Baseline to Each Visit Week 84 (n=16)	0.016 x10^9/L Standard Deviation 0.1631
Eosinophils: Mean Change From Baseline to Each Visit Week 96 (n=11)	0.158 x10^9/L Standard Deviation 0.3207
Eosinophils: Mean Change From Baseline to Each Visit Week 108 (n=9)	-0.002 x10^9/L Standard Deviation 0.0864
Eosinophils: Mean Change From Baseline to Each Visit Week 120 (n=3)	-0.063 x10^9/L Standard Deviation 0.0929

SECONDARY outcome

Timeframe: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.

Outcome measures

Outcome measures
Measure	Adalimumab n=31 Participants Adalimumab 24 mg/m\^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
Basophils: Mean Change From Baseline to Each Visit Week 12 (n=29)	-0.012 x10^9/L Standard Deviation 0.0299
Basophils: Mean Change From Baseline to Each Visit Week 24 (n=29)	-0.002 x10^9/L Standard Deviation 0.0272
Basophils: Mean Change From Baseline to Each Visit Week 36 (n=25)	0.003 x10^9/L Standard Deviation 0.0244
Basophils: Mean Change From Baseline to Each Visit Week 48 (n=24)	0.005 x10^9/L Standard Deviation 0.0412
Basophils: Mean Change From Baseline to Each Visit Week 60 (n=21)	-0.003 x10^9/L Standard Deviation 0.0256
Basophils: Mean Change From Baseline to Each Visit Week 72 (n=17)	0.007 x10^9/L Standard Deviation 0.031
Basophils: Mean Change From Baseline to Each Visit Week 84 (n=16)	-0.001 x10^9/L Standard Deviation 0.0171
Basophils: Mean Change From Baseline to Each Visit Week 96 (n=11)	-0.003 x10^9/L Standard Deviation 0.0205
Basophils: Mean Change From Baseline to Each Visit Week 108 (n=9)	-0.001 x10^9/L Standard Deviation 0.0117
Basophils: Mean Change From Baseline to Each Visit Week 120 (n=3)	0.003 x10^9/L Standard Deviation 0.0306

SECONDARY outcome

Timeframe: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.

Outcome measures

Outcome measures
Measure	Adalimumab n=30 Participants Adalimumab 24 mg/m\^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
Alanine Aminotransferase (SGPT/ALT): Mean Change From Baseline to Each Visit Week 120 (n=3)	-14.3 U/L Standard Deviation 23.12
Alanine Aminotransferase (SGPT/ALT): Mean Change From Baseline to Each Visit Week 12 (n=27)	0.5 U/L Standard Deviation 9.96
Alanine Aminotransferase (SGPT/ALT): Mean Change From Baseline to Each Visit Week 24 (n=28)	-1.1 U/L Standard Deviation 17.13
Alanine Aminotransferase (SGPT/ALT): Mean Change From Baseline to Each Visit Week 36 (n=25)	0 U/L Standard Deviation 29.82
Alanine Aminotransferase (SGPT/ALT): Mean Change From Baseline to Each Visit Week 48 (n=24)	-4.5 U/L Standard Deviation 24.81
Alanine Aminotransferase (SGPT/ALT): Mean Change From Baseline to Each Visit Week 60 (n=21)	-2 U/L Standard Deviation 10.25
Alanine Aminotransferase (SGPT/ALT): Mean Change From Baseline to Each Visit Week 72 (n=16)	-1.8 U/L Standard Deviation 10.1
Alanine Aminotransferase (SGPT/ALT): Mean Change From Baseline to Each Visit Week 84 (n=16)	-0.5 U/L Standard Deviation 14.56
Alanine Aminotransferase (SGPT/ALT): Mean Change From Baseline to Each Visit Week 96 (n=11)	-3.9 U/L Standard Deviation 15.4
Alanine Aminotransferase (SGPT/ALT): Mean Change From Baseline to Each Visit Week 108 (n=9)	-2.4 U/L Standard Deviation 6.31

SECONDARY outcome

Timeframe: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

Baseline is the last value prior to the first dose of study drug.Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.

Outcome measures

Outcome measures
Measure	Adalimumab n=30 Participants Adalimumab 24 mg/m\^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
Aspartate Aminotransferase (SGOT/AST): Mean Change From Baseline to Each Visit Week 96 (n=10)	1.5 U/L Standard Deviation 11.48
Aspartate Aminotransferase (SGOT/AST): Mean Change From Baseline to Each Visit Week 12 (n=26)	2.8 U/L Standard Deviation 7.56
Aspartate Aminotransferase (SGOT/AST): Mean Change From Baseline to Each Visit Week 24 (n=28)	-0.6 U/L Standard Deviation 8.82
Aspartate Aminotransferase (SGOT/AST): Mean Change From Baseline to Each Visit Week 36 (n=25)	2 U/L Standard Deviation 23.26
Aspartate Aminotransferase (SGOT/AST): Mean Change From Baseline to Each Visit Week 48 (n=24)	-0.7 U/L Standard Deviation 16.13
Aspartate Aminotransferase (SGOT/AST): Mean Change From Baseline to Each Visit Week 60 (n=21)	-0.4 U/L Standard Deviation 7.63
Aspartate Aminotransferase (SGOT/AST): Mean Change From Baseline to Each Visit Week 72 (n=16)	0.3 U/L Standard Deviation 7.36
Aspartate Aminotransferase (SGOT/AST): Mean Change From Baseline to Each Visit Week 84 (n=16)	-0.4 U/L Standard Deviation 6.89
Aspartate Aminotransferase (SGOT/AST): Mean Change From Baseline to Each Visit Week 108 (n=9)	0.4 U/L Standard Deviation 6.21
Aspartate Aminotransferase (SGOT/AST): Mean Change From Baseline to Each Visit Week 120 (n=3)	-8.3 U/L Standard Deviation 11.93

SECONDARY outcome

Timeframe: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.

Outcome measures

Outcome measures
Measure	Adalimumab n=30 Participants Adalimumab 24 mg/m\^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
Alkaline Phosphatase (ALP): Mean Change From Baseline to Each Visit Week 12 (n=27)	15.7 U/L Standard Deviation 64.65
Alkaline Phosphatase (ALP): Mean Change From Baseline to Each Visit Week 24 (n=28)	10.6 U/L Standard Deviation 68.75
Alkaline Phosphatase (ALP): Mean Change From Baseline to Each Visit Week 36 (n=25)	23.2 U/L Standard Deviation 73.28
Alkaline Phosphatase (ALP): Mean Change From Baseline to Each Visit Week 48 (n=24)	21.7 U/L Standard Deviation 73.03
Alkaline Phosphatase (ALP): Mean Change From Baseline to Each Visit Week 60 (n=21)	17.9 U/L Standard Deviation 85.55
Alkaline Phosphatase (ALP): Mean Change From Baseline to Each Visit Week 72 (n=16)	17.9 U/L Standard Deviation 83.52
Alkaline Phosphatase (ALP): Mean Change From Baseline to Each Visit Week 84 (n=16)	31.5 U/L Standard Deviation 89.3
Alkaline Phosphatase (ALP): Mean Change From Baseline to Each Visit Week 96 (n=11)	59.4 U/L Standard Deviation 57.65
Alkaline Phosphatase (ALP): Mean Change From Baseline to Each Visit Week 108 (n=9)	-6.3 U/L Standard Deviation 100.72
Alkaline Phosphatase (ALP): Mean Change From Baseline to Each Visit Week 120 (n=3)	-72.3 U/L Standard Deviation 169.19

SECONDARY outcome

Timeframe: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.

Outcome measures

Outcome measures
Measure	Adalimumab n=30 Participants Adalimumab 24 mg/m\^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
Creatine Phosphokinase: Mean Change From Baseline to Each Visit Week 12 (n=27)	17.2 U/L Standard Deviation 50.48
Creatine Phosphokinase: Mean Change From Baseline to Each Visit Week 24 (n=27)	7 U/L Standard Deviation 30.79
Creatine Phosphokinase: Mean Change From Baseline to Each Visit Week 36 (n=25)	24.8 U/L Standard Deviation 44.5
Creatine Phosphokinase: Mean Change From Baseline to Each Visit Week 48 (n=24)	18.4 U/L Standard Deviation 54.02
Creatine Phosphokinase: Mean Change From Baseline to Each Visit Week 60 (n=21)	26.6 U/L Standard Deviation 65.48
Creatine Phosphokinase: Mean Change From Baseline to Each Visit Week 72 (n=16)	41.6 U/L Standard Deviation 40.63
Creatine Phosphokinase: Mean Change From Baseline to Each Visit Week 84 (n=16)	36.4 U/L Standard Deviation 53.64
Creatine Phosphokinase: Mean Change From Baseline to Each Visit Week 96 (n=11)	28.7 U/L Standard Deviation 41.79
Creatine Phosphokinase: Mean Change From Baseline to Each Visit Week 108 (n=9)	7.2 U/L Standard Deviation 22.97
Creatine Phosphokinase: Mean Change From Baseline to Each Visit Week 120 (n=3)	14 U/L Standard Deviation 40.73

SECONDARY outcome

Timeframe: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.

Outcome measures

Outcome measures
Measure	Adalimumab n=30 Participants Adalimumab 24 mg/m\^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
Total Bilirubin: Mean Change From Baseline to Each Visit Week 12 (n=27)	1.2 µmol/L Standard Deviation 2.42
Total Bilirubin: Mean Change From Baseline to Each Visit Week 24 (n=28)	0.6 µmol/L Standard Deviation 1.59
Total Bilirubin: Mean Change From Baseline to Each Visit Week 36 (n=25)	0.6 µmol/L Standard Deviation 1.61
Total Bilirubin: Mean Change From Baseline to Each Visit Week 48 (n=24)	0.9 µmol/L Standard Deviation 2.4
Total Bilirubin: Mean Change From Baseline to Each Visit Week 60 (n=21)	1 µmol/L Standard Deviation 2.09
Total Bilirubin: Mean Change From Baseline to Each Visit Week 72 (n=16)	0.2 µmol/L Standard Deviation 1.25
Total Bilirubin: Mean Change From Baseline to Each Visit Week 84 (n=16)	0.5 µmol/L Standard Deviation 2.36
Total Bilirubin: Mean Change From Baseline to Each Visit Week 96 (n=11)	0.7 µmol/L Standard Deviation 1.62
Total Bilirubin: Mean Change From Baseline to Each Visit Week 108 (n=9)	1.1 µmol/L Standard Deviation 2.71
Total Bilirubin: Mean Change From Baseline to Each Visit Week 120 (n=3)	2.3 µmol/L Standard Deviation 0.58

SECONDARY outcome

Timeframe: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.

Outcome measures

Outcome measures
Measure	Adalimumab n=30 Participants Adalimumab 24 mg/m\^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
Creatinine: Mean Change From Baseline to Each Visit Week 108 (n=9)	6.2 µmol/L Standard Deviation 6.7
Creatinine: Mean Change From Baseline to Each Visit Week 120 (n=3)	8.7 µmol/L Standard Deviation 5.51
Creatinine: Mean Change From Baseline to Each Visit Week 12 (n=27)	1.7 µmol/L Standard Deviation 5.98
Creatinine: Mean Change From Baseline to Each Visit Week 24 (n=28)	0.5 µmol/L Standard Deviation 5.3
Creatinine: Mean Change From Baseline to Each Visit Week 36 (n=25)	0.3 µmol/L Standard Deviation 5.84
Creatinine: Mean Change From Baseline to Each Visit Week 48 (n=24)	2.5 µmol/L Standard Deviation 7.8
Creatinine: Mean Change From Baseline to Each Visit Week 60 (n=21)	2.8 µmol/L Standard Deviation 5.79
Creatinine: Mean Change From Baseline to Each Visit Week 72 (n=16)	3.4 µmol/L Standard Deviation 6.96
Creatinine: Mean Change From Baseline to Each Visit Week 84 (n=16)	4 µmol/L Standard Deviation 6.37
Creatinine: Mean Change From Baseline to Each Visit Week 96 (n=11)	3.2 µmol/L Standard Deviation 5.53

SECONDARY outcome

Timeframe: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.

Outcome measures

Outcome measures
Measure	Adalimumab n=30 Participants Adalimumab 24 mg/m\^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
Uric Acid: Mean Change From Baseline to Each Visit Week 24 (n=27)	6.5 µmol/L Standard Deviation 47.93
Uric Acid: Mean Change From Baseline to Each Visit Week 84 (n=16)	-4.5 µmol/L Standard Deviation 46.76
Uric Acid: Mean Change From Baseline to Each Visit Week 96 (n=11)	13.3 µmol/L Standard Deviation 36.39
Uric Acid: Mean Change From Baseline to Each Visit Week 12 (n=27)	1.7 µmol/L Standard Deviation 48.24
Uric Acid: Mean Change From Baseline to Each Visit Week 36 (n=25)	2.5 µmol/L Standard Deviation 41.77
Uric Acid: Mean Change From Baseline to Each Visit Week 48 (n=24)	5.6 µmol/L Standard Deviation 45.62
Uric Acid: Mean Change From Baseline to Each Visit Week 60 (n=21)	1.9 µmol/L Standard Deviation 30.86
Uric Acid: Mean Change From Baseline to Each Visit Week 72 (n=16)	-0.9 µmol/L Standard Deviation 43.53
Uric Acid: Mean Change From Baseline to Each Visit Week 108 (n=9)	-10.1 µmol/L Standard Deviation 33.55
Uric Acid: Mean Change From Baseline to Each Visit Week 120 (n=3)	-7 µmol/L Standard Deviation 27.78

SECONDARY outcome

Timeframe: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

The PedACR30 response is defined by the PedACR as ≥30% improvement in at least 3 of 6 JIA core set criteria, and ≥30% worsening in ≤1 of 6 JIA core set criteria. The 6 variables for the JIA core set criteria are Physician's Global Assessment (PGA) of participant's disease activity, Parent's Global Assessment of participant's disease activity, number of active joints (joints with swelling not due to deformity or joints with loss of passive motion \[LOM\] and joints with pain on passive motion \[POM\], tenderness, or both), number of joints with LOM, Disability Index of Child Health Assessment Questionnaire (DICHAQ), and C-reactive protein (CRP). Baseline is the last value prior to the first dose of study drug. Missing data were imputed up to Week 60 using last observation carried forward (LOCF) and non-responder imputation (NRI); observed values are presented for timepoints past Week 60. n=number of participants for either observed or imputed methods at given time point.

Outcome measures

Outcome measures
Measure	Adalimumab n=32 Participants Adalimumab 24 mg/m\^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 30% Response (PedACR30) Week 60 NRI (n=32)	56.3 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 30% Response (PedACR30) Week 60 LOCF (n=31)	87.1 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 30% Response (PedACR30) Week 72 Observed (n=17)	100 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 30% Response (PedACR30) Week 108 Observed (n=9)	88.9 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 30% Response (PedACR30) Week 120 Observed (n=3)	100 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 30% Response (PedACR30) Week 12 Observed (n=31)	93.5 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 30% Response (PedACR30) Week 24 Observed (n=30)	90 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 30% Response (PedACR30) Week 24 NRI (n=32)	84.4 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 30% Response (PedACR30) Week 24 LOCF (n=31)	90.3 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 30% Response (PedACR30) Week 12 NRI (n=32)	90.6 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 30% Response (PedACR30) Week 12 LOCF (n=31)	93.5 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 30% Response (PedACR30) Week 36 Observed (n=27)	92.6 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 30% Response (PedACR30) Week 36 NRI (n=32)	78.1 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 30% Response (PedACR30) Week 36 LOCF (n=31)	93.5 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 30% Response (PedACR30) Week 48 Observed (n=24)	83.3 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 30% Response (PedACR30) Week 48 NRI (n=32)	62.5 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 30% Response (PedACR30) Week 48 LOCF (n=31)	83.9 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 30% Response (PedACR30) Week 60 Observed (n=20)	90 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 30% Response (PedACR30) Week 84 Observed (n=17)	100 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 30% Response (PedACR30) Week 96 Observed (n=13)	92.3 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

The PedACR50 response is defined by the PedACR as ≥ 50% improvement in at least 3 of 6 JIA core set criteria, and ≥ 30% worsening in not more than 1 of 6 JIA core set criteria. The 6 variables for the JIA core set criteria include PGA of participant's disease activity, Parent's Global Assessment of participant's disease activity, number of active joints (joints with swelling not due to deformity or joints with LOM and joints with POM, tenderness, or both), number of joints with LOM, DICHAQ, and CRP. Baseline is the last value prior to the first dose of study drug. Missing data were imputed up to Week 60 using LOCF and by NRI; observed values are presented for timepoints past Week 60. n=number of participants for either observed or imputed methods at given time point.

Outcome measures

Outcome measures
Measure	Adalimumab n=32 Participants Adalimumab 24 mg/m\^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 50% Response (PedACR50) Week 12 Observed (n=31)	90.3 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 50% Response (PedACR50) Week 12 NRI (n=32)	87.5 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 50% Response (PedACR50) Week 12 LOCF (n=31)	90.3 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 50% Response (PedACR50) Week 24 Observed (n=30)	83.3 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 50% Response (PedACR50) Week 60 Observed (n=20)	80 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 50% Response (PedACR50) Week 24 NRI (n=32)	78.1 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 50% Response (PedACR50) Week 24 LOCF (n=31)	83.9 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 50% Response (PedACR50) Week 36 Observed (n=27)	88.9 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 50% Response (PedACR50) Week 36 NRI (n=32)	75 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 50% Response (PedACR50) Week 36 LOCF (n=31)	90.3 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 50% Response (PedACR50) Week 48 Observed (n=24)	79.2 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 50% Response (PedACR50) Week 48 NRI (n=32)	59.4 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 50% Response (PedACR50) Week 48 LOCF (n=31)	80.6 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 50% Response (PedACR50) Week 60 NRI (n=32)	50 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 50% Response (PedACR50) Week 60 LOCF (n=31)	80.6 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 50% Response (PedACR50) Week 72 Observed (n=17)	100 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 50% Response (PedACR50) Week 84 Observed (n=17)	94.1 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 50% Response (PedACR50) Week 96 Observed (n=13)	92.3 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 50% Response (PedACR50) Week 108 Observed (n=9)	88.9 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 50% Response (PedACR50) Week 120 Observed (n=3)	100 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

The PedACR70 response is defined by the PedACR as ≥ 70% improvement in at least 3 of 6 JIA core set criteria, and ≥ 30% worsening in not more than 1 of 6 JIA core set criteria. The 6 variables for the JIA core set criteria include PGA of participant's disease activity, Parent's Global Assessment of participant's disease activity, number of active joints (joints with swelling not due to deformity or joints with LOM and joints with POM, tenderness, or both), number of joints with LOM, DICHAQ, and CRP. Baseline is the last value prior to the first dose of study drug. Missing data were imputed up to Week 60 using LOCF and by NRI; observed values are presented for timepoints past Week 60. n=number of participants for either observed or imputed methods at given time point.

Outcome measures

Outcome measures
Measure	Adalimumab n=32 Participants Adalimumab 24 mg/m\^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 70% Response (PedACR70) Week 12 Observed (n=31)	61.3 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 70% Response (PedACR70) Week 12 NRI (n=32)	59.4 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 70% Response (PedACR70) Week 12 LOCF (n=31)	61.3 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 70% Response (PedACR70) Week 24 Observed (n=30)	73.3 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 70% Response (PedACR70) Week 24 NRI (n=32)	68.8 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 70% Response (PedACR70) Week 24 LOCF (n=31)	74.2 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 70% Response (PedACR70) Week 36 Observed (n=27)	66.7 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 70% Response (PedACR70) Week 36 NRI (n=32)	56.3 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 70% Response (PedACR70) Week 36 LOCF (n=31)	67.7 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 70% Response (PedACR70) Week 48 Observed (n=24)	75 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 70% Response (PedACR70) Week 48 NRI (n=32)	56.3 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 70% Response (PedACR70) Week 48 LOCF (n=31)	74.2 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 70% Response (PedACR70) Week 60 Observed (n=20)	70 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 70% Response (PedACR70) Week 60 NRI (n=32)	43.8 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 70% Response (PedACR70) Week 60 LOCF (n=31)	71 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 70% Response (PedACR70) Week 72 Observed (n=17)	76.5 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 70% Response (PedACR70) Week 84 Observed (n=17)	82.4 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 70% Response (PedACR70) Week 96 Observed (n=13)	76.9 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 70% Response (PedACR70) Week 108 Observed (n=9)	77.8 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 70% Response (PedACR70) Week 120 Observed (n=3)	100 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

The PedACR90 response is defined by the PedACR as ≥ 90% improvement in at least 3 of 6 JIA core set criteria, and ≥ 30% worsening in not more than 1 of 6 JIA core set criteria. The 6 variables for the JIA core set criteria include PGA of participant's disease activity, Parent's Global Assessment of participant's disease activity, number of active joints (joints with swelling not due to deformity or joints with LOM and joints with POM, tenderness, or both), number of joints with LOM, DICHAQ, and CRP. Baseline is the last value prior to the first dose of study drug. Missing data were imputed up to Week 60 using LOCF and by NRI; observed values are presented for timepoints past Week 60. n=number of participants for either observed or imputed methods at given time point.

Outcome measures

Outcome measures
Measure	Adalimumab n=32 Participants Adalimumab 24 mg/m\^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 90% Response (PedACR90) Week 24 LOCF (n=31)	35.5 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 90% Response (PedACR90) Week 36 Observed (n=27)	51.9 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 90% Response (PedACR90) Week 36 NRI (n=32)	43.8 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 90% Response (PedACR90) Week 36 LOCF (n=31)	51.6 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 90% Response (PedACR90) Week 48 Observed (n=24)	62.5 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 90% Response (PedACR90) Week 48 NRI (n=32)	46.9 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 90% Response (PedACR90) Week 48 LOCF (n=31)	58.1 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 90% Response (PedACR90) Week 60 Observed (n=20)	50 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 90% Response (PedACR90) Week 60 NRI (n=32)	31.3 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 90% Response (PedACR90) Week 60 LOCF (n=31)	51.6 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 90% Response (PedACR90) Week 72 Observed (n=17)	64.7 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 90% Response (PedACR90) Week 84 Observed (n=17)	64.7 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 90% Response (PedACR90) Week 96 Observed (n=13)	61.5 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 90% Response (PedACR90) Week 108 Observed (n=9)	66.7 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 90% Response (PedACR90) Week 120 Observed (n=3)	100 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 90% Response (PedACR90) Week 12 Observed (n=31)	38.7 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 90% Response (PedACR90) Week 12 NRI (n=32)	37.5 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 90% Response (PedACR90) Week 12 LOCF (n=31)	38.7 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 90% Response (PedACR90) Week 24 Observed (n=30)	36.7 percentage of participants
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 90% Response (PedACR90) Week 24 NRI (n=32)	34.4 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

The physician's assessment of participant's overall disease activity on a visual analog scale (VAS). The VAS is a 100 mm scale, with scores ranging from 0 (very good) to 100 (very bad). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.

Outcome measures

Outcome measures
Measure	Adalimumab n=32 Participants Adalimumab 24 mg/m\^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
Physician's Global Assessment of Disease Activity: Mean Change From Baseline to Each Visit Week 12 (n=31)	-41.4 units on a scale Standard Deviation 21.2
Physician's Global Assessment of Disease Activity: Mean Change From Baseline to Each Visit Week 24 (n=30)	-45.3 units on a scale Standard Deviation 21.32
Physician's Global Assessment of Disease Activity: Mean Change From Baseline to Each Visit Week 36 (n=28)	-43 units on a scale Standard Deviation 23.9
Physician's Global Assessment of Disease Activity: Mean Change From Baseline to Each Visit Week 48 (n=24)	-46.5 units on a scale Standard Deviation 18.35
Physician's Global Assessment of Disease Activity: Mean Change From Baseline to Each Visit Week 60 (n=21)	-42.7 units on a scale Standard Deviation 28.17
Physician's Global Assessment of Disease Activity: Mean Change From Baseline to Each Visit Week 72 (n=17)	-51.1 units on a scale Standard Deviation 19.53
Physician's Global Assessment of Disease Activity: Mean Change From Baseline to Each Visit Week 84 (n=17)	-50.5 units on a scale Standard Deviation 16.77
Physician's Global Assessment of Disease Activity: Mean Change From Baseline to Each Visit Week 96 (n=13)	-47.5 units on a scale Standard Deviation 24.42
Physician's Global Assessment of Disease Activity: Mean Change From Baseline to Each Visit Week 108 (n=9)	-48.3 units on a scale Standard Deviation 28.24
Physician's Global Assessment of Disease Activity: Mean Change From Baseline to Each Visit Week 120 (n=3)	-56.3 units on a scale Standard Deviation 5.13

SECONDARY outcome

Timeframe: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

The parent's assessment of how the participant's arthritis is doing overall on a VAS. The VAS is a 100 mm scale, with scores ranging from 0 (very good) to 100 (very bad). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.

Outcome measures

Outcome measures
Measure	Adalimumab n=32 Participants Adalimumab 24 mg/m\^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
Parent's Global Assessment of Disease Activity: Mean Change From Baseline to Each Visit Week 12 (n=31)	-28.1 units on a scale Standard Deviation 29.91
Parent's Global Assessment of Disease Activity: Mean Change From Baseline to Each Visit Week 24 (n=30)	-32.2 units on a scale Standard Deviation 29.74
Parent's Global Assessment of Disease Activity: Mean Change From Baseline to Each Visit Week 36 (n=27)	-35.1 units on a scale Standard Deviation 27.42
Parent's Global Assessment of Disease Activity: Mean Change From Baseline to Each Visit Week 48 (n=24)	-35.6 units on a scale Standard Deviation 32.19
Parent's Global Assessment of Disease Activity: Mean Change From Baseline to Each Visit Week 60 (n=21)	-34.5 units on a scale Standard Deviation 33.31
Parent's Global Assessment of Disease Activity: Mean Change From Baseline to Each Visit Week 72 (n=17)	-43.8 units on a scale Standard Deviation 25.58
Parent's Global Assessment of Disease Activity: Mean Change From Baseline to Each Visit Week 84 (n=17)	-42.6 units on a scale Standard Deviation 28.62
Parent's Global Assessment of Disease Activity: Mean Change From Baseline to Each Visit Week 96 (n=13)	-45.8 units on a scale Standard Deviation 29.1
Parent's Global Assessment of Disease Activity: Mean Change From Baseline to Each Visit Week 108 (n=9)	-39.9 units on a scale Standard Deviation 37.54
Parent's Global Assessment of Disease Activity: Mean Change From Baseline to Each Visit Week 120 (n=3)	-47.7 units on a scale Standard Deviation 34.96

SECONDARY outcome

Timeframe: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

The DICHAQ is a self-reported participant-oriented outcome measure, calculated as the mean of the following 8 category scores (range: 0 to 3): Dressing and Grooming, Arising, Eating, Walking, Hygiene, Reach, Grip, and Activities. The score of each category is calculated as the maximum of the scores for the questions within that category. If aids and devices and/or help from another person are used for a category, a lower category score is adjusted to 2 for that category. A participant must have scores for at least 6 categories in order to compute the DICHAQ score. Total score is derived as average of all categories: 0 (no disability) to 3 (complete disability). Baseline is the last value prior to the first dose of study drug. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.

Outcome measures

Outcome measures
Measure	Adalimumab n=32 Participants Adalimumab 24 mg/m\^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
Disability Index of Child Health Assessment Questionnaire (DICHAQ): Mean Change From Baseline to Each Visit Week 12 (n=31)	-0.5 units on a scale Standard Deviation 0.64
Disability Index of Child Health Assessment Questionnaire (DICHAQ): Mean Change From Baseline to Each Visit Week 24 (n=30)	-0.5 units on a scale Standard Deviation 0.69
Disability Index of Child Health Assessment Questionnaire (DICHAQ): Mean Change From Baseline to Each Visit Week 36 (n=27)	-0.6 units on a scale Standard Deviation 0.7
Disability Index of Child Health Assessment Questionnaire (DICHAQ): Mean Change From Baseline to Each Visit Week 48 (n=24)	-0.6 units on a scale Standard Deviation 0.68
Disability Index of Child Health Assessment Questionnaire (DICHAQ): Mean Change From Baseline to Each Visit Week 60 (n=21)	-0.6 units on a scale Standard Deviation 0.71
Disability Index of Child Health Assessment Questionnaire (DICHAQ): Mean Change From Baseline to Each Visit Week 72 (n=16)	-0.9 units on a scale Standard Deviation 0.64
Disability Index of Child Health Assessment Questionnaire (DICHAQ): Mean Change From Baseline to Each Visit Week 84 (n=17)	-0.9 units on a scale Standard Deviation 0.68
Disability Index of Child Health Assessment Questionnaire (DICHAQ): Mean Change From Baseline to Each Visit Week 96 (n=13)	-0.8 units on a scale Standard Deviation 0.56
Disability Index of Child Health Assessment Questionnaire (DICHAQ): Mean Change From Baseline to Each Visit Week 108 (n=9)	-0.8 units on a scale Standard Deviation 0.63
Disability Index of Child Health Assessment Questionnaire (DICHAQ): Mean Change From Baseline to Each Visit Week 120 (n=3)	-0.8 units on a scale Standard Deviation 1.09

SECONDARY outcome

Timeframe: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, and 120

A joint assessment was recorded at all study visits to assess the number of active joints, with a total possible score of 0 (no active joints) to 73 (all active joints). Active joints are defined as joints with positive results for tenderness, swelling, pain on passive motion, or limitation of passive motion. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.

Outcome measures

Outcome measures
Measure	Adalimumab n=32 Participants Adalimumab 24 mg/m\^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
Active Joint Counts (AJC73): Mean Change From Baseline to Each Visit Week 2 (n=32)	-5 units on a scale Standard Deviation 6.58
Active Joint Counts (AJC73): Mean Change From Baseline to Each Visit Week 4 (n=32)	-6.1 units on a scale Standard Deviation 6.69
Active Joint Counts (AJC73): Mean Change From Baseline to Each Visit Week 8 (n=32)	-7 units on a scale Standard Deviation 5.24
Active Joint Counts (AJC73): Mean Change From Baseline to Each Visit Week 12 (n=31)	-7.3 units on a scale Standard Deviation 4.52
Active Joint Counts (AJC73): Mean Change From Baseline to Each Visit Week 16 (n=31)	-7.1 units on a scale Standard Deviation 5.87
Active Joint Counts (AJC73): Mean Change From Baseline to Each Visit Week 20 (n=29)	-8 units on a scale Standard Deviation 5.68
Active Joint Counts (AJC73): Mean Change From Baseline to Each Visit Week 24 (n=30)	-7.2 units on a scale Standard Deviation 5.6
Active Joint Counts (AJC73): Mean Change From Baseline to Each Visit Week 36 (n=28)	-7.3 units on a scale Standard Deviation 5.21
Active Joint Counts (AJC73): Mean Change From Baseline to Each Visit Week 48 (n=24)	-8 units on a scale Standard Deviation 5.5
Active Joint Counts (AJC73): Mean Change From Baseline to Each Visit Week 60 (n=20)	-9.5 units on a scale Standard Deviation 7.5
Active Joint Counts (AJC73): Mean Change From Baseline to Each Visit Week 72 (n=17)	-10.2 units on a scale Standard Deviation 6.64
Active Joint Counts (AJC73): Mean Change From Baseline to Each Visit Week 84 (n=17)	-10.4 units on a scale Standard Deviation 7.57
Active Joint Counts (AJC73): Mean Change From Baseline to Each Visit Week 96 (n=13)	-8.9 units on a scale Standard Deviation 7.04
Active Joint Counts (AJC73): Mean Change From Baseline to Each Visit Week 108 (n=9)	-5.9 units on a scale Standard Deviation 3.33
Active Joint Counts (AJC73): Mean Change From Baseline to Each Visit Week 120 (n=3)	-7.3 units on a scale Standard Deviation 2.08

SECONDARY outcome

Timeframe: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, and 120

Sixty-nine joints were assessed by physical examination. The joints to be examined for LOM were the same as those examined for tenderness, except that the sacroiliac, sternoclavicular, and acromio clavicular joints were excluded. LOM of the joint was classified as present ("1"), absent ("0"), or replaced/injected ("9"). Scores range from 0 to 621, with higher scores representing higher disease activity. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.

Outcome measures

Outcome measures
Measure	Adalimumab n=32 Participants Adalimumab 24 mg/m\^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
Limitation of Passive Motion (LOM69) Joint Count: Mean Change From Baseline to Each Visit Week 2 (n=32)	-4.5 units on a scale Standard Deviation 7.14
Limitation of Passive Motion (LOM69) Joint Count: Mean Change From Baseline to Each Visit Week 4 (n=32)	-5.4 units on a scale Standard Deviation 6.48
Limitation of Passive Motion (LOM69) Joint Count: Mean Change From Baseline to Each Visit Week 8 (n=32)	-5.3 units on a scale Standard Deviation 5.02
Limitation of Passive Motion (LOM69) Joint Count: Mean Change From Baseline to Each Visit Week 12 (n=31)	-5.6 units on a scale Standard Deviation 4.8
Limitation of Passive Motion (LOM69) Joint Count: Mean Change From Baseline to Each Visit Week 16 (n=31)	-6.3 units on a scale Standard Deviation 6.31
Limitation of Passive Motion (LOM69) Joint Count: Mean Change From Baseline to Each Visit Week 20 (n=29)	-6.8 units on a scale Standard Deviation 6.63
Limitation of Passive Motion (LOM69) Joint Count: Mean Change From Baseline to Each Visit Week 24 (n=30)	-5.6 units on a scale Standard Deviation 5.54
Limitation of Passive Motion (LOM69) Joint Count: Mean Change From Baseline to Each Visit Week 36 (n=28)	-5.1 units on a scale Standard Deviation 5.29
Limitation of Passive Motion (LOM69) Joint Count: Mean Change From Baseline to Each Visit Week 48 (n=24)	-5.5 units on a scale Standard Deviation 7.06
Limitation of Passive Motion (LOM69) Joint Count: Mean Change From Baseline to Each Visit Week 60 (n=20)	-5.5 units on a scale Standard Deviation 8.31
Limitation of Passive Motion (LOM69) Joint Count: Mean Change From Baseline to Each Visit Week 72 (n=17)	-6.9 units on a scale Standard Deviation 7.84
Limitation of Passive Motion (LOM69) Joint Count: Mean Change From Baseline to Each Visit Week 84 (n=17)	-8.4 units on a scale Standard Deviation 6.9
Limitation of Passive Motion (LOM69) Joint Count: Mean Change From Baseline to Each Visit Week 96 (n=13)	-7.5 units on a scale Standard Deviation 6.73
Limitation of Passive Motion (LOM69) Joint Count: Mean Change From Baseline to Each Visit Week 108 (n=9)	-5.2 units on a scale Standard Deviation 3.96
Limitation of Passive Motion (LOM69) Joint Count: Mean Change From Baseline to Each Visit Week 120 (n=3)	-6 units on a scale Standard Deviation 2.65

SECONDARY outcome

Timeframe: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

CRP is a laboratory parameter and considered as an efficacy variable. CRP is a general marker of inflammation that is sensitive to acute changes in inflammatory response. CRP is reported using mg/dL. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.

Outcome measures

Outcome measures
Measure	Adalimumab n=32 Participants Adalimumab 24 mg/m\^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
C-reactive Protein (CRP): Mean Change From Baseline to Each Visit Week 12 (n=28)	-0.6 mg/dL Standard Deviation 2.65
C-reactive Protein (CRP): Mean Change From Baseline to Each Visit Week 24 (n=28)	-0.2 mg/dL Standard Deviation 3.2
C-reactive Protein (CRP): Mean Change From Baseline to Each Visit Week 36 (n=25)	-0.4 mg/dL Standard Deviation 3.08
C-reactive Protein (CRP): Mean Change From Baseline to Each Visit Week 48 (n=23)	0.4 mg/dL Standard Deviation 2.68
C-reactive Protein (CRP): Mean Change From Baseline to Each Visit Week 60 (n=20)	-0.3 mg/dL Standard Deviation 1.83
C-reactive Protein (CRP): Mean Change From Baseline to Each Visit Week 72 (n=17)	-0.7 mg/dL Standard Deviation 1.25
C-reactive Protein (CRP): Mean Change From Baseline to Each Visit Week 84 (n=17)	-0.7 mg/dL Standard Deviation 1.47
C-reactive Protein (CRP): Mean Change From Baseline to Each Visit Week 96 (n=12)	0.1 mg/dL Standard Deviation 1.6
C-reactive Protein (CRP): Mean Change From Baseline to Each Visit Week 108 (n=9)	0.2 mg/dL Standard Deviation 1.93
C-reactive Protein (CRP): Mean Change From Baseline to Each Visit Week 120 (n=3)	0.3 mg/dL Standard Deviation 0.28

SECONDARY outcome

Timeframe: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, and 120

Seventy-five joints or regions were assessed by pressure and joint manipulation on physical examination. Joint tenderness was classified as either present ("1"), absent ("0") or replaced/injected ("9"). Scores range from 0 to 675, with higher scores representing higher disease activity. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.

Outcome measures

Outcome measures
Measure	Adalimumab n=32 Participants Adalimumab 24 mg/m\^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
Tender Joint Count (TJC75): Mean Change From Baseline to Each Visit Week 2 (n=32)	-2.3 units on a scale Standard Deviation 4.62
Tender Joint Count (TJC75): Mean Change From Baseline to Each Visit Week 4 (n=32)	-2.8 units on a scale Standard Deviation 4.48
Tender Joint Count (TJC75): Mean Change From Baseline to Each Visit Week 8 (n=32)	-3.1 units on a scale Standard Deviation 4.31
Tender Joint Count (TJC75): Mean Change From Baseline to Each Visit Week 12 (n=31)	-2.7 units on a scale Standard Deviation 5.09
Tender Joint Count (TJC75): Mean Change From Baseline to Each Visit Week 16 (n=31)	-3.5 units on a scale Standard Deviation 4.77
Tender Joint Count (TJC75): Mean Change From Baseline to Each Visit Week 20 (n=29)	-3.9 units on a scale Standard Deviation 5.09
Tender Joint Count (TJC75): Mean Change From Baseline to Each Visit Week 24 (n=30)	-3 units on a scale Standard Deviation 5.54
Tender Joint Count (TJC75): Mean Change From Baseline to Each Visit Week 36 (n=28)	-2.9 units on a scale Standard Deviation 5.65
Tender Joint Count (TJC75): Mean Change From Baseline to Each Visit Week 48 (n=24)	-4.4 units on a scale Standard Deviation 4.85
Tender Joint Count (TJC75): Mean Change From Baseline to Each Visit Week 60 (n=20)	-4.5 units on a scale Standard Deviation 5.85
Tender Joint Count (TJC75): Mean Change From Baseline to Each Visit Week 72 (n=17)	-5.3 units on a scale Standard Deviation 5.53
Tender Joint Count (TJC75): Mean Change From Baseline to Each Visit Week 84 (n=17)	-4.8 units on a scale Standard Deviation 5.2
Tender Joint Count (TJC75): Mean Change From Baseline to Each Visit Week 96 (n=13)	-4 units on a scale Standard Deviation 5.46
Tender Joint Count (TJC75): Mean Change From Baseline to Each Visit Week 108 (n=9)	-1.1 units on a scale Standard Deviation 4.73
Tender Joint Count (TJC75): Mean Change From Baseline to Each Visit Week 120 (n=3)	-1.3 units on a scale Standard Deviation 2.31

SECONDARY outcome

Timeframe: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, and 120

Sixty-six joints were assessed by physical examination. The joints to be examined for swelling were the same as those examined for tenderness, except that the hip, subtalar, sacroiliac, lumbar spine, thoracic spine, and cervical spine joints were excluded. Joint swelling was classified as present ("1"), absent ("0") or replaced/injected ("9"). Scores range from 0 to 594, with higher scores representing higher disease activity. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.

Outcome measures

Outcome measures
Measure	Adalimumab n=32 Participants Adalimumab 24 mg/m\^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
Swollen Joint Count (SJC66): Mean Change From Baseline to Each Visit Week 2 (n=32)	-4.5 units on a scale Standard Deviation 6.46
Swollen Joint Count (SJC66): Mean Change From Baseline to Each Visit Week 4 (n=32)	-5.3 units on a scale Standard Deviation 6.63
Swollen Joint Count (SJC66): Mean Change From Baseline to Each Visit Week 8 (n=32)	-6 units on a scale Standard Deviation 5.32
Swollen Joint Count (SJC66): Mean Change From Baseline to Each Visit Week 12 (n=31)	-6.2 units on a scale Standard Deviation 4.24
Swollen Joint Count (SJC66): Mean Change From Baseline to Each Visit Week 16 (n=31)	-6.1 units on a scale Standard Deviation 6.59
Swollen Joint Count (SJC66): Mean Change From Baseline to Each Visit Week 20 (n=29)	-6.9 units on a scale Standard Deviation 5.62
Swollen Joint Count (SJC66): Mean Change From Baseline to Each Visit Week 24 (n=30)	-6.3 units on a scale Standard Deviation 5.83
Swollen Joint Count (SJC66): Mean Change From Baseline to Each Visit Week 36 (n=28)	-6.2 units on a scale Standard Deviation 4.73
Swollen Joint Count (SJC66): Mean Change From Baseline to Each Visit Week 48 (n=24)	-6.7 units on a scale Standard Deviation 5.34
Swollen Joint Count (SJC66): Mean Change From Baseline to Each Visit Week 60 (n=20)	-8.4 units on a scale Standard Deviation 7.15
Swollen Joint Count (SJC66): Mean Change From Baseline to Each Visit Week 72 (n=17)	-8.9 units on a scale Standard Deviation 6.06
Swollen Joint Count (SJC66): Mean Change From Baseline to Each Visit Week 84 (n=17)	-9.4 units on a scale Standard Deviation 7.15
Swollen Joint Count (SJC66): Mean Change From Baseline to Each Visit Week 96 (n=13)	-8.5 units on a scale Standard Deviation 6.89
Swollen Joint Count (SJC66): Mean Change From Baseline to Each Visit Week 108 (n=9)	-5.8 units on a scale Standard Deviation 3.31
Swollen Joint Count (SJC66): Mean Change From Baseline to Each Visit Week 120 (n=3)	-7.3 units on a scale Standard Deviation 2.08

SECONDARY outcome

Timeframe: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, and 120

Seventy-five joints were assessed by physical examination. The joints to be examined for POM were the same as those examined for tenderness. POM of the joint was classified as present ("1"), absent ("0"), or replaced/injected ("9"). Scores range from 0 to 675, with higher scores representing higher disease activity. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.

Outcome measures

Outcome measures
Measure	Adalimumab n=32 Participants Adalimumab 24 mg/m\^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
Pain on Passive Motion (POM75) Joint Count: Mean Change From Baseline to Each Visit Week 2 (n=32)	-3.3 units on a scale Standard Deviation 4.5
Pain on Passive Motion (POM75) Joint Count: Mean Change From Baseline to Each Visit Week 4 (n=32)	-4 units on a scale Standard Deviation 4.01
Pain on Passive Motion (POM75) Joint Count: Mean Change From Baseline to Each Visit Week 8 (n=32)	-4.6 units on a scale Standard Deviation 5.17
Pain on Passive Motion (POM75) Joint Count: Mean Change From Baseline to Each Visit Week 12 (n=31)	-4.9 units on a scale Standard Deviation 4.59
Pain on Passive Motion (POM75) Joint Count: Mean Change From Baseline to Each Visit Week 16 (n=31)	-4.9 units on a scale Standard Deviation 4.6
Pain on Passive Motion (POM75) Joint Count: Mean Change From Baseline to Each Visit Week 20 (n=29)	-5.4 units on a scale Standard Deviation 4.81
Pain on Passive Motion (POM75) Joint Count: Mean Change From Baseline to Each Visit Week 24 (n=30)	-4.1 units on a scale Standard Deviation 7.32
Pain on Passive Motion (POM75) Joint Count: Mean Change From Baseline to Each Visit Week 36 (n=28)	-4.3 units on a scale Standard Deviation 7.34
Pain on Passive Motion (POM75) Joint Count: Mean Change From Baseline to Each Visit Week 48 (n=24)	-5.8 units on a scale Standard Deviation 4.42
Pain on Passive Motion (POM75) Joint Count: Mean Change From Baseline to Each Visit Week 60 (n=20)	-5.9 units on a scale Standard Deviation 5.25
Pain on Passive Motion (POM75) Joint Count: Mean Change From Baseline to Each Visit Week 72 (n=17)	-6.4 units on a scale Standard Deviation 5.41
Pain on Passive Motion (POM75) Joint Count: Mean Change From Baseline to Each Visit Week 84 (n=17)	-6.1 units on a scale Standard Deviation 5.34
Pain on Passive Motion (POM75) Joint Count: Mean Change From Baseline to Each Visit Week 96 (n=13)	5.7 units on a scale Standard Deviation 5.12
Pain on Passive Motion (POM75) Joint Count: Mean Change From Baseline to Each Visit Week 108 (n=9)	-3.6 units on a scale Standard Deviation 5.85
Pain on Passive Motion (POM75) Joint Count: Mean Change From Baseline to Each Visit Week 120 (n=3)	-5.3 units on a scale Standard Deviation 1.53

SECONDARY outcome

Timeframe: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.

Outcome measures

Outcome measures
Measure	Adalimumab n=32 Participants Adalimumab 24 mg/m\^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
Child's Health Questionnaire Parent Form (CHQ-PF50) Global Health Category: Mean Change From Baseline to Each Visit Week 12 (n=29)	17.1 units on a scale Standard Deviation 29.48
Child's Health Questionnaire Parent Form (CHQ-PF50) Global Health Category: Mean Change From Baseline to Each Visit Week 24 (n=28)	24.3 units on a scale Standard Deviation 25.77
Child's Health Questionnaire Parent Form (CHQ-PF50) Global Health Category: Mean Change From Baseline to Each Visit Week 36 (n=24)	25 units on a scale Standard Deviation 27.27
Child's Health Questionnaire Parent Form (CHQ-PF50) Global Health Category: Mean Change From Baseline to Each Visit Week 48 (n=22)	30.9 units on a scale Standard Deviation 23.79
Child's Health Questionnaire Parent Form (CHQ-PF50) Global Health Category: Mean Change From Baseline to Each Visit Week 60 (n=19)	21.8 units on a scale Standard Deviation 27.35
Child's Health Questionnaire Parent Form (CHQ-PF50) Global Health Category: Mean Change From Baseline to Each Visit Week 72 (n=17)	31.5 units on a scale Standard Deviation 24.86
Child's Health Questionnaire Parent Form (CHQ-PF50) Global Health Category: Mean Change From Baseline to Each Visit Week 84 (n=17)	26.2 units on a scale Standard Deviation 25.89
Child's Health Questionnaire Parent Form (CHQ-PF50) Global Health Category: Mean Change From Baseline to Each Visit Week 96 (n=11)	32.7 units on a scale Standard Deviation 20.66
Child's Health Questionnaire Parent Form (CHQ-PF50) Global Health Category: Mean Change From Baseline to Each Visit Week 108 (n=8)	36.9 units on a scale Standard Deviation 19.99
Child's Health Questionnaire Parent Form (CHQ-PF50) Global Health Category: Mean Change From Baseline to Each Visit Week 120 (n=3)	45 units on a scale Standard Deviation 17.32

SECONDARY outcome

Timeframe: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120.

The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.

Outcome measures

Outcome measures
Measure	Adalimumab n=32 Participants Adalimumab 24 mg/m\^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
Child's Health Questionnaire Parent Form (CHQ-PF50) Physical Functioning Category: Mean Change From Baseline to Each Visit Week 72 (n=16)	40.6 units on a scale Standard Deviation 27
Child's Health Questionnaire Parent Form (CHQ-PF50) Physical Functioning Category: Mean Change From Baseline to Each Visit Week 84 (n=17)	40 units on a scale Standard Deviation 30.44
Child's Health Questionnaire Parent Form (CHQ-PF50) Physical Functioning Category: Mean Change From Baseline to Each Visit Week 60 (n=21)	29 units on a scale Standard Deviation 32.3
Child's Health Questionnaire Parent Form (CHQ-PF50) Physical Functioning Category: Mean Change From Baseline to Each Visit Week 96 (n=13)	34.3 units on a scale Standard Deviation 27.88
Child's Health Questionnaire Parent Form (CHQ-PF50) Physical Functioning Category: Mean Change From Baseline to Each Visit Week 108 (n=9)	37 units on a scale Standard Deviation 27.92
Child's Health Questionnaire Parent Form (CHQ-PF50) Physical Functioning Category: Mean Change From Baseline to Each Visit Week 120 (n=3)	53.7 units on a scale Standard Deviation 8.49
Child's Health Questionnaire Parent Form (CHQ-PF50) Physical Functioning Category: Mean Change From Baseline to Each Visit Week 12 (n=31)	30.6 units on a scale Standard Deviation 32.14
Child's Health Questionnaire Parent Form (CHQ-PF50) Physical Functioning Category: Mean Change From Baseline to Each Visit Week 24 (n=30)	31.6 units on a scale Standard Deviation 31.91
Child's Health Questionnaire Parent Form (CHQ-PF50) Physical Functioning Category: Mean Change From Baseline to Each Visit Week 36 (n=27)	36.4 units on a scale Standard Deviation 31.26
Child's Health Questionnaire Parent Form (CHQ-PF50) Physical Functioning Category: Mean Change From Baseline to Each Visit Week 48 (n=23)	31.5 units on a scale Standard Deviation 28.39

SECONDARY outcome

Timeframe: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.

Outcome measures

Outcome measures
Measure	Adalimumab n=32 Participants Adalimumab 24 mg/m\^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
Child's Health Questionnaire Parent Form (CHQ-PF50) Role/Social Limitations/Emotional/Behavioral Category: Mean Change From Baseline to Each Visit Week 12 (n=23)	20.8 units on a scale Standard Deviation 32.53
Child's Health Questionnaire Parent Form (CHQ-PF50) Role/Social Limitations/Emotional/Behavioral Category: Mean Change From Baseline to Each Visit Week 24 (n=22)	17.7 units on a scale Standard Deviation 29.43
Child's Health Questionnaire Parent Form (CHQ-PF50) Role/Social Limitations/Emotional/Behavioral Category: Mean Change From Baseline to Each Visit Week 36 (n=20)	17.2 units on a scale Standard Deviation 25.86
Child's Health Questionnaire Parent Form (CHQ-PF50) Role/Social Limitations/Emotional/Behavioral Category: Mean Change From Baseline to Each Visit Week 48 (n=18)	16 units on a scale Standard Deviation 27.28
Child's Health Questionnaire Parent Form (CHQ-PF50) Role/Social Limitations/Emotional/Behavioral Category: Mean Change From Baseline to Each Visit Week 60 (n=16)	20.8 units on a scale Standard Deviation 31.91
Child's Health Questionnaire Parent Form (CHQ-PF50) Role/Social Limitations/Emotional/Behavioral Category: Mean Change From Baseline to Each Visit Week 72 (n=13)	26.5 units on a scale Standard Deviation 32.25
Child's Health Questionnaire Parent Form (CHQ-PF50) Role/Social Limitations/Emotional/Behavioral Category: Mean Change From Baseline to Each Visit Week 84 (n=13)	20.5 units on a scale Standard Deviation 33.29
Child's Health Questionnaire Parent Form (CHQ-PF50) Role/Social Limitations/Emotional/Behavioral Category: Mean Change From Baseline to Each Visit Week 96 (n=9)	30.9 units on a scale Standard Deviation 32.76
Child's Health Questionnaire Parent Form (CHQ-PF50) Role/Social Limitations/Emotional/Behavioral Category: Mean Change From Baseline to Each Visit Week 108 (n=7)	23.8 units on a scale Standard Deviation 25.2
Child's Health Questionnaire Parent Form (CHQ-PF50) Role/Social Limitations/Emotional/Behavioral Category: Mean Change From Baseline to Each Visit Week 120 (n=2)	33.3 units on a scale Standard Deviation 47.14

SECONDARY outcome

Timeframe: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.

Outcome measures

Outcome measures
Measure	Adalimumab n=32 Participants Adalimumab 24 mg/m\^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
Child's Health Questionnaire Parent Form (CHQ-PF50) Role/Social Limitations - Physical Category: Mean Change From Baseline to Each Visit Week 12 (n=21)	28.6 units on a scale Standard Deviation 32.97
Child's Health Questionnaire Parent Form (CHQ-PF50) Role/Social Limitations - Physical Category: Mean Change From Baseline to Each Visit Week 24 (n=20)	31.7 units on a scale Standard Deviation 35
Child's Health Questionnaire Parent Form (CHQ-PF50) Role/Social Limitations - Physical Category: Mean Change From Baseline to Each Visit Week 36 (n=18)	30.6 units on a scale Standard Deviation 39.3
Child's Health Questionnaire Parent Form (CHQ-PF50) Role/Social Limitations - Physical Category: Mean Change From Baseline to Each Visit Week 48 (n=17)	27.5 units on a scale Standard Deviation 37.24
Child's Health Questionnaire Parent Form (CHQ-PF50) Role/Social Limitations - Physical Category: Mean Change From Baseline to Each Visit Week 60 (n=15)	34.4 units on a scale Standard Deviation 39.07
Child's Health Questionnaire Parent Form (CHQ-PF50) Role/Social Limitations - Physical Category: Mean Change From Baseline to Each Visit Week 72 (n=12)	36.1 units on a scale Standard Deviation 41.34
Child's Health Questionnaire Parent Form (CHQ-PF50) Role/Social Limitations - Physical Category: Mean Change From Baseline to Each Visit Week 84 (n=12)	34.7 units on a scale Standard Deviation 43.5
Child's Health Questionnaire Parent Form (CHQ-PF50) Role/Social Limitations - Physical Category: Mean Change From Baseline to Each Visit Week 96 (n=8)	41.7 units on a scale Standard Deviation 37.8
Child's Health Questionnaire Parent Form (CHQ-PF50) Role/Social Limitations - Physical Category: Mean Change From Baseline to Each Visit Week 108 (n=6)	47.2 units on a scale Standard Deviation 37.14
Child's Health Questionnaire Parent Form (CHQ-PF50) Role/Social Limitations - Physical Category: Mean Change From Baseline to Each Visit Week 120 (n=1)	66.7 units on a scale Standard Deviation 0

SECONDARY outcome

Timeframe: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.

Outcome measures

Outcome measures
Measure	Adalimumab n=32 Participants Adalimumab 24 mg/m\^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
Child's Health Questionnaire Parent Form (CHQ-PF50) Bodily Pain/Discomfort Category: Mean Change From Baseline to Each Visit Week 12 (n=30)	35 units on a scale Standard Deviation 30.6
Child's Health Questionnaire Parent Form (CHQ-PF50) Bodily Pain/Discomfort Category: Mean Change From Baseline to Each Visit Week 24 (n=29)	36.2 units on a scale Standard Deviation 32.99
Child's Health Questionnaire Parent Form (CHQ-PF50) Bodily Pain/Discomfort Category: Mean Change From Baseline to Each Visit Week 36 (n=26)	38.8 units on a scale Standard Deviation 27.76
Child's Health Questionnaire Parent Form (CHQ-PF50) Bodily Pain/Discomfort Category: Mean Change From Baseline to Each Visit Week 48 (n=23)	41.7 units on a scale Standard Deviation 29.64
Child's Health Questionnaire Parent Form (CHQ-PF50) Bodily Pain/Discomfort Category: Mean Change From Baseline to Each Visit Week 60 (n=20)	39 units on a scale Standard Deviation 34.78
Child's Health Questionnaire Parent Form (CHQ-PF50) Bodily Pain/Discomfort Category: Mean Change From Baseline to Each Visit Week 72 (n=17)	48.2 units on a scale Standard Deviation 20.38
Child's Health Questionnaire Parent Form (CHQ-PF50) Bodily Pain/Discomfort Category: Mean Change From Baseline to Each Visit Week 84 (n=17)	41.2 units on a scale Standard Deviation 25.47
Child's Health Questionnaire Parent Form (CHQ-PF50) Bodily Pain/Discomfort Category: Mean Change From Baseline to Each Visit Week 96 (n=13)	42.3 units on a scale Standard Deviation 23.51
Child's Health Questionnaire Parent Form (CHQ-PF50) Bodily Pain/Discomfort Category: Mean Change From Baseline to Each Visit Week 108 (n=9)	41.1 units on a scale Standard Deviation 37.56
Child's Health Questionnaire Parent Form (CHQ-PF50) Bodily Pain/Discomfort Category: Mean Change From Baseline to Each Visit Week 120 (n=3)	50 units on a scale Standard Deviation 17.32

SECONDARY outcome

Timeframe: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.

Outcome measures

Outcome measures
Measure	Adalimumab n=32 Participants Adalimumab 24 mg/m\^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
Child's Health Questionnaire Parent Form (CHQ-PF50) Behavior Category: Mean Change From Baseline to Each Visit Week 24 (n=28)	4.2 units on a scale Standard Deviation 13.58
Child's Health Questionnaire Parent Form (CHQ-PF50) Behavior Category: Mean Change From Baseline to Each Visit Week 36 (n=27)	0.4 units on a scale Standard Deviation 16.87
Child's Health Questionnaire Parent Form (CHQ-PF50) Behavior Category: Mean Change From Baseline to Each Visit Week 48 (n=24)	3.6 units on a scale Standard Deviation 17.04
Child's Health Questionnaire Parent Form (CHQ-PF50) Behavior Category: Mean Change From Baseline to Each Visit Week 60 (n=21)	-0.3 units on a scale Standard Deviation 13.95
Child's Health Questionnaire Parent Form (CHQ-PF50) Behavior Category: Mean Change From Baseline to Each Visit Week 72 (n=17)	0.1 units on a scale Standard Deviation 16.44
Child's Health Questionnaire Parent Form (CHQ-PF50) Behavior Category: Mean Change From Baseline to Each Visit Week 84 (n=17)	1.5 units on a scale Standard Deviation 13.97
Child's Health Questionnaire Parent Form (CHQ-PF50) Behavior Category: Mean Change From Baseline to Each Visit Week 96 (n=13)	7.1 units on a scale Standard Deviation 11.81
Child's Health Questionnaire Parent Form (CHQ-PF50) Behavior Category: Mean Change From Baseline to Each Visit Week 108 (n=9)	8.9 units on a scale Standard Deviation 10.46
Child's Health Questionnaire Parent Form (CHQ-PF50) Behavior Category: Mean Change From Baseline to Each Visit Week 120 (n=3)	-6.1 units on a scale Standard Deviation 31.28
Child's Health Questionnaire Parent Form (CHQ-PF50) Behavior Category: Mean Change From Baseline to Each Visit Week 12 (n=29)	5.6 units on a scale Standard Deviation 15.78

SECONDARY outcome

Timeframe: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.

Outcome measures

Outcome measures
Measure	Adalimumab n=32 Participants Adalimumab 24 mg/m\^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
Child's Health Questionnaire Parent Form (CHQ-PF50) Global Behavior Item: Mean Change From Baseline to Each Visit Week 48 (n=16)	4.1 units on a scale Standard Deviation 18.55
Child's Health Questionnaire Parent Form (CHQ-PF50) Global Behavior Item: Mean Change From Baseline to Each Visit Week 60 (n=13)	-3.5 units on a scale Standard Deviation 20.35
Child's Health Questionnaire Parent Form (CHQ-PF50) Global Behavior Item: Mean Change From Baseline to Each Visit Week 72 (n=10)	2 units on a scale Standard Deviation 15.31
Child's Health Questionnaire Parent Form (CHQ-PF50) Global Behavior Item: Mean Change From Baseline to Each Visit Week 84 (n=11)	-5 units on a scale Standard Deviation 14.32
Child's Health Questionnaire Parent Form (CHQ-PF50) Global Behavior Item: Mean Change From Baseline to Each Visit Week 96 (n=9)	0 units on a scale Standard Deviation 17.68
Child's Health Questionnaire Parent Form (CHQ-PF50) Global Behavior Item: Mean Change From Baseline to Each Visit Week 12 (n=19)	4.5 units on a scale Standard Deviation 18.17
Child's Health Questionnaire Parent Form (CHQ-PF50) Global Behavior Item: Mean Change From Baseline to Each Visit Week 24 (n=19)	10.8 units on a scale Standard Deviation 17.66
Child's Health Questionnaire Parent Form (CHQ-PF50) Global Behavior Item: Mean Change From Baseline to Each Visit Week 36 (n=18)	9.2 units on a scale Standard Deviation 25.04
Child's Health Questionnaire Parent Form (CHQ-PF50) Global Behavior Item: Mean Change From Baseline to Each Visit Week 108 (n=6)	-4.2 units on a scale Standard Deviation 10.21
Child's Health Questionnaire Parent Form (CHQ-PF50) Global Behavior Item: Mean Change From Baseline to Each Visit Week 120 (n=1)	-25 units on a scale Standard Deviation 0

SECONDARY outcome

Timeframe: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.

Outcome measures

Outcome measures
Measure	Adalimumab n=32 Participants Adalimumab 24 mg/m\^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
Child's Health Questionnaire Parent Form (CHQ-PF50) Mental Health Category: Mean Change From Baseline to Each Visit Week 12 (n=31)	3.5 units on a scale Standard Deviation 11.12
Child's Health Questionnaire Parent Form (CHQ-PF50) Mental Health Category: Mean Change From Baseline to Each Visit Week 24 (n=30)	3.5 units on a scale Standard Deviation 10.76
Child's Health Questionnaire Parent Form (CHQ-PF50) Mental Health Category: Mean Change From Baseline to Each Visit Week 36 (n=27)	4.1 units on a scale Standard Deviation 14.01
Child's Health Questionnaire Parent Form (CHQ-PF50) Mental Health Category: Mean Change From Baseline to Each Visit Week 48 (n=24)	5.4 units on a scale Standard Deviation 11.88
Child's Health Questionnaire Parent Form (CHQ-PF50) Mental Health Category: Mean Change From Baseline to Each Visit Week 60 (n=21)	2.1 units on a scale Standard Deviation 14.02
Child's Health Questionnaire Parent Form (CHQ-PF50) Mental Health Category: Mean Change From Baseline to Each Visit Week 72 (n=17)	5 units on a scale Standard Deviation 12.37
Child's Health Questionnaire Parent Form (CHQ-PF50) Mental Health Category: Mean Change From Baseline to Each Visit Week 84 (n=17)	2.6 units on a scale Standard Deviation 8.5
Child's Health Questionnaire Parent Form (CHQ-PF50) Mental Health Category: Mean Change From Baseline to Each Visit Week 96 (n=13)	4.2 units on a scale Standard Deviation 11.88
Child's Health Questionnaire Parent Form (CHQ-PF50) Mental Health Category: Mean Change From Baseline to Each Visit Week 108 (n=9)	-0.8 units on a scale Standard Deviation 15
Child's Health Questionnaire Parent Form (CHQ-PF50) Mental Health Category: Mean Change From Baseline to Each Visit Week 120 (n=3)	-3.3 units on a scale Standard Deviation 20.21

SECONDARY outcome

Timeframe: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.

Outcome measures

Outcome measures
Measure	Adalimumab n=32 Participants Adalimumab 24 mg/m\^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
Child's Health Questionnaire Parent Form (CHQ-PF50) Self Esteem Category: Mean Change From Baseline to Each Visit Week 12 (n=23)	10.6 units on a scale Standard Deviation 23.91
Child's Health Questionnaire Parent Form (CHQ-PF50) Self Esteem Category: Mean Change From Baseline to Each Visit Week 24 (n=22)	10.5 units on a scale Standard Deviation 24.75
Child's Health Questionnaire Parent Form (CHQ-PF50) Self Esteem Category: Mean Change From Baseline to Each Visit Week 36 (n=19)	16.8 units on a scale Standard Deviation 22.02
Child's Health Questionnaire Parent Form (CHQ-PF50) Self Esteem Category: Mean Change From Baseline to Each Visit Week 48 (n=16)	15.2 units on a scale Standard Deviation 22.6
Child's Health Questionnaire Parent Form (CHQ-PF50) Self Esteem Category: Mean Change From Baseline to Each Visit Week 60 (n=14)	10.2 units on a scale Standard Deviation 22.53
Child's Health Questionnaire Parent Form (CHQ-PF50) Self Esteem Category: Mean Change From Baseline to Each Visit Week 72 (n=13)	-2.8 units on a scale Standard Deviation 31.78
Child's Health Questionnaire Parent Form (CHQ-PF50) Self Esteem Category: Mean Change From Baseline to Each Visit Week 84 (n=13)	9.4 units on a scale Standard Deviation 18.52
Child's Health Questionnaire Parent Form (CHQ-PF50) Self Esteem Category: Mean Change From Baseline to Each Visit Week 96 (n=9)	6.9 units on a scale Standard Deviation 19.87
Child's Health Questionnaire Parent Form (CHQ-PF50) Self Esteem Category: Mean Change From Baseline to Each Visit Week 108 (n=6)	-4.2 units on a scale Standard Deviation 10.87
Child's Health Questionnaire Parent Form (CHQ-PF50) Self Esteem Category: Mean Change From Baseline to Each Visit Week 120 (n=1)	4.2 units on a scale Standard Deviation 0

SECONDARY outcome

Timeframe: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.

Outcome measures

Outcome measures
Measure	Adalimumab n=32 Participants Adalimumab 24 mg/m\^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
Child's Health Questionnaire Parent Form (CHQ-PF50) General Health Perceptions Category: Mean Change From Baseline to Each Visit Week 12 (n=26)	0.7 units on a scale Standard Deviation 14.27
Child's Health Questionnaire Parent Form (CHQ-PF50) General Health Perceptions Category: Mean Change From Baseline to Each Visit Week 24 (n=25)	3.8 units on a scale Standard Deviation 14.98
Child's Health Questionnaire Parent Form (CHQ-PF50) General Health Perceptions Category: Mean Change From Baseline to Each Visit Week 36 (n=22)	6.2 units on a scale Standard Deviation 15.99
Child's Health Questionnaire Parent Form (CHQ-PF50) General Health Perceptions Category: Mean Change From Baseline to Each Visit Week 48 (n=19)	7.2 units on a scale Standard Deviation 13.36
Child's Health Questionnaire Parent Form (CHQ-PF50) General Health Perceptions Category: Mean Change From Baseline to Each Visit Week 60 (n=18)	0.7 units on a scale Standard Deviation 10.65
Child's Health Questionnaire Parent Form (CHQ-PF50) General Health Perceptions Category: Mean Change From Baseline to Each Visit Week 72 (n=15)	9.1 units on a scale Standard Deviation 10.1
Child's Health Questionnaire Parent Form (CHQ-PF50) General Health Perceptions Category: Mean Change From Baseline to Each Visit Week 84 (n=15)	7.2 units on a scale Standard Deviation 13.03
Child's Health Questionnaire Parent Form (CHQ-PF50) General Health Perceptions Category: Mean Change From Baseline to Each Visit Week 96 (n=11)	10.9 units on a scale Standard Deviation 16
Child's Health Questionnaire Parent Form (CHQ-PF50) General Health Perceptions Category: Mean Change From Baseline to Each Visit Week 108 (n=7)	9 units on a scale Standard Deviation 16.61
Child's Health Questionnaire Parent Form (CHQ-PF50) General Health Perceptions Category: Mean Change From Baseline to Each Visit Week 120 (n=3)	4.7 units on a scale Standard Deviation 12.92

SECONDARY outcome

Timeframe: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.

Outcome measures

Outcome measures
Measure	Adalimumab n=32 Participants Adalimumab 24 mg/m\^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
Child's Health Questionnaire Parent Form (CHQ-PF50) Change in Health Category: Mean Change From Baseline to Each Visit Week 12 (n=30)	1.4 units on a scale Standard Deviation 1.75
Child's Health Questionnaire Parent Form (CHQ-PF50) Change in Health Category: Mean Change From Baseline to Each Visit Week 24 (n=29)	1.7 units on a scale Standard Deviation 1.67
Child's Health Questionnaire Parent Form (CHQ-PF50) Change in Health Category: Mean Change From Baseline to Each Visit Week 36 (n=25)	1.7 units on a scale Standard Deviation 1.8
Child's Health Questionnaire Parent Form (CHQ-PF50) Change in Health Category: Mean Change From Baseline to Each Visit Week 48 (n=22)	1.7 units on a scale Standard Deviation 2.4
Child's Health Questionnaire Parent Form (CHQ-PF50) Change in Health Category: Mean Change From Baseline to Each Visit Week 60 (n=20)	1.3 units on a scale Standard Deviation 2.57
Child's Health Questionnaire Parent Form (CHQ-PF50) Change in Health Category: Mean Change From Baseline to Each Visit Week 72 (n=16)	1.6 units on a scale Standard Deviation 2.13
Child's Health Questionnaire Parent Form (CHQ-PF50) Change in Health Category: Mean Change From Baseline to Each Visit Week 84(n=16)	1.3 units on a scale Standard Deviation 1.98
Child's Health Questionnaire Parent Form (CHQ-PF50) Change in Health Category: Mean Change From Baseline to Each Visit Week 96 (n=12)	1.5 units on a scale Standard Deviation 2.02
Child's Health Questionnaire Parent Form (CHQ-PF50) Change in Health Category: Mean Change From Baseline to Each Visit Week 108 (n=8)	0.9 units on a scale Standard Deviation 2.7
Child's Health Questionnaire Parent Form (CHQ-PF50) Change in Health Category: Mean Change From Baseline to Each Visit Week 120 (n=3)	2.3 units on a scale Standard Deviation 0.58

SECONDARY outcome

Timeframe: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.

Outcome measures

Outcome measures
Measure	Adalimumab n=32 Participants Adalimumab 24 mg/m\^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
Child's Health Questionnaire Parent Form (CHQ-PF50) Parental Impact - Emotional Category: Mean Change From Baseline to Each Visit Week 12 (n=30)	11.4 units on a scale Standard Deviation 26.12
Child's Health Questionnaire Parent Form (CHQ-PF50) Parental Impact - Emotional Category: Mean Change From Baseline to Each Visit Week 24 (n=28)	19 units on a scale Standard Deviation 28.59
Child's Health Questionnaire Parent Form (CHQ-PF50) Parental Impact - Emotional Category: Mean Change From Baseline to Each Visit Week 36 (n=26)	29.2 units on a scale Standard Deviation 33.1
Child's Health Questionnaire Parent Form (CHQ-PF50) Parental Impact - Emotional Category: Mean Change From Baseline to Each Visit Week 48 (n=23)	34.1 units on a scale Standard Deviation 33.98
Child's Health Questionnaire Parent Form (CHQ-PF50) Parental Impact - Emotional Category: Mean Change From Baseline to Each Visit Week 60 (n=20)	31.7 units on a scale Standard Deviation 32.4
Child's Health Questionnaire Parent Form (CHQ-PF50) Parental Impact - Emotional Category: Mean Change From Baseline to Each Visit Week 72 (n=16)	34.4 units on a scale Standard Deviation 36.37
Child's Health Questionnaire Parent Form (CHQ-PF50) Parental Impact - Emotional Category: Mean Change From Baseline to Each Visit Week 84 (n=16)	27.6 units on a scale Standard Deviation 41.69
Child's Health Questionnaire Parent Form (CHQ-PF50) Parental Impact - Emotional Category: Mean Change From Baseline to Each Visit Week 96 (n=11)	43.9 units on a scale Standard Deviation 40.15
Child's Health Questionnaire Parent Form (CHQ-PF50) Parental Impact - Emotional Category: Mean Change From Baseline to Each Visit Week 108 (n=8)	46.9 units on a scale Standard Deviation 40.81
Child's Health Questionnaire Parent Form (CHQ-PF50) Parental Impact - Emotional Category: Mean Change From Baseline to Each Visit Week 120 (n=2)	62.5 units on a scale Standard Deviation 41.25

SECONDARY outcome

Timeframe: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.

Outcome measures

Outcome measures
Measure	Adalimumab n=32 Participants Adalimumab 24 mg/m\^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
Child's Health Questionnaire Parent Form (CHQ-PF50) Parental Impact - Time Category: Mean Change From Baseline to Each Visit Week 12 (n=30)	4.6 units on a scale Standard Deviation 24.5
Child's Health Questionnaire Parent Form (CHQ-PF50) Parental Impact - Time Category: Mean Change From Baseline to Each Visit Week 24 (n=28)	13.5 units on a scale Standard Deviation 28.59
Child's Health Questionnaire Parent Form (CHQ-PF50) Parental Impact - Time Category: Mean Change From Baseline to Each Visit Week 36 (n=26)	21.8 units on a scale Standard Deviation 24.24
Child's Health Questionnaire Parent Form (CHQ-PF50) Parental Impact - Time Category: Mean Change From Baseline to Each Visit Week 48 (n=23)	18.4 units on a scale Standard Deviation 24.76
Child's Health Questionnaire Parent Form (CHQ-PF50) Parental Impact - Time Category: Mean Change From Baseline to Each Visit Week 60 (n=20)	13.3 units on a scale Standard Deviation 31.55
Child's Health Questionnaire Parent Form (CHQ-PF50) Parental Impact - Time Category: Mean Change From Baseline to Each Visit Week 72 (n=16)	22.2 units on a scale Standard Deviation 30.09
Child's Health Questionnaire Parent Form (CHQ-PF50) Parental Impact - Time Category: Mean Change From Baseline to Each Visit Week 84 (n=16)	17.4 units on a scale Standard Deviation 35.13
Child's Health Questionnaire Parent Form (CHQ-PF50) Parental Impact - Time Category: Mean Change From Baseline to Each Visit Week 96 (n=12)	20.4 units on a scale Standard Deviation 27.15
Child's Health Questionnaire Parent Form (CHQ-PF50) Parental Impact - Time Category: Mean Change From Baseline to Each Visit Week 108 (n=8)	15.3 units on a scale Standard Deviation 25.85
Child's Health Questionnaire Parent Form (CHQ-PF50) Parental Impact - Time Category: Mean Change From Baseline to Each Visit Week 120 (n=2)	55.6 units on a scale Standard Deviation 62.85

SECONDARY outcome

Timeframe: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.

Outcome measures

Outcome measures
Measure	Adalimumab n=32 Participants Adalimumab 24 mg/m\^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
Child's Health Questionnaire Parent Form (CHQ-PF50) Family Activities Category: Mean Change From Baseline to Each Visit Week 12 (n=30)	8.3 units on a scale Standard Deviation 28.41
Child's Health Questionnaire Parent Form (CHQ-PF50) Family Activities Category: Mean Change From Baseline to Each Visit Week 24 (n=28)	17.6 units on a scale Standard Deviation 24.15
Child's Health Questionnaire Parent Form (CHQ-PF50) Family Activities Category: Mean Change From Baseline to Each Visit Week 36 (n=26)	20 units on a scale Standard Deviation 28.5
Child's Health Questionnaire Parent Form (CHQ-PF50) Family Activities Category: Mean Change From Baseline to Each Visit Week 48 (n=23)	16.8 units on a scale Standard Deviation 26.43
Child's Health Questionnaire Parent Form (CHQ-PF50) Family Activities Category: Mean Change From Baseline to Each Visit Week 60 (n=20)	14.8 units on a scale Standard Deviation 30.9
Child's Health Questionnaire Parent Form (CHQ-PF50) Family Activities Category: Mean Change From Baseline to Each Visit Week 72 (n=16)	17.2 units on a scale Standard Deviation 31.43
Child's Health Questionnaire Parent Form (CHQ-PF50) Family Activities Category: Mean Change From Baseline to Each Visit Week 84 (n=16)	18.2 units on a scale Standard Deviation 30.27
Child's Health Questionnaire Parent Form (CHQ-PF50) Family Activities Category: Mean Change From Baseline to Each Visit Week 96 (n=12)	19.4 units on a scale Standard Deviation 27.6
Child's Health Questionnaire Parent Form (CHQ-PF50) Family Activities Category: Mean Change From Baseline to Each Visit Week 108 (n=8)	20.8 units on a scale Standard Deviation 29.38
Child's Health Questionnaire Parent Form (CHQ-PF50) Family Activities Category: Mean Change From Baseline to Each Visit Week 120 (n=2)	68.8 units on a scale Standard Deviation 20.62

SECONDARY outcome

Timeframe: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.

Outcome measures

Outcome measures
Measure	Adalimumab n=32 Participants Adalimumab 24 mg/m\^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
Child's Health Questionnaire Parent Form (CHQ-PF50) Family Cohesion Category: Mean Change From Baseline to Each Visit Week 12 (n=30)	2.5 units on a scale Standard Deviation 14
Child's Health Questionnaire Parent Form (CHQ-PF50) Family Cohesion Category: Mean Change From Baseline to Each Visit Week 24 (n=28)	4.3 units on a scale Standard Deviation 23.28
Child's Health Questionnaire Parent Form (CHQ-PF50) Family Cohesion Category: Mean Change From Baseline to Each Visit Week 36 (n=26)	5.6 units on a scale Standard Deviation 20.66
Child's Health Questionnaire Parent Form (CHQ-PF50) Family Cohesion Category: Mean Change From Baseline to Each Visit Week 48 (n=23)	3.7 units on a scale Standard Deviation 15.61
Child's Health Questionnaire Parent Form (CHQ-PF50) Family Cohesion Category: Mean Change From Baseline to Each Visit Week 60 (n=20)	4.8 units on a scale Standard Deviation 16.66
Child's Health Questionnaire Parent Form (CHQ-PF50) Family Cohesion Category: Mean Change From Baseline to Each Visit Week 72 (n=16)	7.2 units on a scale Standard Deviation 29.15
Child's Health Questionnaire Parent Form (CHQ-PF50) Family Cohesion Category: Mean Change From Baseline to Each Visit Week 84 (n=16)	8.4 units on a scale Standard Deviation 39.19
Child's Health Questionnaire Parent Form (CHQ-PF50) Family Cohesion Category: Mean Change From Baseline to Each Visit Week 96 (n=12)	18.8 units on a scale Standard Deviation 35.36
Child's Health Questionnaire Parent Form (CHQ-PF50) Family Cohesion Category: Mean Change From Baseline to Each Visit Week 108 (n=8)	19.4 units on a scale Standard Deviation 35.3
Child's Health Questionnaire Parent Form (CHQ-PF50) Family Cohesion Category: Mean Change From Baseline to Each Visit Week 120 (n=2)	-27.5 units on a scale Standard Deviation 38.89

Adverse Events

Adalimumab

Serious events: 5 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Adalimumab n=32 participants at risk Adalimumab 24 mg/m\^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
Gastrointestinal disorders Dental caries	3.1% 1/32 • TEAEs were collected from first dose of study drug until 70 days after the last dose of study drug and before start of commercial adalimumab or other biologics (32.5 months); SAEs were collected from the time informed consent was obtained (33.5 months). A treatment-emergent AE (TEAE) is defined as any AE with onset or worsening reported by a participant from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Musculoskeletal and connective tissue disorders Juvenile arthritis	3.1% 1/32 • TEAEs were collected from first dose of study drug until 70 days after the last dose of study drug and before start of commercial adalimumab or other biologics (32.5 months); SAEs were collected from the time informed consent was obtained (33.5 months). A treatment-emergent AE (TEAE) is defined as any AE with onset or worsening reported by a participant from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Metabolism and nutrition disorders Type 1 diabetes mellitus	3.1% 1/32 • TEAEs were collected from first dose of study drug until 70 days after the last dose of study drug and before start of commercial adalimumab or other biologics (32.5 months); SAEs were collected from the time informed consent was obtained (33.5 months). A treatment-emergent AE (TEAE) is defined as any AE with onset or worsening reported by a participant from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations Gastroenteritis rotavirus	3.1% 1/32 • TEAEs were collected from first dose of study drug until 70 days after the last dose of study drug and before start of commercial adalimumab or other biologics (32.5 months); SAEs were collected from the time informed consent was obtained (33.5 months). A treatment-emergent AE (TEAE) is defined as any AE with onset or worsening reported by a participant from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations Varicella	3.1% 1/32 • TEAEs were collected from first dose of study drug until 70 days after the last dose of study drug and before start of commercial adalimumab or other biologics (32.5 months); SAEs were collected from the time informed consent was obtained (33.5 months). A treatment-emergent AE (TEAE) is defined as any AE with onset or worsening reported by a participant from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.

Other adverse events

Other adverse events
Measure	Adalimumab n=32 participants at risk Adalimumab 24 mg/m\^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
Injury, poisoning and procedural complications Arthropod bite	6.2% 2/32 • TEAEs were collected from first dose of study drug until 70 days after the last dose of study drug and before start of commercial adalimumab or other biologics (32.5 months); SAEs were collected from the time informed consent was obtained (33.5 months). A treatment-emergent AE (TEAE) is defined as any AE with onset or worsening reported by a participant from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Investigations Body temperature increased	6.2% 2/32 • TEAEs were collected from first dose of study drug until 70 days after the last dose of study drug and before start of commercial adalimumab or other biologics (32.5 months); SAEs were collected from the time informed consent was obtained (33.5 months). A treatment-emergent AE (TEAE) is defined as any AE with onset or worsening reported by a participant from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Respiratory, thoracic and mediastinal disorders Cough	18.8% 6/32 • TEAEs were collected from first dose of study drug until 70 days after the last dose of study drug and before start of commercial adalimumab or other biologics (32.5 months); SAEs were collected from the time informed consent was obtained (33.5 months). A treatment-emergent AE (TEAE) is defined as any AE with onset or worsening reported by a participant from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	18.8% 6/32 • TEAEs were collected from first dose of study drug until 70 days after the last dose of study drug and before start of commercial adalimumab or other biologics (32.5 months); SAEs were collected from the time informed consent was obtained (33.5 months). A treatment-emergent AE (TEAE) is defined as any AE with onset or worsening reported by a participant from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Nervous system disorders Headache	6.2% 2/32 • TEAEs were collected from first dose of study drug until 70 days after the last dose of study drug and before start of commercial adalimumab or other biologics (32.5 months); SAEs were collected from the time informed consent was obtained (33.5 months). A treatment-emergent AE (TEAE) is defined as any AE with onset or worsening reported by a participant from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Eye disorders Uveitis	6.2% 2/32 • TEAEs were collected from first dose of study drug until 70 days after the last dose of study drug and before start of commercial adalimumab or other biologics (32.5 months); SAEs were collected from the time informed consent was obtained (33.5 months). A treatment-emergent AE (TEAE) is defined as any AE with onset or worsening reported by a participant from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
General disorders Pyrexia	21.9% 7/32 • TEAEs were collected from first dose of study drug until 70 days after the last dose of study drug and before start of commercial adalimumab or other biologics (32.5 months); SAEs were collected from the time informed consent was obtained (33.5 months). A treatment-emergent AE (TEAE) is defined as any AE with onset or worsening reported by a participant from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Gastrointestinal disorders Diarrhoea	12.5% 4/32 • TEAEs were collected from first dose of study drug until 70 days after the last dose of study drug and before start of commercial adalimumab or other biologics (32.5 months); SAEs were collected from the time informed consent was obtained (33.5 months). A treatment-emergent AE (TEAE) is defined as any AE with onset or worsening reported by a participant from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Gastrointestinal disorders Vomiting	15.6% 5/32 • TEAEs were collected from first dose of study drug until 70 days after the last dose of study drug and before start of commercial adalimumab or other biologics (32.5 months); SAEs were collected from the time informed consent was obtained (33.5 months). A treatment-emergent AE (TEAE) is defined as any AE with onset or worsening reported by a participant from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Skin and subcutaneous tissue disorders Rash	12.5% 4/32 • TEAEs were collected from first dose of study drug until 70 days after the last dose of study drug and before start of commercial adalimumab or other biologics (32.5 months); SAEs were collected from the time informed consent was obtained (33.5 months). A treatment-emergent AE (TEAE) is defined as any AE with onset or worsening reported by a participant from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Musculoskeletal and connective tissue disorders Juvenile arthritis	12.5% 4/32 • TEAEs were collected from first dose of study drug until 70 days after the last dose of study drug and before start of commercial adalimumab or other biologics (32.5 months); SAEs were collected from the time informed consent was obtained (33.5 months). A treatment-emergent AE (TEAE) is defined as any AE with onset or worsening reported by a participant from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations Acute tonsillitis	6.2% 2/32 • TEAEs were collected from first dose of study drug until 70 days after the last dose of study drug and before start of commercial adalimumab or other biologics (32.5 months); SAEs were collected from the time informed consent was obtained (33.5 months). A treatment-emergent AE (TEAE) is defined as any AE with onset or worsening reported by a participant from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations Bronchitis	18.8% 6/32 • TEAEs were collected from first dose of study drug until 70 days after the last dose of study drug and before start of commercial adalimumab or other biologics (32.5 months); SAEs were collected from the time informed consent was obtained (33.5 months). A treatment-emergent AE (TEAE) is defined as any AE with onset or worsening reported by a participant from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations Cystitis	6.2% 2/32 • TEAEs were collected from first dose of study drug until 70 days after the last dose of study drug and before start of commercial adalimumab or other biologics (32.5 months); SAEs were collected from the time informed consent was obtained (33.5 months). A treatment-emergent AE (TEAE) is defined as any AE with onset or worsening reported by a participant from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations Ear infection	9.4% 3/32 • TEAEs were collected from first dose of study drug until 70 days after the last dose of study drug and before start of commercial adalimumab or other biologics (32.5 months); SAEs were collected from the time informed consent was obtained (33.5 months). A treatment-emergent AE (TEAE) is defined as any AE with onset or worsening reported by a participant from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations Gastroenteritis	12.5% 4/32 • TEAEs were collected from first dose of study drug until 70 days after the last dose of study drug and before start of commercial adalimumab or other biologics (32.5 months); SAEs were collected from the time informed consent was obtained (33.5 months). A treatment-emergent AE (TEAE) is defined as any AE with onset or worsening reported by a participant from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations Gastroenteritis viral	6.2% 2/32 • TEAEs were collected from first dose of study drug until 70 days after the last dose of study drug and before start of commercial adalimumab or other biologics (32.5 months); SAEs were collected from the time informed consent was obtained (33.5 months). A treatment-emergent AE (TEAE) is defined as any AE with onset or worsening reported by a participant from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations H1N1 influenza	6.2% 2/32 • TEAEs were collected from first dose of study drug until 70 days after the last dose of study drug and before start of commercial adalimumab or other biologics (32.5 months); SAEs were collected from the time informed consent was obtained (33.5 months). A treatment-emergent AE (TEAE) is defined as any AE with onset or worsening reported by a participant from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations Nasopharyngitis	25.0% 8/32 • TEAEs were collected from first dose of study drug until 70 days after the last dose of study drug and before start of commercial adalimumab or other biologics (32.5 months); SAEs were collected from the time informed consent was obtained (33.5 months). A treatment-emergent AE (TEAE) is defined as any AE with onset or worsening reported by a participant from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations Otitis media	15.6% 5/32 • TEAEs were collected from first dose of study drug until 70 days after the last dose of study drug and before start of commercial adalimumab or other biologics (32.5 months); SAEs were collected from the time informed consent was obtained (33.5 months). A treatment-emergent AE (TEAE) is defined as any AE with onset or worsening reported by a participant from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations Pharyngitis	9.4% 3/32 • TEAEs were collected from first dose of study drug until 70 days after the last dose of study drug and before start of commercial adalimumab or other biologics (32.5 months); SAEs were collected from the time informed consent was obtained (33.5 months). A treatment-emergent AE (TEAE) is defined as any AE with onset or worsening reported by a participant from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations Pharyngitis streptococcal	9.4% 3/32 • TEAEs were collected from first dose of study drug until 70 days after the last dose of study drug and before start of commercial adalimumab or other biologics (32.5 months); SAEs were collected from the time informed consent was obtained (33.5 months). A treatment-emergent AE (TEAE) is defined as any AE with onset or worsening reported by a participant from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations Pneumonia	6.2% 2/32 • TEAEs were collected from first dose of study drug until 70 days after the last dose of study drug and before start of commercial adalimumab or other biologics (32.5 months); SAEs were collected from the time informed consent was obtained (33.5 months). A treatment-emergent AE (TEAE) is defined as any AE with onset or worsening reported by a participant from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations Rhinitis	12.5% 4/32 • TEAEs were collected from first dose of study drug until 70 days after the last dose of study drug and before start of commercial adalimumab or other biologics (32.5 months); SAEs were collected from the time informed consent was obtained (33.5 months). A treatment-emergent AE (TEAE) is defined as any AE with onset or worsening reported by a participant from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations Sinusitis	9.4% 3/32 • TEAEs were collected from first dose of study drug until 70 days after the last dose of study drug and before start of commercial adalimumab or other biologics (32.5 months); SAEs were collected from the time informed consent was obtained (33.5 months). A treatment-emergent AE (TEAE) is defined as any AE with onset or worsening reported by a participant from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations Upper respiratory tract infection	18.8% 6/32 • TEAEs were collected from first dose of study drug until 70 days after the last dose of study drug and before start of commercial adalimumab or other biologics (32.5 months); SAEs were collected from the time informed consent was obtained (33.5 months). A treatment-emergent AE (TEAE) is defined as any AE with onset or worsening reported by a participant from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.

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