Extension Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis

Number of participants who had adverse event (AE) of malignancy were reported. An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it.

Time frame: First dose of study medication in parent study up to 96 months in the extension study, for a maximum duration of 118 months (22 months of parent study and 96 months of extension study)

Population: Analysis population included all participants who were enrolled in the parent and extension study.

The considered event was death due to any cause from baseline to the end of the study.

Time frame: Extension study: First dose of study medication up to 30 days after last dose of study drug (maximum up to 97 months)

Population: The analysis set included all participants enrolled in the extension study.

BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored on a 3-point scale ranged from 0 to 2 (0=normal mobility, 2=severe reduction, where higher scores indicated more reduction). The total BASMI score range from 0 to 10, where higher scores indicated more reduction in spinal mobility.

Time frame: Month 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study

Population: FAS included all participants in the parent study who received at least 1 dose of investigational product regardless of whether they received any investigational product during the extension study. Here, Number of Participants Analyzed, signifies participants with ERA and number analyzed signifies participants evaluable at specified time points.

HAQ is a self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ total score range from 0 to 3, where 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; \> 1=significant functional limitation. Participants aged 18 years or above were assessed using HAQ scores.

Time frame: Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study

Population: WAS included participants who entered the withdrawal period. Here, number analyzed signifies participants evaluable at specified time points.

HAQ is a self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ total score range from 0 to 3, where 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; \> 1=significant functional limitation. Participants aged 18 years or above were assessed using HAQ scores.

Time frame: Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study

Population: RTAS included those participants who entered the re-treatment period. Here, number analyzed signifies participants evaluable at specified time points.

HAQ is a self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ total score range from 0 to 3, where 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; \> 1=significant functional limitation. Participants aged 18 years or above were assessed using HAQ scores.

Time frame: Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study

Population: FAS included all participants in the parent study who received at least 1 dose of investigational product regardless of whether they received any investigational product during the extension study. Here, number analyzed signifies participants evaluable at specified time points.

Tanner assessment score: used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Tanner assessment score ranged from 1 (no development) to 5 (adult-like development in quantity and size), higher scores indicated more development.

Time frame: Baseline of the extension study; Month 12, 24, 36, 48, 60, 72, 84 and 96 re-treatment period of extension study

Population: RTAS included those participants who entered the re-treatment period. Here, number analyzed signifies participants evaluable at specified time points.

Tanner assessment score: used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Tanner assessment score ranged from 1 (no development) to 5 (adult-like development in quantity and size), higher scores indicated more development.

Time frame: Baseline of the extension study; Month 12, 24, 36, 48, 60, 72, 84 and 96 withdrawal period of extension study

Population: WAS included participants who entered the withdrawal period. Here, number analyzed signifies participants evaluable at specified time points.

Growth parameters including weight, height and BMI were compared to the standard growth data by using Z-Score. Z-Score is a statistical measure to evaluate how a single data point or mean compares to a standard. A Z-Score describes whether a mean is above or below the standard and how unusual the measurement is. Z-scores range from -3 to +3. A Z-score of 0 indicates the same mean, \>0 a greater mean, and \<0 a lesser mean than the standard.

Time frame: Baseline of the extension study; Month 12, 24, 36, 42, 48, 60, 72, 84 and 96 re-treatment period of extension study

Population: Re-treatment analysis set (RTAS) included those participants who entered the re-treatment period. Here, number analyzed signifies participants evaluable at specified time points.

Growth parameters including weight, height and BMI were compared to the standard growth data by using Z-Score. Z-Score is a statistical measure to evaluate how a single data point or mean compares to a standard. A Z-Score describes whether a mean is above or below the standard and how unusual the measurement is. Z-scores range from -3 to +3. A Z-score of 0 indicates the same mean, \>0 a greater mean, and \<0 a lesser mean than the standard.

Time frame: Baseline of the extension study; Month 12, 24, 36, 42, 48, 60, 72, 84 and 96 withdrawal period of extension study

Population: WAS included participants who entered the withdrawal period. Here, number analyzed signifies participants evaluable at specified time points.

CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report participant's ability to perform activities in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, common activities distributed in total of 30 items. Each item is scored on 4-point Likert scale: 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Highest score reported for each domain is score for that domain. Overall CHAQ score was calculated as sum of domain scores divided by number of domains answered and ranged from 0=no difficulty to 3=extreme difficulty, where higher scores indicated more functional disability and discomfort in pediatrics with rheumatic disease. Participants below 18 years of age were assessed using CHAQ.

Time frame: Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study

Population: WAS included participants who entered the withdrawal period. Here, number analyzed signifies participants evaluable at specified time points.

CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report participant's ability to perform activities in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, common activities distributed in total of 30 items. Each item is scored on 4-point Likert scale: 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Highest score reported for each domain is score for that domain. Overall CHAQ score was calculated as sum of domain scores divided by number of domains answered and ranged from 0=no difficulty to 3=extreme difficulty, where higher scores indicated more functional disability and discomfort in pediatrics with rheumatic disease. Participants below 18 years of age were assessed using CHAQ.

Time frame: Baseline of the parent study; Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study

Population: RTAS included those participants who entered the re-treatment period. Here, number analyzed signifies participants evaluable at specified time points.

CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report participant's ability to perform activities in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, common activities distributed in total of 30 items. Each item is scored on 4-point Likert scale: 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Highest score reported for each domain is score for that domain. Overall CHAQ score was calculated as sum of domain scores divided by number of domains answered and ranged from 0=no difficulty to 3=extreme difficulty, where higher scores indicated more functional disability and discomfort in pediatrics with rheumatic disease. Participants below 18 years of age were assessed using CHAQ.

Time frame: Baseline of the parent study; Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study

Population: FAS included all participants in the parent study who received at least 1 dose of investigational product regardless of whether they received any investigational product during the extension study. Here, number analyzed signifies participants evaluable at specified time points.

The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.

Time frame: Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study

Population: WAS included participants who entered the withdrawal period. Here, number analyzed signifies participants evaluable at specified time points.

The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.

Time frame: Baseline of the parent study; Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78 and 96 re-treatment period of extension study

Population: RTAS included those participants who entered the re-treatment period. Here, number analyzed signifies participants evaluable at specified time points.

The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.

Time frame: Baseline of the parent study; Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study

Population: FAS included all participants in the parent study who received at least 1 dose of investigational product regardless of whether they received any investigational product during the extension study. Here, number analyzed signifies participants evaluable at specified time points.

Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (if none was present = 0; if stiffness persisted the entire day, 1440 minutes was recorded; if morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported).

Time frame: Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study

Population: WAS included participants who entered the withdrawal period. Here, number analyzed signifies participants evaluable at specified time points.

Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (if none was present = 0; if stiffness persisted the entire day, 1440 minutes was recorded; if morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported).

Time frame: Baseline of the parent study; Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study

Population: RTAS included those participants who entered the re-treatment period. Here, number analyzed signifies participants evaluable at specified time points.

Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (if none was present = 0; if stiffness persisted the entire day = 1440 minutes was recorded; if morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported).

Time frame: Baseline of the parent study; Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study

Population: FAS included all participants in the parent study who received at least 1 dose of investigational product regardless of whether they received any investigational product during the extension study. Here, number analyzed signifies participants evaluable at specified time points.

JADAS-73 is a validated composite disease activity measure for JIA. It was derived from four components; 1) Physician global assessment of disease activity (assessed on 10 cm VAS, where 0= no activity and 10=maximum activity, higher scores indicated more disease activity). 2) Parent/participant global assessment of overall well-being (assessed on a VAS, where 0= very well and 10=very poor, higher scores indicated worse condition). 3) Number of joints with active disease (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness). 4) An inflammatory marker, CRP that was measured in mg/L and its value normalized to 0 to 10 scale, where higher scores indicated more disease activity. JADAS total score was calculated as the sum of its four components and ranged from 0-103. A higher score indicates more disease activity.

Time frame: Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study

Population: RTAS included those participants who entered the re-treatment period. Here, number analyzed signifies participants evaluable at specified time points.

JADAS-73 is a validated composite disease activity measure for JIA. It was derived from four components; 1) Physician global assessment of disease activity (assessed on 10 cm VAS, where 0= no activity and 10=maximum activity, higher scores indicated more disease activity). 2) Parent/participant global assessment of overall well-being (assessed on a VAS, where 0= very well and 10=very poor, higher scores indicated worse condition). 3) Number of joints with active disease (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness). 4) An inflammatory marker, CRP that was measured in mg/L and its value normalized to 0 to 10 scale, where higher scores indicated more disease activity. JADAS total score was calculated as the sum of its four components and ranged from 0-103. A higher score indicates more disease activity.

Time frame: Baseline of the parent study; Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study

Population: FAS included all participants in the parent study who received at least 1 dose of investigational product regardless of whether they received any investigational product during the extension study. Here, number analyzed signifies participants evaluable at specified time points.

JADAS-73 is a validated composite disease activity measure for JIA. It was derived from four components; 1) Physician global assessment of disease activity (assessed on 10 cm VAS, where 0= no activity and 10=maximum activity, higher scores indicated more disease activity). 2) Parent/participant global assessment of overall well-being (assessed on a VAS, where 0= very well and 10=very poor, higher scores indicated worse condition). 3) Number of joints with active disease (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness). 4) An inflammatory marker, CRP that was measured in mg/L and its value normalized to 0 to 10 scale, where higher scores indicated more disease activity. JADAS total score was calculated as the sum of its four components and ranged from 0-103. A higher score indicates more disease activity.

Time frame: Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study

Population: WAS included participants who entered the withdrawal period. Here, number analyzed signifies participants evaluable at specified time points.

Nocturnal back pain assessed by participant's parent using a 100 mm VAS with 0 mm = no pain and 100 mm = most severe pain, higher scores indicated more pain.

Time frame: Baseline of the parent study; Month 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study

Population: FAS included all participants in the parent study who received at least 1 dose of investigational product regardless of whether they received any investigational product during the extension study. Here, Number of Participants Analyzed, signifies participants with ERA and number analyzed signifies participants evaluable at specified time points.

Nocturnal back pain assessed by participant's parent using a 100 mm VAS with 0 mm = no pain and 100 mm = most severe pain, higher scores indicated more pain.

Time frame: Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study

Population: WAS included participants who entered the withdrawal period. Here, Number of Participants Analyzed, signifies participants with ERA and number analyzed signifies participants evaluable at specified time points.

Nocturnal back pain assessed by participant's parent using a 100 mm VAS with 0 mm = no pain and 100 mm = most severe pain, higher scores indicated more pain.

Time frame: Baseline of the parent study; Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study

Population: RTAS included those participants who entered the re-treatment period. Here, Number of Participants Analyzed, signifies participants with ERA and number analyzed signifies participants evaluable at specified time points.

Joints with active arthritis were defined as joints that were swollen or, in the absence of swelling, joints with limited range of motion accompanied by pain and/or tenderness.

Time frame: Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study

Population: WAS included participants who entered the withdrawal period. Here, number analyzed signifies participants evaluable at specified time points.

Joints with active arthritis were defined as joints that were swollen or, in the absence of swelling, joints with limited range of motion accompanied by pain and/or tenderness.

Time frame: Baseline of the parent study; Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study

Population: RTAS included those participants who entered the re-treatment period. Here, number analyzed signifies participants evaluable at specified time points.

Joints with active arthritis were defined as joints that were swollen or, in the absence of swelling, joints with limited range of motion accompanied by pain and/or tenderness.

Time frame: Baseline of the parent study; Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study

Population: FAS included all participants in the parent study who received at least 1 dose of investigational product regardless of whether they received any investigational product during the extension study. Here, number analyzed signifies participants evaluable at specified time points.

Total number of joints with limited range of motion was the number of joints with limited range of motion. It was defined as 69\*(total number of joints with score of limited range of motion greater than zero)/number of non-missing limited range of motions. JR and NE were treated as missing. If more than 34 scores of limited range of motion were missing, then the total number of joints with limited range of motion was defined as missing.

Time frame: Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study

Population: WAS included participants who entered the withdrawal period. Here, number analyzed signifies participants evaluable at specified time points.

Total number of joints with limited range of motion was the number of joints with limited range of motion. It was defined as 69\*(total number of joints with score of limited range of motion greater than zero)/number of non-missing limited range of motions. JR and NE were treated as missing. If more than 34 scores of limited range of motion were missing, then the total number of joints with limited range of motion was defined as missing.

Time frame: Baseline of the parent study; Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study

Population: RTAS included those participants who entered the re-treatment period. Here, number analyzed signifies participants evaluable at specified time points.

Total number of joints with limited range of motion was the number of joints with limited range of motion. It was defined as 69\*(total number of joints with score of limited range of motion greater than zero)/number of non-missing limited range of motions. Joint replacement (JR) and not evaluable (NE) were treated as missing. If more than 34 scores of limited range of motion were missing, then the total number of joints with limited range of motion was defined as missing.

Time frame: Baseline of the parent study; Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study

Population: FAS included all participants in the parent study who received at least 1 dose of investigational product regardless of whether they received any investigational product during the extension study. Here, number analyzed signifies participants evaluable at specified time points.

Overall back pain assessed by participant's parent using a 100 millimeter (mm) VAS with 0 mm= no pain and 100 mm= most severe pain, higher scores indicated more pain.

Time frame: Baseline of the parent study; Month 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study

Population: FAS included all participants in the parent study who received at least 1 dose of investigational product regardless of whether they received any investigational product during the extension study. Here, Number of Participants Analyzed, signifies participants with ERA and number analyzed signifies participants evaluable at specified time points.

Overall back pain assessed by participant's parent using a 100 millimeter (mm) VAS with 0 mm= no pain and 100 mm= most severe pain, higher scores indicated more pain.

Time frame: Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of Extension study

Population: WAS included participants who entered the withdrawal period. Here, Number of Participants Analyzed, signifies participants with ERA and number analyzed signifies participants evaluable at specified time points.

Overall back pain assessed by participant's parent using a 100 mm VAS with 0 mm= no pain and 100 mm= most severe pain, higher scores indicated more pain.

Time frame: Baseline of the parent study; Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study

Population: RTAS included those participants who entered the re-treatment period. Here, Number of Participants Analyzed, signifies participants with ERA and number analyzed signifies participants evaluable at specified time points.

Patient/Parent Global Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = very well and 10 = very poor, where higher scores indicated worsening of condition.

Time frame: Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study

Population: WAS included participants who entered the withdrawal period. Here, number analyzed signifies participants evaluable at specified time points.

Patient/Parent Global Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = very well and 10 = very poor, where higher scores indicated worsening of condition.

Time frame: Baseline of the parent study; Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study

Population: RTAS included those participants who entered the re-treatment period. Here, number analyzed signifies participants evaluable at specified time points.

Patient/Parent Global Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = very well and 10 = very poor, where higher scores indicated worsening of condition.

Time frame: Baseline of the parent study; Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study

Population: FAS included all participants in the parent study who received at least 1 dose of investigational product regardless of whether they received any investigational product during the extension study. Here, number analyzed signifies participants evaluable at specified time points.

Percentage of body surface area affected by psoriasis was estimated using the palm method: one of the participant's palm to proximal interphalangeal and thumb= 1% of BSA. Regions of the body were assigned specific number of palms with percentage (Head and neck= 10% \[10 palms\], upper extremities= 20% \[20 palms\], Trunk \[axillae and groin\]= 30% \[30 palms\], lower extremities \[buttocks\]= 40% \[40 palms\]). The total BSA affected was the summation of individual regions affected.

Time frame: Baseline of the parent study; Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study

Population: FAS included all participants in the parent study who received at least 1 dose of investigational product regardless of whether they received any investigational product during the extension study. Here, Number of Participants Analyzed, signifies participants with PsA and number analyzed signifies participants evaluable at specified time points.

PGA of disease activity was measured on a 21-circle VAS ranging from 0 to 10, with 0 = no disease activity and 10= maximum disease activity, where higher score indicated more severe disease.

Time frame: Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study

Population: WAS included participants who entered the withdrawal period. Here, number analyzed signifies participants evaluable at specified time points.

PGA of disease activity was measured on a 21-circle VAS ranging from 0 to 10, with 0 = no disease activity and 10= maximum disease activity, where higher score indicated more severe disease.

Time frame: Baseline of the parent study; Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study

Population: RTAS included those participants who entered the re-treatment period. Here, number analyzed signifies participants evaluable at specified time points.

PGA of disease activity was measured on a 21-circle Visual Analog Scale (VAS) ranging from 0 to 10, with 0 = no disease activity and 10= maximum disease activity, where higher score indicated more severe disease.

Time frame: Baseline of the parent study; Month 12, 24, 36, 48, 60, 72, 84 and 96 active treatment period of extension study

Population: FAS included all participants in the parent study who received at least 1 dose of investigational product regardless of whether they received any investigational product during the extension study. Here, number analyzed signifies participants evaluable at specified time points.

PGA of Psoriasis assessed the amount of induration, erythema, and scaling averaged over all psoriatic lesions on a scale of 0 to 5, where 0= no psoriasis to 5= severe disease, where higher scores indicated more severity. 'Clear' and Almost clear' includes all participants who were scored as a 0 or 1.

Time frame: Baseline of the parent study; Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study

Population: FAS included all participants in the parent study who received at least 1 dose of investigational product regardless of whether they received any investigational product during the extension study. Here, Number of Participants Analyzed, signifies participants with PsA and number analyzed signifies participants evaluable at specified time points.

Tanner assessment score: used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Tanner assessment score ranged from 1 (no development) to 5 (adult-like development in quantity and size), higher scores indicated more development.

Time frame: Baseline of the parent study; Month 12, 24, 36, 48, 60, 72, 84 and 96 active treatment period of extension study

Population: FAS included all participants in the parent study who received at least 1 dose of investigational product regardless of whether they received any investigational product during the extension study. Here, number analyzed signifies participants evaluable at specified time points.

VAS: 10-point pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. A higher score indicates greater pain intensity.

Time frame: Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study

Population: WAS included participants who entered the withdrawal period. Here, number analyzed signifies participants evaluable at specified time points.

VAS: 10-point pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. A higher score indicates greater pain intensity.

Time frame: Baseline of the parent study; Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study

Population: RTAS included those participants who entered the re-treatment period. Here, number analyzed signifies participants evaluable at specified time points.

VAS: 10-point pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. A higher score indicates greater pain intensity.

Time frame: Baseline of the parent study; Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study

Population: FAS included all participants in the parent study who received at least 1 dose of investigational product regardless of whether they received any investigational product during the extension study. Here, number analyzed signifies participants evaluable at specified time points.

Growth parameters including weight, height and body-mass index (BMI) were compared to the standard growth data by using Z-Score. Z-Score is a statistical measure to evaluate how a single data point or mean compares to a standard. A Z-Score describes whether a mean is above or below the standard and how unusual the measurement is. Z-scores range from -3 to +3. A Z-score of 0 indicates the same mean, greater than (\>) 0 a greater mean, and less than (\<0) a lesser mean than the standard.

Time frame: Baseline of the parent study; Month 12, 24, 36, 48, 60, 72, 84 and 96 active treatment period of extension study

Population: FAS included all participants in the parent study who received at least 1 dose of investigational product regardless of whether they received any investigational product during the extension study. Here, number analyzed signifies participants evaluable at specified time points.

The exposure time (in years) to etanercept was calculated for each participant using the following formula: (the last dose date minus the first dose date plus 1)/365.25. If the gap was less than 28 days between two etanercept treatment periods, the cumulative exposure included the gap. Else, the gap was excluded from the cumulative exposure. Exposure time in year was converted into weeks and reported here.

Time frame: Extension study: First dose of study medication up to 30 days after last dose of study drug (maximum up to 97 months)

Population: FAS included all participants in the parent study who received at least 1 dose of investigational product regardless of whether they received any investigational product during the extension study.

After non-study medications referred to any non-study medications taken after the last dose of the investigational product. These included anti-infective, corticosteroids, oral corticosteroids, Parenteral corticosteroids, disease-modifying antirheumatic drugs, oral non-steroidal anti-inflammatory medication and non-steroidal anti-inflammatory medication.

Time frame: Extension study: Last dose of study medication up to 30 days (maximum up to 97 months)

Population: The analysis set included all participants enrolled in the extension study.

Concomitant non-study medications were defined as any non-study medications taken during the treatment period. These included anti-infective medications, corticosteroids, oral corticosteroids, Parenteral corticosteroids, disease-modifying antirheumatic drugs, oral non-steroidal anti-inflammatory drugs and non-steroidal anti-inflammatory drugs.

Time frame: Extension study: First dose of study medication up to 30 days after last dose of study drug (maximum up to 97 months)

Population: The analysis set included all participants enrolled in the extension study.

Participants withdrew from the study due to AEs were reported. An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it.

Time frame: First dose of study medication in parent study up to 96 months in the extension study, for a maximum duration of 118 months (22 months of parent study and 96 months of extension study)

Population: Analysis population included all participants who were enrolled in the parent and extension study.

Participants withdrew from the study due to AEs were reported. An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it.

Time frame: Extension study: Day of study treatment withdrawal up to entering re-treatment period or observational period (for a maximum of 96 months)

Population: WAS included those participants who entered the withdrawal period.

Abnormality of laboratory parameters was graded as Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE.

Time frame: Extension study: Baseline (Day 1) up to 30 days after the last dose of investigational product (maximum up to 97 months)

Population: Analysis population included all participants who were enrolled in the extension study.

Number of participants who had infections as AEs were reported. An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it.

Time frame: First dose of study medication in parent study up to 96 months in the extension study, for a maximum duration of 118 months (22 months of parent study and 96 months of extension study)

Population: Analysis population included all participants who were enrolled in the parent and extension study.

Number of participants who had treatment emergent infections as AEs were reported. An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it.

Time frame: Extension study: Day of study treatment withdrawal up to entering re-treatment period or observational period (for a maximum of 96 months)

Population: Withdrawal analysis set (WAS) included those participants who entered the withdrawal period.

Medically important infections were defined as an infection requiring parenteral (intravenous \[IV\], intramuscular \[IM\]) anti-infective agent(s) and/or hospitalization.

Time frame: First dose of study medication in parent study up to 96 months in the extension study, for a maximum duration of 118 months (22 months of parent study and 96 months of extension study)

Population: Analysis population included all participants who were enrolled in the parent and extension study.

Prior non-study medications were defined as any non-study medications taken before the first dose of investigational product taken at the start of the study. These included anti-infective, corticosteroids, oral corticosteroids, Parenteral corticosteroids, disease-modifying antirheumatic drugs and oral non-steroidal anti-inflammatory medication.

Time frame: Extension study: First dose of study medication up to 30 days after last dose of study drug (maximum up to 97 months)

Population: The analysis set included all participants enrolled in the extension study.

A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it.

Time frame: First dose of study medication in parent study up to 96 months in the extension study, for a maximum duration of 118 months (22 months of parent study and 96 months of extension study)

Population: Analysis population included all participants who were enrolled in the parent and extension study.

Serious infections were defined as any infections those were life threatening or resulted in disability, infections requiring intravenous antibiotic treatment and hospitalization.

Time frame: First dose of study medication in parent study up to 96 months in the extension study, for a maximum duration of 118 months (22 months of parent study and 96 months of extension study)

Population: Analysis population included all participants who were enrolled in the parent and extension study.

Number of participants who had treatment emergent infections and injection site reactions as adverse events were reported. Treatment emergent infections were infections occurring in a participant who received study medication without regard to possibility of causal relationship to it. An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it.

Time frame: Extension study: Baseline (Day 1) up to 30 days after the last dose of investigational product (maximum up to 97 months)

Population: Analysis population included all participants who were enrolled in the extension study.

Vital signs assessment included temperature, pulse, systolic and diastolic blood pressure. Pulse rate was obtained with participant in the seated position, after having sat calmly for at least 5 minutes. Clinical significance of vital signs was determined at the investigator's discretion.

Time frame: Month 96 active treatment period of extension study

Population: FAS included all participants in the parent study who received at least 1 dose of investigational product regardless of whether they received any investigational product during the extension study.

ACR100PR: 100% improvement from baseline in 3 of 6 criteria with worsening \>30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 \[no disease activity\] to 10 \[maximum disease activity\],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 \[very well\] to 10 \[very poor\],higher score=higher pain), childhood health assessment questionnaire (\[CHAQ\] Participants \>18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 \[no difficulty\] to 3 \[unable to do\]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 \[no difficulty\] to 3 \[extreme difficulty\], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein.

Time frame: Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study

Population: WAS included participants who entered the withdrawal period. Here, number analyzed signifies participants evaluable at specified time points.

ACR100PR: 100% improvement from baseline in 3 of 6 criteria with worsening \>30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 \[no disease activity\] to 10 \[maximum disease activity\],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 \[very well\] to 10 \[very poor\],higher score=higher pain), childhood health assessment questionnaire (\[CHAQ\] Participants \>18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 \[no difficulty\] to 3 \[unable to do\]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 \[no difficulty\] to 3 \[extreme difficulty\], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein.

Time frame: Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study

Population: RTAS included those participants who entered the re-treatment period. Here, number analyzed signifies participants evaluable at specified time points.

ACR100PR: 100% improvement from baseline in 3 of 6 criteria with worsening \>30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 \[no disease activity\] to 10 \[maximum disease activity\],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 \[very well\] to 10 \[very poor\],higher score=higher pain), childhood health assessment questionnaire (\[CHAQ\] Participants \>18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 \[no difficulty\] to 3 \[unable to do\]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 \[no difficulty\] to 3 \[extreme difficulty\], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein.

Time frame: Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study

Population: FAS included all participants in the parent study who received at least 1 dose of investigational product regardless of whether they received any investigational product during the extension study. Here, number analyzed signifies participants evaluable at specified time points.

ACR30PR: \>=30% improvement from baseline in 3 of 6 criteria with worsening \>30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 \[no disease activity\] to 10 \[maximum disease activity\],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 \[very well\] to 10 \[very poor\],higher score=higher pain), childhood health assessment questionnaire (\[CHAQ\] Participants \>18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 \[no difficulty\] to 3 \[unable to do\]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 \[no difficulty\] to 3 \[extreme difficulty\], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein.

Time frame: Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 withdrawal period of extension study

Population: WAS included participants who entered the withdrawal period. Here, number analyzed signifies participants evaluable at specified time points.

ACR30PR: \>=30% improvement from baseline in 3 of 6 criteria with worsening \>30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 \[no disease activity\] to 10 \[maximum disease activity\],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 \[very well\] to 10 \[very poor\],higher score=higher pain), childhood health assessment questionnaire (\[CHAQ\] Participants \>18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 \[no difficulty\] to 3 \[unable to do\]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 \[no difficulty\] to 3 \[extreme difficulty\], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein.

Time frame: Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 re-treatment period of extension study

Population: RTAS included those participants who entered the re-treatment period. Here, number analyzed signifies participants evaluable at specified time points.

ACR30PR: \>=30% improvement from baseline in 3 of 6 criteria with worsening \>30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 \[no disease activity\] to 10 \[maximum disease activity\],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 \[very well\] to 10 \[very poor\],higher score=higher pain), childhood health assessment questionnaire (\[CHAQ\] Participants \>18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 \[no difficulty\] to 3 \[unable to do\]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 \[no difficulty\] to 3 \[extreme difficulty\], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein.

Time frame: Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study

Population: FAS included all participants in the parent study who received at least 1 dose of investigational product regardless of whether they received any investigational product during the extension study. Here, number analyzed signifies participants evaluable at specified time points.

ACR50PR: \>=50% improvement from baseline in 3 of 6 criteria with worsening \>30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 \[no disease activity\] to 10 \[maximum disease activity\],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 \[very well\] to 10 \[very poor\],higher score=higher pain), childhood health assessment questionnaire (\[CHAQ\] Participants \>18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 \[no difficulty\] to 3 \[unable to do\]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 \[no difficulty\] to 3 \[extreme difficulty\], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein.

Time frame: Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 withdrawal period of extension study

Population: WAS included participants who entered the withdrawal period. Here, number analyzed signifies participants evaluable at specified time points.

ACR50PR:\>=50% improvement from baseline in 3 of 6 criteria with worsening \>30% in no more than 1 of 6 criteria:1)PGA of disease activity(DA),2)PtGA of arthritis pain,3) CHAQ 4)number(no.) of active joints5)no. of joints with limited range of motion 6)C-reactive protein.PGA of DA: 21-circle VAS ranging 0-10, with 0=&10=maximumDA,higher score=more severe disease.PGA:21-circle VAS ranging 0-10,0=very well,10=very poor,higher scores=worsening condition.CHAQ: assessment of functional disability,discomfort. Ability to perform activities:dressing,arising,eating,walking,hygiene,reach,grip, common activities distributed in total of 30 items. Ranging 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do.Highest score for each domain:score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered.Ranged 0=no difficulty to 3=extreme difficulty;higher scores indicated more functional disability and discomfort. Participants \>18 years assessed using CHAQ.

Time frame: Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 re-treatment period of extension study

Population: RTAS included those participants who entered the re-treatment period. Here, number analyzed signifies participants evaluable at specified time points.

ACR50PR: \>=50% improvement from baseline in 3 of 6 criteria with worsening \>30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 \[no disease activity\] to 10 \[maximum disease activity\],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 \[very well\] to 10 \[very poor\],higher score=higher pain), childhood health assessment questionnaire (\[CHAQ\] Participants \>18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 \[no difficulty\] to 3 \[unable to do\]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 \[no difficulty\] to 3 \[extreme difficulty\], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein.

Time frame: Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study

Population: FAS included all participants in the parent study who received at least 1 dose of investigational product regardless of whether they received any investigational product during the extension study. Here, number analyzed signifies participants evaluable at specified time points.

ACR70PR: \>=70% improvement from baseline in 3 of 6 criteria with worsening \>30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 \[no disease activity\] to 10 \[maximum disease activity\],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 \[very well\] to 10 \[very poor\],higher score=higher pain), childhood health assessment questionnaire (\[CHAQ\] Participants \>18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 \[no difficulty\] to 3 \[unable to do\]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 \[no difficulty\] to 3 \[extreme difficulty\], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein.

Time frame: Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 withdrawal period of extension study

Population: WAS included participants who entered the withdrawal period. Here, number analyzed signifies participants evaluable at specified time points.

ACR70PR: \>=70% improvement from baseline in 3 of 6 criteria with worsening \>30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 \[no disease activity\] to 10 \[maximum disease activity\],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 \[very well\] to 10 \[very poor\],higher score=higher pain), childhood health assessment questionnaire (\[CHAQ\] Participants \>18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 \[no difficulty\] to 3 \[unable to do\]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 \[no difficulty\] to 3 \[extreme difficulty\], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein.

Time frame: Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 re-treatment period of extension study

Population: RTAS included those participants who entered the re-treatment period. Here, number analyzed signifies participants evaluable at specified time points.

ACR70PR: \>=70% improvement from baseline in 3 of 6 criteria with worsening \>30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 \[no disease activity\] to 10 \[maximum disease activity\],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 \[very well\] to 10 \[very poor\],higher score=higher pain), childhood health assessment questionnaire (\[CHAQ\] Participants \>18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 \[no difficulty\] to 3 \[unable to do\]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 \[no difficulty\] to 3 \[extreme difficulty\], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein.

Time frame: Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study

Population: FAS included all participants in the parent study who received at least 1 dose of investigational product regardless of whether they received any investigational product during the extension study. Here, number analyzed signifies participants evaluable at specified time points.

ACR90PR: \>=90% improvement from baseline in 3 of 6 criteria with worsening \>30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 \[no disease activity\] to 10 \[maximum disease activity\],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 \[very well\] to 10 \[very poor\],higher score=higher pain), childhood health assessment questionnaire (\[CHAQ\] Participants \>18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 \[no difficulty\] to 3 \[unable to do\]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 \[no difficulty\] to 3 \[extreme difficulty\], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein.

Time frame: Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 withdrawal period of extension study

Population: WAS included participants who entered the withdrawal period. Here, number analyzed signifies participants evaluable at specified time points.

ACR90PR: \>=90% improvement from baseline in 3 of 6 criteria with worsening \>30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 \[no disease activity\] to 10 \[maximum disease activity\],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 \[very well\] to 10 \[very poor\],higher score=higher pain), childhood health assessment questionnaire (\[CHAQ\] Participants \>18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 \[no difficulty\] to 3 \[unable to do\]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 \[no difficulty\] to 3 \[extreme difficulty\], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein.

Time frame: Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 re-treatment period of extension study

Population: RTAS included those participants who entered the re-treatment period. Here, number analyzed signifies participants evaluable at specified time points.

ACR90PR: \>=90% improvement from baseline in 3 of 6 criteria with worsening \>30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 \[no disease activity\] to 10 \[maximum disease activity\],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 \[very well\] to 10 \[very poor\],higher score=higher pain), childhood health assessment questionnaire (\[CHAQ\] Participants \>18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 \[no difficulty\] to 3 \[unable to do\]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 \[no difficulty\] to 3 \[extreme difficulty\], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein.

Time frame: Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study

Population: FAS included all participants in the parent study who received at least 1 dose of investigational product regardless of whether they received any investigational product during the extension study. Here, number analyzed signifies participants evaluable at specified time points.

Clinically inactive disease was defined as no joints with active arthritis; no fever, rash, serositis, splenomegaly, or generalized lymphadenopathy attributable to JIA; no active uveitis; normal range of CRP; PGA of disease activity of 0 on a 21-circle VAS and duration of morning stiffness of \<=15 minutes.

Time frame: Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study

Population: WAS included participants who entered the withdrawal period. Here, number analyzed signifies participants evaluable at specified time points.

Clinically inactive disease was defined as no joints with active arthritis; no fever, rash, serositis, splenomegaly, or generalized lymphadenopathy attributable to JIA; no active uveitis; normal range of CRP; PGA of disease activity of 0 on a 21-circle VAS and duration of morning stiffness of \<=15 minutes.

Time frame: Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study

Population: RTAS included those participants who entered the re-treatment period. Here, number analyzed signifies participants evaluable at specified time points.

Clinically inactive disease was defined as no joints with active arthritis; no fever, rash, serositis, splenomegaly, or generalized lymphadenopathy attributable to JIA; no active uveitis; normal range of CRP; PGA of disease activity of 0 on a 21-circle VAS and duration of morning stiffness of less than or equal to (\<=) 15 minutes.

Time frame: Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study

Population: FAS included all participants in the parent study who received at least 1 dose of investigational product regardless of whether they received any investigational product during the extension study. Here, number analyzed signifies participants evaluable at specified time points.

CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report participant's ability to perform activities in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, common activities distributed in total of 30 items. Each item is scored on 4-point Likert scale: 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Highest score reported for each domain is score for that domain. Overall CHAQ score was calculated as sum of domain scores divided by number of domains answered and ranged from 0=no difficulty to 3=extreme difficulty, where higher scores indicated more functional disability and discomfort in pediatrics with rheumatic disease. Participants below 18 years of age were assessed using CHAQ.

Time frame: Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study

Population: FAS included all participants in the parent study who received at least 1 dose of investigational product regardless of whether they received any investigational product during the extension study. Here, number analyzed signifies participants evaluable at specified time points.