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Treatment With Recombinant Human Growth Hormone (GH) in Children With Short Stature Secondary to a Long Term Corticoid Therapy

Treatment With Recombinant Human Growth Hormone Genotonorm (Registered) in Children With Short Stature Secondary to a Long Term Corticoid Therapy. A Study of Efficacy and Safety.

Status
Terminated
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00174187
Enrollment
30
Registered
2005-09-15
Start date
2000-09-30
Completion date
2011-09-30
Last updated
2012-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endocrine System Diseases

Brief summary

* To assess the effect of a long-term treatment by Genotonorm on linear growth in children with short stature receiving steroid therapy * To assess the effect of a long term treatment with Genotonorm on bone mineralisation * To assess the effect of a long term treatment with Genotonorm on body composition

Detailed description

This trial terminated on 10-Jun-2011 due to prolonged issues with drug accountability and data collection discrepancies. The decision to terminate was not based on any safety concerns.

Interventions

DRUGSomatropin

liquid, daily, until final height Dosage: 0,46 mg/kg/week . The maximum dose should not exceed 50 µg/Kg/day

Sponsors

Pfizer
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
11 Years to 17 Years
Healthy volunteers
No

Inclusion criteria

* Children with juvenile arthritis or nephrotic syndrome * Before or during puberty

Exclusion criteria

* Diabetes Type 1 and 2 * Endocrine disease, except well substituted hypothyroidism

Design outcomes

Primary

MeasureTime frameDescription
Change From Baseline in Height Standard Deviation Score According to Chronological Age (SDS/CA) at Final HeightBaseline, when final height was reached (assessed up to Year 11)Height was measured using a wall mounted device (example, Harpenden stadiometer). Height SDS/CA was obtained by measuring the height, subtracting chronological age- and gender-appropriate mean height and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population.
Change From Baseline in Height Standard Deviation Score According to Chronological Age (SDS/CA) at Year 3Baseline, Year 3Height was measured using a wall mounted device (example, Harpenden stadiometer). Height SDS/CA was obtained by measuring the height, subtracting chronological age- and gender-appropriate mean height and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population.
Puberty Stage at Final HeightWhen final height was reached (assessed up to Year 11)Pubertal stage (graded from I to V for breast development and pubic hair development) according to the Tanner's method was collected. A low stage (Stage I) corresponds to a pre-pubertal stage and a high stage (Stage V) to an adult stage.
Change From Baseline in Weight Standard Deviation Score (SDS) at Final HeightBaseline, when final height was reached (assessed up to Year 11)Body weight was measured using a balance scale. Weight SDS was obtained by measuring the weight, subtracting age- and gender-appropriate mean weight and dividing the result by standard deviation of that mean (as obtained from age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population.

Secondary

MeasureTime frameDescription
Percent Change From Baseline in Lean Body Mass at Year 3Baseline, Year 3Lean body mass, a measurement of body composition, was assessed by DEXA scan. Percent change: (Lean body mass at Year 3 minus lean body mass at baseline) divided by lean body mass at baseline, multiplied by 100.
Lean Body Mass as Percentage of Total WeightBaseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11Lean body mass, a measurement of body composition, was assessed by DEXA scan.
Lean Body Mass Standard Deviation Score According to Chronological Age (SDS/CA)Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11Lean body mass was assessed by DEXA scan. Lean body mass SDS/CA was obtained by measuring lean body mass, subtracting the chronological age- and gender-appropriate mean lean body mass and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population.
Fat MassBaseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11Fat mass, a measurement of body composition, was assessed by DEXA scan.
Annual Percent Change in Fat Mass at Year 1, 2 and 3Baseline, Year 1, 2, 3Fat mass, a measurement of body composition, was assessed by DEXA scan. Annual percent change: (Fat mass at current year minus fat mass at previous year) divided by fat mass at previous year, multiplied by 100.
Percent Change From Baseline in Fat Mass at Year 3Baseline, Year 3Fat mass, a measurement of body composition, was assessed by DEXA scan. Percent change: (Fat mass at Year 3 minus fat mass at baseline) divided by fat mass at baseline, multiplied by 100.
Fat Mass as Percentage of Total WeightBaseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11Fat mass, a measurement of body composition, was assessed by DEXA scan.
Fat Mass Standard Deviation Score According to Chronological Age (SDS/CA)Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11Fat mass was assessed by DEXA scan. Fat mass SDS/CA was obtained by measuring fat mass, subtracting chronological age- and gender-appropriate mean fat mass and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population.
Bone AgeBaseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11Bone age was determined by the Greulich and Pyle method using left wrist and hand X-ray.
Lean Body MassBaseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11Lean body mass, a measurement of body composition, was assessed by Dual Energy X-ray Absorptiometry (DEXA) scan.
Annual Percent Change in Lean Body Mass at Year 1, 2 and 3Baseline, Year 1, 2, 3Lean body mass, a measurement of body composition, was assessed by DEXA scan. Annual percent change: (Lean body mass at current year minus lean body mass at previous year) divided by lean body mass at previous year, multiplied by 100.
Bone Mineral Content of Total Body (BMC [TB])Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11DEXA scan of BMC was used to evaluate potential bone effects of treatment. BMC is an estimate of the amount of mineral (such as calcium) in the bone.
Annual Percent Change in Bone Mineral Content of Total Body (BMC [TB]) at Year 1, 2 and 3Baseline, Year 1, 2, 3BMC is an estimate of the amount of mineral (such as calcium) in the bone. Annual percent change: (BMC \[TB\] at current year minus BMC \[TB\] at previous year) divided by BMC \[TB\] at previous year, multiplied by 100.
Percent Change From Baseline in Bone Mineral Content of Total Body (BMC [TB]) at Year 3Baseline, Year 3BMC is an estimate of the amount of mineral (such as calcium) in the bone. Percent change: (BMC \[TB\] at Year 3 minus BMC \[TB\] at baseline) divided by BMC \[TB\] at baseline, multiplied by 100.
Bone Mineral Content Standard Deviation Score of Total Body According to Chronological Age (BMC [TB] [SDS/CA])Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11BMC (TB) was measured by DEXA scan. BMC (TB) (SDS/CA) was obtained by measuring BMC (TB), subtracting the chronological age- and gender-appropriate mean BMC (TB) and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population.
Bone Mineral Content Standard Deviation Score of Total Body According to Tanner Puberty Stage (BMC [TB] [SDS/Tanner Puberty Stage])Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11BMC (TB) was measured by DEXA scan. BMC (TB) (SDS/Tanner Puberty Stage) was obtained by measuring BMC (TB), subtracting the Tanner puberty stage- and gender-appropriate mean BMC (TB) and dividing the result by standard deviation of that mean (as obtained from Tanner puberty stage- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population.
Apparent Bone Mineral Density of Lumbar Spine (BMAD [LS])Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11BMAD (LS) was assessed by DEXA scan.
Apparent Bone Mineral Density Standard Deviation Score of Lumbar Spine According to Chronological Age (BMAD [LS] [SDS/CA])Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11BMAD (LS) was assessed by DEXA scan. BMAD (LS) (SDS/CA) was obtained by measuring the BMAD (LS), subtracting chronological age- and gender-appropriate mean BMAD (LS) and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population.
Apparent Bone Mineral Density Standard Deviation Score of Lumber Spine According to Tanner Puberty Stage (BMAD [LS] [SDS/Tanner Puberty Stage])Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11BMAD (LS) was assessed by DEXA scan. BMAD (LS) (SDS/Tanner Puberty Stage) was obtained by measuring BMAD (LS), subtracting Tanner puberty stage- and gender-appropriate mean BMAD (LS) and dividing the result by standard deviation of that mean (as obtained from Tanner puberty stage- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population.
Bone Mineral Density of Total Body (BMD [TB])Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11BMD (TB) was assessed by DEXA scan.
Bone Mineral Density of Lumbar Spine (BMD [LS])Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11BMD (LS) was assessed by DEXA scan.

Other

MeasureTime frameDescription
Growth Velocity (GV)Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11Growth velocity measures the annual rate of increase in height.
Growth Velocity Standard Deviation Score According to Bone Age (GV [SDS/BA])Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11GV measures the annual rate of increase in height. GV (SDS/BA) was obtained by measuring GV, subtracting the bone age- and gender-appropriate mean GV and dividing the result by standard deviation of that mean (as obtained from bone age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population.
Growth Velocity Standard Deviation Score According to Chronological Age (GV [SDS/CA])Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11GV measures the annual rate of increase in height. GV (SDS/CA) was obtained by measuring GV, subtracting the chronological age- and gender-appropriate mean GV and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population.
Insulin-like Growth Factor-1 (IGF-1) Concentration After Year 3Year 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10; 0.5 and 1 year after somatropin discontinuation, Final Height (assessed up to Year 11)—
Insulin-like Growth Factor-1 (IGF-1) Concentration up to Year 3Baseline, Year 1, 2, 3—

Countries

France

Participant flow

Participants by arm

ArmCount
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)
Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
15
Somatropin- Up To Year 3 (Nephrotic Syndrome)
Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
15
Total30

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Between Period 1 and Period 2Consented, not assigned to treatment003
Between Period 1 and Period 2Did not consent to continue treatment002
Period 1 (up to 3 Years)Non compliance010
Period 1 (up to 3 Years)Other010
Period 1 (up to 3 Years)Serious adverse event010
Period 1 (up to 3 Years)Withdrawal by Subject010
Period 2 (After 3 Years)Lost to Follow-up002
Period 2 (After 3 Years)Other005
Period 2 (After 3 Years)Withdrawal by Subject001

Baseline characteristics

CharacteristicSomatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Somatropin- Up To Year 3 (Nephrotic Syndrome)Total
Age Continuous11.14 years
STANDARD_DEVIATION 3.32
11.96 years
STANDARD_DEVIATION 3.8
11.55 years
STANDARD_DEVIATION 3.53
Sex: Female, Male
Female
9 Participants2 Participants11 Participants
Sex: Female, Male
Male
6 Participants13 Participants19 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
13 / 1514 / 1521 / 21
serious
Total, serious adverse events
13 / 1514 / 1519 / 21

Outcome results

Primary

Change From Baseline in Height Standard Deviation Score According to Chronological Age (SDS/CA) at Final Height

Height was measured using a wall mounted device (example, Harpenden stadiometer). Height SDS/CA was obtained by measuring the height, subtracting chronological age- and gender-appropriate mean height and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population.

Time frame: Baseline, when final height was reached (assessed up to Year 11)

Population: FAS- after Year 3: included all participants who received at least 1 dose of the study treatment and who had at least 1 post-baseline height measurement. Here, 'n' signifies those participants who were evaluable for this measure at given time points.

ArmMeasureGroupValue (MEDIAN)
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Change From Baseline in Height Standard Deviation Score According to Chronological Age (SDS/CA) at Final HeightBaseline (n = 21)-2.86 SDS
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Change From Baseline in Height Standard Deviation Score According to Chronological Age (SDS/CA) at Final HeightChange at Final Height (n = 4)0.71 SDS
Primary

Change From Baseline in Height Standard Deviation Score According to Chronological Age (SDS/CA) at Year 3

Height was measured using a wall mounted device (example, Harpenden stadiometer). Height SDS/CA was obtained by measuring the height, subtracting chronological age- and gender-appropriate mean height and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population.

Time frame: Baseline, Year 3

Population: Full Analysis Set (FAS) up to Year 3: included all participants who had at least 1 post-baseline height measurement and were treated with the study drug for at least 1 year.

ArmMeasureGroupValue (MEDIAN)
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Change From Baseline in Height Standard Deviation Score According to Chronological Age (SDS/CA) at Year 3Baseline-3.6 Standard Deviation Score (SDS)
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Change From Baseline in Height Standard Deviation Score According to Chronological Age (SDS/CA) at Year 3Change at Year 30.2 Standard Deviation Score (SDS)
Somatropin- Up To Year 3 (Nephrotic Syndrome)Change From Baseline in Height Standard Deviation Score According to Chronological Age (SDS/CA) at Year 3Baseline-2.5 Standard Deviation Score (SDS)
Somatropin- Up To Year 3 (Nephrotic Syndrome)Change From Baseline in Height Standard Deviation Score According to Chronological Age (SDS/CA) at Year 3Change at Year 31.1 Standard Deviation Score (SDS)
Primary

Change From Baseline in Weight Standard Deviation Score (SDS) at Final Height

Body weight was measured using a balance scale. Weight SDS was obtained by measuring the weight, subtracting age- and gender-appropriate mean weight and dividing the result by standard deviation of that mean (as obtained from age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population.

Time frame: Baseline, when final height was reached (assessed up to Year 11)

Population: FAS- after Year 3: included all participants who received at least one dose of the study treatment and who had at least one post-baseline height measurement. Here, 'n' signifies those participants who were evaluable for this measure at given time point.

ArmMeasureGroupValue (MEDIAN)
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Change From Baseline in Weight Standard Deviation Score (SDS) at Final HeightBaseline (n = 21)-1.53 SDS
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Change From Baseline in Weight Standard Deviation Score (SDS) at Final HeightChange at Final Height (n = 4)-0.43 SDS
Primary

Puberty Stage at Final Height

Pubertal stage (graded from I to V for breast development and pubic hair development) according to the Tanner's method was collected. A low stage (Stage I) corresponds to a pre-pubertal stage and a high stage (Stage V) to an adult stage.

Time frame: When final height was reached (assessed up to Year 11)

Population: FAS- after Year 3: included all participants who received at least one dose of study treatment and who had at least one post-baseline height measurement. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants who were evaluable for given components of puberty assessment.

ArmMeasureGroupValue (NUMBER)
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Puberty Stage at Final HeightPubic hair: Stage V (n=4)4 participants
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Puberty Stage at Final HeightPubic hair: Stage III (n=4)0 participants
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Puberty Stage at Final HeightPubic hair: Stage IV (n=4)0 participants
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Puberty Stage at Final HeightPubic hair: Stage I (n=4)0 participants
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Puberty Stage at Final HeightPubic hair: Stage II (n=4)0 participants
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Puberty Stage at Final HeightBreast development: Stage I (n=1)0 participants
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Puberty Stage at Final HeightBreast development: Stage II (n=1)0 participants
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Puberty Stage at Final HeightBreast development: Stage III (n=1)0 participants
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Puberty Stage at Final HeightBreast development: Stage IV (n=1)0 participants
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Puberty Stage at Final HeightBreast development: Stage V (n=1)1 participants
Secondary

Annual Percent Change in Bone Mineral Content of Total Body (BMC [TB]) at Year 1, 2 and 3

BMC is an estimate of the amount of mineral (such as calcium) in the bone. Annual percent change: (BMC \[TB\] at current year minus BMC \[TB\] at previous year) divided by BMC \[TB\] at previous year, multiplied by 100.

Time frame: Baseline, Year 1, 2, 3

Population: FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.

ArmMeasureGroupValue (MEDIAN)
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Annual Percent Change in Bone Mineral Content of Total Body (BMC [TB]) at Year 1, 2 and 3Year 2 (n = 14, 11)17.47 percent change
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Annual Percent Change in Bone Mineral Content of Total Body (BMC [TB]) at Year 1, 2 and 3Year 1 (n = 15, 14)12.51 percent change
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Annual Percent Change in Bone Mineral Content of Total Body (BMC [TB]) at Year 1, 2 and 3Year 3 (n = 12, 9)12.03 percent change
Somatropin- Up To Year 3 (Nephrotic Syndrome)Annual Percent Change in Bone Mineral Content of Total Body (BMC [TB]) at Year 1, 2 and 3Year 1 (n = 15, 14)20.16 percent change
Somatropin- Up To Year 3 (Nephrotic Syndrome)Annual Percent Change in Bone Mineral Content of Total Body (BMC [TB]) at Year 1, 2 and 3Year 2 (n = 14, 11)13.91 percent change
Somatropin- Up To Year 3 (Nephrotic Syndrome)Annual Percent Change in Bone Mineral Content of Total Body (BMC [TB]) at Year 1, 2 and 3Year 3 (n = 12, 9)7.39 percent change
Secondary

Annual Percent Change in Fat Mass at Year 1, 2 and 3

Fat mass, a measurement of body composition, was assessed by DEXA scan. Annual percent change: (Fat mass at current year minus fat mass at previous year) divided by fat mass at previous year, multiplied by 100.

Time frame: Baseline, Year 1, 2, 3

Population: FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.

ArmMeasureGroupValue (MEDIAN)
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Annual Percent Change in Fat Mass at Year 1, 2 and 3Annual Change at Year 2 (n = 14, 11)29.52 percent change
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Annual Percent Change in Fat Mass at Year 1, 2 and 3Annual Change at Year 1 (n = 15, 13)-11.21 percent change
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Annual Percent Change in Fat Mass at Year 1, 2 and 3Annual Change at Year 3 (n = 13, 9)26.61 percent change
Somatropin- Up To Year 3 (Nephrotic Syndrome)Annual Percent Change in Fat Mass at Year 1, 2 and 3Annual Change at Year 1 (n = 15, 13)-3.71 percent change
Somatropin- Up To Year 3 (Nephrotic Syndrome)Annual Percent Change in Fat Mass at Year 1, 2 and 3Annual Change at Year 2 (n = 14, 11)-1.05 percent change
Somatropin- Up To Year 3 (Nephrotic Syndrome)Annual Percent Change in Fat Mass at Year 1, 2 and 3Annual Change at Year 3 (n = 13, 9)19.37 percent change
Secondary

Annual Percent Change in Lean Body Mass at Year 1, 2 and 3

Lean body mass, a measurement of body composition, was assessed by DEXA scan. Annual percent change: (Lean body mass at current year minus lean body mass at previous year) divided by lean body mass at previous year, multiplied by 100.

Time frame: Baseline, Year 1, 2, 3

Population: FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.

ArmMeasureGroupValue (MEDIAN)
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Annual Percent Change in Lean Body Mass at Year 1, 2 and 3Annual Change at Year 1 (n = 15, 13)18.95 percent change
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Annual Percent Change in Lean Body Mass at Year 1, 2 and 3Annual Change at Year 2 (n = 14, 11)7.75 percent change
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Annual Percent Change in Lean Body Mass at Year 1, 2 and 3Annual Change at Year 3 (n = 13, 9)9.83 percent change
Somatropin- Up To Year 3 (Nephrotic Syndrome)Annual Percent Change in Lean Body Mass at Year 1, 2 and 3Annual Change at Year 1 (n = 15, 13)22.97 percent change
Somatropin- Up To Year 3 (Nephrotic Syndrome)Annual Percent Change in Lean Body Mass at Year 1, 2 and 3Annual Change at Year 2 (n = 14, 11)7.33 percent change
Somatropin- Up To Year 3 (Nephrotic Syndrome)Annual Percent Change in Lean Body Mass at Year 1, 2 and 3Annual Change at Year 3 (n = 13, 9)7.90 percent change
Secondary

Apparent Bone Mineral Density of Lumbar Spine (BMAD [LS])

BMAD (LS) was assessed by DEXA scan.

Time frame: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11

Population: FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.

ArmMeasureGroupValue (MEDIAN)
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Apparent Bone Mineral Density of Lumbar Spine (BMAD [LS])Baseline (n = 15, 14)0.184 gram per cubic centimeter (g/cm^3)
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Apparent Bone Mineral Density of Lumbar Spine (BMAD [LS])Year 2 (n = 15, 14)0.215 gram per cubic centimeter (g/cm^3)
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Apparent Bone Mineral Density of Lumbar Spine (BMAD [LS])Year 3 (n = 13, 12)0.239 gram per cubic centimeter (g/cm^3)
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Apparent Bone Mineral Density of Lumbar Spine (BMAD [LS])Year 1 (n = 14, 13)0.209 gram per cubic centimeter (g/cm^3)
Somatropin- Up To Year 3 (Nephrotic Syndrome)Apparent Bone Mineral Density of Lumbar Spine (BMAD [LS])Year 3 (n = 13, 12)0.242 gram per cubic centimeter (g/cm^3)
Somatropin- Up To Year 3 (Nephrotic Syndrome)Apparent Bone Mineral Density of Lumbar Spine (BMAD [LS])Baseline (n = 15, 14)0.223 gram per cubic centimeter (g/cm^3)
Somatropin- Up To Year 3 (Nephrotic Syndrome)Apparent Bone Mineral Density of Lumbar Spine (BMAD [LS])Year 1 (n = 14, 13)0.237 gram per cubic centimeter (g/cm^3)
Somatropin- Up To Year 3 (Nephrotic Syndrome)Apparent Bone Mineral Density of Lumbar Spine (BMAD [LS])Year 2 (n = 15, 14)0.249 gram per cubic centimeter (g/cm^3)
Secondary

Apparent Bone Mineral Density Standard Deviation Score of Lumbar Spine According to Chronological Age (BMAD [LS] [SDS/CA])

BMAD (LS) was assessed by DEXA scan. BMAD (LS) (SDS/CA) was obtained by measuring the BMAD (LS), subtracting chronological age- and gender-appropriate mean BMAD (LS) and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population.

Time frame: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11

Population: FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.

ArmMeasureGroupValue (MEDIAN)
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Apparent Bone Mineral Density Standard Deviation Score of Lumbar Spine According to Chronological Age (BMAD [LS] [SDS/CA])Baseline (n = 15, 14)-3.21 SDS
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Apparent Bone Mineral Density Standard Deviation Score of Lumbar Spine According to Chronological Age (BMAD [LS] [SDS/CA])Year 1 (n = 14, 13)-2.66 SDS
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Apparent Bone Mineral Density Standard Deviation Score of Lumbar Spine According to Chronological Age (BMAD [LS] [SDS/CA])Year 2 (n = 15, 14)-2.55 SDS
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Apparent Bone Mineral Density Standard Deviation Score of Lumbar Spine According to Chronological Age (BMAD [LS] [SDS/CA])Year 3 (n 12, 12)-1.77 SDS
Somatropin- Up To Year 3 (Nephrotic Syndrome)Apparent Bone Mineral Density Standard Deviation Score of Lumbar Spine According to Chronological Age (BMAD [LS] [SDS/CA])Year 3 (n 12, 12)-1.63 SDS
Somatropin- Up To Year 3 (Nephrotic Syndrome)Apparent Bone Mineral Density Standard Deviation Score of Lumbar Spine According to Chronological Age (BMAD [LS] [SDS/CA])Baseline (n = 15, 14)-1.53 SDS
Somatropin- Up To Year 3 (Nephrotic Syndrome)Apparent Bone Mineral Density Standard Deviation Score of Lumbar Spine According to Chronological Age (BMAD [LS] [SDS/CA])Year 2 (n = 15, 14)-1.42 SDS
Somatropin- Up To Year 3 (Nephrotic Syndrome)Apparent Bone Mineral Density Standard Deviation Score of Lumbar Spine According to Chronological Age (BMAD [LS] [SDS/CA])Year 1 (n = 14, 13)-1.51 SDS
Secondary

Apparent Bone Mineral Density Standard Deviation Score of Lumber Spine According to Tanner Puberty Stage (BMAD [LS] [SDS/Tanner Puberty Stage])

BMAD (LS) was assessed by DEXA scan. BMAD (LS) (SDS/Tanner Puberty Stage) was obtained by measuring BMAD (LS), subtracting Tanner puberty stage- and gender-appropriate mean BMAD (LS) and dividing the result by standard deviation of that mean (as obtained from Tanner puberty stage- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population.

Time frame: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11

Population: FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.

ArmMeasureGroupValue (MEDIAN)
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Apparent Bone Mineral Density Standard Deviation Score of Lumber Spine According to Tanner Puberty Stage (BMAD [LS] [SDS/Tanner Puberty Stage])Year 1 (n = 10, 7)-3.70 SDS
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Apparent Bone Mineral Density Standard Deviation Score of Lumber Spine According to Tanner Puberty Stage (BMAD [LS] [SDS/Tanner Puberty Stage])Year 2 (n = 10, 9)-4.11 SDS
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Apparent Bone Mineral Density Standard Deviation Score of Lumber Spine According to Tanner Puberty Stage (BMAD [LS] [SDS/Tanner Puberty Stage])Baseline (n = 8, 8)-4.27 SDS
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Apparent Bone Mineral Density Standard Deviation Score of Lumber Spine According to Tanner Puberty Stage (BMAD [LS] [SDS/Tanner Puberty Stage])Year 3 (n = 10, 8)-3.04 SDS
Somatropin- Up To Year 3 (Nephrotic Syndrome)Apparent Bone Mineral Density Standard Deviation Score of Lumber Spine According to Tanner Puberty Stage (BMAD [LS] [SDS/Tanner Puberty Stage])Year 3 (n = 10, 8)-2.96 SDS
Somatropin- Up To Year 3 (Nephrotic Syndrome)Apparent Bone Mineral Density Standard Deviation Score of Lumber Spine According to Tanner Puberty Stage (BMAD [LS] [SDS/Tanner Puberty Stage])Baseline (n = 8, 8)-3.09 SDS
Somatropin- Up To Year 3 (Nephrotic Syndrome)Apparent Bone Mineral Density Standard Deviation Score of Lumber Spine According to Tanner Puberty Stage (BMAD [LS] [SDS/Tanner Puberty Stage])Year 2 (n = 10, 9)-2.60 SDS
Somatropin- Up To Year 3 (Nephrotic Syndrome)Apparent Bone Mineral Density Standard Deviation Score of Lumber Spine According to Tanner Puberty Stage (BMAD [LS] [SDS/Tanner Puberty Stage])Year 1 (n = 10, 7)-3.23 SDS
Secondary

Bone Age

Bone age was determined by the Greulich and Pyle method using left wrist and hand X-ray.

Time frame: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11

Population: FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.

ArmMeasureGroupValue (MEDIAN)
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Bone AgeBaseline (n = 14, 15)8.9 years
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Bone AgeYear 1 (n = 14, 15)9.5 years
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Bone AgeYear 2 (n = 15, 13)10.0 years
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Bone AgeYear 3 (n = 15, 14)11.3 years
Somatropin- Up To Year 3 (Nephrotic Syndrome)Bone AgeYear 3 (n = 15, 14)14.0 years
Somatropin- Up To Year 3 (Nephrotic Syndrome)Bone AgeBaseline (n = 14, 15)10.5 years
Somatropin- Up To Year 3 (Nephrotic Syndrome)Bone AgeYear 2 (n = 15, 13)14.0 years
Somatropin- Up To Year 3 (Nephrotic Syndrome)Bone AgeYear 1 (n = 14, 15)11.5 years
Secondary

Bone Mineral Content of Total Body (BMC [TB])

DEXA scan of BMC was used to evaluate potential bone effects of treatment. BMC is an estimate of the amount of mineral (such as calcium) in the bone.

Time frame: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11

Population: FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.

ArmMeasureGroupValue (MEDIAN)
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Bone Mineral Content of Total Body (BMC [TB])Baseline (n = 15, 15)636.36 gram
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Bone Mineral Content of Total Body (BMC [TB])Year 1 (n = 15, 14)775.46 gram
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Bone Mineral Content of Total Body (BMC [TB])Year 2 (n = 14, 11)855.70 gram
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Bone Mineral Content of Total Body (BMC [TB])Year 3 (n = 13, 11)1112.78 gram
Somatropin- Up To Year 3 (Nephrotic Syndrome)Bone Mineral Content of Total Body (BMC [TB])Year 3 (n = 13, 11)1997.74 gram
Somatropin- Up To Year 3 (Nephrotic Syndrome)Bone Mineral Content of Total Body (BMC [TB])Baseline (n = 15, 15)1233.58 gram
Somatropin- Up To Year 3 (Nephrotic Syndrome)Bone Mineral Content of Total Body (BMC [TB])Year 2 (n = 14, 11)2003.49 gram
Somatropin- Up To Year 3 (Nephrotic Syndrome)Bone Mineral Content of Total Body (BMC [TB])Year 1 (n = 15, 14)1576.15 gram
Secondary

Bone Mineral Content Standard Deviation Score of Total Body According to Chronological Age (BMC [TB] [SDS/CA])

BMC (TB) was measured by DEXA scan. BMC (TB) (SDS/CA) was obtained by measuring BMC (TB), subtracting the chronological age- and gender-appropriate mean BMC (TB) and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population.

Time frame: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11

Population: FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.

ArmMeasureGroupValue (MEDIAN)
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Bone Mineral Content Standard Deviation Score of Total Body According to Chronological Age (BMC [TB] [SDS/CA])Baseline (n = 15, 15)-1.95 SDS
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Bone Mineral Content Standard Deviation Score of Total Body According to Chronological Age (BMC [TB] [SDS/CA])Year 1 (n = 15, 14)-1.85 SDS
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Bone Mineral Content Standard Deviation Score of Total Body According to Chronological Age (BMC [TB] [SDS/CA])Year 2 (n = 14, 11)-1.66 SDS
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Bone Mineral Content Standard Deviation Score of Total Body According to Chronological Age (BMC [TB] [SDS/CA])Year 3 (n = 12, 11)-1.65 SDS
Somatropin- Up To Year 3 (Nephrotic Syndrome)Bone Mineral Content Standard Deviation Score of Total Body According to Chronological Age (BMC [TB] [SDS/CA])Year 3 (n = 12, 11)-0.09 SDS
Somatropin- Up To Year 3 (Nephrotic Syndrome)Bone Mineral Content Standard Deviation Score of Total Body According to Chronological Age (BMC [TB] [SDS/CA])Baseline (n = 15, 15)-0.42 SDS
Somatropin- Up To Year 3 (Nephrotic Syndrome)Bone Mineral Content Standard Deviation Score of Total Body According to Chronological Age (BMC [TB] [SDS/CA])Year 2 (n = 14, 11)-0.37 SDS
Somatropin- Up To Year 3 (Nephrotic Syndrome)Bone Mineral Content Standard Deviation Score of Total Body According to Chronological Age (BMC [TB] [SDS/CA])Year 1 (n = 15, 14)-0.19 SDS
Secondary

Bone Mineral Content Standard Deviation Score of Total Body According to Tanner Puberty Stage (BMC [TB] [SDS/Tanner Puberty Stage])

BMC (TB) was measured by DEXA scan. BMC (TB) (SDS/Tanner Puberty Stage) was obtained by measuring BMC (TB), subtracting the Tanner puberty stage- and gender-appropriate mean BMC (TB) and dividing the result by standard deviation of that mean (as obtained from Tanner puberty stage- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population.

Time frame: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11

Population: FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.

ArmMeasureGroupValue (MEDIAN)
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Bone Mineral Content Standard Deviation Score of Total Body According to Tanner Puberty Stage (BMC [TB] [SDS/Tanner Puberty Stage])Baseline (n = 8, 8)-2.19 SDS
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Bone Mineral Content Standard Deviation Score of Total Body According to Tanner Puberty Stage (BMC [TB] [SDS/Tanner Puberty Stage])Year 1 (n = 10, 8)-1.56 SDS
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Bone Mineral Content Standard Deviation Score of Total Body According to Tanner Puberty Stage (BMC [TB] [SDS/Tanner Puberty Stage])Year 2 (n = 9, 7)-2.38 SDS
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Bone Mineral Content Standard Deviation Score of Total Body According to Tanner Puberty Stage (BMC [TB] [SDS/Tanner Puberty Stage])Year 3 (n = 9, 7)-2.38 SDS
Somatropin- Up To Year 3 (Nephrotic Syndrome)Bone Mineral Content Standard Deviation Score of Total Body According to Tanner Puberty Stage (BMC [TB] [SDS/Tanner Puberty Stage])Year 3 (n = 9, 7)-0.17 SDS
Somatropin- Up To Year 3 (Nephrotic Syndrome)Bone Mineral Content Standard Deviation Score of Total Body According to Tanner Puberty Stage (BMC [TB] [SDS/Tanner Puberty Stage])Baseline (n = 8, 8)1.41 SDS
Somatropin- Up To Year 3 (Nephrotic Syndrome)Bone Mineral Content Standard Deviation Score of Total Body According to Tanner Puberty Stage (BMC [TB] [SDS/Tanner Puberty Stage])Year 2 (n = 9, 7)-0.47 SDS
Somatropin- Up To Year 3 (Nephrotic Syndrome)Bone Mineral Content Standard Deviation Score of Total Body According to Tanner Puberty Stage (BMC [TB] [SDS/Tanner Puberty Stage])Year 1 (n = 10, 8)-0.52 SDS
Secondary

Bone Mineral Density of Lumbar Spine (BMD [LS])

BMD (LS) was assessed by DEXA scan.

Time frame: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11

Population: FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.

ArmMeasureGroupValue (MEDIAN)
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Bone Mineral Density of Lumbar Spine (BMD [LS])Year 3 (n = 13, 12)0.74 g/cm^2
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Bone Mineral Density of Lumbar Spine (BMD [LS])Year 1 (n = 14, 14)0.61 g/cm^2
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Bone Mineral Density of Lumbar Spine (BMD [LS])Baseline (n = 15, 15)0.55 g/cm^2
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Bone Mineral Density of Lumbar Spine (BMD [LS])Year 2 (n = 15, 14)0.64 g/cm^2
Somatropin- Up To Year 3 (Nephrotic Syndrome)Bone Mineral Density of Lumbar Spine (BMD [LS])Baseline (n = 15, 15)0.72 g/cm^2
Somatropin- Up To Year 3 (Nephrotic Syndrome)Bone Mineral Density of Lumbar Spine (BMD [LS])Year 3 (n = 13, 12)0.93 g/cm^2
Somatropin- Up To Year 3 (Nephrotic Syndrome)Bone Mineral Density of Lumbar Spine (BMD [LS])Year 2 (n = 15, 14)0.85 g/cm^2
Somatropin- Up To Year 3 (Nephrotic Syndrome)Bone Mineral Density of Lumbar Spine (BMD [LS])Year 1 (n = 14, 14)0.76 g/cm^2
Secondary

Bone Mineral Density of Total Body (BMD [TB])

BMD (TB) was assessed by DEXA scan.

Time frame: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11

Population: FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.

ArmMeasureGroupValue (MEDIAN)
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Bone Mineral Density of Total Body (BMD [TB])Baseline (n = 15, 15)0.78 gram per square centimeter (g/cm^2)
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Bone Mineral Density of Total Body (BMD [TB])Year 1 (n = 15, 14)0.80 gram per square centimeter (g/cm^2)
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Bone Mineral Density of Total Body (BMD [TB])Year 2 (n = 14, 11)0.81 gram per square centimeter (g/cm^2)
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Bone Mineral Density of Total Body (BMD [TB])Year 3 (n = 13, 11)0.84 gram per square centimeter (g/cm^2)
Somatropin- Up To Year 3 (Nephrotic Syndrome)Bone Mineral Density of Total Body (BMD [TB])Year 3 (n = 13, 11)0.99 gram per square centimeter (g/cm^2)
Somatropin- Up To Year 3 (Nephrotic Syndrome)Bone Mineral Density of Total Body (BMD [TB])Baseline (n = 15, 15)0.90 gram per square centimeter (g/cm^2)
Somatropin- Up To Year 3 (Nephrotic Syndrome)Bone Mineral Density of Total Body (BMD [TB])Year 2 (n = 14, 11)0.96 gram per square centimeter (g/cm^2)
Somatropin- Up To Year 3 (Nephrotic Syndrome)Bone Mineral Density of Total Body (BMD [TB])Year 1 (n = 15, 14)0.92 gram per square centimeter (g/cm^2)
Secondary

Fat Mass

Fat mass, a measurement of body composition, was assessed by DEXA scan.

Time frame: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11

Population: FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.

ArmMeasureGroupValue (MEDIAN)
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Fat MassYear 2 (n = 14, 12)6.97 kg
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Fat MassYear 1 (n = 15, 13)4.81 kg
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Fat MassYear 3 (n = 14, 11)6.90 kg
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Fat MassBaseline (n = 15, 15)5.47 kg
Somatropin- Up To Year 3 (Nephrotic Syndrome)Fat MassYear 3 (n = 14, 11)15.19 kg
Somatropin- Up To Year 3 (Nephrotic Syndrome)Fat MassYear 1 (n = 15, 13)10.99 kg
Somatropin- Up To Year 3 (Nephrotic Syndrome)Fat MassYear 2 (n = 14, 12)16.70 kg
Somatropin- Up To Year 3 (Nephrotic Syndrome)Fat MassBaseline (n = 15, 15)13.62 kg
Secondary

Fat Mass as Percentage of Total Weight

Fat mass, a measurement of body composition, was assessed by DEXA scan.

Time frame: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11

Population: FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.

ArmMeasureGroupValue (MEDIAN)
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Fat Mass as Percentage of Total WeightYear 2 (n = 14, 12)21.1 percentage of total weight
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Fat Mass as Percentage of Total WeightYear 1 (n = 15, 13)17.4 percentage of total weight
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Fat Mass as Percentage of Total WeightYear 3 (n = 14, 11)21.3 percentage of total weight
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Fat Mass as Percentage of Total WeightBaseline (n = 15, 15)25.0 percentage of total weight
Somatropin- Up To Year 3 (Nephrotic Syndrome)Fat Mass as Percentage of Total WeightYear 3 (n = 14, 11)26.4 percentage of total weight
Somatropin- Up To Year 3 (Nephrotic Syndrome)Fat Mass as Percentage of Total WeightBaseline (n = 15, 15)33.8 percentage of total weight
Somatropin- Up To Year 3 (Nephrotic Syndrome)Fat Mass as Percentage of Total WeightYear 1 (n = 15, 13)30.0 percentage of total weight
Somatropin- Up To Year 3 (Nephrotic Syndrome)Fat Mass as Percentage of Total WeightYear 2 (n = 14, 12)27.1 percentage of total weight
Secondary

Fat Mass Standard Deviation Score According to Chronological Age (SDS/CA)

Fat mass was assessed by DEXA scan. Fat mass SDS/CA was obtained by measuring fat mass, subtracting chronological age- and gender-appropriate mean fat mass and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population.

Time frame: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11

Population: FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.

ArmMeasureGroupValue (MEDIAN)
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Fat Mass Standard Deviation Score According to Chronological Age (SDS/CA)Baseline (n = 15, 15)1.51 SDS
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Fat Mass Standard Deviation Score According to Chronological Age (SDS/CA)Year 2 (n = 14, 12)0.86 SDS
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Fat Mass Standard Deviation Score According to Chronological Age (SDS/CA)Year 3 (n = 13, 11)1.27 SDS
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Fat Mass Standard Deviation Score According to Chronological Age (SDS/CA)Year 1 (n = 15, 13)0.80 SDS
Somatropin- Up To Year 3 (Nephrotic Syndrome)Fat Mass Standard Deviation Score According to Chronological Age (SDS/CA)Year 3 (n = 13, 11)1.74 SDS
Somatropin- Up To Year 3 (Nephrotic Syndrome)Fat Mass Standard Deviation Score According to Chronological Age (SDS/CA)Year 1 (n = 15, 13)1.98 SDS
Somatropin- Up To Year 3 (Nephrotic Syndrome)Fat Mass Standard Deviation Score According to Chronological Age (SDS/CA)Year 2 (n = 14, 12)1.79 SDS
Somatropin- Up To Year 3 (Nephrotic Syndrome)Fat Mass Standard Deviation Score According to Chronological Age (SDS/CA)Baseline (n = 15, 15)2.20 SDS
Secondary

Lean Body Mass

Lean body mass, a measurement of body composition, was assessed by Dual Energy X-ray Absorptiometry (DEXA) scan.

Time frame: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11

Population: FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.

ArmMeasureGroupValue (MEDIAN)
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Lean Body MassBaseline (n = 15, 15)17.69 kilogram (kg)
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Lean Body MassYear 1 (n = 15, 13)19.77 kilogram (kg)
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Lean Body MassYear 2 (n = 14, 12)21.20 kilogram (kg)
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Lean Body MassYear 3 (n = 14, 11)23.21 kilogram (kg)
Somatropin- Up To Year 3 (Nephrotic Syndrome)Lean Body MassYear 3 (n = 14, 11)36.38 kilogram (kg)
Somatropin- Up To Year 3 (Nephrotic Syndrome)Lean Body MassBaseline (n = 15, 15)23.56 kilogram (kg)
Somatropin- Up To Year 3 (Nephrotic Syndrome)Lean Body MassYear 2 (n = 14, 12)34.14 kilogram (kg)
Somatropin- Up To Year 3 (Nephrotic Syndrome)Lean Body MassYear 1 (n = 15, 13)31.16 kilogram (kg)
Secondary

Lean Body Mass as Percentage of Total Weight

Lean body mass, a measurement of body composition, was assessed by DEXA scan.

Time frame: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11

Population: FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.

ArmMeasureGroupValue (MEDIAN)
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Lean Body Mass as Percentage of Total WeightBaseline (n = 15, 15)70.56 percentage of total weight
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Lean Body Mass as Percentage of Total WeightYear 1 (n = 15, 13)76.57 percentage of total weight
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Lean Body Mass as Percentage of Total WeightYear 2 (n = 14, 12)73.32 percentage of total weight
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Lean Body Mass as Percentage of Total WeightYear 3 (n = 14, 11)72.94 percentage of total weight
Somatropin- Up To Year 3 (Nephrotic Syndrome)Lean Body Mass as Percentage of Total WeightYear 3 (n = 14, 11)67.24 percentage of total weight
Somatropin- Up To Year 3 (Nephrotic Syndrome)Lean Body Mass as Percentage of Total WeightBaseline (n = 15, 15)60.69 percentage of total weight
Somatropin- Up To Year 3 (Nephrotic Syndrome)Lean Body Mass as Percentage of Total WeightYear 2 (n = 14, 12)69.95 percentage of total weight
Somatropin- Up To Year 3 (Nephrotic Syndrome)Lean Body Mass as Percentage of Total WeightYear 1 (n = 15, 13)65.97 percentage of total weight
Secondary

Lean Body Mass Standard Deviation Score According to Chronological Age (SDS/CA)

Lean body mass was assessed by DEXA scan. Lean body mass SDS/CA was obtained by measuring lean body mass, subtracting the chronological age- and gender-appropriate mean lean body mass and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population.

Time frame: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11

Population: FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.

ArmMeasureGroupValue (MEDIAN)
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Lean Body Mass Standard Deviation Score According to Chronological Age (SDS/CA)Baseline (n = 15, 15)-1.50 SDS
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Lean Body Mass Standard Deviation Score According to Chronological Age (SDS/CA)Year 1 (n = 15, 13)-1.13 SDS
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Lean Body Mass Standard Deviation Score According to Chronological Age (SDS/CA)Year 2 (n = 14, 12)-1.26 SDS
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Lean Body Mass Standard Deviation Score According to Chronological Age (SDS/CA)Year 3 (n = 13, 11)-1.75 SDS
Somatropin- Up To Year 3 (Nephrotic Syndrome)Lean Body Mass Standard Deviation Score According to Chronological Age (SDS/CA)Year 3 (n = 13, 11)-1.29 SDS
Somatropin- Up To Year 3 (Nephrotic Syndrome)Lean Body Mass Standard Deviation Score According to Chronological Age (SDS/CA)Baseline (n = 15, 15)-0.90 SDS
Somatropin- Up To Year 3 (Nephrotic Syndrome)Lean Body Mass Standard Deviation Score According to Chronological Age (SDS/CA)Year 2 (n = 14, 12)-0.87 SDS
Somatropin- Up To Year 3 (Nephrotic Syndrome)Lean Body Mass Standard Deviation Score According to Chronological Age (SDS/CA)Year 1 (n = 15, 13)-0.52 SDS
Secondary

Percent Change From Baseline in Bone Mineral Content of Total Body (BMC [TB]) at Year 3

BMC is an estimate of the amount of mineral (such as calcium) in the bone. Percent change: (BMC \[TB\] at Year 3 minus BMC \[TB\] at baseline) divided by BMC \[TB\] at baseline, multiplied by 100.

Time frame: Baseline, Year 3

Population: FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

ArmMeasureValue (MEDIAN)
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Percent Change From Baseline in Bone Mineral Content of Total Body (BMC [TB]) at Year 346.63 percent change
Somatropin- Up To Year 3 (Nephrotic Syndrome)Percent Change From Baseline in Bone Mineral Content of Total Body (BMC [TB]) at Year 360.56 percent change
Secondary

Percent Change From Baseline in Fat Mass at Year 3

Fat mass, a measurement of body composition, was assessed by DEXA scan. Percent change: (Fat mass at Year 3 minus fat mass at baseline) divided by fat mass at baseline, multiplied by 100.

Time frame: Baseline, Year 3

Population: FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

ArmMeasureValue (MEDIAN)
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Percent Change From Baseline in Fat Mass at Year 319.46 percent change
Somatropin- Up To Year 3 (Nephrotic Syndrome)Percent Change From Baseline in Fat Mass at Year 337.56 percent change
Secondary

Percent Change From Baseline in Lean Body Mass at Year 3

Lean body mass, a measurement of body composition, was assessed by DEXA scan. Percent change: (Lean body mass at Year 3 minus lean body mass at baseline) divided by lean body mass at baseline, multiplied by 100.

Time frame: Baseline, Year 3

Population: FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

ArmMeasureValue (MEDIAN)
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Percent Change From Baseline in Lean Body Mass at Year 336.82 percent change
Somatropin- Up To Year 3 (Nephrotic Syndrome)Percent Change From Baseline in Lean Body Mass at Year 354.44 percent change
Other Pre-specified

Growth Velocity (GV)

Growth velocity measures the annual rate of increase in height.

Time frame: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11

Population: FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.

ArmMeasureGroupValue (MEDIAN)
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Growth Velocity (GV)Year 2 (n = 14, 15)5.3 cm/year
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Growth Velocity (GV)Baseline (n = 11, 14)2.9 cm/year
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Growth Velocity (GV)Year 3 (n = 14, 14)4.5 cm/year
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Growth Velocity (GV)Year 1 (n = 14, 15)6.5 cm/year
Somatropin- Up To Year 3 (Nephrotic Syndrome)Growth Velocity (GV)Year 3 (n = 14, 14)5.9 cm/year
Somatropin- Up To Year 3 (Nephrotic Syndrome)Growth Velocity (GV)Year 1 (n = 14, 15)8.3 cm/year
Somatropin- Up To Year 3 (Nephrotic Syndrome)Growth Velocity (GV)Year 2 (n = 14, 15)7.0 cm/year
Somatropin- Up To Year 3 (Nephrotic Syndrome)Growth Velocity (GV)Baseline (n = 11, 14)3.8 cm/year
Other Pre-specified

Growth Velocity Standard Deviation Score According to Bone Age (GV [SDS/BA])

GV measures the annual rate of increase in height. GV (SDS/BA) was obtained by measuring GV, subtracting the bone age- and gender-appropriate mean GV and dividing the result by standard deviation of that mean (as obtained from bone age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population.

Time frame: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11

Population: FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.

ArmMeasureGroupValue (MEDIAN)
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Growth Velocity Standard Deviation Score According to Bone Age (GV [SDS/BA])Baseline (n = 9, 14)-2.8 SDS
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Growth Velocity Standard Deviation Score According to Bone Age (GV [SDS/BA])Year 1 (n = 13, 15)0.8 SDS
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Growth Velocity Standard Deviation Score According to Bone Age (GV [SDS/BA])Year 2 (n = 14, 13)-0.3 SDS
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Growth Velocity Standard Deviation Score According to Bone Age (GV [SDS/BA])Year 3 (n = 14, 14)-0.9 SDS
Somatropin- Up To Year 3 (Nephrotic Syndrome)Growth Velocity Standard Deviation Score According to Bone Age (GV [SDS/BA])Year 3 (n = 14, 14)0.1 SDS
Somatropin- Up To Year 3 (Nephrotic Syndrome)Growth Velocity Standard Deviation Score According to Bone Age (GV [SDS/BA])Baseline (n = 9, 14)-2.1 SDS
Somatropin- Up To Year 3 (Nephrotic Syndrome)Growth Velocity Standard Deviation Score According to Bone Age (GV [SDS/BA])Year 2 (n = 14, 13)1.4 SDS
Somatropin- Up To Year 3 (Nephrotic Syndrome)Growth Velocity Standard Deviation Score According to Bone Age (GV [SDS/BA])Year 1 (n = 13, 15)0.6 SDS
Other Pre-specified

Growth Velocity Standard Deviation Score According to Chronological Age (GV [SDS/CA])

GV measures the annual rate of increase in height. GV (SDS/CA) was obtained by measuring GV, subtracting the chronological age- and gender-appropriate mean GV and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population.

Time frame: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11

Population: FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.

ArmMeasureGroupValue (MEDIAN)
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Growth Velocity Standard Deviation Score According to Chronological Age (GV [SDS/CA])Baseline (n = 10, 14)-1.7 SDS
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Growth Velocity Standard Deviation Score According to Chronological Age (GV [SDS/CA])Year 1 (n = 14, 15)1.0 SDS
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Growth Velocity Standard Deviation Score According to Chronological Age (GV [SDS/CA])Year 2 (n = 14, 15)0.1 SDS
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Growth Velocity Standard Deviation Score According to Chronological Age (GV [SDS/CA])Year 3 (n = 14, 14)0.4 SDS
Somatropin- Up To Year 3 (Nephrotic Syndrome)Growth Velocity Standard Deviation Score According to Chronological Age (GV [SDS/CA])Year 3 (n = 14, 14)2.9 SDS
Somatropin- Up To Year 3 (Nephrotic Syndrome)Growth Velocity Standard Deviation Score According to Chronological Age (GV [SDS/CA])Baseline (n = 10, 14)-2.2 SDS
Somatropin- Up To Year 3 (Nephrotic Syndrome)Growth Velocity Standard Deviation Score According to Chronological Age (GV [SDS/CA])Year 2 (n = 14, 15)2.9 SDS
Somatropin- Up To Year 3 (Nephrotic Syndrome)Growth Velocity Standard Deviation Score According to Chronological Age (GV [SDS/CA])Year 1 (n = 14, 15)1.3 SDS
Other Pre-specified

Insulin-like Growth Factor-1 (IGF-1) Concentration After Year 3

Time frame: Year 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10; 0.5 and 1 year after somatropin discontinuation, Final Height (assessed up to Year 11)

Population: FAS After year 3: included all participants who received at least 1 dose of the study treatment and who had at least 1 post-baseline height measurement. Here, 'n' signifies those participants who were evaluable for this measure at given time point.

ArmMeasureGroupValue (MEDIAN)
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Insulin-like Growth Factor-1 (IGF-1) Concentration After Year 3Year 3.5 (n = 8)0.05 milligram per deciliter (mg/dL)
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Insulin-like Growth Factor-1 (IGF-1) Concentration After Year 3Year 4 (n = 19)0.06 milligram per deciliter (mg/dL)
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Insulin-like Growth Factor-1 (IGF-1) Concentration After Year 3Year 4.5 (n = 16)0.06 milligram per deciliter (mg/dL)
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Insulin-like Growth Factor-1 (IGF-1) Concentration After Year 3Year 5 (n = 17)0.05 milligram per deciliter (mg/dL)
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Insulin-like Growth Factor-1 (IGF-1) Concentration After Year 3Year 5.5 (n = 11)0.06 milligram per deciliter (mg/dL)
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Insulin-like Growth Factor-1 (IGF-1) Concentration After Year 3Year 6 (n = 14)0.05 milligram per deciliter (mg/dL)
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Insulin-like Growth Factor-1 (IGF-1) Concentration After Year 3Year 6.5 (n = 8)0.07 milligram per deciliter (mg/dL)
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Insulin-like Growth Factor-1 (IGF-1) Concentration After Year 3Year 7 (n = 8)0.06 milligram per deciliter (mg/dL)
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Insulin-like Growth Factor-1 (IGF-1) Concentration After Year 3Year 7.5 (n = 4)0.05 milligram per deciliter (mg/dL)
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Insulin-like Growth Factor-1 (IGF-1) Concentration After Year 3Year 8 (n = 6)0.06 milligram per deciliter (mg/dL)
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Insulin-like Growth Factor-1 (IGF-1) Concentration After Year 3Year 8.5 (n = 2)0.08 milligram per deciliter (mg/dL)
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Insulin-like Growth Factor-1 (IGF-1) Concentration After Year 3Year 9 (n = 2)0.06 milligram per deciliter (mg/dL)
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Insulin-like Growth Factor-1 (IGF-1) Concentration After Year 3Year 9.5 (n = 1)0.07 milligram per deciliter (mg/dL)
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Insulin-like Growth Factor-1 (IGF-1) Concentration After Year 3Year 10 (n = 1)0.05 milligram per deciliter (mg/dL)
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Insulin-like Growth Factor-1 (IGF-1) Concentration After Year 30.5 years after somatropin discontinuation (n = 2)0.03 milligram per deciliter (mg/dL)
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Insulin-like Growth Factor-1 (IGF-1) Concentration After Year 31 year after somatropin discontinuation (n = 2)0.03 milligram per deciliter (mg/dL)
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Insulin-like Growth Factor-1 (IGF-1) Concentration After Year 3Final height (n = 3)0.06 milligram per deciliter (mg/dL)
Other Pre-specified

Insulin-like Growth Factor-1 (IGF-1) Concentration up to Year 3

Time frame: Baseline, Year 1, 2, 3

Population: FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.

ArmMeasureGroupValue (MEDIAN)
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Insulin-like Growth Factor-1 (IGF-1) Concentration up to Year 3Baseline (n = 15, 12)157.0 nanogram per milliliter (ng/mL)
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Insulin-like Growth Factor-1 (IGF-1) Concentration up to Year 3Year 1 (n = 15, 15)400.0 nanogram per milliliter (ng/mL)
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Insulin-like Growth Factor-1 (IGF-1) Concentration up to Year 3Year 2 (n = 15, 14)388.0 nanogram per milliliter (ng/mL)
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Insulin-like Growth Factor-1 (IGF-1) Concentration up to Year 3Year 3 (n = 15, 14)405.0 nanogram per milliliter (ng/mL)
Somatropin- Up To Year 3 (Nephrotic Syndrome)Insulin-like Growth Factor-1 (IGF-1) Concentration up to Year 3Year 3 (n = 15, 14)657.0 nanogram per milliliter (ng/mL)
Somatropin- Up To Year 3 (Nephrotic Syndrome)Insulin-like Growth Factor-1 (IGF-1) Concentration up to Year 3Baseline (n = 15, 12)344.5 nanogram per milliliter (ng/mL)
Somatropin- Up To Year 3 (Nephrotic Syndrome)Insulin-like Growth Factor-1 (IGF-1) Concentration up to Year 3Year 2 (n = 15, 14)880.0 nanogram per milliliter (ng/mL)
Somatropin- Up To Year 3 (Nephrotic Syndrome)Insulin-like Growth Factor-1 (IGF-1) Concentration up to Year 3Year 1 (n = 15, 15)952.0 nanogram per milliliter (ng/mL)

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026