Trial · Interventional

TerminatedPhase 3Results postedRegistry data

Prevention of Growth Retardation by Early Treatment With Growth Hormone (GH) in Children With CJA Treated by Corticosteroid Therapy

NCTNCT00174291Other id307-MET-9002-052Other idA6281024

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

Reason given at the registry: See termination reason in detailed description.

Results were posted for this trial.

Overview

Status: Terminated
Phase: Phase 3
Enrollment: 21 participants (actual)
Sponsor: Pfizer · Industry
Design: Not randomized · Open label (no masking)
Countries: 1 country
France
Start: Mar 2002
Primary completion: Oct 2011
Completion: Oct 2011
First posted: 15 Sept 2005 (estimated)
Last update posted: 4 Dec 2012 (estimated)
Conditions: Endocrine System Diseases

Timeline

1 trial · 1 stopped early · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

200220042006200820102012

Ph 3
Prevention of Growth Retardation by Early Treatment With Growth Hormone (GH) in Children With CJA Treated by Corticosteroid Therapy
NCT00174291
Mar 2002 to Oct 2011
Terminated
Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

* To evaluate the effect of increasing the growth hormone dose on the statural response * To assess the value of early treatment during the course of arthritic disease by comparing the height acquired in the medium term by children in the two groups: treated from the start, or 1 year to 15 months after the diagnosis of CJA, or treated for 4 years after the diagnosis

Interventions

SomatropinDrug

Arms1

Experimental
Somatropin

Primary outcomes6

Outcomes the sponsor listed as primary.

Change From Baseline in Annual Rate of Growth Standard Deviation Score (SDS) at Year 3
Time frame · Baseline, Year 3
Registry description
Annual rate of growth SDS was obtained by measuring the annual growth rate, subtracting chronological age- and gender-appropriate mean annual growth rate 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 Annual Rate of Growth Standard Deviation Score (SDS) at Final Height
Time frame · Baseline, final height (assessed up to Year 9.5)
Registry description
Annual rate of growth SDS was obtained by measuring the annual growth rate, subtracting chronological age- and gender-appropriate mean annual growth rate 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 (SDS) at Year 3
Time frame · Baseline, Year 3
Registry description
Height was measured using a wall mounted device (example, Harpenden stadiometer). Height SDS 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 (SDS) at Final Height
Time frame · Baseline, final height (assessed up to Year 9.5)
Registry description
Height was measured using a wall mounted device (example, Harpenden stadiometer). Height SDS 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 Predicted Height Standard Deviation Score (SDS) at Year 3
Time frame · Baseline, Year 3
Registry description
Predicted height was calculated according to Greulich and Pyle using Bayley Pinneau method. Predicted height SDS was obtained by calculating the predicted height, subtracting chronological age- and gender-appropriate mean predicted 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 Predicted Height Standard Deviation Score (SDS) at Final Height
Time frame · Baseline, final height (assessed up to Year 9.5)
Registry description
Predicted height was calculated according to Greulich and Pyle using Bayley Pinneau method. Predicted height SDS was obtained by calculating the predicted height, subtracting chronological age- and gender-appropriate mean predicted 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.

Secondary outcomes(6)

Change From Baseline in Insulin-like Growth Factor-1 (IGF-1) Concentration at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9
Time frame · Baseline, Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9
Change From Baseline in Insulin-like Growth Factor Binding Protein 3 (IGFBP3) Concentration at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9
Time frame · Baseline, Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9
Change From Baseline in Lean Mass and Fat Mass at Year 1, 2, 3, 4, 5, 6, 7, 8 and 9
Time frame · Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9
Registry description
Lean mass and fat mass: measurements of body composition assessed using Dual Energy X-ray Absorptiometry (DEXA) scan.
Change From Baseline in Bone Mineralization at Year 1, 2, 3, 4, 5, 6, 7, 8 and 9
Time frame · Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9
Registry description
Bone mineralization, an estimate of the amount of mineral (such as calcium) in the bone, was assessed using DEXA scan.
Change From Baseline in Weight Standard Deviation Score (SDS) at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9
Time frame · Baseline, Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9
Registry description
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.
Change From Baseline in Corticosteroid Dose at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9
Time frame · Baseline, Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMedian· Baseline, Year 3

Change From Baseline in Annual Rate of Growth Standard Deviation Score (SDS) at Year 3

Group	Value (SDS)
Somatropin (With Previous Somatropin Exposure)	-0.21
Somatropin (Without Previous Somatropin Exposure)	-2.96

Primary outcome· Baseline, final height (assessed up to Year 9.5)

Change From Baseline in Annual Rate of Growth Standard Deviation Score (SDS) at Final Height

Group	Value
Somatropin (With Previous Somatropin Exposure)	not posted
Somatropin (Without Previous Somatropin Exposure)	not posted

Primary outcomeMedian· Baseline, Year 3

Change From Baseline in Height Standard Deviation Score (SDS) at Year 3

Group	Value (SDS)
Somatropin (With Previous Somatropin Exposure)	-0.61
Somatropin (Without Previous Somatropin Exposure)	-2.34

Primary outcomeMedian· Baseline, final height (assessed up to Year 9.5)

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

Group	Value (SDS)
Somatropin (With Previous Somatropin Exposure)	0.96
Somatropin (Without Previous Somatropin Exposure)	-0.94

Primary outcomeMedian· Baseline, Year 3

Change From Baseline in Predicted Height Standard Deviation Score (SDS) at Year 3

Group	Value (SDS)
Somatropin (With Previous Somatropin Exposure)	-0.76
Somatropin (Without Previous Somatropin Exposure)	-2.43

Primary outcomeMedian· Baseline, final height (assessed up to Year 9.5)

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

Group	Value (SDS)
Somatropin (With Previous Somatropin Exposure)	-0.84
Somatropin (Without Previous Somatropin Exposure)	-1.74

Secondary and other outcome results(2)

Secondary outcomeMedian· Baseline, Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9

Change From Baseline in Insulin-like Growth Factor-1 (IGF-1) Concentration at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9

Group	Value (milligram per deciliter (mg/dL))
Somatropin (With Previous Somatropin Exposure)	0.0361
Somatropin (Without Previous Somatropin Exposure)	0.0165

Secondary outcome· Baseline, Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9

Change From Baseline in Insulin-like Growth Factor Binding Protein 3 (IGFBP3) Concentration at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9

Group	Value
Somatropin (With Previous Somatropin Exposure)	not posted
Somatropin (Without Previous Somatropin Exposure)	not posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Somatropin (With Previous Somatropin Exposure)Participants who received low dose of somatropin (Genotonorm) for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 milligram per kilogram per week (mg/kg/week), equivalent to 1.8 international units/kg/week (IU/kg/week), divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 microgram/kg/day (mcg/kg/day), equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.	–	6 / 11	11 / 11
Somatropin (Without Previous Somatropin Exposure)Participants who received matching placebo for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 mg/kg/week, equivalent to 1.8 IU/kg/week, divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 mcg/kg/day, equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 cm per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.	–	2 / 10	9 / 10

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

DerivedDavid H, Aupiais C, Louveau B, Quartier P, Jacqz-Aigrain E, Carel JC, Simon D. Growth Outcomes After GH Therapy of Patients Given Long-Term Corticosteroids for Juvenile Idiopathic Arthritis. J Clin Endocrinol Metab. 2017 Dec 1;102(12):4578-4587. doi: 10.1210/jc.2017-01455. PMID 29029101

Eligibility

Who could join, as posted.

Sex: All
Age: from 4 Years up to 14 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * This study will be proposed to all patients previously included in study CTN 97-8129-016 Exclusion Criteria: * Discontinuation of corticosteroid therapy for more than a year during study CTN 97-8129-016 * Patients withdrawing from the study prematurely

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