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

Endocrine System Diseases Clinical Trial

Official title:

Prevention of Retarded Growth by Early Treatment With Recombinant Human Growth Factor Genotonorm (Registered) in Children With Systemic Forms of Chronic Juvenile Arthritis Receiving Long-term Corticosteroid Therapy. Extension of the Study Beyond Three Years

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00174291
• Other study ID #: 307-MET-9002-052
• Secondary ID: A6281024
• Status: Terminated
• Phase: Phase 3
• First received: September 9, 2005
• Last updated: October 26, 2012
• Start date: March 2002
• Est. completion date: October 2011

Study information

• Verified date: October 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

• 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 14 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endocrine System Diseases

Intervention

Drug:
• Somatropin
Liquid, daily to final height Maximum Dosage: 50 µg/kg/day

Locations

Country	Name	City	State
France	Pfizer Investigational Site	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Annual Rate of Growth Standard Deviation Score (SDS) at Year 3	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.	Baseline, Year 3	No
Primary	Change From Baseline in Annual Rate of Growth Standard Deviation Score (SDS) at Final Height	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.	Baseline, final height (assessed up to Year 9.5)	No
Primary	Change From Baseline in Height Standard Deviation Score (SDS) at Year 3	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.	Baseline, Year 3	No
Primary	Change From Baseline in Height Standard Deviation Score (SDS) at Final Height	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.	Baseline, final height (assessed up to Year 9.5)	No
Primary	Change From Baseline in Predicted Height Standard Deviation Score (SDS) at Year 3	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.	Baseline, Year 3	No
Primary	Change From Baseline in Predicted Height Standard Deviation Score (SDS) at Final Height	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.	Baseline, final height (assessed up to Year 9.5)	No
Secondary	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		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	No
Secondary	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		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	No
Secondary	Change From Baseline in Lean Mass and Fat Mass at Year 1, 2, 3, 4, 5, 6, 7, 8 and 9	Lean mass and fat mass: measurements of body composition assessed using Dual Energy X-ray Absorptiometry (DEXA) scan.	Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9	No
Secondary	Change From Baseline in Bone Mineralization at Year 1, 2, 3, 4, 5, 6, 7, 8 and 9	Bone mineralization, an estimate of the amount of mineral (such as calcium) in the bone, was assessed using DEXA scan.	Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9	No
Secondary	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	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.	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	No
Secondary	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		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	No

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