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

Pfizer

Status and phase: Terminated; Phase 3

Conditions: Endocrine System Diseases

Treatments: Drug: Somatropin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00174291

307-MET-9002-052

A6281024

Details and patient eligibility

About

• 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

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 4 to 14 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

Somatropin

Experimental group

Treatment:

Drug: Somatropin