Efficacy and Safety of Growth Hormone Treatment in Juvenile Idiopathic Arthritis

Phase 3

Completed

• Conditions: Juvenile Idiopathic Arthritis; Still Disease, Juvenile-Onset

• Registration Number: NCT00420251
• Lead Sponsor: Ludwig-Maximilians - University of Munich

Brief Summary

Growth retardation is well known in patients with severe forms of juvenile idiopathic arthritis. Especially those who were under additional treatment with glucocorticoids for high disease activity. The hypothesis is, that treatment with growth hormone can, at leat in part, overcome growth hormone resistance state and increase final height. In a controlled study we follow patients with juvenile idiopathic arthritis with and without growth hormone treatment until final height. Additionally, we are interested in bone density development in those treated with growth hormone.

Detailed Description

Growth retardation is well known in patients with severe forms of juvenile idiopathic arthritis. Especially those who were under additional treatment with glucocorticoids for high disease activity. This is the case in patients with a polyarticular and a systemic form of juvenile idiopathic arthritis. The permanent consequence is short stature at final height. Up to 30% of these patients will have a final height below the 3rd percentile, even after discontinuation of glucocorticoid treatment. The hypothesis is, that treatment with growth hormone can, at leat in part, overcome growth hormone resistance state and increase final height. In a controlled study we follow patients with juvenile idiopathic arthritis with and without growth hormone treatment until final height. From safety aspects we were interested in the effect of growth hormone on the disease activity. Additionally, we are interested in bone density development in those treated with growth hormone up to final height.

Study Timeline

• Study Start: 1996-03
• Study Completion: 2006-07
• Status Verified: 2007-01
• Study First Submitted: 2007-01-09
• Study First Submitted QC: 2007-01-09
• Last Update Submitted: 2007-01-09
• Study First Posted: 2007-01-11
• Last Update Posted: 2007-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Polyarticular or systemic juvenile idiopathic arthritis,
• Growth velocity below the 25th percentile and or short stature ,
• Treatment with glucocorticoids for at least the previous 6 months before inclusion,
• Prepubertal stage,
• Bone age below 10 in girls and 12 in boys,
• Growth hormone levels after stimulation with clonidine or arginine above 10 ng/ml

Exclusion Criteria

• Previous treatment with growth hormone,
• Endocrinopathy,
• Additional chronic disease beside juvenile idiopathic arthritis,
• Malignant disase,
• Chromosomal aberration or othe syndromal disease,
• Previous treatment with Oxandrolone,
• Small for gestational age,
• Elevated fasting glucose level

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Final height

Secondary Outcome Measures

Name	Time	Method
Bone geometry and density

Trial Locations

Locations (1)

Center For Rheumatic Diseases in Childhood; 🇩🇪 Garmisch Partenkirchen, Germany