Efficacy and Safety of Growth Hormone Treatment in Juvenile Idiopathic Arthritis

Ludwig Maximilian University of Munich

Status and phase: Completed; Phase 3

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

Treatments: Drug: Genotropin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00420251

13042004

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 4 to 14 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)