Efficacy and Safety of Growth Hormone Treatment in Juvenile Idiopathic Arthritis

• Status: Completed
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ludwig-Maximilians - University of Munich
• Collaborator: Pfizer
• Treatments: Hormones

Criteria

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