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Completed

NCT Number: NCT00420251

Efficacy and Safety of Growth Hormone Treatment in Juvenile Idiopathic Arthritis

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.

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Key information

Age range

4 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Center For Rheumatic Diseases in Childhood

Garmisch-Partenkirchen, 82152, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Genotropin

Drug

Primary outcomes

  1. Final height

Secondary outcomes

  1. Bone geometry and density

Sponsors and collaborators

Lead sponsor

Ludwig-Maximilians - University of Munich

Other

Collaborators

  • Pfizer

Registry information

Official study title

Recombinant Human Growth Hormone Treatment in Juvenile Idiopathic Arthritis: Controlled Study on the Effect on Growth and Bone Development

Important dates

Study start
1996
Study completion
2006
First posted
Jan 11, 2007
Registry last updated
Jan 11, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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