Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Efficacy and Safety of Growth Hormone Treatment in Juvenile Idiopathic Arthritis

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT00420251
First received: January 9, 2007
Last updated: NA
Last verified: January 2007
History: No changes posted

January 9, 2007
January 9, 2007
March 1996
Not Provided
Final height
Same as current
No Changes Posted
Bone geometry and density
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Growth Hormone Treatment in Juvenile Idiopathic Arthritis
Recombinant Human Growth Hormone Treatment in Juvenile Idiopathic Arthritis: Controlled Study on the Effect on Growth and Bone Development

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Juvenile Idiopathic Arthritis
  • Still Disease, Juvenile-Onset
Drug: Genotropin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
July 2006
Not Provided

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
Both
4 Years to 14 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00420251
13042004
Not Provided
Not Provided
Ludwig-Maximilians - University of Munich
Pfizer
Principal Investigator: Susanne M Bechtold, MD University Children´s Hospital, Munich
Ludwig-Maximilians - University of Munich
January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP