Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00420251
Status:
COMPLETED
Last Update Posted:
2007-01-11
First Post:
2007-01-09
Brief Title:
Efficacy and Safety of Growth Hormone Treatment in Juvenile Idiopathic Arthritis
Sponsor:
Ludwig-Maximilians - University of Munich
Organization:
Ludwig-Maximilians - University of Munich
Study Overview
Official Title:
Recombinant Human Growth Hormone Treatment in Juvenile Idiopathic Arthritis Controlled Study on the Effect on Growth and Bone Development
Status:
COMPLETED
Status Verified Date:
2007-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None