Efficacy and Safety of Growth Hormone Treatment in Juvenile Idiopathic Arthritis
Primary Purpose
Juvenile Idiopathic Arthritis, Still Disease, Juvenile-Onset
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Genotropin
Sponsored by
About this trial
This is an interventional treatment trial for Juvenile Idiopathic Arthritis
Eligibility 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
Sites / Locations
- Center For Rheumatic Diseases in Childhood
Outcomes
Primary Outcome Measures
Final height
Secondary Outcome Measures
Bone geometry and density
Full Information
NCT ID
NCT00420251
First Posted
January 9, 2007
Last Updated
January 9, 2007
Sponsor
Ludwig-Maximilians - University of Munich
Collaborators
Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00420251
Brief Title
Efficacy and Safety of Growth Hormone Treatment in Juvenile Idiopathic Arthritis
Official Title
Recombinant Human Growth Hormone Treatment in Juvenile Idiopathic Arthritis: Controlled Study on the Effect on Growth and Bone Development
Study Type
Interventional
2. Study Status
Record Verification Date
January 2007
Overall Recruitment Status
Completed
Study Start Date
March 1996 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Ludwig-Maximilians - University of Munich
Collaborators
Pfizer
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Juvenile Idiopathic Arthritis, Still Disease, Juvenile-Onset
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Genotropin
Primary Outcome Measure Information:
Title
Final height
Secondary Outcome Measure Information:
Title
Bone geometry and density
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susanne M Bechtold, MD
Organizational Affiliation
University Children´s Hospital, Munich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center For Rheumatic Diseases in Childhood
City
Garmisch Partenkirchen
ZIP/Postal Code
82152
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
11739431
Citation
Bechtold S, Ripperger P, Muhlbayer D, Truckenbrodt H, Hafner R, Butenandt O, Schwarz HP. GH therapy in juvenile chronic arthritis: results of a two-year controlled study on growth and bone. J Clin Endocrinol Metab. 2001 Dec;86(12):5737-44. doi: 10.1210/jcem.86.12.8083.
Results Reference
result
PubMed Identifier
14571231
Citation
Bechtold S, Ripperger P, Hafner R, Said E, Schwarz HP. Growth hormone improves height in patients with juvenile idiopathic arthritis: 4-year data of a controlled study. J Pediatr. 2003 Oct;143(4):512-9. doi: 10.1067/S0022-3476(03)00390-1.
Results Reference
result
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Efficacy and Safety of Growth Hormone Treatment in Juvenile Idiopathic Arthritis
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