Status:
COMPLETED
Efficacy and Safety of Growth Hormone Treatment in Juvenile Idiopathic Arthritis
Lead Sponsor:
Ludwig-Maximilians - University of Munich
Collaborating Sponsors:
Pfizer
Conditions:
Juvenile Idiopathic Arthritis
Still Disease, Juvenile-Onset
Eligibility:
All Genders
4-14 years
Phase:
PHASE3
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. Th...
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. Th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 1996
Trial Type :
INTERVENTIONAL
End Date :
July 1 2006
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00420251
Start Date
March 1 1996
End Date
July 1 2006
Last Update
January 11 2007
Active Locations (1)
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1
Center For Rheumatic Diseases in Childhood
Garmisch-Partenkirchen, Germany, 82152