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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
  Purpose

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.


Condition Intervention Phase
Juvenile Idiopathic Arthritis
Still Disease, Juvenile-Onset
 Drug: Genotropin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Recombinant Human Growth Hormone Treatment in Juvenile Idiopathic Arthritis: Controlled Study on the Effect on Growth and Bone Development

Resource links provided by NLM:

Drug Information available for: Somatropin
U.S. FDA Resources

Further study details as provided by Ludwig-Maximilians - University of Munich:

Primary Outcome Measures:
  • Final height

Secondary Outcome Measures:
  • Bone geometry and density

Estimated Enrollment: 50
Study Start Date: March 1996
Estimated Study Completion Date: July 2006
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.

  Eligibility

Ages Eligible for Study:   4 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00420251

Locations
Germany
Center For Rheumatic Diseases in Childhood
Garmisch Partenkirchen, Germany, 82152
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Pfizer
Investigators
Principal Investigator: Susanne M Bechtold, MD University Children´s Hospital, Munich
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00420251     History of Changes
Other Study ID Numbers: 13042004
Study First Received: January 9, 2007
Last Updated: January 9, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Arthritis
Arthritis, Juvenile Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Connective Tissue Diseases
 Autoimmune Diseases
Immune System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013