Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2026-01-01 @ 6:51 PM
Study NCT ID:
NCT00420251
Status:
COMPLETED
Last Update Posted:
2007-01-11
First Post:
2007-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Growth Hormone Treatment in Juvenile Idiopathic Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001171', 'term': 'Arthritis, Juvenile'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019382', 'term': 'Human Growth Hormone'}], 'ancestors': [{'id': 'D013006', 'term': 'Growth Hormone'}, {'id': 'D010908', 'term': 'Pituitary Hormones, Anterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1996-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-01', 'completionDateStruct': {'date': '2006-07'}, 'lastUpdateSubmitDate': '2007-01-09', 'studyFirstSubmitDate': '2007-01-09', 'studyFirstSubmitQcDate': '2007-01-09', 'lastUpdatePostDateStruct': {'date': '2007-01-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-01-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Final height'}], 'secondaryOutcomes': [{'measure': 'Bone geometry and density'}]}, 'conditionsModule': {'conditions': ['Juvenile Idiopathic Arthritis', 'Still Disease, Juvenile-Onset']}, 'referencesModule': {'references': [{'pmid': '11739431', 'type': 'RESULT', '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.'}, {'pmid': '14571231', 'type': 'RESULT', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Polyarticular or systemic juvenile idiopathic arthritis,\n* Growth velocity below the 25th percentile and or short stature ,\n* Treatment with glucocorticoids for at least the previous 6 months before inclusion,\n* Prepubertal stage,\n* Bone age below 10 in girls and 12 in boys,\n* Growth hormone levels after stimulation with clonidine or arginine above 10 ng/ml\n\nExclusion Criteria:\n\n* Previous treatment with growth hormone,\n* Endocrinopathy,\n* Additional chronic disease beside juvenile idiopathic arthritis,\n* Malignant disase,\n* Chromosomal aberration or othe syndromal disease,\n* Previous treatment with Oxandrolone,\n* Small for gestational age,\n* Elevated fasting glucose level'}, 'identificationModule': {'nctId': 'NCT00420251', 'briefTitle': 'Efficacy and Safety of Growth Hormone Treatment in Juvenile Idiopathic Arthritis', 'organization': {'class': 'OTHER', 'fullName': 'Ludwig-Maximilians - University of Munich'}, 'officialTitle': 'Recombinant Human Growth Hormone Treatment in Juvenile Idiopathic Arthritis: Controlled Study on the Effect on Growth and Bone Development', 'orgStudyIdInfo': {'id': '13042004'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Genotropin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '82152', 'city': 'Garmisch-Partenkirchen', 'country': 'Germany', 'facility': 'Center For Rheumatic Diseases in Childhood', 'geoPoint': {'lat': 47.49209, 'lon': 11.09576}}], 'overallOfficials': [{'name': 'Susanne M Bechtold, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Children´s Hospital, Munich'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ludwig-Maximilians - University of Munich', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}]}}}