Prevention of Growth Retardation by Early Treatment With Growth Hormone (GH) in Children With CJA Treated by Corticosteroid Therapy - Full Text View

Sponsor:	Pfizer
Information provided by (Responsible Party):	Pfizer
ClinicalTrials.gov Identifier:	NCT00174291

Purpose

To evaluate the effect of increasing the growth hormone dose on the statural response
To assess the value of early treatment during the course of arthritic disease by comparing the height acquired in the medium term by children in the two groups: treated from the start, or 1 year to 15 months after the diagnosis of CJA, or treated for 4 years after the diagnosis

Condition	Intervention	Phase
Endocrine System Diseases	Drug: Somatropin	Phase III

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Prevention of Retarded Growth by Early Treatment With Recombinant Human Growth Factor Genotonorm (Registered) in Children With Systemic Forms of Chronic Juvenile Arthritis Receiving Long-term Corticosteroid Therapy. Extension of the Study Beyond Three Years

Resource links provided by NLM:

Genetics Home Reference related topics: juvenile idiopathic arthritis

MedlinePlus related topics: Endocrine Diseases

Drug Information available for: Somatropin Corticosteroids Somatotropin

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Statural gain in standard deviation score (SDS), evaluated by changes in size expressed in SDS by comparison with the chronological age [ Time Frame: Each 3 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

- Changes to lean mass and fat mass, assessed by dual energy X-ray absorptiometry (DEXA) [ Time Frame: Once a year ] [ Designated as safety issue: No ]
- Changes to bone mineralisation: spinal bone mineral density and bone mineral content of the whole body assessed using DEXA [ Time Frame: Once a year ] [ Designated as safety issue: No ]
- Changes to levels of insulinlike growth factor-1 (IGF1) and insuline like growth factor bind protein 3 (IGFBP3), assayed every 6 months. [ Time Frame: Every 6 months ] [ Designated as safety issue: Yes ]

Enrollment:	21
Study Start Date:	March 2002
Study Completion Date:	October 2011
Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Somatropin	Drug: Somatropin Liquide, daily to finale height Maximum Dosage: 50 µg/kg/day

Detailed Description:

This trial terminated on 10-Jun-2011 due to prolonged issues with drug accountability and data collection discrepancies. The decision to terminate was not based on any safety concerns.

Eligibility

Ages Eligible for Study:	4 Years to 14 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

This study will be proposed to all patients previously included in study CTN 97-8129-016

Exclusion Criteria:

Discontinuation of corticosteroid therapy for more than a year during study CTN 97-8129-016
Patients withdrawing from the study prematurely

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00174291

Locations

France
Pfizer Investigational Site
Paris, France, 75019

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00174291 History of Changes
Other Study ID Numbers:	307-MET-9002-052, A6281024
Study First Received:	September 9, 2005
Last Updated:	December 5, 2011
Health Authority:	France: Afssaps - French Health Products Safety Agency

Additional relevant MeSH terms:

Endocrine System Diseases

ClinicalTrials.gov processed this record on February 12, 2012