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

NCT ID: NCT00174291

Last Updated: 2012-12-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-03-31

Study Completion Date

2011-10-31

Brief Summary

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* 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

Detailed Description

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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.

Conditions

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Endocrine System Diseases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Somatropin

Group Type EXPERIMENTAL

Somatropin

Intervention Type DRUG

Liquid, daily to final height Maximum Dosage: 50 µg/kg/day

Interventions

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Somatropin

Liquid, daily to final height Maximum Dosage: 50 µg/kg/day

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Paris, , France

Site Status

Countries

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France

References

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David H, Aupiais C, Louveau B, Quartier P, Jacqz-Aigrain E, Carel JC, Simon D. Growth Outcomes After GH Therapy of Patients Given Long-Term Corticosteroids for Juvenile Idiopathic Arthritis. J Clin Endocrinol Metab. 2017 Dec 1;102(12):4578-4587. doi: 10.1210/jc.2017-01455.

Reference Type DERIVED
PMID: 29029101 (View on PubMed)

Related Links

Other Identifiers

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A6281024

Identifier Type: -

Identifier Source: secondary_id

307-MET-9002-052

Identifier Type: -

Identifier Source: org_study_id