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

Tracking Information

First Received Date ^ICMJE

September 9, 2005

Last Updated Date

October 21, 2009

Start Date ^ICMJE

March 2002

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

The principal efficacy end-point will be the statural gain in SDS, evaluated by changes in size expressed in SDS by comparison with the chronological age during the three years of treatment with growth hormone

Change History

Complete list of historical versions of study NCT00174291 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

- 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 ]

Original Secondary Outcome Measures ^ICMJE

- Changes to levels of IGF1 and IGFBP3, assayed every 6 months. - Changes to lean mass and fat mass, assessed by DEXA - Changes to bone mineralisation: spinal bone mineral density and bone mineral content of the whole body assessed using DEXA

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Endocrine System Diseases

Intervention ^ICMJE

Drug: Somatropin

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2015

Estimated Primary Completion Date

December 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

14 Years to 18 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT ID ^ICMJE

NCT00174291

Responsible Party

Director, Clinical Trial Disclosure Group, Pfizer, Inc.

Study ID Numbers ^ICMJE

307-MET-9002-052, A6281024

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP