Effect of recombinant growth hormone on growth and chondrocyte dynamics in children with juvenile idiopathic arthritis (JIA) and growth failure. - rhGH in JIA

• Conditions: Growth retardation secondary to juvenile idiopathic arthritis

• Registration Number: EUCTR2004-004153-25-GB
• Lead Sponsor: Royal Hospital For Sick Children, Yorkhill Division

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-02-17
• Last Update Posted: 15 July 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Diagnosis of JIA
Height Velocity SDS of less than –0.5 over 6 months prior to study.
Patients of all ages will be eligible but boys and girls with significant pubertal delay shall only be eligible after a period of treatment with sex steroids (see section 6).
Written informed consent must be obtained from parents/legual guardians, prior to any study related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
Patients willing and being able to comply with the protocol for the duration of the study.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Previous treatment with rhGH
Diabetes mellitus or history of significant glucose intolerance (fasting blood glucose>5.5mmol/l)
Endocrinopathy other than GC excess or GHD
Surgery within last 6 months
Active malignancy
Ongoing anti-cancer therapy
Benign intracranial hypertension.
Severe arterial hypertension, defined as diastolic blood pressure > 110 mmHg with or without antihypertensive treatment.
Known or suspected allergy to the trial product or related products.
Lactation/pregnancy or intent to become pregnant during the planned trial period.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the effect of rhGH, in children with growth failure associated with JIA;Secondary Objective: To assess changes in body composition and bone health after rhGH treatment in children with growth failure associated with JIA.;Primary end point(s): Evaluation of the effect of rhGH on growth and metabolic markers assessed between baseline value and at 3 and 6 month treatment period (end point).