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

Royal Hospital For Sick Children, Yorkhill Division0 sitesFebruary 17, 2005

Overview

No summary available.

Registry

who.int

Start Date

February 17, 2005

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Royal Hospital For Sick Children, Yorkhill Division

•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prior to any study related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.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

•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.