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 个研究点开始时间: 2005年2月17日最近更新: 2013年7月15日

适应症

试验速览

暂无简介。

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prior to any study related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.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

•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.

发起方

Royal Hospital For Sick Children, Yorkhill Division