Growth retardation secondary to juvenile idiopathic arthritis
Conditions
Interventions
Trade Name: Norditropin SimpleXx 5mg/1.5ml
Product Name: Norditropin SimpleXx
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Somatropin
Other descriptive name: Growth Hormone
Concent
Sponsors
Royal Hospital For Sick Children, Yorkhill Division
Eligibility
Sex/Gender
All
Inclusion criteria
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prior to any study related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
United Kingdom
Outcome results
None listed