Juvenile idiopathic arthritis (JIA)
Conditions
Interventions
Product Name: Genotropin
Pharmaceutical Form: Powder and solution for solution for injection
INN or Proposed INN: Somatropin
Current Sponsor code: Genotropn
Other descriptive name: SOMATROPIN
Concentr
Sponsors
Pfizer Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. All subjects had to be previously included in Study CTN 97-8129-016 to continue somatropin treatment until FH was reached. 2. All subjects should have received corticosteroid therapy, whatever the dose or the method of administration. Are the trial subjects under 18? yes Number of subjects for this age range: 21 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: 1. Discontinuation of corticosteroid therapy for more than a year during Study CTN 97-8129-016. 2. Concomitant severe, chronic disease: renal failure (glomerular filtration less than or equal to [<=] 50 mililiter per min per meter [ml/mn/1m] ^2 73), nephrotic syndrome, hepatic failure, diabetes. 3. Endocrine disorder except for adequately compensated hypothyroidism. 4. Subjects withdrawing from the study prematurely. 5. Non-compliant subjects. 6. Inclusion in another protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of increasing the Human growth hormone (hGH) dose (0.6 versus 0.46 milligram per kilogram per week [mg/kg/week ] or 1.8 versus 1.4 international unit per kilogram per week [IU/kg/week]) on the statural response in subjects initially in the treated group of Study CTN 97-8129-016, by comparing the statural response observed with that obtained during the first therapeutic phase at a dose of 0.46 mg/kg/week, or 1.4 IU/kg/week ;Secondary Objective: To assess the value of early treatment during the course of arthritic disease by comparing changes to the body composition and bone mineralization in the 2 groups of children. To assess safety by monitoring of arthritic disease (clinical) and glucose tolerance (biological). ;Primary end point(s): 1) Change From Baseline in Annual Rate of Growth Standard Deviation Score (SDS) at Year 3 2) Change From Baseline in Annual Rate of Growth Standard Deviation Score (SDS) at Final Height 3) Change From Baseline in Height Standard Deviation Score (SDS) at Year 3 4) Change From Baseline in Height Standard Deviation Score (SDS) at Final Height 5) Change From Baseline in Predicted Height Standard Deviation Score (SDS) at Year 3 6) Change From Baseline in Predicted Height Standard Deviation Score (SDS) at Final Height ;Timepoint(s) of evaluation of this end point: 1) Baseline, Year 3 2) Baseline, final height (assessed up to Year 9.5) 3) Baseline, Year 3 4) Baseline, final height (assessed up to Year 9.5) 5) Baseline, Year 3 6) Baseline, final height (assessed up to Year 9.5) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Change From Baseline in Insulin-like Growth Factor Binding Protein 3 (IGFBP3) Concentration at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 2) Change From Baseline in Lean Mass and Fat Mass at Year 1, 2, 3, 4, 5, 6, 7, 8 and 9 3) Change From Baseline in Bone Mineralization at Year 1, 2, 3, 4, 5, 6, 7, 8 and 9 4) Change From Baseline in Weight Standard Deviation Score (SDS) at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 5) Change From Baseline in Corticosteroid Dose at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 6) Change From Baseline in Insulin-like Growth Factor Binding Protein 3 (IGFBP3) Concentration at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 ;Timepoint(s) of evaluation of this end point: 1) Baseline, Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9 2) Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9 3) Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9 4) Baseline, Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9 5) Baseline, Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9 6)Baseline, Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9 | — |
Countries
France
Contacts
Public ContactPfizerCallCenter
Pfizer Inc
Outcome results
None listed