drugset / Trial / NCT00420251
Efficacy and Safety of Growth Hormone Treatment in Juvenile Idiopathic Arthritis
RandomizedParallel-groupOpen-labelTreatment
Summary
Growth retardation is well known in patients with severe forms of juvenile idiopathic arthritis. Especially those who were under additional treatment with glucocorticoids for high disease activity. The hypothesis is, that treatment with growth hormone can, at leat in part, overcome growth hormone resistance state and increase final height. In a controlled study we follow patients with juvenile idiopathic arthritis with and without growth hormone treatment until final height. Additionally, we are interested in bone density development in those treated with growth hormone.
Timeline
- Start
- 1996-03
- Primary completion
- —
- Completion
- 2006-07
Publications
- Results Bechtold S, Ripperger P, Muhlbayer D, Truckenbrodt H, Hafner R, Butenandt O, Schwarz HP. GH therapy in juvenile chronic arthritis: results of a two-year controlled study on growth and bone. J Clin Endocrinol Metab. 2001 Dec;86(12):5737-44. doi: 10.1210/jcem.86.12.8083.
- Results Bechtold S, Ripperger P, Hafner R, Said E, Schwarz HP. Growth hormone improves height in patients with juvenile idiopathic arthritis: 4-year data of a controlled study. J Pediatr. 2003 Oct;143(4):512-9. doi: 10.1067/S0022-3476(03)00390-1.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Somatropin | Protein / enzyme biologic | 0.2 mg/kg | — |
| Subject | Somatropin | Protein / enzyme biologic | 0.33 mg/kg | — |
| Subject | Somatropin | Protein / enzyme biologic | 0.5 iu | — |
| Subject | Somatropin | Protein / enzyme biologic | 1 iu/kg | — |