Treatment With Recombinant Human Growth Hormone (Genotonorm) in Children With Short Stature Secondary to a Long Term Corticoid Therapy. A Study of Efficacy and Safety

Conditions: Juvenile idiopathic arthritis (JIA) and nephrotic syndrome (NeS)
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: EUCTR2014-004104-30-Outside-EU/EEA

Lead Sponsor: Pharmacia & Upjohn S.A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 30

Inclusion Criteria

1.Children with JIA or NeS,
2.Chronological age (CA) (greater than)> 3 years old,
3.Before or during puberty,
4.Treated with corticoids for at least 1 year at a dose greater than equal to (>=) 0.2 mg/kg/day equivalent prednisone, IV or orally, daily or alternate day regimen, and were intending to continue corticotherapy with hGH treatment,
5.Height less than (<) -2 standard deviation (SD) or loss of 1 SD during the 2 years preceding inclusion in the study,
6.Bone age (BA) <13 years for females and; <14 years for males,
7.In pubertal subjects B2 =breast development less than equal to (<=) B3 for females and 4 ml <= testicular volume <= 12 ml for males,
8.Provided signed informed consent.

Are the trial subjects under 18? yes
Number of subjects for this age range: 30
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

1.Diabetes Type 1 and 2,
2.Endocrine disease, except well substituted hypothyroidism,
3.Chronic renal diseases with glomerular filtration rate <50 ml/min/1.73 m2,
4.Known or suspected allergy to the preservative m-cresol, Non compliant subjects,
5.Subjects treated with sexual steroids (estrogens, testosterone) during the 6 months before inclusion in the study,
6.Secondary resistance to the treatment of NeS defined by proteinuria with albuminemia <30 grams per liter (g/l) for >3 consecutive months,
7.Malignancies,
8.Previous human growth hormone (hGH) treatment,
9.Inclusion in other study protocol.