Prevention of Growth Retardation by Early Treatment With Growth Hormone (GH) in Children With Chronic Juvenile Arthritis (CJA) Treated by Corticosteroid Therapy

• Conditions: Juvenile idiopathic arthritis (JIA); Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2014-004105-32-Outside-EU/EEA
• Lead Sponsor: Pfizer Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-01
• Last Update Posted: 7 April 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 21

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified