Growth Hormone in Children With Juvenile Rheumatoid Arthritis (JRA) and With Crohn's Disease

NCT00511329 | Terminated Phase 2 Results

• 1 other identifier: GA628132
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators hypothesize that the anabolic effects of Genotropin (somatropin) will improve the height and weight of children with inflammatory based chronic illness who have failed to grow despite receiving adequate nutrition. The investigators will test the hypothesis by treating 32 chronically ill children (16 JRA and 16 Crohn's) with growth hormone (GH) for 12 months and comparing them to baseline.

Conditions

Arthritis, Juvenile Rheumatoid; Crohn Disease

Keywords

growth hormone; short stature; growth failure; chronic illness

Outcome Measures

Primary Outcomes (1)

• The Primary Outcome Variables Will be Height and Weight Z Score.

  12 months

Secondary Outcomes (1)

• Secondary Outcome Variables Will Include Change in Lean Body Mass, Change in Bone Mineral Content, Change in Inflammatory Mediated Cytokine Levels and Change in Bone Turnover.

  12 months

Study Arms (1)

Somatropin

EXPERIMENTAL

Drug: somatropin [rDNA origin] for injection

Interventions

somatropin [rDNA origin] for injection DRUG

Genotropin will be started at 0.3 mg/kg/week administered by daily subcutaneous injection. Doses will be increased by weight at each visit. Additionally, we will monitor IGF-1 levels at month 3, and 6 and adjust the Genotropin dose to maintain IGF-1 levels in the 50th -75th percentile for ages.

Also known as: Genotropin

Somatropin

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Referral for continued poor growth (growth velocity less than the 25th percentile)
• Height less than the 10th percentile
• Weight less than the 10th percentile compared to age and gender- matched normal values.

You may not qualify if:

• Previous diagnosis with diabetes, chronic fevers (temp \> 101.5) or chronic bacterial infection
• Previous treatment with GH
• Bone age \> 17

Sponsors & Collaborators

• Nationwide Children's Hospital: lead
• Pfizer: collaborator

Study Sites (1)

Columbus Children's Hospital

Columbus, Ohio, 43205, United States

Location

Related Publications (5)

• 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.

  PMID: 11739431 BACKGROUND

• Mauras N, George D, Evans J, Milov D, Abrams S, Rini A, Welch S, Haymond MW. Growth hormone has anabolic effects in glucocorticosteroid-dependent children with inflammatory bowel disease: a pilot study. Metabolism. 2002 Jan;51(1):127-35. doi: 10.1053/meta.2002.28972.

  PMID: 11782884 BACKGROUND

• Hardin DS, Ellis KJ, Dyson M, Rice J, McConnell R, Seilheimer DK. Growth hormone decreases protein catabolism in children with cystic fibrosis. J Clin Endocrinol Metab. 2001 Sep;86(9):4424-8. doi: 10.1210/jcem.86.9.7822.

  PMID: 11549686 BACKGROUND

• Hardin DS, Rice J, Doyle ME, Pavia A. Growth hormone improves protein catabolism and growth in prepubertal children with HIV infection. Clin Endocrinol (Oxf). 2005 Sep;63(3):259-62. doi: 10.1111/j.1365-2265.2005.02331.x.

  PMID: 16117811 BACKGROUND

• Hardin DS, Adams-Huet B, Brown D, Chatfield B, Dyson M, Ferkol T, Howenstine M, Prestidge C, Royce F, Rice J, Seilheimer DK, Steelman J, Shepherds R. Growth hormone treatment improves growth and clinical status in prepubertal children with cystic fibrosis: results of a multicenter randomized controlled trial. J Clin Endocrinol Metab. 2006 Dec;91(12):4925-9. doi: 10.1210/jc.2006-1101. Epub 2006 Oct 3.

  PMID: 17018651 BACKGROUND

MeSH Terms

Conditions

Arthritis, Juvenile; Crohn Disease; Dwarfism; Failure to Thrive; Chronic Disease

Interventions

Human Growth Hormone; WW Domain-Containing Oxidoreductase

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Bone Diseases, Developmental; Bone Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Growth Hormone; Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Short Chain Dehydrogenase-Reductases; NAD (+) and NADP (+) Dependent Alcohol Oxidoreductases; Alcohol Oxidoreductases; Oxidoreductases; Enzymes; Enzymes and Coenzymes; Tumor Suppressor Proteins; Neoplasm Proteins; Proteins

Results Point of Contact

• Title: Julie Rice, RN
• Organization: Nationwide Children's Hospital

julie.rice@nationwidechildrens.org

6143553142

Study Officials

• Dana S Hardin, MD

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2007
• First Posted: August 3, 2007
• Study Start: August 1, 2007
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: April 12, 2018
• Results First Posted: April 12, 2018

Record last verified: 2018-03

Locations

US (1)