Arthritis, Juvenile RheumatoidPhase 2/3NCT00511329
Growth Hormone in Children With Juvenile Rheumatoid Arthritis (JRA) and With Crohn's Disease
A Phase 2/3 study testing somatropin [rDNA origin] for injection in people with Arthritis, Juvenile Rheumatoid and Crohn Disease, run by Nationwide Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Arthritis, Juvenile Rheumatoid, Crohn Disease
- What is being tested?
- somatropin [rDNA origin] for injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to May 2010
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Previous diagnosis with diabetes, chronic fevers (temp > 101.5) or chronic bacterial infection
- Previous treatment with GH
- Bone age > 17
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Growth and the Effect of Genotropin in Chronically Ill Children With Juvenile Rheumatoid Arthritis and With Crohn's Disease
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.
Read the detailed description
- To determine the effect of GenotropinTM on height, height velocity, body weight and lean body mass. Growth records from previous years will be assessed to determine growth velocity and weight gain. We will measure height and weight during the study using a standardized stadiometer and scale. These parameters will be converted to Z scores (GenenCalcTM, Genentech). Lean body mass (LBM) will be measured by DXA every six months. This specific aim tests the hypothesis that GH significantly improves height, height velocity, weight, weight velocity and LBM in chronically ill children who have grown poorly despite adequate nutritional rehabilitation.
- To determine the effect of GenotropinTM on whole body protein turnover (WBPT), IGF-1 levels and cytokines. Utilizing the stable isotope 1-[13C] leucine, we will measure WBPT. Measurements of WBPT will be correlated with LBM and changes in height and weight velocity. This data will be compared to that from age matched normal children (archival data maintained by the PI). We will measure IGF-1 and the cytokines TNF-α, IL-6 and IL-10 at baseline and very six months. These measures will be correlated with height and weight velocity and IGF-1 levels. Cytokine levels will also be correlated with protein catabolism. This specific aim tests the hypothesis that chronically ill children have increased catabolism, caused by high levels of circulating cytokines and low levels of IGF-1, and that these abnormalities improve with GenotropinTM.
- Evaluation of bone mineral content (BMC) and bone turnover. At baseline and every six months we will measure BMC of the whole body, hip and spine using DXA. Results will be compared to those from age-matched normal children whose results are archived in the body composition laboratory of Dr. Ken Ellis (Children's Nutrition Research Center, Houston). At baseline and every six months we will also measure bone mineral turnover markers including: osteocalcin, bone specific alkaline phosphatase activity, and deoxypyridinoline. All findings will be related to cytokine levels and to use of glucocorticoids. This specific aim tests the hypothesis that bone density is low in chronically ill children secondary to increased osteoclast activity correlating with elevated cytokine levels.
- Conditions
- Arthritis, Juvenile Rheumatoid, Crohn Disease
- Being tested
- somatropin [rDNA origin] for injection
- Keywords
- growth hormone, short stature, growth failure, chronic illness
- Medical subject headings
- Arthritis, Juvenile, Crohn Disease, Dwarfism, Failure to Thrive, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
somatropin [rDNA origin] for injectionDrug
Also called Genotropin
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.
| Study group | Role | What they receive |
|---|---|---|
| Somatropin | Experimental | Not described Receives: Drug: somatropin [rDNA origin] for injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary Outcome Variables Will be Height and Weight Z Score.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionMay 2010
- Study completionMay 2010
Why it stopped: PI left the institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Arthritis, Juvenile RheumatoidStudies of the same condition, open and under way.
- More trials run by Nationwide Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Dana S Hardin, MD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00511329
- Sponsor's protocol ID
- GA628132
- Status last verified
- Mar 2018
- First submitted
- 2 Aug 2007
- Last updated
- 12 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 11739431Mauras 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.
PubMed 11782884Hardin 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.
PubMed 11549686Hardin 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.
PubMed 16117811Hardin 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.
PubMed 17018651
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth and the Effect of Genotropin in Chronically Ill Children With Juvenile Rheumatoid Arthritis and With Crohn's Disease
- ClinicalTrials.gov ID
- NCT00511329
- Acronym / sponsor ID
- GA628132
- Conditions
- Arthritis, Juvenile Rheumatoid, Crohn Disease
- Keywords
- growth hormone, short stature, growth failure, chronic illness
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI left the institution
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Aug 2007
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 3 Aug 2007 (estimated)
- Results
- Posted 12 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- To determine the effect of GenotropinTM on height, height velocity, body weight and lean body mass. Growth records from previous years will be assessed to determine growth velocity and weight gain. We will measure height and weight during the study using a standardized stadiometer and scale. These parameters will be converted to Z scores (GenenCalcTM, Genentech). Lean body mass (LBM) will be measured by DXA every six months. This specific aim tests the hypothesis that GH significantly improves height, height velocity, weight, weight velocity and LBM in chronically ill children who have grown poorly despite adequate nutritional rehabilitation.
- To determine the effect of GenotropinTM on whole body protein turnover (WBPT), IGF-1 levels and cytokines. Utilizing the stable isotope 1-[13C] leucine, we will measure WBPT. Measurements of WBPT will be correlated with LBM and changes in height and weight velocity. This data will be compared to that from age matched normal children (archival data maintained by the PI). We will measure IGF-1 and the cytokines TNF-α, IL-6 and IL-10 at baseline and very six months. These measures will be correlated with height and weight velocity and IGF-1 levels. Cytokine levels will also be correlated with protein catabolism. This specific aim tests the hypothesis that chronically ill children have increased catabolism, caused by high levels of circulating cytokines and low levels of IGF-1, and that these abnormalities improve with GenotropinTM.
- Evaluation of bone mineral content (BMC) and bone turnover. At baseline and every six months we will measure BMC of the whole body, hip and spine using DXA. Results will be compared to those from age-matched normal children whose results are archived in the body composition laboratory of Dr. Ken Ellis (Children's Nutrition Research Center, Houston). At baseline and every six months we will also measure bone mineral turnover markers including: osteocalcin, bone specific alkaline phosphatase activity, and deoxypyridinoline. All findings will be related to cytokine levels and to use of glucocorticoids. This specific aim tests the hypothesis that bone density is low in chronically ill children secondary to increased osteoclast activity correlating with elevated cytokine levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Somatropin | Experimental | Drug: somatropin [rDNA origin] for injection |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Previous diagnosis with diabetes, chronic fevers (temp > 101.5) or chronic bacterial infection
- Previous treatment with GH
- Bone age > 17
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| somatropin [rDNA origin] for injectionAlso: GenotropinGenotropin 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. | Drug | Somatropin |
Primary outcome
The Primary Outcome Variables Will be Height and Weight Z Score.
Time frame: 12 months
1 secondary outcome
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.
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11739431Bechtold 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.
- Background: PubMed 11782884Mauras 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.
- Background: PubMed 11549686Hardin 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.
- Background: PubMed 16117811Hardin 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.
- Background: PubMed 17018651Hardin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dana S Hardin, MD principal investigator
Nationwide Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing somatropin [rDNA origin] for injection in people with Arthritis, Juvenile Rheumatoid and Crohn Disease, run by Nationwide Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Primary Outcome Variables Will be Height and Weight Z Score. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00511329, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2018.