ClinicalTrials.gov
History of Changes for Study: NCT00059748
Natural History and Cause of Neonatal Onset Multisystem Inflammatory Disease
Latest version (submitted May 14, 2024) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 23, 2005 None (earliest Version on record)
2 June 19, 2006 Study Status, References, Contacts/Locations, Eligibility, Study Design, Study Description, Oversight and Study Identification
3 August 23, 2006 Contacts/Locations and Study Status
4 August 29, 2006 Study Design and Study Status
5 September 16, 2006 Eligibility and Study Status
6 October 26, 2006 Study Status
7 December 12, 2006 Study Status, Contacts/Locations and Eligibility
8 February 22, 2007 Study Status and Study Identification
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11 April 27, 2007 Study Status
12 October 3, 2007 Study Description and Study Status
13 October 14, 2007 Study Status and Study Design
14 October 26, 2007 Study Status
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17 July 16, 2008 References and Study Status
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20 April 21, 2009 Study Status and Study Identification
21 April 22, 2009 Eligibility, Study Description, Study Status and Study Identification
22 April 24, 2009 Eligibility and Study Status
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27 July 16, 2009 Study Status
28 July 23, 2009 Study Design and Study Status
29 November 25, 2009 Study Design and Study Status
30 April 16, 2010 Conditions and Study Status
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34 September 17, 2010 References and Study Status
35 September 24, 2010 Eligibility and Study Status
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42 October 18, 2012 Study Description, Study Status and Study Identification
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51 January 14, 2014 Contacts/Locations and Study Status
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53 February 19, 2014 Study Description, Study Identification and Study Status
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55 July 29, 2014 Contacts/Locations and Study Status
56 July 30, 2014 References and Study Status
57 August 1, 2014 Contacts/Locations and Study Status
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59 August 20, 2014 Study Status and Study Identification
60 October 28, 2014 Study Description, Study Status and Study Identification
61 November 11, 2014 Sponsor/Collaborators and Study Status
62 December 16, 2014 Study Status and Study Identification
63 February 20, 2015 Contacts/Locations, Study Description and Study Status
64 March 19, 2015 Contacts/Locations and Study Status
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68 September 29, 2015 Study Status and Study Identification
69 January 6, 2016 Eligibility and Study Status
70 January 7, 2016 Eligibility, Study Description and Study Status
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93 June 1, 2018 Eligibility, Study Description, Study Status and Study Identification
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97 August 8, 2018 Oversight and Study Status
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111 April 3, 2019 Eligibility, Study Design, Conditions, Outcome Measures, Groups and Interventions, Study Status and Study Identification
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126 November 28, 2019 Eligibility, Conditions, Study Status and Outcome Measures
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128 December 19, 2019 Study Description and Study Status
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162 November 26, 2020 Groups and Interventions, Study Status, References, Eligibility and Conditions
163 December 5, 2020 Study Description and Study Status
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Study NCT00059748
Submitted Date:  June 23, 2005 (v1)
Open or close this module Study Identification
Unique Protocol ID: 030173
Brief Title: Natural History and Cause of Neonatal Onset Multisystem Inflammatory Disease
Official Title: Studies of the Pathogenesis and Natural History of Neonatal Onset Multisystem Inflammatory Disease (NOMID)
Secondary IDs: 03-AR-0173
Open or close this module Study Status
Record Verification: November 21, 2005
Overall Status: Recruiting
Study Start: April 30, 2003
Primary Completion:
Study Completion:
First Submitted: May 5, 2003
First Submitted that
Met QC Criteria:		 May 5, 2003
First Posted: May 6, 2003 [Estimate]
Last Update Submitted that
Met QC Criteria:		 June 23, 2005
Last Update Posted: June 24, 2005 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
Brief Summary: This study will examine and test patients with neonatal onset multi-system inflammatory disease (NOMID) to learn more about the cause and course of the disease. It will study the disease signs and symptoms and the possible role of a gene called CIAS1, and it will develop a database to gather information on patients with NOMID in the United States and around the world. It will also serve as a screening protocol to offer eligible patients participation in a treatment protocol, if an appropriate one is available.Patients with this rare disease usually develop a chronic rash in the first days to weeks of life that can affect the entire body. Almost all patients have eye problems such as inflammation, optic atrophy, or swelling of the optic nerve. Joint problems can lead to severe disability. Nervous system problems can include chronic meningitis, brain atrophy, seizures, mental retardation, migraine headaches, hearing loss and others.Patients with NOMID whose symptoms include a rash since birth along with one of the following: joint disease or bone overgrowth; central nervous system problem, eye problems, enlarged liver and spleen, or elevated inflammatory markers (substances that indicate inflammation) may be eligible for this study.Participants will be admitted to the NIH Clinical Center for 3 to 4 days for the following tests:- Medical history and physical, neurological, and eye examinations.- Hearing test.- Completion of quality of life questionnaires.- Evaluation of memory and learning ability.- Urine test.- Blood tests for genetic analysis, HIV infection, and other laboratory values.- Blood test to evaluate growth hormones in order to learn more about how inflammation affects the patient's growth. For this test, a small amount of blood is drawn every 20 minutes for 8 hours while the patient is sleeping. The tests show if the rhythm of growth hormone and other substances in the body is normal. This test is optional.- Lumbar puncture (spinal tap) to collect cerebrospinal fluid (CSF) from the spinal canal. For this procedure, a local anesthetic is given and a needle is inserted in the space between the bones in the lower back where the CSF circulates below the spinal cord. A small amount of fluid is collected through the needle.- Skin biopsy (surgical removal of tissue for microscopic examination) to characterize the rash and learn more about what causes it. The biopsy area is numbed and the superficial top layers of skin are shaved.- Photographs of the patient in a bathing suit or underwear. These pictures are taken to document the skin rash and joint changes.- X-rays and magnetic resonance (MRI) scans of the knees or other affected joints. X-rays will be done in patients who do not have recent x-rays (within the past 3 months) available. MRI will be done in patients who can lie in the scanner without requiring sedation.- Brain MRI to evaluate the central nervous system involvement, done only in patients who can lie still for 45 minutes.- Bone density scan to evaluate bone mineralization.Rehabilitation evaluation to assess hand coordination, the ability to walk, and other functions.
Detailed Description: Neonatal Onset Multisystem Inflammatory Disease (NOMID) is a chronic inflammatory disorder characterized by early onset of urticarial rash, arthropathy, epiphyseal overgrowth, lymphadenopathy, and central nervous anomalies. We have recently identified a spontaneously occurring genetic mutation in CIAS1, a gene located at chromosome 1q44, that is present in about 50% of children with NOMID. In vitro functional studies have suggested that the genetic defect identified may be directly associated with an increase in IL-1 activity. In this research protocol we seek to comprehensively evaluate affected children clinically, genetically, immunologically, and endrocrinologically to better characterize the abnormalities in these patients. Sensitive imaging modalities will be used to visualize bone and cartilage findings. These studies will help to develop a better understanding of the pathophysiology underlying this syndrome. Data from these studies will be used to develop a comprehensive treatment approach.
Open or close this module Conditions
Conditions: Urticaria
Arthropathy
Lymphadenopathy
Nervous System Anomalies
Keywords: Central Nervous System Abnormalities
Arthropathy
Urticaria
Papilledema
Auto Inflammation
Neonatal Onset Multisystem Imflammatory
Disease
NOMID
Open or close this module Study Design
Study Type: Observational
Time Perspective:
Biospecimen Retention:
Biospecimen Description:
Enrollment: 9999
Number of Groups/Cohorts 0
Open or close this module Groups and Interventions
Open or close this module Outcome Measures
Open or close this module Eligibility
Minimum Age:
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria: INCLUSION CRITERIA:Subjects with known or suspected diagnosis of NOMID will be evaluated either at the outpatient or inpatient unit of the Clinical Center as indicated. Patients with, but not limited to, clinical symptoms of persistent urticaria since birth, arthropathy, and central nervous system abnormalities are eligible to be included in the protocol.Age over 2 yearsInclude a rash since birth and one of the following symptoms:arthropathy, bone overgrowth, CNS anomaly such as chronic meningitis, increased intracranial pressure, eye involvement,hepatosplenomegaly, elevated inflammatory markers.Patient's ability and willingness to give informed consent or in pediatric patients, the parent's willingness to give informed consent and the parent's willingness to give informed consent and the patient's willingness to assent to the protocol whenever possible.EXCLUSION CRITERIA:None if patients fulfill inclusion criteria.
Open or close this module Contacts/Locations
Locations: United States, Maryland
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
[Recruiting]
Bethesda, Maryland, United States, 20892
Contact:Contact: Patient Recruitment and Public Liaison Office 8004111222 prpl@mail.cc.nih.gov
Contact:Contact: TTY 1-866-411-1010
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations: Hashkes PJ, Lovell DJ. Recognition of infantile-onset multisystem inflammatory disease as a unique entity. J Pediatr. 1997 Apr;130(4):513-5. No abstract available. PubMed 9108844
Sadiq SA, Gregson RM, Downes RN. The CINCA syndrome: a rare cause of uveitis in childhood. J Pediatr Ophthalmol Strabismus. 1996 Jan-Feb;33(1):59-63. doi: 10.3928/0191-3913-19960101-15. No abstract available. PubMed 8965228
Miura M, Okabe T, Tsubata S, Takizawa N, Sawaguchi T. Chronic infantile neurological cutaneous articular syndrome in a patient from Japan. Eur J Pediatr. 1997 Aug;156(8):624-6. doi: 10.1007/s004310050678. PubMed 9266194
Links: Description: Detailed Web Page
Available IPD/Information:
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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services