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NCT02974595 · ClinicalTrials.gov registry record
Natural History, Pathogenesis, and Outcome of Autoinflammatory Diseases (NOMID/CAPS, DIRA, CANDLE, SAVI, NLRC4-MAS, Still'S-like Diseases, and Other Undifferentiated Autoinflammatory Diseases)
A clinical trial of NOMID and DIRA, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Recruiting
- Registry status
- 3,200
- Enrollment target
- 1
- Study location
NCT02974595: Recruiting study of NOMID and DIRA, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT02974595 is a study of NOMID and DIRA that is actively recruiting participants, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 3,200 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02974595, a study of NOMID and DIRA, is actively recruiting participants, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- RECRUITING
- Registry status
- 3,200 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Some diseases cause chronic inflammation with intermittent flares in the body. These are called autoinflammatory diseases. They can cause fevers, rashes, ulcers, and other problems. Researchers want to learn more about the causes and effects of these diseases. They hope this will improve how the disease is managed in the future. Objectives: To understand the underlying immune dysregulation To identify the genetic cause To translate our findings into novel treatments that improve patients disease outcomes Eligibility: Patients with known NOMID/CAPS, DIRA, CANDLE, SAVI, NLRC4-MAS, Still's Disease, and with other yet undifferentiated autoinflammatory diseases. Unaffected relatives of participants with a known or undifferentiated autoinflammatory disease Healthy adult volunteers at least 18 years of age Design: Participants will be screened with blood sample and medical history. They may provide copies of their medical records. Enrolled participants will be evaluated at the NIH for 2-5 days. All participants will have a detailed medical history, physical exam, blood tests, and other evaluations depending on the extent of their autoinflammatory disease. Participants may also expect the following assessments: 1. Clinical tests that help assess organ damage and function such as hearing, vision, memory, and learning tests. 2. Imaging studies to characterize organ involvement of the inflammatory disease including: X-rays, CT scans, special MRIs, and bone scans. 3. Laboratory evaluations including clinical markers of disease activity, research samples for genetic studies, blood samples for cytokine/biomarker assessment, and gene expression profiling. 4. Questionnaires to assess disease activity and quality of life. 5. If indicated, other procedures may be administered that include: a lumbar puncture if CNS inflammation is suspected, a skin biopsy if skin inflammation is present, and/or gastrointestinal and pulmonary procedures if they are clinically
Primary Outcome
To study the pathogenesis of patients affected with autoinflammatory diseases, including their clinical, immunological, genetic and metabolic/endocrinological characteristics.
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,200 participants |
| Start Date | 2016-12-09 |
| Est. Completion | 2032-09-30 |
What NCT02974595 shows while recruiting
NCT02974595 is an observational study that tracks outcomes without assigning an intervention. Its 3,200 participants enrollment target places it among the larger protocols in the corpus.
The record links to 5 conditions, with NOMID appearing as the primary indexed condition, and to 0 interventions.
NCT02974595 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT02974595 about?
NCT02974595 is a clinical study titled "Natural History, Pathogenesis, and Outcome of Autoinflammatory Diseases (NOMID/CAPS, DIRA, CANDLE, SAVI, NLRC4-MAS, Still'S-like Diseases, and Other Undifferentiated Autoinflammatory Diseases)". Background: Some diseases cause chronic inflammation with intermittent flares in the body. These are called autoinflammatory diseases. They can cause fevers, rashes, ulcers, and other problems. Researchers want to learn more about the causes and effects of these diseases. They hope this will improv...
What is the current status of trial NCT02974595?
This trial is currently recruiting. The enrollment target is 3,200 participants. The study started on 2016-12-09. Estimated completion is 2032-09-30.
What conditions does trial NCT02974595 study?
This clinical trial studies the following conditions: NOMID, DIRA, NLRC4-MAS, SAVI, CANDLE.
Who is sponsoring clinical trial NCT02974595?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02974595 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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