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Studies of the Natural History, Pathogenesis, and Outcome of Autoinflammatory Diseases Including Juvenile Dermatomyositis

StatusCompleted
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Amendment history

The 50 most recent of 465 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Minor

    Re-verified, no change to tracked fields

  2. Minor

    Re-verified, no change to tracked fields

  3. Minor

    Re-verified, no change to tracked fields

  4. Minor

    Re-verified, no change to tracked fields

  5. Minor

    Eligibility criteria expanded, about 11 words

    Publications: details revised at 4 of 4 entries

    Show what changed: Eligibility criteria
    * INCLUSION CRITERIA: * Patients with CANDLE, SAVI, and JDM who are mutation positiv [...] or the disease or fulfill clinical criteria of the disease. * Patients who fulfill criteria for definite or probable JDM * Patients with other suspected autoinflammatory diseases * There is: * 2 years old or older * Patients or their legal guardians need to be able and willin [...] atient relatives and healthy volunteers EXCLUSION CRITERIA: * Active malignancy or any medical condition that in the opinion of the investigator would warrant exclusion * Inability to return for follow up visits * Pregnancy * Adults without [...]

  6. Minor

    3 amendments

    3 re-verifications since 2026-08-21, no change to tracked fields

    v458-v460

  7. Minor

    Trial completed

    Enrollment target: 756 to 757

    Study Status, Study Designv457

  8. Minor

    Study Status, Study Description

    Re-verified, no change to tracked fields

    v456

  9. Notable

    Enrollment reduced: 5000 → 756 participants

    Enrollment closed, study ongoing; Site details revised

    Study Status, Study Design, Contacts/Locations, Referencesv455

  10. Minor

    30 amendments

    30 re-verifications since 2025-08-19, no change to tracked fields

    v425-v454

  11. Minor

    Eligibility criteria shortened, about 1 word

    Show what changed: Eligibility criteria
    [...] uations will be conducted in collaboration with Dr. Fleisher's laboratory at the Clinical Center laboratory and other gro [...]

    Study Status, Eligibilityv424

  12. Minor

    8 amendments

    8 re-verifications since 2025-05-03, no change to tracked fields

    v416-v423

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Purpose: The purpose of this protocol is 1. To comprehensively evaluate patients with autoinflammatory diseases clinically, genetically and immunologically at the autoinflammatory disease clinic at the NIH. 2. To follow patients with autoinflammatory Diseases that are genetically defined including Neonatal-Onset Multisystem Inflammatory Disease (NOMID), the most severe clinical phenotype of Cryopyrin-Associated Periodic Syndromes (CAPS), Deficiency of IL-1 Receptor Antagonist (DIRA), Chronic Atypical Neutrophilic Dermatosis with Lipodystrophy and Elevated temperatures (CANDLE), and STING-Associated Vasculopathy with onset in Infancy (SAVI), and those with genetically undefined autoinflammatory disorders to determine long-term disease outcomes. 3. To develop biomarkers that help us assess disease activity and response to treatment. 4. To assess the eligibility of affected patients for inclusion in ongoing and planned treatment protocols. Goal: The goals of our studies are to understand the underlying immune dysregulation, to identify the genetic cause and to translate our findings into novel treatments that improve patients disease outcome. Eligibility: * Patients with known NOMID/CAPS, DIRA, CANDLE, SAVI, CRMO, Still's Disease, and with other yet undifferentiated autoinflammatory diseases. * Healthy adult and pediatric relatives. * Volunteers Design: 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 extend of their autoinflammatory disease. Participants may also expect the following assessments: 1. Clinical test that help assess organ damage and functional impact such as hearing vision, memory and learning tests. 2. Imaging studies to characterize the organ involvement of the inflammatory disease including: X-rays, CT scans, special MRIs, bone scans. 3. Laboratory evaluations including clinical markers of disease activity, research samples for genetic studies, and blood samples for cytokine/biomarker assessment, and gene expression profiling.\<TAB\> 4. Completion of 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 and a skin biopsy if skin inflammation is present. other gastrointestinal procedures as they are clinically indicated. 6. Patients my have a research skin biopsy taken. Participants may return for a single follow-up visits or for long term-follow up depending on their disease and willingness to be followed long-term. ...
Trial Details
NCT Number NCT00059748
Lead Sponsor National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions Autoinflammatory Disease, Juvenile Dermatomyositis
Enrollment 757 participants
Start Date
Updated on ClinicalTrials.gov