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Study of Families With Twins or Siblings Discordant for Rheumatic Disorders

StatusCompleted
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Amendment history

The 50 most recent of 400 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Minor

    Re-verified, no change to tracked fields

  2. Minor

    Eligibility criteria expanded, about 6 words

    Publications: details revised at 4 of 4 entries

    Show what changed: Eligibility criteria
    * INCLUSION CRITERIA: The minimum inclusion criteria needed fo [...] e to provide informed consent). Proband inclusion criteria: \- Children (\< 18 years of age) or adults (18 or more years of age) requi [...] ildhood-onset diseases: JRA will be defined by age of onset \<17 years of age; for other diseases age of onset will be \< 18 years. Probands will be diagnosed within 5 years of enr [...] ION CRITERIA: Exclusion criteria for all protocol subjects: 1. severe trauma or vaccinations within 8 weeks of enrollment; 2. Still s disease/systemic-onset or pauciarticular JRA; 3. medical illness that in the judgment of t [...] [...]
  3. Minor

    48 amendments

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

    v351-v398

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This study will examine families in which one sibling of a sibling pair, or twin pair, has developed a systemic rheumatic disease and one has not, to see if and how the two differ in the following: * Blood cell metabolism; * Types of cells in the blood; * Environmental exposures or genetic factors that might explain why one developed disease and the other did not. Families in which one sibling has developed a systemic rheumatic disease, rheumatoid arthritis, systemic lupus erythematosus, scleroderma, dermatomyositis, or myositis, and the other has not, are eligible for this study. The siblings may or may not be twins, but must be of the same gender and be within a 5-year age difference. Biological parents, or, in some cases, children, will also be included in the study. Normal, healthy volunteers will serve as control subjects. Participants will undergo some or all of the following tests and procedures: * Medical history and physical examination. Participants will also be asked permission to obtain medical records for review. * Questionnaires about environmental exposures at work, at home, and elsewhere. Probands (participants with rheumatic disease) and their healthy siblings will also answer questions about infections, vaccinations, medications or dietary supplements, sun exposure, and stressful events during the year before disease diagnosis in the affected sibling. * Blood and urine collection for the following tests: * Routine blood chemistries and other studies to rule out certain diseases or medical problems; * Evidence of past toxic exposures and certain infections; * Presence of cells from the mother in the child s blood and vice versa. (Recent studies suggest that during pregnancy or delivery, cells from the mother and baby may be exchanged and circulate in the body for many years, possibly causing problems); * In twin or sibling pairs, presence of certain genes that may be more common in patients with systematic rheumatic diseases as compared with their unaffected siblings and normal volunteers; * In identical twins, comparison of their blood cell metabolism to see if and how the metabolism differs in people with rheumatic disease. Participants may be asked for permission to have some of their blood and urine samples stored and to obtain previously collected blood or tissue biopsy specimens that are no longer needed for clinical care, for research purposes. They may also be asked to give additional blood or urine samples. Participants will be followed every year for 5 years (either in person or by questionnaire) to evaluate any changes in their condition. The final 5-year evaluation will repeat some of the questionnaires and procedures described above. ...
Trial Details
NCT Number NCT00055055
Lead Sponsor National Institute of Environmental Health Sciences (NIEHS)
Conditions Rheumatoid Arthritis, Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathies
Enrollment 1,056 participants
Start Date
Updated on ClinicalTrials.gov