ClinicalTrials.gov record NCT05927454

Acostill ( RaDiCo Cohort) (RaDiCo Acostill)

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Aug 22, 2026

Cohorte d'Adultes et d'Enfants Avec Maladie de Still

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
SexAll
LocationFrance
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

ACOSTILL is a prospective observational cohort study collecting clinical and biological data from people with adult-onset and juvenile-onset Still disease. The study seeks to compare pediatric and adult forms, study disease biology over time, and identify diagnostic and prognostic markers. Participants provide clinical information, questionnaires and biological samples and are followed over time.

What it is studying. The study is trying to describe differences between pediatric and adult forms of Still disease, understand underlying inflammatory and biological mechanisms, identify early diagnostic or prognostic biomarkers, and create a standardized patient dataset to support future research and therapy evaluation.

What the researchers hope to learn. Scientific goals: compare pediatric and adult forms of Still disease; improve understanding of the disease's pathophysiology; identify early diagnostic and prognostic markers; and assemble a standardized, active patient dataset to help evaluate new therapies in the future.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

Adult Onset Still Disease (AOSD) and Systemic onset Juvenile Idiopathic Arthritis (SoJIA) are two rare multifactorial diseases associated with systemic inflammation. These two forms AOSD and SoJIA are considered to be two facets of the same syndrome, combining four cardinal symptoms [hectic fever> 39 °, arthralgia or arthritis, skin rash, a leukocyte formula with more than 80% of neutrophils]; lymphadenopathy and splenomegaly may also be found. There is an important biological inflammatory syndrome with elevation of the reactive C protein, of serum ferritin with a dramatic drop in the glycosylated fraction. The incidence of the disease is low, around 0.1/100,000 for adults and 0.6/100,000 for children. Its prevalence is approximately 1 to 3/100,000 and 3/100,000 for children, so there are approximately 500 to 1,500 adults and 450 children affected in France. It is subdivided into pediatric and adult forms according to the age of onset before or after 16 years. The prognosis of the disease is functional and vital. Macrophage activation syndrome (SAM) is frequently associated with either the onset of the disease or the initiation of treatment or concomitantly with viral reactivation. The course over time has mainly been studied in children and is variable: regression, course by flare-ups with term regression and chronic joint development. In adults we can also observe these 3 evolutionary modes. However, differences seem to exist between AOSD and SoJIA. The various clinical questions posed by this disease are as follows:

  • Why does it differentially affect two age groups of the population?
  • Why is the clinical expression heterogeneous with pure systemic or articular forms, the frequency of SAM, and rare organ damage?
  • Why is the evolution over time different with resolving monocyclic forms or polycyclic forms and sometimes chronic evolutions?

These differences could be explained by distinct underlying pathogenic mechanisms. But at present, the pathophysiology of this entity remains unknown, although several hypotheses can be formulated involving several pathophysiological pathways. The pathogenesis of Still's disease has not yet been elucidated but there is a significant inflammatory reaction without the production of autoantibodies, which makes this disease a form of autoinflammatory syndrome with abnormalities of the innate immunity (activation of macrophages, strong elevations of pro-inflammatory cytokines: interleukins 1 and 18, possible abnormalities of inflammasomes and NK cells). The treatment is based on anti-inflammatory drugs, corticosteroids with the usefulness of methotrexate and anti-TNF in the event of significant joint damage. Interleukin 1 and 6 inhibitors have been shown to be effective in this disease. In adults and children, there are forms that are refractory to treatment, with a risk of AA amyloidosis for these patients. The expected outcomes of this work are to improve knowledge of Still disease and patient management on the following aspects:

  • Comparison of pediatric and adult forms (which has never been done on a large number of patients),
  • Better understanding of the pathogenic mechanisms of the disease,
  • The identification of early diagnostic/prognostic markers,
  • The possibility of promoting the evaluation of new therapies to come thanks to the constitution of an active file of patients with a standardized follow-up.

The ACOSTILL study group is thus a unique collaboration of adult clinicians (rheumatologists and internists) and pediatricians, who have decided to unite their efforts to increase knowledge about the pathogenesis of Still disease in order to better understand the disease and improve care pathways. Many of them participated in the development of the national diagnostic and care protocol published in 2018.

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • Aged over 16 (age> 16) meeting the diagnostic criteria of Yamaguchi or Fautrel criteria (appendix 5)
  • Aged 16 years or less (age ≤16 years) fulfilling the 2001 criteria for ILAR systemic form of juvenile idiopathic arthritis
  • Having signed a consent to participate in the cohort and in the collection of clinical and biological data; in accordance with the regulations, for patients who are minors or adults who are protected, the non-opposition of the legal representatives will be sought.
  • Affiliated to the "Régime National d'Assurance Maladie".

Exclusion criteria

  • Other cause of relapsing infectious fever (such as tuberculosis, toxoplasmosis, deep abscesses, viroses, sepsis) or tumor (such as lymphomas)
  • Other defined inflammatory rheumatism such as rheumatoid arthritis, psoriatic arthritis, spondyloarthropathies.
  • Autoimmune inflammatory disease (systemic lupus erythematosus), granulomatosis (sarcoidosis, Blau syndrome), vasculitis (Behçet's disease, nodular arteritis), polymyositis and dermatomyositis.
  • Well-defined auto-inflammatory syndromes with unambiguous mutations, such as familial Mediterranean fever, cryopyrinopathies, TRAPS, mevalonate kinase deficiency.
  • Known macrophage activation syndromes of genetic origin.
  • Patients unable to understand the information leaflet and sign the informed consent form
  • Patients not affiliated to the "Régime National d'Assurance Maladie"

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants will have standardized clinical follow-up with data collected over time (outcomes are measured at baseline and at 1, 2, 3, 4 and 5 years). They will complete questionnaires (including quality-of-life measures and the AIDAI activity index), have blood samples taken for biomarker testing (examples listed in the record include cytokines, S100 proteins, soluble CD163, ferritin and glycosylated ferritin), and provide family-history information for a family tree. Medical records will be reviewed and entered into the cohort database; deceased patients' records may be included for historical data. Signing the informed consent form (or legal representative non-opposition for minors/protected adults) is required before participation.

How the study is structured. This is a prospective observational cohort. Participants give clinical information, complete questionnaires, and provide biological samples (blood and other routine samples as defined by the study) at visits. Their symptoms, clinical signs and laboratory results are recorded repeatedly over time (outcomes are tracked through yearly assessments listed up to 5 years in the registry). No experimental treatment is assigned by the study.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The listed sites are in France. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on adult-onset Still's disease

Clinical trials13 trials listed for adult-onset Still's diseaseEvery trial the registry lists for adult-onset Still's disease, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in adult-onset Still's disease researchLatest monthly update: September 2026. Includes: MAS initial treatment. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Jul 11, 2017
Primary completion
July 2027 (estimated)
Study completion
July 2027 (estimated)
Target enrollment
500 participants (estimated)
Last updated on registry
Feb 12, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Institut National de la Santé Et de la Recherche Médicale, France

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

corticosteroids
Steroid medicines, such as prednisone, that reduce inflammation. Studies often require a stable dose at entry or measure whether the study treatment allows the dose to be reduced.
refractory
A condition that has not responded to a treatment. 'Relapsed' means it responded and then came back; 'refractory' means it did not respond in the first place.
follow-up
The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
study group
One of the groups in a study. Each arm receives a particular intervention, comparator or no intervention, so the groups can be compared.
cohort
A group of people who share a characteristic, such as a diagnosis, and are studied together. 'Prospective' means they are followed forward from enrolment; 'retrospective' means existing records are reviewed.
informed consent form
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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