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Recruiting

NCT Number: NCT07106931

Early STratification of Acute ARThritis

The prospective observational study "Early STratification of acute inflammatory ARThritis" (START) aims to build a platform for identification of markers for early stratification of inflammatory arthritis to ensure timely diagnosis and correct initial treatment. Management of early-stage inflammatory arthritis is a daily challenge for the rheumatologist and encompasses a range of conditions. Stratification is needed both for optimal diagnostics and for personalising therapy, but is hampered by a lack of tools. Current evaluation is inadequate for early diagnosis and treatment of inflammatory joint diseases as well as for timely diagnosis of infections. The clinical role of novel biomarkers needs to be investigated in large patient samples. In the START study, an extensive data collection will be performed to build a platform for identification and validation of biomarkers for stratification of early-stage inflammatory arthritis. The study has an ambitious goal of improving patient care by increased understanding of the disease. The project applies a unique multitude of approaches to characterisation of patients, including modern imaging techniques, analyses of synovial fluid and -biopsies, genetic and epigenetic markers, proteomics, microbiota analyses and immunological markers. The results will enable clinicians to make better informed treatment decisions for the individual patient with early-stage inflammatory arthritis.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Diakonhjemmet Hospital

Oslo, 0319, Norway

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Arthritis* in one or more joints of less than 12 weeks' duration**
  • Adult patients (> 18 years) capable of understanding and signing an informed consent form
  • Defined as currently active clinical synovitis (ie, swelling) in at least one joint as determined by an expert assessor which might be confirmed by ultrasonography ** Prior patient reported swollen joint not confirmed as arthritis by a rheumatologist is not an exclusion

Exclusion criteria

  • Swollen joint related to trauma
  • Subject not capable of adhering to the study protocol

Treatment and study plan

This is an observational study with no intervention

Other

This is an observational study with no intervention

Primary outcomes

  1. Final diagnosis

    Time frame: 12 months

    Number of patients with a final diagnoses of the differnent forms of arthritis assed by the ICD-10 codes given by the investigator

Study contacts

Contact information is provided by the study sponsor or research team.

Silje W Syversen, MD PhD

CONTACT

[email protected]

+4792040315

Sponsors and collaborators

Lead sponsor

Diakonhjemmet Hospital

Other

Collaborators

  • Oslo University Hospital

Registry information

Official study title

Early STratification of Acute ARThritis (START)- A Prospective Observational Study

Acronym: START

Important dates

Study start
2024
Primary completion
2044
Study completion
2044
First posted
Aug 6, 2025
Registry last updated
Aug 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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