Early STratification of Acute ARThritis

NCT ID: NCT07106931

Last Updated: 2025-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-05

Study Completion Date

2044-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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This is an observational study with no intervention

This is an observational study with no intervention

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role collaborator

Diakonhjemmet Hospital

OTHER

Sponsor Role lead

Responsible Party

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Silje Watterdal Syversen

MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Diakonhjemmet Hospital

Oslo, , Norway

Site Status RECRUITING

Countries

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Norway

Central Contacts

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Silje W Syversen, MD PhD

Role: CONTACT

+4792040315

Other Identifiers

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REC671173

Identifier Type: -

Identifier Source: org_study_id

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