NCT07106931 Early STratification of Acute ARThritis
| NCT ID | NCT07106931 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Diakonhjemmet Hospital |
| Condition | Arthritis |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2024-11-05 |
| Primary Completion | 2044-12-31 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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.
Eligibility Criteria
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