NCT07106931

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
227mo left

Started Nov 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress7%
Nov 2024Dec 2044

Study Start

First participant enrolled

November 5, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 6, 2025

Completed
19.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2044

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2044

Last Updated

August 6, 2025

Status Verified

August 1, 2025

Enrollment Period

20.2 years

First QC Date

June 3, 2025

Last Update Submit

August 4, 2025

Conditions

Keywords

early onset arthritis

Outcome Measures

Primary Outcomes (1)

  • Final diagnosis

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

    12 months

Interventions

This is an observational study with no intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients refered to the outpatient clinic

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diakonhjemmet Hospital

Oslo, 0319, Norway

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, synovial fluid and synovial biopsies

MeSH Terms

Conditions

Arthritis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Central Study Contacts

Silje W Syversen, MD PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

June 3, 2025

First Posted

August 6, 2025

Study Start

November 5, 2024

Primary Completion (Estimated)

December 31, 2044

Study Completion (Estimated)

December 31, 2044

Last Updated

August 6, 2025

Record last verified: 2025-08

Locations