ArthritisSTARTNCT07106931
Early STratification of Acute ARThritis
An observational study of Arthritis, run by Diakonhjemmet Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis
- How many people
- 400 participants
- Where
- 1 siteNorway
- Study dates
- 5 Nov 2024to 31 Dec 2044
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients refered to the outpatient clinic
Who may be able to join
- 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
Who cannot join
- Swollen joint related to trauma
- Subject not capable of adhering to the study protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Early STratification of Acute ARThritis (START)- A Prospective Observational Study
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.
- Conditions
- Arthritis
- Being tested
- This is an observational study with no intervention
- Keywords
- early onset arthritis
- Medical subject headings
- Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This is an observational study with no interventionOther
This is an observational study with no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start5 Nov 2024
- Primary completion31 Dec 2044 (estimated)
- Study completion31 Dec 2044 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diakonhjemmet Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital
- Responsible party
- Principal investigator, Silje Watterdal Syversen, Diakonhjemmet Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07106931
- Sponsor's protocol ID
- REC671173
- Acronym
- START
- Status last verified
- Aug 2025
- First submitted
- 3 Jun 2025
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Not decided yet
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early STratification of Acute ARThritis (START)- A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07106931
- Acronym / sponsor ID
- START / REC671173
- Conditions
- Arthritis
- Keywords
- early onset arthritis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Diakonhjemmet HospitalUniversity, hospital or other
- Collaborators
- Oslo University Hospital
- Study start
- 5 Nov 2024 (actual)
- Primary completion
- 31 Dec 2044 (estimated)
- Study completion
- 31 Dec 2044 (estimated)
- First posted
- 6 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients refered to the outpatient clinic
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Swollen joint related to trauma
- Subject not capable of adhering to the study protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| This is an observational study with no interventionThis is an observational study with no intervention | Other | – |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
- Individual participant dataSharing planned: Undecided. Not decided yet
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis, run by Diakonhjemmet Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Silje W Syversen, MD PhD (+4792040315, s.w.syversen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Final diagnosis (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025.