NCT06337513Enrolling by invitation
Spondyloarthritis Inception Cohort of Southern Denmark
Source: ClinicalTrials.gov · Last updated 22 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
People with axial spondyloarthritis (axSpA) experience a diagnostic delay of 6.5 years in men and up to 8.8 years in women. One of the reasons for the diagnostic delay seems to be limited awareness of the disease characteristics in the referring health care professionals in primary care. By raising awareness about the disease, the study aims at reducing the diagnostic delay and improving early treatment. In addition to diagnostic and pharmacological treatment, physical exercise and rehabilitation are recommended in people with axSpA. In Denmark, people with axSpA are only offered free of charge physiotherapy when the disease has progressed to a stage with radiographic changes of the spine even though people in the early stage of axSpA report a similar disease burden. The overall objective of Spondyloarthritis Inception Cohort of Southern Denmark (SPINCODE) is to set up an axSpA inception cohort among individuals with low back pain ≥ 3 months who are considered to be at risk for axSpA. The investigators aim to learn more about the course of axSpA during the early stage of disease appropriately assess outcomes, including novel imaging techniques and identify predictive outcomes. Moreover, the investigators want to test the effect of an outpatient physiotherapist-coordinated rehabilitation intervention in people suspected of having axSpA.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 250 (estimated)
- First submitted
- 12 Mar 2024
- Start date
- 1 May 2024
- Primary completion date
- Aug 2028
- Lead sponsor
- The Danish Center for Expertise in Rheumatology
- Diseases
- Ankylosing spondylitis
- NCT number
- NCT06337513
What you commit to
- Study type: Interventional
- Planned participants: 250
- From 1 May 2024 to the primary completion date, Aug 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with disease modifying antirheumatic drugs (DMARDs) for other conditions
Age
- Age \< 18 years
- Age at symptom onset \> 45 years
- Recurrent episodes of low back pain for \>3 years
Other
- Incapable of complying with the examination program for physical or mental reasons
- Not able to provide written consent
- Not able to understand Danish
- A priori SpA diagnosis
- Contradictions to MRI
- Pregnancy
Who the study is looking for
- Age ≥ 18 years
- Age at symptom onset ≤ 45 years
- Currently diagnosed with undifferentiated lower back pain
- Onset of back pain ≥ 3 months ≤ 3 years at referral
- Diagnosed with anterior uveitis (AU) and/or psoriasis and/or inflammatory bowel disease (IBD) regardless of human leukocyte antigen B27 (HLA-B27) status
- HLA-B 27 positivity (obligatory in case of absence of AU, psoriasis or IBD)
- Imaging findings suggestive of axSpA as defined by trained musculoskeletal radiologists, regardless of HLA-B27 status
- Patients capable of giving written informed consent
Criteria the registry did not label
- Patients with low back pain suspected of axSpA will be included based on the following inclusion and exclusion criteria.
Age in the registry: 18 years to 48 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Danish Hospital for Rheumatic Diseases Coordinator of this site? Confirm its status | Sønderborg | Denmark | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.