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Factors for the Onset and Course of Axial Spondylitis

ConditionAxial Spondyloarthritis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKarolinska Institutet

About this trial

In a research project, investigators want to study the course of the disease of axial spondylitis: the causes of disease onset, prognosis, and treatment effects. The goal is to improve treatment and in the long run also prevention of the disease. The project has a focus on the body\'s own substance prostaglandin, and its proinflammatory role in spondylitis, but also other substances may be analyzed in blood and urine samples.

The purpose of the research project is include newly diagnosed treatment-naive patients with axial spondyloarthritis, to follow them after 1 and 2 years after treatment start, to collect clinical data, questionnaires, blood and urinsamples to find blood or urine markers that can be used for precision therapy of axial spondylitis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

newly diagnosed patients with axial spondyloarthritis

treatment-naive

18 years of age or older

Swedish-speaking

Disqualifiers

DMARD treatment,

ongoing infection

ongoing malignancy

Trial population

Consecutive newly diagnosed adult patients with axial spondyloarthritis who are treatment-naïve, speak Swedish, and do not have an ongoing malignancy or infection. Patients need to be able to give an informed consent. Investigators include 20 anonymised blood samples of blood donors for comparison of prostaglandin levels.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,000 Participants
are grouped into 1 trial group
Group A: 1 cohort at Karolinska University Hospital and 1 at the Center for Rheumatology in Stockholm

Trial outcomes

Primary outcomes

1

Prostaglandin levels

Investigators measure prostaglandin levels in treatment-naïve patients at baseline, and then after therapy start after 1 and 2 years.

Time frame
2 years

Secondary outcomes

1

Questionnaires

Investigators collect data on modifiable environmental factors and lifestyle that may contribute to the onset of the disease.

Time frame
2 years
2

Clinical data

Investigators collect clinical data as entered in the Swedish Rheumatology Quality Register (SRQ) plus the ASAS-health index (0-17, with a lower score indicating a better health status), such as inflammatory markers ESR (mm/hour)/CRP (mg/l), and other variables in the ASAS core outcome set for all trials as defined by ASAS-Omeract.

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Karolinska Institutet

Lead sponsor

Karolinska University Hospital

Collaborator

Source ClinicalTrials.gov
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