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Factors for the Onset and Course of Axial Spondylitis

Faktorer För Uppkomst Och Förlopp Av Axial Spondylartrit

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06594107
Acronym
EISPA
Enrollment
1000
Registered
2024-09-19
Start date
2022-09-01
Completion date
2035-12-31
Last updated
2024-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Axial Spondyloarthritis

Keywords

observational, axial spondyloarthritis, prostaglandins, predictive factors

Brief summary

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.

Detailed description

The EISPA study is an epidemiological and translational study in axial spondylitis patients who are included in the Swedish Rheumatology Quality Register (SRQ). EISPA aims to include consecutive newly diagnosed axial spondylitis patients. Despite the fact that the disease is relatively common, it takes on average 10 years after start of symptoms for patients be diagnosed with axial spondylitis. Axial spondylitis diagnosis is based on clinical findings rather than diagnostic tests, which reflects lack of knowledge about what causes the disease. At present, our possibilities to predict the course of the disease (and thereby individualize the care of the patient) are limited. Current treatment decreases inflammation rather than treating the cause of the disease. The first treatment step of axial spondylitis is with non-steroidal anti-inflammatory drugs or COX inhibitors, which usually have insufficient effect against inflammatory pain and stiffness. In addition, these drugs are associated with side effects, such as gastrointestinal and cardiovascular side effects. Axial spondylitis is a multifactorial disease where the arachidonic acid cascade, an increased prostaglandin production and release may play a major role. With this there is a clear potential to develop new specific drugs to slow down the prostaglandin cascade in patients with axial spondylitis.

Interventions

None listed

Sponsors

Karolinska University Hospital
CollaboratorOTHER
Karolinska Institutet
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* newly diagnosed patients with axial spondyloarthritis * treatment-naive * 18 years of age or older * Swedish-speaking * Able to give informed consent

Exclusion criteria

* DMARD treatment, * ongoing infection * ongoing malignancy

Design outcomes

Primary

MeasureTime frameDescription
Prostaglandin levels2 yearsInvestigators measure prostaglandin levels in treatment-naïve patients at baseline, and then after therapy start after 1 and 2 years.

Secondary

MeasureTime frameDescription
Questionnaires2 yearsInvestigators collect data on modifiable environmental factors and lifestyle that may contribute to the onset of the disease.
Clinical data2 yearsInvestigators 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.

Countries

Sweden

Contacts

Primary ContactPer-Johan Jakobsson, MD PhD Professor
per-johan-jakobsson@ki.se0725848033

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026