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NCT Number: NCT06594107

Factors for the Onset and Course of Axial Spondylitis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Karolinska University Hospital, Huddinge, Stockholm County, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Prostaglandin levels

    Time frame: 2 years

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

Secondary outcomes

  1. Questionnaires

    Time frame: 2 years

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

  2. Clinical data

    Time frame: 2 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Per-Johan Jakobsson, MD PhD Professor

CONTACT

[email protected]

0725848033 ext. 0046 Sweden

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Karolinska University Hospital

Registry information

Official study title

Faktorer För Uppkomst Och Förlopp Av Axial Spondylartrit

Acronym: EISPA

Important dates

Study start
2022
Primary completion
2035
Study completion
2035
First posted
Sep 19, 2024
Registry last updated
Sep 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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