Factors for the Onset and Course of Axial Spondylitis (EISPA)

Faktorer För Uppkomst Och Förlopp Av Axial Spondylartrit

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.

Study Overview

• Status: Recruiting
• Conditions: Axial Spondyloarthritis

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.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Per-Johan Jakobsson, MD PhD Professor; Phone Number: 0046 Sweden 0725848033; Email: per-johan-jakobsson@ki.se

Study Locations

• Sweden
  • Stockholm, Sweden, 113 65
    • Recruiting
    • Center for Rheumatology Stockholm
    • Contact: Marika K Kvarnström, MD PhD; Phone Number: 0046 0812367650; Email: marika.kvarnstrom@regionstockholm.se
    • Contact: Zoja Holgersson, Research nurse; Phone Number: 0046 0812367650; Email: zoja.holgersson@regionstockholm.se
    • Contact: Marika Kvarnström, MD PhD
  • Stockholm
    • Huddinge, Stockholm, Sweden, 141 86
      • Recruiting
      • Karolinska University Hospital
      • Contact: Mirjam K de Vries, MD PhD; Phone Number: 0046 0725948031; Email: mirjam.devries@regionstockholm.se
      • Contact: Sara Brolin, Research nurse; Phone Number: 0046724682252; Email: sara.brolin@regionstockholm.se
      • Contact: Mirjam K de Vries, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
1 cohort at Karolinska University Hospital and 1 at the Center for Rheumatology in Stockholm; This cohortstudy is performed at 2 sites.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prostaglandin levels	Investigators measure prostaglandin levels in treatment-naïve patients at baseline, and then after therapy start after 1 and 2 years.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Questionnaires	Investigators collect data on modifiable environmental factors and lifestyle that may contribute to the onset of the disease.	2 years
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.	2 years

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Karolinska University Hospital

Publications and helpful links

General Publications

• Jakobsson PJ, Thoren S, Morgenstern R, Samuelsson B. Identification of human prostaglandin E synthase: a microsomal, glutathione-dependent, inducible enzyme, constituting a potential novel drug target. Proc Natl Acad Sci U S A. 1999 Jun 22;96(13):7220-5. doi: 10.1073/pnas.96.13.7220.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Estimated): December 31, 2035
• Study Completion (Estimated): December 31, 2035

Study Registration Dates

• First Submitted: September 10, 2024
• First Submitted That Met QC Criteria: September 12, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): September 24, 2024
• Last Update Submitted That Met QC Criteria: September 23, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: observational; predictive factors; axial spondyloarthritis; prostaglandins
• Additional Relevant MeSH Terms: Infections; Joint Diseases; Musculoskeletal Diseases; Arthritis; Spinal Diseases; Bone Diseases; Spondylarthropathies; Bone Diseases, Infectious; Ankylosis; Spondylitis; Spondylarthritis; Axial Spondyloarthritis
• Other Study ID Numbers: EISPA; 2022-01789-01 (Other Identifier: Karolinska Institute and University Hospital)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No