Axial SpondyloarthritisEISPANCT06594107
Factors for the Onset and Course of Axial Spondylitis
An observational study of Axial Spondyloarthritis, run by Karolinska Institutet at 2 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Axial Spondyloarthritis
- How many people
- 1,000 participants
- Where
- 2 sitesSweden
- Study dates
- 1 Sep 2022to 31 Dec 2035
- How long will I take part?
- 2 Years
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- newly diagnosed patients with axial spondyloarthritis
- treatment-naive
- 18 years of age or older
- Swedish-speaking
- Able to give informed consent
Who cannot join
- DMARD treatment,
- ongoing infection
- ongoing malignancy
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden2 sites, 2 recruiting
- Recruiting
Karolinska University Hospital
Huddinge, Stockholm County, 141 86
Mirjam K de Vries, MD PhD, 0725948031 ext. 0046, mirjam.devries@regionstockholm.se
Sara Brolin, Research nurse, 0046724682252, sara.brolin@regionstockholm.se
- Recruiting
Center for Rheumatology Stockholm
Stockholm, Stockholm County, 113 65
Marika K Kvarnström, MD PhD, 0812367650 ext. 0046, marika.kvarnstrom@regionstockholm.se
Zoja Holgersson, Research nurse, 0812367650 ext. 0046, zoja.holgersson@regionstockholm.se
About this study
Official title: 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.
Read the 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.
- Conditions
- Axial Spondyloarthritis
- Keywords
- observational, axial spondyloarthritis, prostaglandins, predictive factors
- Medical subject headings
- Axial Spondyloarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 cohort at Karolinska University Hospital and 1 at the Center for Rheumatology in Stockholm | This cohortstudy is performed at 2 sites. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prostaglandin levels
Investigators measure prostaglandin levels in treatment-naïve patients at baseline, and then after therapy start after 1 and 2 years.
Measured: 2 years
Secondary outcomes (2)
Questionnaires
Investigators collect data on modifiable environmental factors and lifestyle that may contribute to the onset of the disease.
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Sep 2022
- Primary completion31 Dec 2035 (estimated)
- Study completion31 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Axial SpondyloarthritisStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska University Hospital
- Responsible party
- Principal investigator, Per-Johan Jakobsson, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06594107
- Sponsor's protocol ID
- EISPA
- Other IDs
- 2022-01789-01
- Acronym
- EISPA
- Status last verified
- Sep 2024
- First submitted
- 10 Sep 2024
- Last updated
- 24 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 10377395