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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-01789-01 | Other Identifier | Karolinska Institute and University Hospital |
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| Name | Class |
|---|---|
| Karolinska University Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 cohort at Karolinska University Hospital and 1 at the Center for Rheumatology in Stockholm | This cohortstudy is performed at 2 sites. |
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| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Per-Johan Jakobsson, MD PhD Professor | Contact | 0725848033 | 0046 Sweden | per-johan-jakobsson@ki.se |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska University Hospital | Recruiting | Huddinge | Stockholm County | 141 86 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10377395 | Background | 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. |
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| ID | Term |
|---|---|
| D000089183 | Axial Spondyloarthritis |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
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Whole blood samples heparin blood, EDTA blood and urine samples are collected at baseline, after 1 and 2 years in the first 100 patients.
1 group, 2 cohorts 1 at Karolinska and 1 at the center for Rheumatology in Stockholm.
| 2 years |
| Center for Rheumatology Stockholm | Recruiting | Stockholm | Stockholm County | 113 65 | Sweden |
|
| D001847 |
| Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D000844 | Ankylosis |
| D007592 | Joint Diseases |
| D001168 | Arthritis |