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Eine Studie entspricht den Filterkriterien
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Factors for the Onset and Course of Axial Spondylitis (EISPA)

Offene Rekrutierung
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT06594107 (EISPA) ist eine beobachtungsstudie zur Untersuchung von Axiale Spondyloarthritis und hat den Status offene rekrutierung. Die Studie startete am 1. September 2022 und soll 1.000 Teilnehmer aufnehmen. Durchgeführt von Karolinska-Institut ist der Abschluss für 31. Dezember 2035 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 24. September 2024 aktualisiert.
Kurzbeschreibung
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.

Ausführliche Beschreibung
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.

Offizieller Titel

Faktorer För Uppkomst Och Förlopp Av Axial Spondylartrit

Erkrankungen
Axiale Spondyloarthritis
Publikationen
Wissenschaftliche Artikel und Forschungspapiere zu dieser klinischen Studie:
Weitere Studien-IDs
  • EISPA
  • 2022-01789-01 (Andere Kennung) (Karolinska Institute and University Hospital)
NCT-Nummer
Studienbeginn (tatsächlich)
2022-09-01
Zuletzt aktualisiert
2024-09-24
Studienende (vorauss.)
2035-12-31
Geplante Rekrutierung
1.000
Studientyp
Beobachtungsstudie
Status
Offene Rekrutierung
Stichwörter
observational
axial spondyloarthritis
prostaglandins
predictive factors
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
1 cohort at Karolinska University Hospital and 1 at the Center for Rheumatology in Stockholm
This cohortstudy is performed at 2 sites.
Nicht zutreffend
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
Prostaglandin levels
Investigators measure prostaglandin levels in treatment-naïve patients at baseline, and then after therapy start after 1 and 2 years.
2 years
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
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
Eignungskriterien

Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
  • newly diagnosed patients with axial spondyloarthritis
  • treatment-naive
  • 18 years of age or older
  • Swedish-speaking
  • Able to give informed consent

  • DMARD treatment,
  • ongoing infection
  • ongoing malignancy
Karolinska Institutet logoKarolinska-Institut
Karolinska University Hospital logoKarolinska University Hospital
Verantwortliche Partei
Per-Johan Jakobsson, Hauptprüfer, MD PhD Professor, Karolinska Institutet
Zentrale Studienkontakte
Kontakt: Per-Johan Jakobsson, MD PhD Professor, 0725848033, [email protected]
2 Studienstandorte in 1 Ländern

Stockholm County

Karolinska University Hospital, Huddinge, Stockholm County, 141 86, Sweden
Mirjam K de Vries, MD PhD, Kontakt, 0725948031, [email protected]
Sara Brolin, Research nurse, Kontakt, 0046724682252, [email protected]
Mirjam K de Vries, MD PhD, Kontakt
Offene Rekrutierung
Center for Rheumatology Stockholm, Stockholm, Stockholm County, 113 65, Sweden
Marika K Kvarnström, MD PhD, Kontakt, 0812367650, [email protected]
Zoja Holgersson, Research nurse, Kontakt, 0812367650, [email protected]
Marika Kvarnström, MD PhD, Kontakt
Offene Rekrutierung