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L'essai clinique NCT06594107 (EISPA) pour Spondyloarthrite axiale est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici.
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Factors for the Onset and Course of Axial Spondylitis (EISPA)

En recrutement
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L'étude clinique NCT06594107 (EISPA) est un essai observationnel pour Spondyloarthrite axiale. Son statut actuel est : en recrutement. L'étude a débuté le 1 septembre 2022 et vise à recruter 1 000 participants. Dirigé par l'Institut Karolinska, l'essai devrait être terminé d'ici le 31 décembre 2035. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 24 septembre 2024.
Résumé succinct
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.

Description détaillée
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.

Titre officiel

Faktorer För Uppkomst Och Förlopp Av Axial Spondylartrit

Conditions
Spondyloarthrite axiale
Publications
Articles scientifiques et travaux de recherche publiés sur cet essai clinique:
Autres identifiants de l'essai
  • EISPA
  • 2022-01789-01 (Autre Identifiant) (Karolinska Institute and University Hospital)
Numéro NCT
Date de début (réel)
2022-09-01
Dernière mise à jour publiée
2024-09-24
Date de fin (estimée)
2035-12-31
Inscription (estimée)
1 000
Type d'essai
Observationnel
Statut
En recrutement
Mots clés
observational
axial spondyloarthritis
prostaglandins
predictive factors
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
1 cohort at Karolinska University Hospital and 1 at the Center for Rheumatology in Stockholm
This cohortstudy is performed at 2 sites.
N/A
Critère principal d'évaluation
Critères d'évaluationDescription de critèresPériode
Prostaglandin levels
Investigators measure prostaglandin levels in treatment-naïve patients at baseline, and then after therapy start after 1 and 2 years.
2 years
Critère secondaire d'évaluation
Critères d'évaluationDescription de critèresPériode
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
Critères d'éligibilité

Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
  • 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 logoInstitut Karolinska
Karolinska University Hospital logoKarolinska University Hospital
Partie responsable de l'essai
Per-Johan Jakobsson, Investigateur principal, MD PhD Professor, Karolinska Institutet
Contact central de l'essai
Contact: Per-Johan Jakobsson, MD PhD Professor, 0725848033, [email protected]
2 Centres de l'essai dans 1 pays

Stockholm County

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