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El ensayo clínico NCT06594107 (EISPA) para Espondiloartritis Axial está reclutando. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí.
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Factors for the Onset and Course of Axial Spondylitis (EISPA)

Reclutando
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el ensayo' para ver y discutir la información del ensayo en el idioma que haya seleccionado.
El estudio clínico NCT06594107 (EISPA) es un ensayo observacional para Espondiloartritis Axial. Su estado actual es: reclutando. El ensayo se inició el 1 de septiembre de 2022, con el objetivo de reclutar a 1000 participantes. Dirigido por el Instituto Karolinska, se espera que finalice el 31 de diciembre de 2035. Los datos se actualizaron por última vez en ClinicalTrials.gov el 24 de septiembre de 2024.
Resumen
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.

Descripción detallada
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.

Título oficial

Faktorer För Uppkomst Och Förlopp Av Axial Spondylartrit

Condiciones médicas
Espondiloartritis Axial
Publicaciones
Artículos científicos y trabajos de investigación publicados sobre este ensayo clínico:
Otros ID del ensayo
  • EISPA
  • 2022-01789-01 (Otro identificador) (Karolinska Institute and University Hospital)
Número del NCT
Inicio del ensayo (real)
2022-09-01
Última actualización
2024-09-24
Fecha de finalización (estimada)
2035-12-31
Inscripción (prevista)
1000
Tipo de estudio
Observacional
Estado general
Reclutando
Palabras clave
observational
axial spondyloarthritis
prostaglandins
predictive factors
Brazos / Intervenciones
Grupo de participantesIntervención/Tratamiento
1 cohort at Karolinska University Hospital and 1 at the Center for Rheumatology in Stockholm
This cohortstudy is performed at 2 sites.
N/A
Resultado primario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Prostaglandin levels
Investigators measure prostaglandin levels in treatment-naïve patients at baseline, and then after therapy start after 1 and 2 years.
2 years
Resultado secundario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
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
Criterios de elegibilidad

Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Todos
  • 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 logoInstituto Karolinska
Karolinska University Hospital logoKarolinska University Hospital
Parte responsable del ensayo
Per-Johan Jakobsson, Investigador principal, MD PhD Professor, Karolinska Institutet
Contactos centrales del ensayo
Contacto: Per-Johan Jakobsson, MD PhD Professor, 0725848033, [email protected]
2 Sitios del ensayo en 1 países

Stockholm County

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