Longitudinal ULtrasonographic Study of Patients With Spondylarthritis Starting Biological Therapy (ULSPABIT)
Longitudinal ULtrasonographic Study of Patients With Spondylarthritis Starting First Time or Switching to a New Biological Therapy; the ULSpABiT Study.
Patients with spondylarthritis (SpA) (including ankylosing spondylitis, psoriatic arthritis, arthritis as part of inflammatory bowel disease and reactive arthritis) have axial involvement (the spine) as well as peripheral inflammation in joints and entheses (where the tendons and ligaments are anchored to the bone). Patients with high disease activity of SpA may need biological treatment (anti-TNF alpha), which are very expensive medications. Thus it is necessary to have a sensitive method for assessing the response to treatment. Ultrasonography (US) is a validated and reliable method for assessing disease activity in joints and tendons, and may be used to follow the treatment response.
The present study will include patients with SpA starting on anti-TNF alpha treatment (as first biologic medication or when switching to a new biologic treatment). The study is an extension of the ongoing NORDMARD study (Norwegian longitudinal observational study of arthritic patients starting disease-modifying treatment). The patients will be examined by use of US of 38 joints and 14 entheses at baseline and after 3, 6 and 12 months.
The objectives are to explore US as a method to assess peripheral inflammatory activity for evaluation of response to medication as well as to compare the US pathology with clinical and laboratory findings.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Oslo, Noruega, 0319
- Department of Rheumatology, Diakonhjemmet Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- SpA
- Planning to start anti-TNF alpha treatment
Exclusion Criteria:
- Patients not being able to communicate in Norwegian or not being able to fill in questionnaires
- Surgery in more than 5 of the joints/entheses to be examined by US
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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SpA patients
The patients may be included when their rheumatologist has decided that the patient are going to start biological medication.
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All medical treatment will be standardizes following good medical practice
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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To assess the sensitivity to change of US pathology in joints and entheses in SpA patients starting biological treatment.
Periodo de tiempo: Including patients for about 1.5 years
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The joints will be assessed according to a US atlas by use of a semi-quantitative (0-3) scoring system and the entheses will be evaluated according to internationally accepted scoring methods.
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Including patients for about 1.5 years
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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1. Explore whether the US (B-mode and power Doppler) scores at baseline or after 3 months predict patients responding to biological treatment after 6 and 12 months.
Periodo de tiempo: 2.5 years
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2.5 years
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2. Explore whether the sensitivity for change is higher for US (B-mode and/or power Doppler) than for the traditional assessments for inflammatory activity.
Periodo de tiempo: 2.5 years
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2.5 years
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3. Explore potential differences of US detected pathology in joints and entheses between subgroups of spondylarthritis patients.
Periodo de tiempo: 2.5 years
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2.5 years
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4. Explore whether the different subgroups of spondylarthritis patients have different US response (B-mode synovitis and power Doppler in joints and entheses) to biological treatment.
Periodo de tiempo: 2.5 years
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2.5 years
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5. Explore the association between the US findings (BM and/or PD) and the patient's experience of pain and fatigue.
Periodo de tiempo: 2.5 years
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2.5 years
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6. Explore the associations between calprotectin and US detected inflammation in joints and/or entheses as well as traditional assessments of disease activity.
Periodo de tiempo: 2.5 years
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Calprotectin, a major granulocyte protein, is assessed by use of ELISA in plasma.
Plasma samples will be frozen at all visits, and the calprotectin assessments will be performed when all patients have finished the study.
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2.5 years
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7. Explore whether baseline calprotectin or other biomarkers in blood may predict response to biological medication.
Periodo de tiempo: 2.5 years
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Plasma and serum will be frozen at each visit, and the S100 proteins calprotectin as well as A12 will be assessed.
In addition, other relevant biomarkers may be analyzed after 2.5 years.
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2.5 years
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Hilde B Hammer, MD, PhD, Diakonhjemmet Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Infecciones
- Enfermedades Articulares
- Enfermedades musculoesqueléticas
- Artritis
- Enfermedades de la columna
- Enfermedades óseas
- Enfermedades De Los Huesos Infecciosas
- Espondilitis
- Espondiloartritis
- Efectos fisiológicos de las drogas
- Agentes del sistema nervioso periférico
- Analgésicos
- Agentes del sistema sensorial
- Agentes antiinflamatorios no esteroideos
- Analgésicos no narcóticos
- Agentes antiinflamatorios
- Agentes antirreumáticos
- Agentes inmunosupresores
- Factores inmunológicos
- Agentes Gastrointestinales
- Agentes dermatológicos
- Inhibidores del factor de necrosis tumoral
- Etanercept
- Adalimumab
- Infliximab
- Golimumab
Otros números de identificación del estudio
- 011110
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