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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Oslo, Noruega, 0319
- Department of Rheumatology, Diakonhjemmet Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
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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
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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To assess the sensitivity to change of US pathology in joints and entheses in SpA patients starting biological treatment.
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Infecções
- Doenças articulares
- Doenças musculoesqueléticas
- Artrite
- Doenças da coluna vertebral
- Doenças ósseas
- Doenças Ósseas Infecciosas
- Espondilite
- Espondilartrite
- Efeitos Fisiológicos das Drogas
- Agentes do Sistema Nervoso Periférico
- Analgésicos
- Agentes do Sistema Sensorial
- Agentes anti-inflamatórios não esteróides
- Analgésicos, Não Narcóticos
- Antiinflamatórios
- Agentes Antirreumáticos
- Agentes imunossupressores
- Fatores imunológicos
- Agentes gastrointestinais
- Agentes dermatológicos
- Inibidores do Fator de Necrose Tumoral
- Etanercepte
- Adalimumabe
- Infliximabe
- Golimumabe
Outros números de identificação do estudo
- 011110
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