Progression of Bone Erosions in Rheumatoid Arthritis Assessed by HR-pQCT and Conventional X-ray (RACTX)
12 de janeiro de 2021 atualizado por: Rasmus Klose-Jensen, Aarhus University Hospital
An Observational Study of Bone Erosion Determination and Progression in Rheumatoid Arthritis Assessed by HR-pQCT and Conventional X-ray
Today, regular X-ray examination is not sufficiently sensitive for detecting progression of bone destruction in rheumatoid arthritis, but a new type of high-resolution CT scanner, the High-Resolution peripheral Quantitative Computed Tomography (HR-pQCT) can detect very early and minor joint injuries.
The purpose of this study is to use HR-pQCT techniques to look at the damage and disease activity progression in the hand and wrist joints of patients with rheumatoid arthritis.
Visão geral do estudo
Status
Inscrevendo-se por convite
Condições
Descrição detalhada
The design of the trial is an observational study with three distinct groups. At the start of the trial period and at one-year of follow-up, the trial subject will have their hand X-rayed by conventional radiography, and their metacarpophalangeal (MCP) joint and wrist scanned by HR-pQCT-Imaging. The 28-joint Disease Activity Score(DAS28-CRP), Health Assessment Questionnaire (HAQ), Visual analogue scale(VAS)-score for pain, fatigue and quality of life are performed to investigate the correlation between radiographic changes and disease activity. Blood samples are collected to investigate serological markers of bone metabolism and inflammation and the radiographic changes. The following groups are investigated:
- Rheumatoid Arthritis(RA): Patients with RA ≥5 years according to the ACR/EULAR 2010 classification criteria or the American Rheumatism Association 1987 revised criteria are recruited from the outpatient clinic at the Department of Rheumatology, Aarhus University Hospital. Treatment will be adjusted according to the patient's need and according to national guidelines. (n=450)
- Pre-RA patients: Patients with pre-RA, (joint pain, but no swelling and Anti-CCP 3 times above the upper limit) are recruited from the outpatient clinic at the Department of Rheumatology, Aarhus University Hospital. (n=75)
- Healthy subjects: Healthy age- and sex-matched Individuals are recruited, as a control group, by posting at libraries in Aarhus, Aarhus University, Aarhus University Hospital and postings on the websites www.forsøgsperson.dk and www.Sundhed.dk. (N=100)
Tipo de estudo
Observacional
Inscrição (Antecipado)
625
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Aarhus, Dinamarca, 8000
- Department of Rheumatology, Aarhus University Hospital
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
N/D
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra Não Probabilística
População do estudo
Rheumatoid arthritis patients and pre-rheumatoid patients are recruited from the outpatient clinic at the Department of Rheumatology, Aarhus University Hospital.
Healthy age- and sex-matched Individuals are recruited, as a control group, by posting at libraries in Aarhus, Aarhus University, Aarhus University Hospital and postings on the websites www.forsøgsperson.dk and www.Sundhed.dk.
Descrição
Rheumatoid arthritis patients Inclusion criteria
- Patients (> 18 years) with rheumatoid arthritis ≥5 years according to the ACR/EULAR (2010) classification criteria or American Rheumatism Association 1987 revised criteria for the patients who were diagnosed before 2010.
- Patients who are receiving treatment on an outpatient basis.
- Ability and willingness to give written informed consent and to meet the requirements of the trial protocol.
Exclusion criteria
- Patients who have previously suffered trauma in the form of fracture or luxation of the hand are excluded.
- Evidence of active malignant disease.
- Hypo- or hyperthyroidism.
- Hypocalcaemia.
- Impaired renal function (eGFR <35ml/min).
- Pregnancy. Pre-rheumatoid arthritis patients Inclusion criteria
- Age over 18 years.
- Anti-CCP 3 times the upper limit of the reference interval.
- Arthralgia.
- Ability and willingness to give written informed consent and to meet the requirements of the trial protocol.
Exclusion criteria
- Pregnancy.
- Swelling of joints. Verified by clinical ultrasound.
- Patients who have previously suffered trauma in the form of fracture or luxation of the hand are excluded.
- Evidence of malignant disease.
- Hypo- or hyperthyroidism.
- Hypocalcaemia. Healthy subjects Inclusion criteria
- Age over 18 years.
- No joint complaints.
- Ability and willingness to give written informed consent and to meet the requirements of the trial protocol.
Exclusion criteria
- Patients who have previously suffered trauma in the form of fracture or luxation of the hand are excluded.
- Evidence of malignant disease.
- Hypo- or hyperthyroidism.
- Hypocalcaemia.
- Impaired renal function (eGFR <35ml/min).
- Earlier or present rheumatological disease or bone metabolic disease.
- Positive anti-CCP.
- Pregnancy.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: Coorte
- Perspectivas de Tempo: Prospectivo
Coortes e Intervenções
Grupo / Coorte |
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Rheumatoid arthritis
Patients with Rheumatoid arthritis ≥5 years according to the ACR/EULAR 2010 classification criteria or the American Rheumatism Association 1987 revised criteria. ICD-10: M059 Seropositive rheumatoid arthritis UNS, M060 Seronegative rheumatoid arthritis, M069 Rheumatoid arthritis UNS. |
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Pre-Rheumatoid arthritis
Patients with joint pain, but no swelling and Anti-CCP 3 times above the upper limit.
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Healthy Subjects
Healthy age- and sex-matched Individuals are recruited, as a control group.
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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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Erosion changes by HR-pQCT
Prazo: One year
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Changes in bone erosions volume in mm3 by HR-pQCT-imaging from baseline to one-year follow-up, in the three groups.
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One year
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Volumetric bone mineral density(vBMD) changes by HR-pQCT
Prazo: One year
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Changes in volumetric bone mineral density(vBMD) in mgHA/cm3 by HR-pQCT-imaging from baseline to one-year follow-up, in the three groups.
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One year
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Erosion changes by HR-pQCT
Prazo: One year
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Changes in bone erosions width in mm by HR-pQCT-imaging from baseline to one-year follow-up, in the three groups.
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One year
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Erosion changes by HR-pQCT
Prazo: One year
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Changes in bone erosions depth in mm by HR-pQCT-imaging from baseline to one-year follow-up, in the three groups.
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One year
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Radiographic erosion score
Prazo: One year
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Change in Sharp/van der Heijde (SvH) score from baseline to one-year follow-up, in the three groups.
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One year
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CTX
Prazo: one year
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Changes from baseline to one-year follow-up in C-terminal telopeptide (CTX) in pg/mL, in the three groups.
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one year
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P1NP
Prazo: one year
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Changes from baseline to one-year follow-up in Procollagen type 1 N-terminal propeptide (P1NP) in pg/mL, in the three groups.
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one year
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BAP
Prazo: one year
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Changes from baseline to one-year follow-up in Bone-specific alkaline phosphatase (BAP) in pg/mL, in the three groups.
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one year
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TNF-α
Prazo: one year
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Changes from baseline to one-year follow-up in the Tumor necrosis factor-alfa (TNF-α) in pg/mL, in the three groups.
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one year
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RANK-L
Prazo: one year
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Changes from baseline to one-year follow-up in RANK-Ligand (RANK-L) in pg/mL, in the three groups.
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one year
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OPG
Prazo: one year
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Changes from baseline to one-year follow-up in Osteoprotegerin (OPG) in pg/mL, in the three groups.
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one year
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BGLAP
Prazo: one year
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Changes from baseline to one-year follow-up in Osteocalcin (BGLAP) in pg/mL, in the three groups.
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one year
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SCL
Prazo: one year
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Changes from baseline to one-year follow-up in Sclerostin(SCL) in pg/mL, in the three groups.
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one year
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Dkk-1
Prazo: one year
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Changes from baseline to one-year follow-up in Dickkopf-related protein 1 (Dkk-1) in pg/mL, in the three groups.
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one year
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IL-1
Prazo: one year
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Changes from baseline to one-year follow-up in Interleukins 1 (IL-1) in pg/mL, in the three groups.
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one year
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IL-6
Prazo: one year
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Changes from baseline to one-year follow-up in Interleukins 6 (IL-6) in pg/mL, in the three groups.
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one year
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IL-15
Prazo: one year
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Changes from baseline to one-year follow-up in Interleukins 15 (IL-15) in pg/mL, in the three groups.
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one year
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IL-16
Prazo: one year
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Changes from baseline to one-year follow-up in Interleukins 16 (IL-16) in pg/mL, in the three groups.
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one year
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IL-17
Prazo: one year
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Changes from baseline to one-year follow-up in Interleukins 17 (IL-17) in pg/mL, in the three groups.
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one year
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IL-22
Prazo: one year
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Changes from baseline to one-year follow-up in Interleukins 22 (IL-22) in pg/mL, in the three groups.
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one year
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IL-33
Prazo: one year
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Changes from baseline to one-year follow-up in Interleukins 33 (IL-33) in pg/mL, in the three groups.
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one year
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CCL11
Prazo: one year
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Changes from baseline to one-year follow-up in Chemokine ligand 11 (CCL11) in pg/mL, in the three groups.
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one year
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CXCL13
Prazo: one year
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Changes from baseline to one-year follow-up in Chemokine (C-X-C) motif ligand (CXCL13) in pg/mL, in the three groups.
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one year
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TRACP 5b
Prazo: one year
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Changes from baseline to one-year follow-up in Tartrate-resistant acid phosphatase 5b (TRACP 5b) in pg/mL, in the three groups.
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one year
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CRP
Prazo: one year
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Changes from baseline to one-year follow-up in C-reactive protein (CRP) in mg/L, in the three groups.
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one year
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Disease Activity Score
Prazo: one year
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Disease Activity Score (DAS28-CRP) [2.0-10.0]
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one year
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Health Assessment Questionnaire
Prazo: one year
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Health Assessment Questionnaire (HAQ) [0-3 HAQ Total Score]
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one year
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VAS for pain
Prazo: one year
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Visual Analog Scale(VAS) for pain [0-100mm]
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one year
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VAS for fatigue
Prazo: one year
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Visual Analog Scale(VAS) for fatigue [0-100mm]
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one year
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VAS for quality of life
Prazo: one year
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Visual Analog Scale(VAS) for quality of life [0-100mm]
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one year
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
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areal bone mineral density (aBMD)
Prazo: one year
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aBMD in the lumbar spine, and the left hip by DXA, in RA patients
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one year
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Diretor de estudo: Ellen-Margrethe Hauge, MD, PhD, Department of Rheumatology - Aarhus University Hospital
Publicações e links úteis
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Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
15 de fevereiro de 2018
Conclusão Primária (Antecipado)
1 de fevereiro de 2022
Conclusão do estudo (Antecipado)
31 de dezembro de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
24 de janeiro de 2018
Enviado pela primeira vez que atendeu aos critérios de CQ
5 de fevereiro de 2018
Primeira postagem (Real)
12 de fevereiro de 2018
Atualizações de registro de estudo
Última Atualização Postada (Real)
13 de janeiro de 2021
Última atualização enviada que atendeu aos critérios de controle de qualidade
12 de janeiro de 2021
Última verificação
1 de janeiro de 2021
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- RACTX
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Indeciso
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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