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Ultrassom para guiar decisões de tratamento em pacientes com artrite reumatóide de acordo com uma abordagem T2T (US-RA-T2T)

3 de novembro de 2026 atualizado por: Italian Society for Rheumatology

Population

Patients with a diagnosis of Rheumatoid Arthritis (RA), moderate or high clinical disease activity (CDAI>10) despite conventional synthetic (cs)DMARD(s) or bs-ts-DMARDs therapy for ≥3 months, and a maximum of 2 swollen joints (out of 44 joints)

Study design

Randomised multicentre, parallel-arm clinical study

Primary objective

Non-inferiority of the experimental arm (i.e. clinical therapy together with ultrasound guided treatment decision) in comparison to the control arm (clinically guided decision) concerning the proportion of patients reaching low disease activity (CDAI ≤10) and a minimal clinical important improvement (MCII: improvement of ≥6 points if starting from moderate disease activity, any case starting from high disease activity and achieving low disease activity) or remission according to ACR/EULAR index-based remission criteria (CDAI ≤2.8/Boolean remission) at week 24.

Intervention

This is a randomised multicentre, national, parallel-arm clinical study. Patients with a diagnosis of RA, moderate or high clinical disease activity (CDAI>10) despite conventional synthetic (cs)DMARD(s) or b-tsDMARDs therapy for ≥3 months, and a maximum of 2 swollen joints (out of 44 joints) will be included and randomized to one of the following two strategic arms:

  1. Clinical decision strategy: All patients receive a new course of b-ts-DMARDs, with or without concomitant cDMARD. If a CDAI ≤10 is not achieved after 12 weeks, patients are switched to a bDMARD or tsDMARD. The decision on which b/tsDMARD to use at week 12 is at the discretion of the investigator.
  2. Clinical plus ultrasound-based decision strategy. All patients in this group will be evaluated by ultrasound at 44 joints. In case of clinically-verified plus ultrasound verified inflammation, patients will receive a new b-ts-DMARD while continuing or not background csDMARD(s) therapy. If a CDAI ≤10 is not achieved after 12 weeks, patients are again evaluated by ultrasound at 44 joints. In case clinically-verified plus ultrasound-verified inflammation is present, patients are switched to a bDMARD or tsDMARD. The decision on which b/tsDMARD to use is at the discretion of the investigator. In case clinically-verified plus ultrasound-verified inflammation is absent, patients receive step-up pain therapy while background treatment will be continued.

Sample size

158 patients

Time plan

  • Total duration of the study: 72 months
  • Active phase for each patient: 48 weeks (24 weeks for the interventional treatment strategy and 24 weeks for follow-up visit)
  • Recruitment: 60 months

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

158

Estágio

  • Não aplicável

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.

Contato de estudo

Locais de estudo

  • Itália
    • Bolzano
      • Bruneck, Bolzano, Itália, 39031
        • Recrutamento
        • Azienda Sanitaria dell'Alto Adige
        • Contato:

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 a 84 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  1. Classification of RA according to the ACR-EULAR 2010 criteria
  2. Age of the patients: 18 to 84 years
  3. Patients with moderate or high disease activity according to CDAI (>10)
  4. Maximum of 2 clinically swollen joints out of a 44-joint count
  5. Current stable treatment with a single csDMARD or bDMARD or tsDMARD for at least 3 months
  6. No glucocorticoid therapy or stable glucocorticoid dose for at least 4 weeks and at a maximum dose of 5 mg/day prednisone equivalent.
  7. No corticosteroid intraarticular injection within 4 weeks
  8. Stable or absent dose of NSAIDs for at least 1 week
  9. Patients able and willing to give written informed consent and compliant with the requirements of the study protocol

Exclusion Criteria:

  1. Complete (clinically evident) destruction of any joint to be investigated by ultrasound as judged by the physician
  2. Current RA-related vasculitis or other active systemic (i.e. extraarticular) RA-manifestation except for rheumatoid nodules, which in the opinion of the investigator would expose the study subject to a high risk of morbidity or mortality
  3. Initial arthritis manifestations before the age of 18 years
  4. Planned surgery within the study period for any of the joints investigated either clinically or by sonography
  5. Current severe medical illness requiring hospitalization
  6. Active infection or active malignancy at screening <5 years
  7. Any contraindication to b/ts DMARDs according to the "Summary of Product Characteristics"
  8. Pregnancy or lactation

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

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Triplo

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Sem intervenção: Conventional decision strategy

All patients receive a new course of b-ts-DMARDs, with or without concomitant cDMARD. If a CDAI ≤10 is not achieved after 12 weeks, patients are switched to a bDMARD or tsDMARD. The decision on which b/tsDMARD to use at week 12 is at the discretion of the investigator.
Experimental: Clinical plus ultrasound-based decision strategy

All patients in this group will be evaluated by ultrasound at 44 joints. In case of clinically-verified plus ultrasound verified inflammation, patients will receive a new b-ts-DMARD while continuing or not background csDMARD(s) therapy. If a CDAI ≤10 is not achieved after 12 weeks, patients are again evaluated by ultrasound at 44 joints. In case clinically-verified plus ultrasound-verified inflammation is present, patients are switched to a bDMARD or tsDMARD. The decision on which b/tsDMARD to use is at the discretion of the investigator. In case clinically-verified plus ultrasound-verified inflammation is absent, patients receive step-up pain therapy while background treatment will be continued.
Teste de diagnostico: Ultrasound

At baseline and at weeks 12, 24 and 48, patients will undergo an ultrasound examination of 44 joints by one investigator, who is blinded to the strategic arm and all clinical data. The following joints will be assessed: bilateral wrists (distal radio-ulnar joint, radio-carpal, mid-carpal recesses), 1st - 5th MCP, 1st - 5th PIP, elbows, glenohumeral, acromioclavicular, sternoclavicular, knees, ankles and 1st - 5th MTP. At wrists, MCP and PIP joints, palmar and dorsal sites including synovial recess, extensor and flexor tendons will be investigated whereas at feet the dorsal site (plus the lateral aspects of MTP5) including synovial recess and extensor tendons will be evaluated. Further, we will assess the following: at elbows the dorsal and anterior recess, at shoulders the dorsal recess, at knees the suprapatellar as well as the medial and lateral femoro-tibial recess and at ankles the anterior, lateral and medial recess of the tibiotalar joint.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Non-inferiority of ultrasound-based decision strategy compared to clinically-based strategy.
Prazo: 24 weeks

Non-inferiority of the experimental arm (i.e. clinical plus ultrasound-guided treatment decision) in comparison to the control arm (clinically-guided decision) concerning the proportion of patients reaching low disease activity (CDAI ≤10) and a minimal clinical important improvement (MCII: improvement of ≥6 points if starting from moderate disease activity, any case achieving low disease activity who started from high disease activity) [19] or remission according to ACR/EULAR index-based remission criteria (CDAI ≤2.8/Boolean remission) at week 24.
24 weeks

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Comparação da proporção de pacientes em baixa atividade da doença e MCII ou remissão de acordo com os critérios de remissão baseados no índice ACR/EULAR na semana 12 e 48
Prazo: 12 e 48 semanas
12 e 48 semanas
Comparação da proporção de pacientes em remissão de acordo com os critérios de remissão baseados no índice ACR/EULAR (CDAI ≤2,8/remissão booleana, respectivamente) nas semanas 12, 24 e 48
Prazo: 12, 24 e 48 semanas
12, 24 e 48 semanas
Comparação da proporção de pacientes em remissão de acordo com DAS-28 (DAS-28 ≤2,6) ou SDAI (≤3,3) nas semanas 12, 24 e 48
Prazo: 12, 24 e 48 semanas
12, 24 e 48 semanas
Comparação do valor da contagem de articulações sensíveis nas semanas 12, 24 e 48
Prazo: 12, 24 e 48 semanas
12, 24 e 48 semanas
Comparação do valor das contagens de articulações inchadas nas semanas 12, 24 e 48
Prazo: 12, 24 e 48 semanas
12, 24 e 48 semanas
Comparação do valor da taxa de hemossedimentação (ESR) nas semanas 12, 24 e 48
Prazo: 12, 24 e 48 semanas
12, 24 e 48 semanas
Comparação do valor da proteína C reativa (PCR) nas semanas 12, 24 e 48
Prazo: 12, 24 e 48 semanas
12, 24 e 48 semanas
Comparação da pontuação das dimensões do EuroQol-5 (EQ5D) nas semanas 24 e 48
Prazo: 24 e 48 semanas
24 e 48 semanas
Comparação de pacientes que atingiram uma pontuação de DP de ≤1 (contagem de 44 articulações) nas semanas 12, 24 e 48
Prazo: 12, 24 e 48 semanas
12, 24 e 48 semanas
Comparison of value of VAS (Visual Analogue Scale) pain at weeks 12, 24 and 48
Prazo: 12, 24 and 48 weeks

Range: 0, better outcome - 100, worse outcome
12, 24 and 48 weeks
Comparison of value of VAS (Visual Analogue Scale) Patient Global Assessment of Disease Activity at weeks 12, 24 and 48
Prazo: 12, 24 and 48 weeks

Range: 0, better outcome - 100, worse outcome
12, 24 and 48 weeks
Comparison of value of VAS (Visual Analogue Scale) Physician Global Assessment of Disease Activity at weeks 12, 24 and 48
Prazo: 12, 24 and 48 weeks

Range: 0, better outcome - 100, worse outcome
12, 24 and 48 weeks
Comparison of Health assessment questionnaire (HAQ) score at week 24 and 48
Prazo: 24 and 48 weeks

Range: 0, better outcome - 3, worse outcome
24 and 48 weeks
Comparison of Rheumatoid Arthritis Impact of Disease (RAID) score at week 24 and 48
Prazo: 24 and 48 weeks

Range: 0, better outcome - 10, worse outcome
24 and 48 weeks
Comparison of Fatigue Assessment Scale (FAS) score at week 24 and 48
Prazo: 24 and 48 weeks

Range: 10, better outcome - 50, worse outcome
24 and 48 weeks
Comparison of the trend of VAS (Visual Analogue Scale) pain across all study visits
Prazo: 48 weeks

Absolute and relative change of parameter with respect to the baseline and between different visits
48 weeks
Comparison of the trend of VAS (Visual Analogue Scale) Patient Global Assessment of Disease Activity across all study visits
Prazo: 48 weeks

Absolute and relative change of parameter with respect to the baseline and between different visits
48 weeks
Comparison of the trend of Health assessment questionnaire (HAQ) score across all study visits
Prazo: 48 weeks

Absolute and relative change of score with respect to the baseline and between different visits
48 weeks
Comparison of the trend of Rheumatoid Arthritis Impact of Disease (RAID) score across all study visits
Prazo: 48 weeks

Absolute and relative change of score with respect to the baseline and between different visits
48 weeks
Comparison of the trend of Fatigue Assessment Scale (FAS) score across all study visits
Prazo: 48 weeks

Absolute and relative change of score with respect to the baseline and between different visits
48 weeks
Comparison of the trend of EuroQol-5 dimensions (EQ5D) score across all study visits
Prazo: 48 weeks

Absolute and relative change of score with respect to the baseline and between different visits
48 weeks
Comparison of the differences in the Sharp van der Heijde Score from baseline to week 48
Prazo: 48 weeks

Range: 0, better outcome - 448, worse outcome
48 weeks
Comparison of direct medical costs of treatment arms from baseline to week 24 and 48
Prazo: 24 and 48 weeks

Measurement: Incremental cost-effectiveness ratio (ICER)
24 and 48 weeks
Analysis regarding predictors of low disease activity or remission at 12, 24 and 48 weeks in patients treated with ≥1bDMARD as compared to those who receive pain therapy
Prazo: 12, 24 and 48 weeks

Investigated predictors: baseline erythrocyte sedimentation rate, baseline C reactive protein, baseline ultrasound score (EULAR-OMERACT combined score)
12, 24 and 48 weeks

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Italian Society for Rheumatology

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)

22 de fevereiro de 2023

Conclusão Primária (Estimado)

1 de agosto de 2028

Conclusão do estudo (Estimado)

1 de fevereiro de 2029

Datas de inscrição no estudo

Enviado pela primeira vez

15 de dezembro de 2022

Enviado pela primeira vez que atendeu aos critérios de CQ

6 de fevereiro de 2023

Primeira postagem (Real)

8 de fevereiro de 2023

Atualizações de registro de estudo

Última Atualização Postada (Real)

4 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

3 de novembro de 2026

Última verificação

1 de novembro de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • US-RA-T2T

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

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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