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Ultrasonido para guiar las decisiones de tratamiento en pacientes con artritis reumatoide según un enfoque T2T (US-RA-T2T)

3 de noviembre de 2026 actualizado 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

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

158

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Italia
    • Bolzano
      • Bruneck, Bolzano, Italia, 39031
        • Reclutamiento
        • Azienda Sanitaria dell'Alto Adige
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 84 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Sin intervención: 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.
Prueba de diagnóstico: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Non-inferiority of ultrasound-based decision strategy compared to clinically-based strategy.
Periodo de tiempo: 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 resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Comparación de la proporción de pacientes con baja actividad de la enfermedad y MCII o remisión según los criterios de remisión basados ​​en el índice ACR/EULAR en la semana 12 y 48
Periodo de tiempo: 12 y 48 semanas
12 y 48 semanas
Comparación de la proporción de pacientes en remisión según los criterios de remisión basados ​​en índices ACR/EULAR (CDAI ≤2,8/remisión booleana, respectivamente) en las semanas 12, 24 y 48
Periodo de tiempo: 12, 24 y 48 semanas
12, 24 y 48 semanas
Comparación de la proporción de pacientes en remisión según DAS-28 (DAS-28 ≤2,6) o SDAI (≤3,3) en las semanas 12, 24 y 48
Periodo de tiempo: 12, 24 y 48 semanas
12, 24 y 48 semanas
Comparación del valor del recuento de juntas tiernas en las semanas 12, 24 y 48
Periodo de tiempo: 12, 24 y 48 semanas
12, 24 y 48 semanas
Comparación del valor de los recuentos de articulaciones inflamadas en las semanas 12, 24 y 48
Periodo de tiempo: 12, 24 y 48 semanas
12, 24 y 48 semanas
Comparación del valor de la velocidad de sedimentación globular (VSG) en las semanas 12, 24 y 48
Periodo de tiempo: 12, 24 y 48 semanas
12, 24 y 48 semanas
Comparación del valor de la proteína C reactiva (PCR) en las semanas 12, 24 y 48
Periodo de tiempo: 12, 24 y 48 semanas
12, 24 y 48 semanas
Comparación de la puntuación de las dimensiones EuroQol-5 (EQ5D) en la semana 24 y 48
Periodo de tiempo: 24 y 48 semanas
24 y 48 semanas
Comparación de pacientes que lograron una puntuación de PD de ≤1 (recuento de 44 articulaciones) en las semanas 12, 24 y 48
Periodo de tiempo: 12, 24 y 48 semanas
12, 24 y 48 semanas
Comparison of value of VAS (Visual Analogue Scale) pain at weeks 12, 24 and 48
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Italian Society for Rheumatology

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

22 de febrero de 2023

Finalización primaria (Estimado)

1 de agosto de 2028

Finalización del estudio (Estimado)

1 de febrero de 2029

Fechas de registro del estudio

Enviado por primera vez

15 de diciembre de 2022

Primero enviado que cumplió con los criterios de control de calidad

6 de febrero de 2023

Publicado por primera vez (Actual)

8 de febrero de 2023

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

4 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

3 de noviembre de 2026

Última verificación

1 de noviembre de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • US-RA-T2T

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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