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REstore Working Ability in RheumatoiD Arthritis (REWARD)

28 de julio de 2011 actualizado por: The Rheumatological Center of Helsinki

The Effect of Six Months Adalimumab Treatment on Sick Leaves and Retirement in Patients With Rheumatoid Arthritis Who Are at a Risk of Losing Their Ability to Work

The purpose of the study is to assess whether a 6-month treatment with adalimumab added on the treatment with conventional antirheumatic drugs (DMARD) will decrease the number of days on sick leave compared to placebo. In addition, the cost-effectiveness and cost-utility of the intervention compared to the conventional treatment is evaluated, and the patients who benefit most are characterized.

Descripción general del estudio

Estado

Desconocido

Condiciones

Intervención / Tratamiento

Descripción detallada

In spite of the improved medical treatment, rheumatoid arthritis (RA) is still causing both significant morbidity and marked loss of work productivity. Short periods of work inability, i.e., sick leaves represent a significant part of the socioeconomic burden of RA. The study is a randomized, controlled double blind multi-center study. 160 patients of 25 to 55 years of age with recent-onset (≤2 years from diagnosis) RA who have been treated with a combination of conventional antirheumatic drugs but have an inadequate response to treatment and are at the risk of losing their ability to work, are enrolled. The patients should be biologic-naïve. Their RA should be active, but not so active that the conventional criteria for biologic therapy would be fulfilled. The subjects are randomized at 1:1 ratio to receive either adalimumab (40 mg every two weeks) or placebo for 6 months added on their concurrent antirheumatic therapy. The RA-related sickness absence and clinical response will be evaluated.

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

160

Fase

  • Fase 4

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

  • Nombre: Kari K Eklund, MD
  • Número de teléfono: +358405832866
  • Correo electrónico: kari.eklund@welho.com

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

      • Helsinki, Finlandia, 00029
        • Reclutamiento
        • Helsinki University Central Hopsital
        • Contacto:
        • Investigador principal:
          • Ritva Peltomaa, MD
        • Sub-Investigador:
          • Heikki Valleala, MD
      • Rovaniemi, Finlandia, 96101
        • Reclutamiento
        • Lappland Central Hospital
        • Contacto:
        • Investigador principal:
          • Toini Uutela, MD
      • Tampere, Finlandia, 33521
        • Reclutamiento
        • Tampere University hospital, Rheumatology Centre
        • Contacto:
        • Investigador principal:
          • Heidi Mäkinen, MD
      • Turku, Finlandia
        • Reclutamiento
        • The Turku Universitry Central Hopsital
        • Contacto:
        • Investigador principal:
          • Laura Pirilä, MD

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

25 años a 55 años (Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  1. Diagnosis of RA according to the 1987 revised American College of Rheumatology (ACR) criteria
  2. Time from diagnosis of RA < 2 years
  3. Age 25-55 years
  4. Active RA with at least 3 active joints (tender and/or swollen joints)
  5. Stable DMARD combination treatment for more than 3 months
  6. At least one of the following

    • Rheumatoid factor positive
    • One or more erosions in x-rays of the hands and feet
    • Anti-citrulline antibodies positive
  7. At least other of the following

    • HAQ-index 0.5 or more
    • Patient or physician evaluation of RA activity >25 mm (VAS 0-10 cm)
  8. Patient has been steadily in work-life for at least one year and is currently working or on sick- leave but not applying for pension
  9. Patient feels that he/she will likely have to be off-work during the following 6 months due to his/her RA
  10. Patient must be willing and able to provide written informed consent for the trial
  11. Each female subject must agree to use a medically accepted method of contraception while receiving study medication

Exclusion Criteria:

  1. A subject must not have a history of biological drug use for RA
  2. A subject must not have evidence of active or latent tuberculosis,
  3. A subject must not have any history of lymphoproliferative disease or malignancy within the previous 5 years
  4. A subject must not have any other condition, that according to the investigator's judgment makes him or her non-eligible for anti-TNF use
  5. A subject must not have any inflammatory rheumatic disease other than RA
  6. A subject must not have received any other investigational agents within 30 days prior to baseline visit, and must not receive them during the current trial
  7. A female subject must not be pregnant or breast-feeding or planning pregnancy during the study
  8. A subject must not have had a major surgery within one month prior to study entry and must not have a scheduled operation during the 6-month follow up
  9. A subject must not have any clinically significant condition or situation, other than the condition being studied, that in the opinion of the investigator would interfere with the optimal participation in the trial.
  10. A subject must not fulfill the criteria for reimbursement for biologics for RA and he/she would not normally be prescribed a biological drug according to physicians discretion and national treatment guidelines
  11. A patient must not be currently on reimbursed rehabilitation period, or such period must not be scheduled for the next six months

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

  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Adalimumab
Adalimumab treatment for 6 months
40mg sc. every two weeks for six months
Otros nombres:
  • Humira
Comparador de placebos: Pacebo
Corresponding placebo for active treatment group
40mg sc. every two weeks for six months
Otros nombres:
  • Humira

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Number of lost work days due to RA during the 6-month follow up.
Periodo de tiempo: 6 months
6 months

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Change in health-related quality of life as measured by the EQ-5D index over the 6-month follow up
Periodo de tiempo: baseline and 6 months
baseline and 6 months
Change in functionality assessed by the HAQ over the 6-month follow up
Periodo de tiempo: baseline and 6 months
baseline and 6 months
Change in disease activity measured with DAS28 with CRP and ESR over the 6-month follow up
Periodo de tiempo: baseline and 6 months
baseline and 6 months
Work Productivity and Activity Impairment Questionnaire (WPAI)
Periodo de tiempo: 6 months
6 months

Colaboradores e Investigadores

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

Colaboradores

Investigadores

  • Investigador principal: Kari K Eklund, MD, The Rheumatological Center of Helsinki

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

1 de mayo de 2011

Finalización primaria (Anticipado)

1 de diciembre de 2012

Finalización del estudio (Anticipado)

1 de marzo de 2013

Fechas de registro del estudio

Enviado por primera vez

30 de junio de 2011

Primero enviado que cumplió con los criterios de control de calidad

28 de julio de 2011

Publicado por primera vez (Estimar)

29 de julio de 2011

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

29 de julio de 2011

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

28 de julio de 2011

Última verificación

1 de julio de 2011

Más información

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. .

Ensayos clínicos sobre adalimumab

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