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A Non-Interventional Study of Rheumatoid Arthritis Patients Treated With RoActemra/Actemra (Tocilizumab) in Monotherapy

30 de agosto de 2018 actualizado por: Hoffmann-La Roche

Mon-ACT: A Multi-center, Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab in Monotherapy

This observational study will evaluate the use and efficacy of RoActemra/Actemra (tocilizumab) in monotherapy in routine clinical practice in participants with rheumatoid arthritis. Eligible participants initiated on RoActemra/Actemra treatment according to the licensed label will be followed for 6 months.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

De observación

Inscripción (Actual)

71

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.

Ubicaciones de estudio

  • Bélgica
      • Aalst, Bélgica, 9300
        • ASZ Aalst
      • Ath, Bélgica, 7800
        • CH EpiCURA Site Ath
      • Bruxelles, Bélgica, 1020
        • CHU Brugmann (Victor Horta)
      • Bruxelles, Bélgica, 1070
        • Hospital Erasme; Neurologie
      • Genk, Bélgica, 3600
        • ReumaClinic
      • Gilly (Charleroi), Bélgica, 6000
        • GHdC Site Saint-Joseph
      • Gosselies, Bélgica, 6041
        • Clinique Notre Dame de Grâce
      • Haine-Saint-Paul, Bélgica, 7100
        • CH Jolimont - Lobbes (Jolimont)
      • Kortrijk, Bélgica, 8500
        • Az Groeninge
      • Liège, Bélgica, 4000
        • CHR de la Citadelle
      • Liège, Bélgica, 4000
        • Clinique Saint-Joseph
      • Mons, Bélgica, 7000
        • CHU Ambroise Paré
      • Oostende, Bélgica, 8400
        • AZ Damiaan
      • Ottignies, Bélgica, 1340
        • Clinique St Pierre asbl
      • Roeselare, Bélgica, 8800
        • AZ Delta (Campus Wilgenstraat)
      • Turnhout, Bélgica, 2300
        • AZ Turnhout Sint Jozef
      • Wilrijk, Bélgica, 2610
        • Sint Augustinus Wilrijk

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 y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra de probabilidad

Población de estudio

Participants with rheumatoid arthritis initiating treatment with RoActemra/Actemra in monotherapy

Descripción

Inclusion Criteria:

  • Adult participants, >/= 18 years of age
  • Moderate to severe rheumatoid arthritis according to the revised (1987) ACR criteria
  • Participants in whom the treating physician has made the decision to commence RoActemra/Actemra treatment in monotherapy in accordance with the local label and the reimbursement criteria indicating that RoActemra/Actemra can be given in monotherapy in case of methotrexate intolerance or where continued treatment with methotrexate is inappropriate; this can include participants who have received RoActemra/Actemra treatment within 8 weeks prior to the enrolment visit
  • Concomitant treatment with NSAIDs and/or corticosteroids is allowed

Exclusion Criteria:

  • Participants who have received RoActemra/Actemra more than 8 weeks prior to the enrolment visit
  • Participants who have previously received RoActemra/Actemra in a clinical trial or for compassionate use
  • Participants receiving concomitant DMARD treatment for rheumatoid arthritis at baseline (e.g. hydroxychloroquine, sulfasalazine, methotrexate, leflunomide, gold compounds, cyclosporine) will be excluded from the study
  • Participants who have received treatment with an investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra
  • Participants with a history of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis

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

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
Tocilizumab
Participants with rheumatoid arthritis (RA) received tocilizumab monotherapy according to individualized physician-prescribed regimens.
Droga: tocilizumab
Participants received tocilizumab monotherapy according to individualized physician-prescribed regimens.
Otros nombres:
  • Actemra

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Percentage of Participants on Tocilizumab Treatment at Month 6 After Treatment Initiation
Periodo de tiempo: Month 6 after treatment initiation
Month 6 after treatment initiation

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of Participants With Systemic Manifestations of RA at Baseline
Periodo de tiempo: Baseline
Systemic manifestations of RA included anemia, fatigue, conventional risk factors for cardiovascular disease, C-Reactive Protein (CRP) above upper limit of normal, rheumatoid nodules, rheumatoid vasculitis and interstitial lung disease. Participants were included if they experienced at least any one of the conditions.
Baseline
Number of Participants With Disease-Modifying Antirheumatic Drugs (DMARDs) Intolerance and Inadequate Response
Periodo de tiempo: Baseline
Baseline
Number of Participants With Inadequate Response to Other Biologics
Periodo de tiempo: Baseline
Baseline
Time to Addition of Disease-Modifying Anti-rheumatic Drugs (DMARDs)
Periodo de tiempo: Month 6
The time to DMARD addition equals to the time (days) between tocilizumab start and first start date of DMARDs.
Month 6
Percentage of Participants Who Had DMARDs During Study
Periodo de tiempo: Month 6
Month 6
Number of Participants With Dose Reductions
Periodo de tiempo: 6 months
6 months
Number of Participants With Starting Tocilizumab After Failing DMARDs
Periodo de tiempo: Baseline
Baseline
Number of Participants With Starting Tocilizumab After Stopping Other Biologic Agents
Periodo de tiempo: Baseline
Baseline
Time to Reduction/Withdrawal of Corticosteroids
Periodo de tiempo: Month 6
Month 6
Number of Dose Modifications Per Participant at Month 6
Periodo de tiempo: Month 6
Number of dose modification per participant at Month 6 was reported.
Month 6
Mean Dosing Interval Per Participant at Month 6
Periodo de tiempo: Month 6
Month 6
Percentage of Participants Discontinued From Tocilizumab for Safety Versus Efficacy
Periodo de tiempo: Month 6
Month 6
Time for Restoration of Initial Dosing Regimen
Periodo de tiempo: Month 6
Month 6
Percentage of Participants Who Were Not Adhering to Recommended Dosing Regimen
Periodo de tiempo: Month 6
Month 6
Number of Participants Who Were Not Adhering to Recommended Management of AEs
Periodo de tiempo: Month 6
Month 6
Percentage of Participants Still on Tocilizumab Monotherapy at Month 6
Periodo de tiempo: Month 6
Month 6
Percentage of Participants With Reason for Choice of Monotherapy at Baseline
Periodo de tiempo: Baseline
Baseline
Tender Joint Count (TJC)
Periodo de tiempo: Baseline, Month 3, 6
TJC was determined by examining 28 and 68 joints and identifying the joints that were painful under pressure or to passive motion. Tenderness was recorded on the joint assessment form at baseline, no tenderness = 0, tenderness = 1.
Baseline, Month 3, 6
Swollen Joint Count (SJC)
Periodo de tiempo: Baseline, Month 3, 6
SJC was determined by examining 28 and 66 joints and identifying when swelling was present. Swelling was recorded on the joint assessment form at baseline, no swelling = 0, swelling =1.
Baseline, Month 3, 6
Percentage of Participants With Disease Activity Score-28 (DAS28)
Periodo de tiempo: Baseline, Month 3, 6
DAS28 was calculated from SJC and TJC using 28 joints count, erythrocyte sedimentation rate (ESR) (millimeter per hour [mm/hr]), and patient global assessment of disease activity (PGH) (measured on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0=no disease activity and 100=worst disease activity). DAS28 is a measurement of RA activity on a 0 to 10 scale: a score greater than (>) 5.1 indicates high disease activity; a score between 3.2 and 5.1 indicates moderate disease activity; a score of less than 3.2 indicates low disease activity; a score of less than (<) 2.6 is considered remission.
Baseline, Month 3, 6
Percentage of Participants With Good European League Against Rheumatism (EULAR) Response at Month 3 and Month 6
Periodo de tiempo: Month 3, 6
Clinical response assessed as per EULAR categorical DAS28 response criteria was defined as clinically meaningful improvement at a particular time point. EULAR response was based on change from baseline (CFB) in the DAS28 score and also on the actual DAS28 score at the time point so was more reflective of the current status of the participant. EULAR Good response: DAS28 <=3.2 and a CFB <-1.2. EULAR Moderate response: DAS28 >3.2 to ≤ 5.1 or a CFB < -0.6 to ≥ -1.2. EULAR No response: DAS28 ≤3.2 or CFB greater than or equal to (>=) -0.6, DAS28 >3.2 to <=5.1 or CFB>=-0.6 and DAS28 >5.1 or CFB >=-0.6. The DAS28 score was a measure of the participant's disease activity, based on the TJC (28 joints), SJC (28 joints), PGH, and ESR. DAS28 total scores ranged from 0 to approximately 10. Scores <2.6 = best disease control and scores >5.1 = worse disease control. A negative CFB indicated clinically meaningful improvement.
Month 3, 6
Percentage of Participants With American College of Rheumatology (ACR) Response at Month 3 and Month 6
Periodo de tiempo: Month 3, 6
ACR response was calculated based on total joint count evaluation (28 or 66/68 joint count) and other clinical and laboratory assessments. A positive ACR20 response required at least a 20% improvement (reduction) compared to baseline in swollen joint count (66 joints) and tender joint count (68 joints) and at least 3 of the following 5 assessments: patient's global assessment of pain, PGH, PhGH (all 3 assessed at 0 [good] to 100 mm [worst] VAS scale), participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity), Acute phase reactant (CRP or ESR). A reduction in the level of and acute phase reactants was considered an improvement. ACR50, ACR70, ACR90 require a 50%, 70%, 90% improvement from baseline respectively.
Month 3, 6
Percentage of Participants With Disease Activity According to Clinical Disease Activity Index (CDAI) Response
Periodo de tiempo: Baseline, Month 3, 6
CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PGH and physician global assessment of disease activity (PhGH) assessed on 0-10 cm VAS; 0 = no disease activity and 10 = worst disease activity. CDAI total score = 0-76. CDAI <= 2.8 indicates clinical remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high (or severe) disease activity.
Baseline, Month 3, 6
Percentage of Participants With Disease Activity According to Simplified Disease Activity Index (SDAI) Response
Periodo de tiempo: Baseline, Month 3, 6
The SDAI was a combined index for measuring disease activity in RA which reflected the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PGH and PhGH, assessed on 0-100 mm VAS where 0 = no disease activity and 100 = worst disease activity, and C-reactive protein (CRP). SDAI total score = 0-86. A SDAI score </= 3.3 represented clinical remission, a score of between 3.4 and 11.0 represented low disease activity, a score between 11 and 26.0 represented moderate disease activity and a score > 26.0 represented high (or severe) disease.
Baseline, Month 3, 6
Change From Baseline in Patient's Global Assessment of Disease Activity at Month 3 and Month 6
Periodo de tiempo: Baseline, Month 3, 6
The Patient Global Assessment of disease activity provides an overall assessment of how RA affects the participant using a visual analogue score, where 0 indicates they are managing very well and 100 indicates they are managing very poorly. A decrease in the score indicates improvement.
Baseline, Month 3, 6
Change From Baseline in Physician Global Assessment of Disease Activity at Month 3 and Month 6
Periodo de tiempo: Baseline, Month 3, 6
The physician's global assessment of disease activity was assessed using a 0 to 100 mm horizontal VAS by the physician. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity). A negative change from Baseline indicated improvement.
Baseline, Month 3, 6
Change From Baseline in Health Assessment Questionnaire (HAQ) at Month 3 and Month 6
Periodo de tiempo: Baseline, Month 3, 6
The HAQ was a participant self-reported questionnaire for assessing the extent of a participant's functional ability. It consisted of 20 questions in 8 categories (dressing and grooming, rising, eating, walking, reach, grip, hygiene, and carrying out daily activities). Each question had 4 response options, ranging from 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. The HAQ scale was an average of all the scores and ranged from 0 to 3, where higher scores represented higher disease activity.
Baseline, Month 3, 6
Change From Baseline in VAS-Fatigue at Month 3 and Month 6
Periodo de tiempo: Baseline, Month 3, 6
The VAS-fatigue provides an overall assessment of the level of fatigue that the participant is experiencing using a visual analogue score, where 0 indicates no fatigue and 100 indicates extreme fatigue. A decrease in the score indicates improvement.
Baseline, Month 3, 6
Change From Baseline in Patient's Global Assessment of Pain at Month 3 and Month 6
Periodo de tiempo: Baseline, Month 3, 6
The Patient Global Assessment of pain provides an overall assessment of the severity of pain that the participant is experiencing using a visual analogue score, where 0 indicates no pain and 100 indicates unbearable pain. A decrease in the score indicates improvement.
Baseline, Month 3, 6
Change From Baseline in VAS-Morning Stiffness at Month 3 and Month 6
Periodo de tiempo: Baseline, Month 3, 6
Morning stiffness was defined by the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was as limber as he/she would be during a day involving typical activities. Morning stiffness was assessed on a 100 mm VAS, where 0= none and 100= very severe.
Baseline, Month 3, 6
Percentage of Participants With an Adverse Event (AEs), Serious Adverse Events (SAEs), AEs of Special Interest (AESIs)
Periodo de tiempo: Month 6
An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. An Serious Adverse Events (SAEs) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect. AESI included- serious/medically significant infections; myocardial Infarction/acute coronary syndrome; gastrointestinal perforations; malignancies; anaphylaxis/hypersensitivity reactions; demyelinating disorders; stroke; serious/medically significant bleeding events; serious/medically significant hepatic events.
Month 6
Percentage of Participants With AEs Leading to Dose Modifications
Periodo de tiempo: Month 6
Month 6
C-reactive Protein (CRP]) Level
Periodo de tiempo: Baseline, Month 3, 6
CRP is an acute phase reactant and is a measure of inflammation.
Baseline, Month 3, 6
Erythrocyte Sedimentation Rate (ESR) Level
Periodo de tiempo: Baseline, Month 3, 6
ESR is an acute phase reactant and is a measure of inflammation.
Baseline, Month 3, 6

Colaboradores e Investigadores

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

Patrocinador

Hoffmann-La Roche

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)

31 de julio de 2012

Finalización primaria (Actual)

12 de diciembre de 2014

Finalización del estudio (Actual)

12 de diciembre de 2014

Fechas de registro del estudio

Enviado por primera vez

10 de octubre de 2012

Primero enviado que cumplió con los criterios de control de calidad

10 de octubre de 2012

Publicado por primera vez (Estimar)

12 de octubre de 2012

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

4 de septiembre de 2018

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

30 de agosto de 2018

Última verificación

1 de agosto de 2018

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • ML28269

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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