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A Study of Tocilizumab Added to DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis and an Inadequate Response to DMARDs.

28 de febrero de 2018 actualizado por: Hoffmann-La Roche

Local Open-label Multicenter Study to Evaluate the Quality of Life in Patients With Moderate to Severe Active Rheumatoid Arthritis and an Inadequate Response to DMARDs When Adding Tocilizumab (TCZ)

This open-label single arm study will evaluate the efficacy and safety of tocilizumab added to traditional disease-modifying antirheumatic drugs (DMARDs) in patients with moderate to severe active rheumatoid arthritis and an inadequate response to DMARDs. Patients will receive tocilizumab 8 mg/kg by intravenous infusion every 4 weeks for 24 weeks, in addition to their current non-biologic DMARDs at stable doses. Anticipated time on study treatment is 24 weeks, and the target sample size is 200.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

201

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.

Ubicaciones de estudio

  • Federación Rusa
      • Chelyabinsk, Federación Rusa, 454076
        • Chelyabinsk Regional Clinical Hospital; Rheumatology
      • Cherkess, Federación Rusa, 369000
        • Republican clinical hospital of Karachai-Cherkess; Rheumatologic Department
      • Ekaterinburg, Federación Rusa, 620102
        • Municipal Autonomous Institution of Healthcare "City Clinical Hospital #40"
      • Ekaterinburg, Federación Rusa, 620102
        • Sverdlovsk Regional Clinical Hospital # 1; Rheumatology Dept
      • Irkutsk, Federación Rusa, 664047
        • Irkutsk Regional Consulting and Diagnostic Clinical Center; Regional Center of Reumatolodic Deasise
      • Izhevsk, Federación Rusa, 426009
        • Republican Clinicodiagnostic Center
      • Kaliningrad, Federación Rusa, 236016
        • Kaliningrad Regional Clinical Hospital; Rheumatologic Department
      • Kemerovo, Federación Rusa, 650099
        • War Veterans Regional Clinical Hospital;Therapy Department
      • Kirov, Federación Rusa, 610028
        • Kirov Regional Clinical Hospital; Reumatology Department
      • Krasnodar, Federación Rusa, 350086
        • GUZ Regional clinical hospital # 1
      • Kursk, Federación Rusa, 305007
        • GMU Kursk regional clinical hospital
      • Moscow, Federación Rusa, 123060
        • Head Clinical Hospital of Internal Affair Ministry of Russia
      • Moscow, Federación Rusa, 129110
        • Vladimirskiy Regional Scientific Research Inst.
      • Moscow, Federación Rusa, 115522
        • FSBI "Scientific Research Institute of Rheumatology" of russian Academy of Medical Sciences
      • Moscow, Federación Rusa, 115682
        • FSBI "FSCC of particularized sorts of medical care and medical technologies of FMBA"
      • Moscow, Federación Rusa, 121359
        • FGU Central Clinical Hospital with Polyclinic Administration President RF
      • Nizhny Novgorod, Federación Rusa, 603126
        • SIH Nizhny Novgorod Regional Clinical Hospital n.a. Semashko
      • Petrozavodsk, Federación Rusa, 185019
        • Republican Hospital Named After V.A. Baranov
      • Rostov-na-Donu, Federación Rusa, 344022
        • Rostov State Medical University; Cardiorheumatology Department
      • Smolensk, Federación Rusa, 214001
        • Clinical hospital #1
      • Surgut, Federación Rusa, 628408
        • Surgut Region Clinical Hospital
      • Tjumen, Federación Rusa, 625023
        • Glpu Tjumen Regional Clinical Hospital #1
      • UFA, Federación Rusa, 450005
        • Republican clinical hospital named after G.G. Kuvatov
      • Ulyanovsk, Federación Rusa, 432063
        • State Institution of Healthcare Ulyanovsk Regional Clinical Hospital
      • Veliky Novgorod, Federación Rusa, 173008
        • GUZ "Novgorod Regional Clinical Hospital"; Cardioreumatological
      • Voronezh, Federación Rusa, 394066
        • Voronezh Regional Clinical Hospital #1
      • Voronezh, Federación Rusa, 394066
        • Budget Institution of Healthcare of Voronezh Region "Voronezh Regional Clinical Hospital #1"
      • Yaroslavl, Federación Rusa, 150062
        • SHI Yaroslavl Regional Clinical Hospital

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

Descripción

Inclusion Criteria:

  • adult patients, >/= 18 years of age
  • moderate to severe active rheumatoid arthritis of >/=6 months duration
  • inadequate clinical response to current non-biologic DMARDs
  • current DMARDs must be at stable dose for 8 weeks prior to study entry
  • oral corticosteroids (</=10mg/day prednisone or equivalent) and NSAIDs must be at stable dose for >/=4 weeks prior to screening

Exclusion Criteria:

  • rheumatic autoimmune disease other than RA
  • history of or current inflammatory joint disease other than RA
  • previous treatment with any biologic DMARD
  • functional class IV as defined by the ACR classification
  • intra-articular or parenteral corticosteroids within 6 weeks prior to screening

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: No aleatorizado
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 1
Droga: tocilizumab [RoActemra/Actemra]
8 mg/kg iv every 4 weeks for 24 weeks
Droga: DMARDs (disease-modifying antirheumatic drugs)
stable doses at investigator's prescription

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Health Assessment Questionnaire (HAQ) Score
Periodo de tiempo: Weeks 0, 4, 8, 12, 16, 20, and 24 and Withdrawal Visit
HAQ includes 20 questions concerning participant's activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant's everyday activities: 0 (equals)=without difficulties; 1=with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3. Withdrawal Visit is the final visit prior to the withdrawal of the subject from the study.
Weeks 0, 4, 8, 12, 16, 20, and 24 and Withdrawal Visit
Percentage of Participants With an HAQ Score Decrease of 20 Percent (%), 50%, and 70% During Tocilizumab Treatment
Periodo de tiempo: Weeks 4, 8, 12, 16, 20, and 24
HAQ includes 20 questions concerning participant's activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant's everyday activities: 0=without difficulties; 1=with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3.
Weeks 4, 8, 12, 16, 20, and 24
Change in HAQ Score at Week 24
Periodo de tiempo: Baseline and Week 24
HAQ includes 20 questions concerning participant's activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant's everyday activities: 0=without difficulties; 1=with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3.
Baseline and Week 24

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Pain Score as Assessed by Visual Analogue Scale (VAS)
Periodo de tiempo: Weeks 0, 4, 8, 12, 16, 20, and 24
Participant's global assessment of pain was assessed using a 100-millimeter (mm) horizontal VAS (0 to 100 mm) with 0=pain absent and 100=intolerable pain. Participants responded by placing a mark on the line to indicate their current level of pain.
Weeks 0, 4, 8, 12, 16, 20, and 24
European Quality of Life - 5 Dimensions (EQ-5D) Score
Periodo de tiempo: Weeks 0, 4, 8, 12, 16, 20, and 24
EQ-5D questionnaire assess 5 domains of quality of life including mobility, self-care, habitual daily activities, pain, discomfort, and anxiety/depression. Each of five domains was assessed by 3 levels depending on severity of a problem and scored using the following: 1=no disturbances, 2=moderate disturbances, 3=severe disturbances. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Weeks 0, 4, 8, 12, 16, 20, and 24
Change in EQ-5D Score at Week 24 From Baseline
Periodo de tiempo: Baseline and Week 24
EQ-5D questionnaire assess 5 domains of quality of life including mobility, self-care, habitual daily activities, pain, discomfort, and anxiety/depression. Each of five domains was assessed by 3 levels depending on severity of a problem and scored using the following: 1=no disturbances, 2=moderate disturbances, 3=severe disturbances. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. Minimum clinically significant change in EQ-5D corresponds to the parameter differences before and after treatment = 0.10. Graduations of assessment of the therapy efficacy by EQ-5D are: Difference (Δ) EQ-5D less than (<)0.10 points: none; 0.10 less than or equal to (≤)Δ EQ-5D ≤0.24: minimal effect; 0.24≤ Δ EQ-5D <0.31: satisfactory effect; Δ EQ-5D greater than or equal to (≥)0.31 points: pronounced effect.
Baseline and Week 24
General Health Score as Assessed by EQ-5D VAS
Periodo de tiempo: Weeks 0, 4, 8, 12, 16, 20, and 24
Participant-reported general health quality was assessed using an EQ-5D 100-mm horizontal VAS (0 to 100 mm) with 0=worst health state and 100=the best health state. The participants were asked to mark the line that corresponded to assessment of general health quality.
Weeks 0, 4, 8, 12, 16, 20, and 24
Percentage of Participants Achieving a Positive Response on Health Quality Assessment of EQ-5D
Periodo de tiempo: Weeks 0, 4, 8, 12, 16, 20, and 24
Participant-reported general health quality was assessed using an EQ-5D 100-mm horizontal VAS (0 to 100 mm) with 0=worst health state and 100=the best health state. The participants were asked to mark the line that corresponded to assessment of general health quality. Positive response was defined as an increase of EQ-5D score by 0.1 or more i.e. it is a clinically significant increase.
Weeks 0, 4, 8, 12, 16, 20, and 24
Change in General Health Assessed by VAS
Periodo de tiempo: Baseline and Week 24
Participant-reported general health quality was assessed using an EQ-5D 100-mm horizontal VAS (0 to 100 mm) with 0=worst health state and 100=the best health state. The participants were asked to mark the line that corresponded to assessment of general health quality.
Baseline and Week 24
Disease Activity Score Based on 28-Joint Count (DAS28)
Periodo de tiempo: Weeks 0, 4, 8, 12, 16, 20, and 24
DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and global health assessment (participant rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity.
Weeks 0, 4, 8, 12, 16, 20, and 24
Change in DAS28 Score From Baseline to Week 24
Periodo de tiempo: Baseline and Week 24
Baseline and Week 24
Percentage of Patients With Varied Disease Activity Assessed Using DAS28 During Tocilizumab Treatment
Periodo de tiempo: Weeks 0, 4, 8, 12, 16, 20, and 24
DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR mm/hour, and global health assessment (participant rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. Disease activity: 0=remission (DAS28 less than [<] 2.6), I=low (DAS28 less than or equal to [≤]2.6 to <3.2), II=moderate (DAS28=3.2 to 5.1), III=high (DAS28 greater than [>]5.1).
Weeks 0, 4, 8, 12, 16, 20, and 24
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20), 50% (ACR50), and 70% (ACR70) Response
Periodo de tiempo: Weeks 0, 4, 8, 12, 16, 20, and 24
ACR20/50/70 response: ≥20%, ≥50%, or ≥70% improvement, respectively, in swollen/tender joint count (66 joints assessed for swelling and 68 joints assessed for tenderness) and in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and acute phase response: C-reactive protein (CRP) or ESR.
Weeks 0, 4, 8, 12, 16, 20, and 24
Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28
Periodo de tiempo: Weeks 4, 8, 12, 16, 20, and 24
The DAS28-based EULAR response criteria were used to measure individual response as no effect, good effect, and moderate effect, depending on the extent of change from baseline and the level of disease activity reached. Good effect: change from baseline >1.2 with DAS28 score ≤3.2; moderate effect: change from baseline >1.2 with DAS28 score 3.2 to 5.1 or change from baseline >0.6 to <1.2 with DAS28 score <3.2; no effect: change from baseline ≤0.6 or change from baseline >0.6 and ≤1.2 with DAS28 score >5.1.
Weeks 4, 8, 12, 16, 20, and 24
C-Reactive Protein
Periodo de tiempo: Weeks 4, 8, 12, 16, 20, and 24
CRP (milligrams/Liter) is a mediator of inflammation, acute phase protein.
Weeks 4, 8, 12, 16, 20, and 24
Erythrocyte Sedimentation Rate
Periodo de tiempo: Weeks 4, 8, 12, 16, 20, and 24
ESR (mm/hr) is used to determine the acute phase response.
Weeks 4, 8, 12, 16, 20, and 24

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 octubre de 2009

Finalización primaria (Actual)

14 de febrero de 2011

Finalización del estudio (Actual)

14 de febrero de 2011

Fechas de registro del estudio

Enviado por primera vez

15 de octubre de 2009

Primero enviado que cumplió con los criterios de control de calidad

15 de octubre de 2009

Publicado por primera vez (Estimar)

16 de octubre de 2009

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

29 de marzo de 2018

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

28 de febrero de 2018

Última verificación

1 de febrero de 2018

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • ML22665

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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