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To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)

23 de junio de 2017 actualizado por: Sanofi

A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists

Primary Objective:

To assess, in the same study, the safety of sarilumab and tocilizumab in participants with rheumatoid arthritis (RA) who were inadequate responders to or intolerant of tumor necrosis factor (TNF) antagonists.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

Total study duration was up to 34 weeks: Screening up to 28 days, treatment phase of 24 weeks, and post-treatment follow-up of 6 weeks.

After completion of the treatment phase of this study, participants were eligible to enter a long term safety study (LTS11210) for active treatment with SAR153191 (REGN88).

Tipo de estudio

Intervencionista

Inscripción (Actual)

202

Fase

  • Fase 3

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

  • Argentina
      • Caba, Argentina, C1015ABO
        • Investigational Site Number 032006
      • Ramos Mejia, Argentina, B1704ETD
        • Investigational Site Number 032010
      • Rosario, Argentina, S200PBJ
        • Investigational Site Number 032013
      • San Fernando, Argentina
        • Investigational Site Number 032015
      • San Miguel De Tucuman, Argentina, 4000
        • Investigational Site Number 032004
      • Tucuman, Argentina, 4000
        • Investigational Site Number 032005
  • Brasil
      • Curitiba, Brasil, 80060-240
        • Investigational Site Number 076001
      • Sao Jose Do Rio Preto, Brasil, 15090-000
        • Investigational Site Number 076030
  • Bélgica
      • Leuven, Bélgica, 3000
        • Investigational Site Number 056010
  • Chequia
      • Liberec, Chequia, 46063
        • Investigational Site Number 203009
      • Praha 2, Chequia, 12850
        • Investigational Site Number 203011
      • Praha 4, Chequia, 140 00
        • Investigational Site Number 203010
  • España
      • Barcelona, España, 08035
        • Investigational Site Number 724020
      • Santander, España, 39008
        • Investigational Site Number 724021
      • Sevilla, España, 41010
        • Investigational Site Number 724022
  • Estados Unidos
    • Alabama
      • Huntsville, Alabama, Estados Unidos, 35801
        • Investigational Site Number 840152
    • Colorado
      • Colorado Springs, Colorado, Estados Unidos, 80903
        • Investigational Site Number 840151
    • Florida
      • Aventura, Florida, Estados Unidos, 33180
        • Investigational Site Number 840153
      • Fort Lauderdale, Florida, Estados Unidos, 33334
        • Investigational Site Number 840033
      • Miami, Florida, Estados Unidos, 33155
        • Investigational Site Number 840048
      • Palm Harbor, Florida, Estados Unidos, 34684
        • Investigational Site Number 840155
    • Maryland
      • Wheaton, Maryland, Estados Unidos, 20902
        • Investigational Site Number 840013
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02115
        • Investigational Site Number 840154
    • Michigan
      • Lansing, Michigan, Estados Unidos, 48910
        • Investigational Site Number 840150
    • Pennsylvania
      • Reading, Pennsylvania, Estados Unidos, 19611
        • Investigational Site Number 840062
    • Texas
      • Austin, Texas, Estados Unidos, 78705
        • Investigational Site Number 840038
      • Dallas, Texas, Estados Unidos, 75235
        • Investigational Site Number 840022
      • Dallas, Texas, Estados Unidos, 75246
        • Investigational Site Number 840156
      • Mesquite, Texas, Estados Unidos, 75150
        • Investigational Site Number 840074
  • Estonia
      • Tallinn, Estonia, 10138
        • Investigational Site Number 233010
      • Tallinn, Estonia, 13419
        • Investigational Site Number 233002
  • Federación Rusa
      • Kemerovo, Federación Rusa, 650066
        • Investigational Site Number 643017
      • Moscow, Federación Rusa, 115404
        • Investigational Site Number 643020
      • Moscow, Federación Rusa, 115522
        • Investigational Site Number 643001
      • Moscow, Federación Rusa, 117997
        • Investigational Site Number 643002
      • Moscow, Federación Rusa, 121374
        • Investigational Site Number 643031
      • Moscow, Federación Rusa, 125284
        • Investigational Site Number 643030
      • St-Petersburg, Federación Rusa, 191186
        • Investigational Site Number 643032
  • Finlandia
      • Helsinki, Finlandia, 00290
        • Investigational Site Number 246001
      • Riihimäki, Finlandia, 11120
        • Investigational Site Number 246010
  • Hungría
      • Budapest, Hungría, 1027
        • Investigational Site Number 348014
      • Budapest, Hungría, 1036
        • Investigational Site Number 348022
      • Esztergom, Hungría, 2500
        • Investigational Site Number 348021
      • Kistarcsa, Hungría, 2143
        • Investigational Site Number 348016
      • Szolnok, Hungría, 5000
        • Investigational Site Number 348009
      • Szombathely, Hungría, 9700
        • Investigational Site Number 348015
  • Israel
      • Haifa, Israel, 31096
        • Investigational Site Number 376010
      • Tel Aviv, Israel, 64239
        • Investigational Site Number 376011
  • Italia
      • Firenze, Italia, 50141
        • Investigational Site Number 380002
      • Genova, Italia, 16132
        • Investigational Site Number 380005
  • México
      • Durango, México, 34080
        • Investigational Site Number 484008
      • Leon, México, 37000
        • Investigational Site Number 484035
      • Merida, México, 97000
        • Investigational Site Number 484009
      • México, D.F., México, 11850
        • Investigational Site Number 484001
      • Zapopan, México, 44280
        • Investigational Site Number 484036
  • Noruega
      • Kristiansand, Noruega, 4604
        • Investigational Site Number 578010
      • Tønsberg, Noruega, 3105
        • Investigational Site Number 578006
  • Países Bajos
      • Amsterdam, Países Bajos, 1056 AB
        • Investigational Site Number 528010
      • Leiden, Países Bajos, 2333 ZA
        • Investigational Site Number 528001
  • Polonia
      • Bydgoszcz, Polonia, 85-168
        • Investigational Site Number 616019
      • Bytom, Polonia, 41-902
        • Investigational Site Number 616054
      • Lublin, Polonia, 20-090
        • Investigational Site Number 616030
      • Warszawa, Polonia, 01-518
        • Investigational Site Number 616031
      • Warszawa, Polonia, 02-653
        • Investigational Site Number 616017
  • Reino Unido
      • Doncaster, Reino Unido, DN2 5LT
        • Investigational Site Number 826004
      • Edinburgh, Reino Unido, EH4 2XU
        • Investigational Site Number 826006
      • Leeds, Reino Unido, LS7 4SA
        • Investigational Site Number 826001
      • London, Reino Unido, E11 1NR
        • Investigational Site Number 826002
      • Southampton, Reino Unido, SO16 6YD
        • Investigational Site Number 826005
      • Wigan, Reino Unido, WN6 9EP
        • Investigational Site Number 826025
  • Rumania
      • Braila, Rumania, 810019
        • Investigational Site Number 642006
      • Bucharest, Rumania
        • Investigational Site Number 642010
      • Bucharest, Rumania, 020125
        • Investigational Site Number 642020
      • Bucuresti, Rumania, 010584
        • Investigational Site Number 642021
      • Bucuresti, Rumania, 010976
        • Investigational Site Number 642001
      • Targoviste, Rumania, 130083
        • Investigational Site Number 642022
  • Suecia
      • Malmö, Suecia, 205 02
        • Investigational Site Number 752004
      • Uppsala, Suecia, 751 85
        • Investigational Site Number 752002

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:

Diagnosis of RA was, according to the American College of Rheumatology (ACR)/European League against Rheumatism (EULAR) 2010 Rheumatoid Arthritis Classification Criteria with ≥ 3 months disease duration

ACR Class I-III functional status, was based on the 1991 revised criteria. Moderate-to-severely active RA. Anti-TNF therapy failures, was defined as participants with an inadequate clinical response was defined by the investigator, after being treated for at least 3 consecutive months, and/or intolerance to at least 1 TNF-antagonist, resulting in or requiring their discontinuation. TNF-antagonists were include, but were not limited to, etanercept, infliximab, adalimumab, golimumab and/or certolizumab pegol

Continuous treatment with one or a combination of non-biologic disease modifying antirheumatic drugs (DMARDs) for at least 12 consecutive weeks prior to screening and on a stable dose(s) for at least 6 consecutive weeks prior to screening:

  • Methotrexate - 10 to 25 milligram/week orally or parenteral (or per local labelling requirements if the dose range differs)
  • Leflunomide - 10 to 20 mg orally daily
  • Sulfasalazine (SSZ) - 1000 to 3000 mg orally daily
  • Hydroxychloroquine (HCQ) - 200 to 400 mg orally daily

Exclusion criteria:

Participants <18 years of age. Use of parenteral corticosteroids or intra-articular corticosteroids within 4 weeks prior to screening

Use of oral corticosteroids in a dose higher than prednisone 10 mg or equivalent per day, or a change in dosage within 4 weeks prior to screening

Past history of, or current, autoimmune or inflammatory systemic or localized joint disease(s) other than RA

History of juvenile idiopathic arthritis or arthritis onset prior to age 16. Severe systemic RA, including but not limited to vasculitis, pulmonary fibrosis, and/or Felty's syndrome

Participation in any clinical research study that evaluated an investigational drug or therapy within 5 half-lives or 60 days of the Screening Visit, whichever was longer

Participants with active tuberculosis or latent tuberculosis infection. Prior or current history of interstitial lung disease. Prior treatment with anti-interleukin (IL) -6 or anti-IL-6R therapies, including but not limited to tocilizumab or sarilumab

Treatment with anti-TNF agents, as follows:

  • Etanercept: within 28 days prior to randomization
  • Infliximab, adalimumab, golimumab, certolizumab pegol: within 42 days prior to randomization

Treatment with RA-directed biologic agents with non- TNF-α antagonist mechanisms without adequate washout as follows:

  • Anakinra: within 28 days prior to randomization
  • Abatacept: within 42 days prior to randomization
  • Rituximab or other cell depleting agent: Within 6 months prior to randomization or until total lymphocyte count and CD 19+ lymphocyte count were normalized, or whichever was longer

Prior treatment with a janus kinase (JAK) inhibitor (eg, tofacitinib). Participants with a history of invasive opportunistic infection. Prior or current history of malignancy, including lymphoproliferative diseases, other than adequately-treated carcinoma in-situ of the cervix, nonmetastatic squamous cell or basal cell carcinoma of the skin, within 5 years prior to the randomization (baseline) visit

Prior or current history of other significant concomitant illness(es) that, according to Investigator's judgement, was adversely affect the participant's participation in the study.

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

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: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Sarilumab 150 mg q2w
Sarilumab 150 mg subcutaneous (SC) injection once every 2 weeks (q2w) and placebo intravenous (IV) infusion once every 4 weeks (q4w) was added to one or a combination of the nonbiologic disease modifying antirheumatic drug (DMARD), hydroxychloroquine, methotrexate, sulfasalazine and/or leflunomide for 24 weeks, except for the simultaneous use of leflunomide and methotrexate.
Droga: sarilumab SAR153191 (REGN88)
Pharmaceutical form: solution Route of administration: subcutaneous
Droga: hydroxychloroquine
Dispensed according to local practice.
Droga: methotrexate
Dispensed according to local practice.
Droga: sulfasalazine
Dispensed according to local practice.
Droga: leflunomide
Dispensed according to local practice.
Droga: intravenous placebo
Pharmaceutical form: solution Route of administration: intravenous
Experimental: Sarilumab 200 mg q2w
Sarilumab 200 mg SC injection q2w and placebo IV infusion q4w was added to one or a combination of the nonbiologic DMARD, hydroxychloroquine, methotrexate, sulfasalazine and/or leflunomide for 24 weeks, except for the simultaneous use of leflunomide and methotrexate.
Droga: sarilumab SAR153191 (REGN88)
Pharmaceutical form: solution Route of administration: subcutaneous
Droga: hydroxychloroquine
Dispensed according to local practice.
Droga: methotrexate
Dispensed according to local practice.
Droga: sulfasalazine
Dispensed according to local practice.
Droga: leflunomide
Dispensed according to local practice.
Droga: intravenous placebo
Pharmaceutical form: solution Route of administration: intravenous
Comparador activo: Tocilizumab q4w
Tocilizumab 4 mg/kg or 8 mg/kg IV infusion q4w and placebo SC injection q2w was added to one or a combination of the nonbiologic DMARD, hydroxychloroquine, methotrexate, sulfasalazine and/or leflunomide for 24 weeks, except for the simultaneous use of leflunomide and methotrexate.
Droga: hydroxychloroquine
Dispensed according to local practice.
Droga: methotrexate
Dispensed according to local practice.
Droga: sulfasalazine
Dispensed according to local practice.
Droga: leflunomide
Dispensed according to local practice.
Droga: tocilizumab
Pharmaceutical form: solution Route of administration: intravenous
Droga: subcutaneous placebo
Pharmaceutical form: solution Route of administration: subcutaneous

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Periodo de tiempo: Up to 211 days
Adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug and does not necessary have to have a causal relationship with treatment. All adverse events that occurred from the first dose of the study drug administration up to 60 days after the end of treatment visit were considered as TEAEs. Serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or a medically important event. A summary of SAEs, all other non-serious AEs, regardless of causality, are reported in AE section.
Up to 211 days

Colaboradores e Investigadores

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

Patrocinador

Sanofi

Colaboradores

Regeneron Pharmaceuticals

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

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 marzo de 2013

Finalización primaria (Actual)

1 de octubre de 2014

Finalización del estudio (Actual)

1 de octubre de 2014

Fechas de registro del estudio

Enviado por primera vez

11 de enero de 2013

Primero enviado que cumplió con los criterios de control de calidad

11 de enero de 2013

Publicado por primera vez (Estimar)

15 de enero de 2013

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

26 de junio de 2017

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

23 de junio de 2017

Última verificación

1 de junio de 2017

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • SFY13370
  • 2012-003536-23
  • U1111-1133-7839 (Otro identificador: UTN)

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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