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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 juin 2017 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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).

Type d'étude

Interventionnel

Inscription (Réel)

202

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Médicament: sarilumab SAR153191 (REGN88)
Pharmaceutical form: solution Route of administration: subcutaneous
Médicament: hydroxychloroquine
Dispensed according to local practice.
Médicament: methotrexate
Dispensed according to local practice.
Médicament: sulfasalazine
Dispensed according to local practice.
Médicament: leflunomide
Dispensed according to local practice.
Médicament: intravenous placebo
Pharmaceutical form: solution Route of administration: intravenous
Expérimental: 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.
Médicament: sarilumab SAR153191 (REGN88)
Pharmaceutical form: solution Route of administration: subcutaneous
Médicament: hydroxychloroquine
Dispensed according to local practice.
Médicament: methotrexate
Dispensed according to local practice.
Médicament: sulfasalazine
Dispensed according to local practice.
Médicament: leflunomide
Dispensed according to local practice.
Médicament: intravenous placebo
Pharmaceutical form: solution Route of administration: intravenous
Comparateur actif: 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.
Médicament: hydroxychloroquine
Dispensed according to local practice.
Médicament: methotrexate
Dispensed according to local practice.
Médicament: sulfasalazine
Dispensed according to local practice.
Médicament: leflunomide
Dispensed according to local practice.
Médicament: tocilizumab
Pharmaceutical form: solution Route of administration: intravenous
Médicament: subcutaneous placebo
Pharmaceutical form: solution Route of administration: subcutaneous

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Sanofi

Collaborateurs

Regeneron Pharmaceuticals

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 mars 2013

Achèvement primaire (Réel)

1 octobre 2014

Achèvement de l'étude (Réel)

1 octobre 2014

Dates d'inscription aux études

Première soumission

11 janvier 2013

Première soumission répondant aux critères de contrôle qualité

11 janvier 2013

Première publication (Estimation)

15 janvier 2013

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

26 juin 2017

Dernière mise à jour soumise répondant aux critères de contrôle qualité

23 juin 2017

Dernière vérification

1 juin 2017

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • SFY13370
  • 2012-003536-23
  • U1111-1133-7839 (Autre identifiant: UTN)

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

Essais cliniques sur sarilumab SAR153191 (REGN88)

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Conditions

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Commanditaire / collaborateurs

Emplacements

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