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A Study of the Safety and Efficacy of Golimumab in Subjects With Rheumatoid Arthritis That Are Methotrexate-naive

27 août 2014 mis à jour par: Centocor, Inc.

A Multicenter, Randomized, Double-blind, Placebo-controlledTrial of Golimumab, a Fully Human Anti-TNFa MonoclonalAntibody, Administered Subcutaneously, in Methotrexate-naive Subjects With Active Rheumatoid Arthritis

The purpose of this study is to evaluate the efficacy and safety of golimumab, alone or in combination with methotrexate, as compared to methotrexate alone in rheumatoid arthritis subjects who have not been previously treated with methotrexate.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

Golimumab is a fully human protein (antibody) which binds to tumor necrosis factor (TNFa). TNFa is increased in patients with rheumatoid arthritis (RA), and plays a major role in causing the joint pain, swelling, and damage from RA. Other marketed drugs that target TNFa (anti-TNFa drugs) have been shown to be effective in reducing the symptoms, signs, and joint damage of RA, but have limitations with respect to safety and ease of use. This is a randomized, double-blind, placebo-controlled trial of the efficacy and safety of a new anti-TNFa drug, golimumab, at 2 doses, injected under the skin every 4 weeks, alone or in combination with methotrexate, compared with methotrexate alone, in subjects with active RA who have not been previously treated with methotrexate. The study hypothesis is that golimumab, alone or in combination with methotrexate, will be more effective in treatment of RA than methotrexate alone, as measured by the American College of Rheumatology (ACR) response criteria and change from baseline in van der Heide Modified Sharp (vdH-S) score, without causing unacceptable significant adverse effects. The ACR response criteria were designed to determine the percentage of subjects who have achieved a certain level of improvement in their signs and symptoms of rheumatoid arthritis. The vdH-S score is a measurement of the amount of joint damage in a subject as seen by x-ray. Other secondary measures of effectiveness include the Health Assessment Questionnaire (HAQ), which is a series of questions that measure a subject's impairment in physical function caused by RA. Golimumab 50 mg or 100 mg, or placebo injections under the skin every 4 weeks until Week52. Methotrexate (MTX) or placebo capsules will be given in addition. At Week52, subjects on MTX alone with joint pain or swelling get golimumab 50mg, and all subjects receive golimumab for about 4 more years.

Type d'étude

Interventionnel

Inscription (Réel)

637

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
      • Buenos Aires, Argentine
      • Cordoba, Argentine
      • Rosario, Argentine
      • S.M. De Tucuman, Argentine
      • San Miguel De Tucuman, Argentine
  • Australie
      • Maroochydore, Australie
      • Melbourne, Australie
  • Belgique
      • Brussels, Belgique
      • Liege, Belgique
  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada
    • Newfoundland and Labrador
      • St. John'S, Newfoundland and Labrador, Canada
  • Chili
      • Rancagua, Chili
      • Santiago, Chili
  • Corée, République de
      • Daejeon, Corée, République de
      • Incheon, Corée, République de
      • Seoul, Corée, République de
      • Suwon, Corée, République de
  • Espagne
      • Madrid, Espagne
      • Santander, Espagne
      • Sevilla, Espagne
      • Sevilla N/A, Espagne
      • Valencia, Espagne
  • Fédération Russe
      • Moscow, Fédération Russe
      • Saratov, Fédération Russe
      • Yaroslavl, Fédération Russe
  • Hongrie
      • Budapest, Hongrie
      • Gyula, Hongrie
      • Szombathely, Hongrie
  • Inde
      • Bangalore, Inde
      • Lucknow Gpo, Inde
      • Secunderabad, Inde
  • L'Autriche
      • Wien, L'Autriche
  • Malaisie
      • Precinct 7, Malaisie
      • Saemban, Malaisie
      • Selayang N/A, Malaisie
  • Nouvelle-Zélande
      • Auckland, Nouvelle-Zélande
      • Timaru, Nouvelle-Zélande
  • Philippines
      • Cebu, Philippines
      • Manila, Philippines
      • Quezon, Philippines
  • Pologne
      • Bialystok, Pologne
      • Elblag, Pologne
      • Kalisz, Pologne
      • Szczecin, Pologne
      • Warsaw, Pologne
  • Royaume-Uni
      • Leeds, Royaume-Uni
      • London, Royaume-Uni
  • Singapour
      • Singapore, Singapour
  • Taïwan
      • Kaohsiung, Taïwan
      • Taichung, Taïwan
      • Taipei, Taïwan
      • Tiachung, Taïwan
  • Thaïlande
      • Bangkok, Thaïlande
      • Chiang Mai, Thaïlande
  • Ukraine
      • Dnipropetrovsk, Ukraine
      • Donetsk, Ukraine
      • Kharkiv, Ukraine
      • Kiev, Ukraine
  • États-Unis
    • Alabama
      • Birmingham, Alabama, États-Unis
      • Mobile, Alabama, États-Unis
    • California
      • Upland, California, États-Unis
    • Florida
      • Jacksonville, Florida, États-Unis
      • Miami, Florida, États-Unis
    • Idaho
      • Coeur D'Alene, Idaho, États-Unis
    • Illinois
      • Moline, Illinois, États-Unis
      • Springfield, Illinois, États-Unis
    • Kansas
      • Kansas City, Kansas, États-Unis
      • Witchita, Kansas, États-Unis
    • Minnesota
      • Saint Paul, Minnesota, États-Unis
    • Missouri
      • Kansas City, Missouri, États-Unis
    • Nebraska
      • Lincoln, Nebraska, États-Unis
    • North Carolina
      • Charlotte, North Carolina, États-Unis
    • Pennsylvania
      • Duncansville, Pennsylvania, États-Unis
    • Texas
      • Dallas, Texas, États-Unis
      • Fort Worth, Texas, États-Unis
      • Lubbock, Texas, États-Unis

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:

  • Have a diagnosis of rheumatoid arthritis (RA) (according to the revised 1987 criteria of the ACR) for at least 3 months prior to first administration of study agent
  • Are methotrexate (MTX)-naïve (ie, have not received more than 3 weekly doses of MTX for RA at any time)
  • Have active RA as defined by persistent disease activity with at least 4 swollen and 4 tender joints, at the time of screening and baseline, and at least 2 of the following 4 criteria: a) C-reactive protein (CRP) >=1.5 mg/dL at screening or erythrocyte sedimentation rate (ESR) by Westergren method of >= 28 mm in the first hour at screening or baseline, b)Morning stiffness of >= 30 minutes at screening and baseline, c)Bone erosion by x-ray and/or MRI prior to first administration of study agent, d)Anti-cyclic citrullinated peptide (anti-CCP) antibody-positive or rheumatoid factor (RF) positive at screening
  • If using oral corticosteroids, must be on a stable dose equivalent to <= 10 mg of prednisone/day for at least 2 weeks prior to first administration of study agent.

Exclusion Criteria:

  • Can not have inflammatory diseases other than RA that might confound the evaluation of the benefit of golimumab therapy
  • No treatment with disease-modifying anti-rheumatic drugs (DMARDs)/systemic immunosuppressives during the 4 weeks prior to the first administration of study agent
  • No prior treatment with biologic anti-TNF drugs (infliximab, etanercept, adalimumab)
  • No history of, or ongoing, chronic or recurrent infectious disease
  • No serious infection within 2 months prior to first administration of study agent.

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: Group 1: Placebo + Methotrexate
Placebo subcutaneous injections (SC) every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 50 mg SC injections every 4 weeks from Week 28 up to 5 years; Golimumab - Dr's discretion after unblinding (in participants receiving methotrexate plus placebo), 50 mg SC injections every 4 weeks up to 5 years; Golimumab- Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period will be until the week-52 database lock.
Médicament: Placebo injections
SC injections
Médicament: Methotrexate capsules
Methotrexate capsules will be filled with microcrystalline cellulose (Avicel PH 102) and a 2.5 mg methotrexate tablet.
Biologique: Golimumab 50 mg injections
SC injections
Biologique: Golimumab 100 mg injections
SC injections
Expérimental: Group 2: Golimumab 100 mg + Placebo
Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; placebo capsules weekly from Week 0 for up to 5 years (unless early escape at Week 28); Methotrexate - if early escape, 10 to 20 mg weekly from Week 28 up to 5 years; Methotrexate - Dr's discretion after unblinding (in participants receiving golimumab plus placebo) 10 to 20 mg weekly for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period will be until the week-52 database lock.
Médicament: Methotrexate capsules
Methotrexate capsules will be filled with microcrystalline cellulose (Avicel PH 102) and a 2.5 mg methotrexate tablet.
Biologique: Golimumab 50 mg injections
SC injections
Biologique: Golimumab 100 mg injections
SC injections
Médicament: Placebo capsules
Placebo capsules will be filled with microcrystalline cellulose (Avicel PH 102).
Expérimental: Group 3: Golimumab 50 mg + Methotrexate
Golimumab 50 mg SC injections every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 28 for up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period will be until the week-52 database lock.
Médicament: Methotrexate capsules
Methotrexate capsules will be filled with microcrystalline cellulose (Avicel PH 102) and a 2.5 mg methotrexate tablet.
Biologique: Golimumab 50 mg injections
SC injections
Biologique: Golimumab 100 mg injections
SC injections
Expérimental: Group 4: Golimumab 100 mg + Methotrexate
Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period will be until the week-52 database lock.
Médicament: Methotrexate capsules
Methotrexate capsules will be filled with microcrystalline cellulose (Avicel PH 102) and a 2.5 mg methotrexate tablet.
Biologique: Golimumab 50 mg injections
SC injections
Biologique: Golimumab 100 mg injections
SC injections

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Number of Participants Who Achieved American College of Rheumatology (ACR) 50 Response at Week 24
Délai: Week 24
ACR 50 response is defined as a greater than or equal to 50 percent improvement from baseline in: 1. Swollen joint count (66 joints) and tender joint count (68 joints) 2. greater than or equal to 50 percentage improvement in 3 of the following 5 assessments: a. Patient's assessment of pain by the Visual Analogue Scale (VAS) (0-10 cm) b.Patient's Global Assessment of Disease activity VAS (0-10 cm) c. Physician's Global Assessment of Disease Activity VAS (0-10 cm) d. Patient's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C reactive protein.
Week 24
Change From Baseline in Total Van Der Heijde Modified Sharp (vdH-S) Score at Week 52
Délai: Baseline and Week 52
The vdH-S score is the sum of the joint erosion score and the joint-space narrowing (JSN) score. The total score ranges from 0 (best) to 448 (worst) with higher scores indicating more joint damage.
Baseline and Week 52

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Number of Participants Who Achieved American College of Rheumatology (ACR) 20 Response at Week 24
Délai: Week 24
ACR 20 response is defined as a greater than or equal to 20 percent improvement from baseline in: 1. Swollen joint count (66 joints) and tender joint count (68 joints) 2. greater than or equal to 20 percentage improvement in 3 of the following 5 assessments: a. Patient's assessment of pain by the Visual Analogue Scale (VAS) (0-10 cm) b.Patient's Global Assessment of Disease activity VAS (0-10 cm) c. Physician's Global Assessment of Disease Activity VAS (0-10 cm) d. Patient's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C reactive protein.
Week 24
Number of Patients With Abnormal Baseline C-reactive Protein (CRP) Who Achieved American College of Rheumatology (ACR) 50 Response at Week 24
Délai: Week 24
ACR 50 response is defined as a greater than or equal to 50 percent improvement from baseline in: 1. Swollen joint count (66 joints) and tender joint count (68 joints) 2. greater than or equal to 50 percentage improvement in 3 of the following 5 assessments: a. Patient's assessment of pain by the Visual Analogue Scale (VAS) (0-10 cm) b.Patient's Global Assessment of Disease activity VAS (0-10 cm) c. Physician's Global Assessment of Disease Activity VAS (0-10 cm) d. Patient's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C reactive protein.
Week 24
Change From Baseline in Total Van Der Heijde Modified Sharp (vdH-S) Score at Week 52 in Patients With Abnormal C-reactive Protein (CRP Greater Than 1.0 mg/dL) at Baseline
Délai: Baseline and Week 52
The vdH-S score is the sum of the joint erosion score and the joint-space narrowing (JSN) score. The total score ranges from 0 (best) to 448 (worst) with higher scores indicating more joint damage.
Baseline and Week 52

Collaborateurs et enquêteurs

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

Parrainer

Centocor, Inc.

Collaborateurs

Schering-Plough

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 décembre 2005

Achèvement primaire (Réel)

1 avril 2008

Achèvement de l'étude (Réel)

1 juin 2012

Dates d'inscription aux études

Première soumission

11 décembre 2005

Première soumission répondant aux critères de contrôle qualité

11 décembre 2005

Première publication (Estimation)

13 décembre 2005

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

5 septembre 2014

Dernière mise à jour soumise répondant aux critères de contrôle qualité

27 août 2014

Dernière vérification

1 août 2014

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • CR006331
  • GO-BEFORE
  • C0524T05

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 .

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