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A Golimumab Phase 3b, Multicenter, Assessment of Intravenous Efficacy in Rheumatoid Arthritis Subjects Who Have Diminished Disease Control Despite Treatment With Infliximab (REMICADE®) (REGAIN)

1 marzo 2017 aggiornato da: Janssen Biotech, Inc.

This is a Phase 3b, multicenter study of the efficacy of golimumab 2 mg/kg IV in subjects with active rheumatoid arthritis who are receiving methotrexate and have inadequate disease control (defined as an erythrocyte sedimentation rate [ESR]-based Disease Activity Score in 28 joints [DAS28] ≥ 3.2 and ≥ 4 swollen and ≥ 4 tender joints) despite current anti-TNFα therapy with infliximab 2 - 4 mg/kg every 4 weeks, 2 - 5 mg/kg every 5 weeks, 3 - 6 mg/kg every 6 weeks, 3 - 7mg/kg every 7 weeks, or 4 - 8 mg/kg every 8 weeks.

To be eligible for participation, subjects must have previously demonstrated initial and/or temporary improvement in disease signs and symptoms, who have since exhibited a diminished response despite continued treatment. It is estimated that 200 subjects will be enrolled in the study at approximately 85 global sites.

Panoramica dello studio

Stato

Terminato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

The study employs an open-label "active switch" design that moves subjects from infliximab to golimumab 2 mg/kg IV. In general, subjects eligible for the study include men or women who are currently receiving infliximab in actual clinical practice who are at least 18 years of age with active rheumatoid arthritis, and have previously demonstrated initial and/or temporary improvement in disease signs and symptoms, but now exhibit a diminished response and inadequate disease control despite continued treatment. Subjects must have received infliximab in combination with methotrexate for a minimum of 9 months prior to the first screening visit.

The screening visit will occur sometime between Week -12 and Week -10. Consenting subjects who meet screening criteria will receive their final dose of infliximab at Week -8 as part of actual clinical practice. Golimumab IV treatment, which will be supplied by the sponsor, will be received at Weeks 0, 4, 12, 20, and 28. The primary endpoint is at Week 24, the final efficacy assessment is at Week 32, and a follow-up safety assessment by telephone is at Week 44. There will be a maximum of 36 weeks between the last infliximab infusion at Week -8 and the last infusion of golimumab at Week 28. The duration of study participation is expected to be a maximum of 56 weeks (including the Screening Period, 32 weeks of golimumab treatment and assessment, and a 12-week safety follow-up).

Tipo di studio

Interventistico

Iscrizione (Effettivo)

7

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Canada
      • Rimouski, Canada
    • British Columbia
      • Victoria, British Columbia, Canada
    • Newfoundland and Labrador
      • Saint-John'S, Newfoundland and Labrador, Canada
      • St. John'S, Newfoundland and Labrador, Canada
    • Ontario
      • Hamilton, Ontario, Canada
    • Quebec
      • Montreal, Quebec, Canada
  • Stati Uniti
    • Alabama
      • Birmingham, Alabama, Stati Uniti
      • Huntsville, Alabama, Stati Uniti
    • Arizona
      • Peoria, Arizona, Stati Uniti
      • Phoenix, Arizona, Stati Uniti
    • Arkansas
      • Fort Smith, Arkansas, Stati Uniti
    • California
      • Fremont, California, Stati Uniti
      • Fullerton, California, Stati Uniti
      • Long Beach, California, Stati Uniti
      • Santa Maria, California, Stati Uniti
      • Thousand Oaks, California, Stati Uniti
      • Whittier, California, Stati Uniti
    • Connecticut
      • Bridgeport, Connecticut, Stati Uniti
    • Florida
      • Clearwater, Florida, Stati Uniti
      • Miami, Florida, Stati Uniti
      • Orlando, Florida, Stati Uniti
      • Sarasota, Florida, Stati Uniti
      • Tampa, Florida, Stati Uniti
    • Idaho
      • Coeur D'Alene, Idaho, Stati Uniti
    • Indiana
      • Indianapolis, Indiana, Stati Uniti
      • South Bend, Indiana, Stati Uniti
    • Minnesota
      • Eagan, Minnesota, Stati Uniti
      • Edina, Minnesota, Stati Uniti
    • Missouri
      • Saint Louis, Missouri, Stati Uniti
    • New Mexico
      • Albuquerque, New Mexico, Stati Uniti
    • New York
      • Orchard Park, New York, Stati Uniti
    • North Carolina
      • Asheville, North Carolina, Stati Uniti
      • Charlotte, North Carolina, Stati Uniti
      • Greensboro, North Carolina, Stati Uniti
      • Hickory, North Carolina, Stati Uniti
      • Wilmington, North Carolina, Stati Uniti
    • Ohio
      • Dayton, Ohio, Stati Uniti
    • Pennsylvania
      • Duncansville, Pennsylvania, Stati Uniti
      • Philadelphia, Pennsylvania, Stati Uniti
      • Pittsburgh, Pennsylvania, Stati Uniti
      • Wyomissing, Pennsylvania, Stati Uniti
    • South Carolina
      • Charleston, South Carolina, Stati Uniti
      • Columbia, South Carolina, Stati Uniti
      • Myrtle Beach, South Carolina, Stati Uniti
    • Tennessee
      • Hixson, Tennessee, Stati Uniti
      • Jakson, Tennessee, Stati Uniti
      • Nashville, Tennessee, Stati Uniti
    • Texas
      • Houston, Texas, Stati Uniti
      • Plano, Texas, Stati Uniti
      • San Antonio, Texas, Stati Uniti
    • Virginia
      • Arlington, Virginia, Stati Uniti
    • Washington
      • Spokane, Washington, Stati Uniti
    • Wisconsin
      • Glendale, Wisconsin, Stati Uniti

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 76 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Major Inclusion Criteria include (but not limited to):

  • Have a diagnosis of Rheumatoid Arthritis (according to the revised 1987 criteria of the American Rheumatism Association).
  • Treatment with infliximab and methotrexate for >= 9 months, (with stable doses of methotrexate over last 16 weeks of 7.5 mg/week to 25 mg/week) and (anti-TNFα therapy with infliximab 2 - 4 mg/kg every 4 weeks, 2 - 5 mg/kg every 5 weeks, 3 - 6 mg/kg every 6 weeks, 3 - 7mg/kg every 7 weeks, or 4 - 8 mg/kg every 8 weeks).
  • Disease Activity Score 28 (DAS28) ≥ 3.2 based on Erythrocyte Sedimentation Rate (ESR) at Week -8 and Week 0.
  • Swollen joint count (SJC) ≥ 4 and tender joint count (TJC) ≥ 4 at Week - 8 and at Week 0.
  • Prior response confirmed by physician.

Major Exclusion Criteria include (but not limited to):

  • Have a history of latent or active granulomatous infection, including histoplasmosis, or Have a history of latent or active granulomatous infection, including histoplasmosis, or coccidioidomycosis, prior to the first screening visit or during the Screening Period.
  • Have had a Bacille Calmette-Guérin (BCG) vaccination within 12 months of screening.
  • Have a chest radiograph within 3 months prior to the first administration of study agent that shows an abnormality suggestive of a malignancy or current active infection, including tuberculosis (TB), histoplasmosis, or coccidioidomycosis.
  • Have previously received more than 1 of the currently approved subcutaneous (SC) administered anti-TNFα agents, etanercept, certolizumab pegol, golimumab, or adalimumab.
  • Are pregnant, nursing, or planning a pregnancy or fathering a child within 6 months after receiving the last administration of the study agent.
  • Weight less than 35 kg or greater than 110 kg (less than 77 pounds or greater than 242 pounds).

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Golimumab 2 mg/kg IV
Study drug (golimumab 2 mg/kg IV) will be administered as an intravenous (IV) infusion at Weeks 0, 4, 12, 20 and 28.
Biologico: Golimumab 2 mg/kg IV
Study drug (golimumab 2 mg/kg IV) will be administered as an intravenous (IV) infusion at Weeks 0, 4, 12, 20 and 28.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20) Response at Week 24
Lasso di tempo: Week 24
The ACR 20 Response is defined as greater than or equal to (>=) 20 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=20 percent improvement in 3 of following 5 assessments: patient's assessment of pain using Visual Analog Scale (VAS; 0-10 millimeter [mm], 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and erythrocyte sedimentation rate (ESR).
Week 24

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Participants Who Achieved an ACR 20 Response at Week 24 With Confirmed Presence of Antibodies to Infliximab
Lasso di tempo: Week 24
The ACR 20 Response is defined as >= 20 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=20 percent improvement in 3 of following 5 assessments: patient's assessment of pain using VAS (010 millimeter [mm], 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and ESR.
Week 24
Percentage of Participants Who Acheived ACR 20 Response at Week 24 With Trough Infliximab Levels Below the Lower Limit of Quantification (LLOQ)
Lasso di tempo: Week 24
The ACR 20 Response is defined as >= 20 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=20 percent improvement in 3 of following 5 assessments: patient's assessment of pain using VAS (010 millimeter [mm], 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and ESR.
Week 24

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Janssen Biotech, Inc.

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 ottobre 2013

Completamento primario (Effettivo)

1 dicembre 2014

Completamento dello studio (Effettivo)

1 dicembre 2014

Date di iscrizione allo studio

Primo inviato

11 ottobre 2013

Primo inviato che soddisfa i criteri di controllo qualità

11 ottobre 2013

Primo Inserito (Stima)

16 ottobre 2013

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

12 aprile 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

1 marzo 2017

Ultimo verificato

1 marzo 2017

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CR102117
  • CNTO148ART3003 (Altro identificatore: Janssen Biotech, Inc.)
  • 2013-001809-91 (Numero EudraCT)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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