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RESTART C0168Z05 Rheumatoid Arthritis Study

29. august 2013 oppdatert av: Centocor Ortho Biotech Services, L.L.C.

A Phase 4, Multicenter, Open-Label, Assessor-Blinded Switch Study of the Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) or Adalimumab (HUMIRA).

The purpose of this study is to assess the effectiveness of treatment in patients with active rheumatoid arthritis who are having an inadequate response to at least 3 months of treatment with etanercept or adalimumab in addition to methotrexate.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This is a Phase 4, multi center, open-label, assessor blinded, switch study of infliximab in patients with active rheumatoid arthritis who are receiving methotrexate and are having an inadequate response to their current treatment with etanercept or adalimumab. The last dose of etanercept must have been at least 1 week but not more than 2 weeks prior to the first infliximab study infusion. The last dose of adalimumab must have been administered at least 2 weeks but not more than 4 weeks prior to the first infliximab study infusion. The study will be conducted for 30 weeks and will include 200 patients. All eligible patients will receive 3 mg/kg infliximab infusions (drug given into a vein) at weeks 0, 2, and 6 and every 8 weeks thereafter, if they achieve a European League Against Rheumatism (EULAR) response on their current dose of infliximab. Patients who do not achieve a EULAR response will increase their dose from 3mg/kg to 5 mg/kg at week 14. Patients who do not achieve a EULAR response at week 22 will increase from either 3 mg/kg to 5 mg/kg or from 5mg/kg to 7 mg/kg. The last study infusion will take place at week 22. The last study visit for effectiveness evaluations will take place at week 26. A week 30 follow-up visit will be performed for adverse events and tuberculosis evaluations, health economics assessments, and review of concomitant medications. All patients who end the study early will be required to complete all assessments. Patients will receive 3 mg/kg infliximab infusions at weeks 0, 2, and 6. If patients achieve European League Against Rheumatism (EULAR) response, they will remain on their current dose. Patients who do not demonstrate a EULAR response will increase their infliximab dose from 3 mg/kg to 5 mg/kg at week 14. At week 22, patients will also increase their infliximab dose from 3 mg/kg to 5mg/kg or from 5 mg/kg to 7mg/kg if they do not demonstrate a EULAR response.

Studietype

Intervensjonell

Registrering (Faktiske)

203

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Canada
      • Hamilton Ontario, Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada
    • Newfoundland and Labrador
      • St. John'S, Newfoundland and Labrador, Canada
    • Ontario
      • Toronto, Ontario, Canada
  • Finland
      • Helsinki, Finland
  • Forente stater
    • Alabama
      • Huntsville, Alabama, Forente stater
    • Arizona
      • Paradise Valley, Arizona, Forente stater
      • Tucson, Arizona, Forente stater
    • California
      • Santa Monica, California, Forente stater
    • Connecticut
      • Bridgeport, Connecticut, Forente stater
    • Delaware
      • Lewes, Delaware, Forente stater
    • Florida
      • Boca Raton, Florida, Forente stater
      • Palm Harbor, Florida, Forente stater
      • Tamarac, Florida, Forente stater
      • Vero Beach, Florida, Forente stater
    • Georgia
      • Atlanta, Georgia, Forente stater
    • Illinois
      • Moline, Illinois, Forente stater
      • Springfield, Illinois, Forente stater
    • Kentucky
      • Lexington, Kentucky, Forente stater
    • Maryland
      • Wheaton, Maryland, Forente stater
    • Michigan
      • Saint Clair Shores, Michigan, Forente stater
    • Minnesota
      • Eagan, Minnesota, Forente stater
    • Missouri
      • Saint Louis, Missouri, Forente stater
      • Springfield, Missouri, Forente stater
    • New Jersey
      • Berkeley Heights, New Jersey, Forente stater
      • Freehold, New Jersey, Forente stater
    • New York
      • Albany, New York, Forente stater
      • Syracuse, New York, Forente stater
    • North Carolina
      • Chapel Hill, North Carolina, Forente stater
    • Ohio
      • Columbus, Ohio, Forente stater
      • Mayfield, Ohio, Forente stater
      • Middleburg Heights, Ohio, Forente stater
    • Oklahoma
      • Tulsa, Oklahoma, Forente stater
    • Pennsylvania
      • Allentown, Pennsylvania, Forente stater
      • Duncansville, Pennsylvania, Forente stater
      • Wexford, Pennsylvania, Forente stater
    • South Carolina
      • Charleston, South Carolina, Forente stater
      • Greenville, South Carolina, Forente stater
    • Tennessee
      • Jackson, Tennessee, Forente stater
      • Nashville, Tennessee, Forente stater
    • Texas
      • Amarillo, Texas, Forente stater
      • Dallas, Texas, Forente stater
      • Fort Worth, Texas, Forente stater
      • Houston, Texas, Forente stater
      • Mesquite, Texas, Forente stater
      • Temple, Texas, Forente stater
      • Tyler, Texas, Forente stater
    • Virginia
      • Burke, Virginia, Forente stater
      • Reston, Virginia, Forente stater
    • Washington
      • Seattle, Washington, Forente stater
  • Frankrike
      • Bordeaux Cedex, Frankrike
      • Limoges, Frankrike
      • Montivilliers, Frankrike
      • Orleans, Frankrike
  • Israel
      • Ashkelon, Israel
      • Beer Yaakov, Israel
      • Haifa, Israel
      • Kfar Saba, Israel
      • Ramat Gan, Israel
      • Rehovot, Israel
      • Tel-Aviv, Israel
  • Nederland
      • Alkmaar, Nederland
  • Spania
      • Madrid, Spania
      • Oviedo, Spania
      • Santiago De Compostela, Spania
  • Storbritannia
      • Leeds, Storbritannia
      • London, Storbritannia
      • Wigan, Storbritannia
  • Tyskland
      • Frankfurt, Tyskland
      • Holdenfelde, Tyskland
      • Leipzig, Tyskland
      • Muenchen, Tyskland
      • München, Tyskland
      • Ratingen, Tyskland
  • Østerrike
      • Graz-Eggenberg, Østerrike
      • Wien, Østerrike

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Patients must have rheumatoid arthritis
  • Patients must have greater than or equal to 6 tender joints and greater than or equal to 6 swollen joints
  • Patients must have inadequate disease response to etanercept or adalimumab
  • Patients must have received etanercept or adalimumab in combination with methotrexate for a minimum of at least 3 months prior to the screening visit. The last dose of etanercept must have been given at least 1 week but not more than 2 weeks prior to first infliximab infusion. The last dose of adalimumab must have been administered at least 2 weeks but not more than 4 weeks prior to first infliximab infusion.

Exclusion Criteria:

  • Patients who have a history of latent or active TB
  • Have inflammatory disease other than rheumatoid arthritis
  • Have had a chronic or recurrent infectious disease.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Annen: 001
Infliximab3 mg/kg at week 0,2,6; Increase to 5mg/kg or 7 mg/kg based on EULAR response
Biologisk: Infliximab
3 mg/kg at week 0,2,6; Increase to 5mg/kg or 7 mg/kg based on EULAR response

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percent of Patients Who Achieved a EULAR (The European League Against Rheumatism) Response at Week 10
Tidsramme: Week 10
Percent of patients who achieved EULAR response at Week 10. EULAR response is defined based on the DAS28 score and the EULAR response criteria (Van Gestel et al, 1996 and 1999). At a given visit, patients with a DAS28 score of ≤ 5.1 are considered EULAR responders if the improvement from baseline in their DAS28 score is greater than 0.6; Or patients with a DAS28 score > 5.1 are considered EULAR responders if the improvement from baseline in their DAS28 score is > 1.2.
Week 10

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percent of Patients Who Acheived EULAR Response at Week 10 and Maintained Through Week 26 Without Infliximab Dose Increase
Tidsramme: Week 26
Percent of patients who achieved EULAR response at Week 10 and maintained through Week 26 without infliximab dose increase
Week 26
Percent of Patients Who Achieved EULAR Response at Week 26, Regardless of EULAR Response Status at Weeks 10, 14, and 22, With or Without Dose Increase Prior to Week 26
Tidsramme: Week 26
Percent of patients who achieved EULAR response at Week 26, regardless of EULAR response status at Weeks 10, 14, and 22, with or without dose increase prior to Week 26
Week 26
Change From Baseline in Physical Function (HAQ)
Tidsramme: Week 10
Change from baseline in physical function (HAQ) at Week 10. HAQ assesses the degree of difficulty a person has in accomplishing tasks. A lower HAQ score indicates less difficulty. Change from baseline is computed as Week 10 value minus baseline value. A negative value in change from baseline indicates an improvement.
Week 10
Change From Baseline in Physical Function (HAQ)
Tidsramme: Week 26
Change from baseline in physical function (HAQ) at Week 26. HAQ assesses the degree of difficulty a person has in accomplishing tasks. A lower HAQ score indicates less difficulty. Change from baseline is computed as Week 26 value minus baseline value. A negative value in change from baseline indicates an improvement.
Week 26
Percent of Patients Who Achieved ACR20 at Week 10
Tidsramme: Week 10
Percent of patients who achieved ACR20 at Week 10. A patient is considered achieving ACR20 if the following two conditions are met: 1) An improvement of ≥ 20% from baseline in both the swollen joint count (66 joints) and tender joint count (68 joints; 2) An improvement of ≥ 20% from baseline in at least 3 of the following 5 assessments:Patient's assessment of pain visual analog scale (VAS), Patient's global assessment of disease activity (VAS), Evaluator's global assessment of disease activity (VAS), Patient's assessment of physical function as measured by the HAQ disability index, and CRP.
Week 10
Percent of Patients Who Achieved ACR20 at Weeks 26.
Tidsramme: Week 26
Percent of patients who achieved ACR20 at Weeks 26. A patient is considered achieving ACR20 if the following two conditions are met: 1) An improvement of ≥ 20% from baseline in both the swollen joint count (66 joints) and tender joint count (68 joints; 2) An improvement of ≥ 20% from baseline in at least 3 of the following 5 assessments:Patient's assessment of pain visual analog scale (VAS), Patient's global assessment of disease activity (VAS), Evaluator's global assessment of disease activity (VAS), Patient's assessment of physical function as measured by the HAQ disability index, and CRP.
Week 26

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Centocor Ortho Biotech Services, L.L.C.

Samarbeidspartnere

Schering-Plough

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juli 2008

Primær fullføring (Faktiske)

1. januar 2010

Studiet fullført (Faktiske)

1. juni 2010

Datoer for studieregistrering

Først innsendt

10. juli 2008

Først innsendt som oppfylte QC-kriteriene

11. juli 2008

Først lagt ut (Anslag)

14. juli 2008

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

12. september 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. august 2013

Sist bekreftet

1. august 2013

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CR013879
  • C0168Z05 (Annen identifikator: Centocor Ortho Biotech Services, L.L.C.)

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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