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RESTART C0168Z05 Rheumatoid Arthritis Study

29. august 2013 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

203

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

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
  • Det Forenede Kongerige
      • Leeds, Det Forenede Kongerige
      • London, Det Forenede Kongerige
      • Wigan, Det Forenede Kongerige
  • Finland
      • Helsinki, Finland
  • Forenede Stater
    • Alabama
      • Huntsville, Alabama, Forenede Stater
    • Arizona
      • Paradise Valley, Arizona, Forenede Stater
      • Tucson, Arizona, Forenede Stater
    • California
      • Santa Monica, California, Forenede Stater
    • Connecticut
      • Bridgeport, Connecticut, Forenede Stater
    • Delaware
      • Lewes, Delaware, Forenede Stater
    • Florida
      • Boca Raton, Florida, Forenede Stater
      • Palm Harbor, Florida, Forenede Stater
      • Tamarac, Florida, Forenede Stater
      • Vero Beach, Florida, Forenede Stater
    • Georgia
      • Atlanta, Georgia, Forenede Stater
    • Illinois
      • Moline, Illinois, Forenede Stater
      • Springfield, Illinois, Forenede Stater
    • Kentucky
      • Lexington, Kentucky, Forenede Stater
    • Maryland
      • Wheaton, Maryland, Forenede Stater
    • Michigan
      • Saint Clair Shores, Michigan, Forenede Stater
    • Minnesota
      • Eagan, Minnesota, Forenede Stater
    • Missouri
      • Saint Louis, Missouri, Forenede Stater
      • Springfield, Missouri, Forenede Stater
    • New Jersey
      • Berkeley Heights, New Jersey, Forenede Stater
      • Freehold, New Jersey, Forenede Stater
    • New York
      • Albany, New York, Forenede Stater
      • Syracuse, New York, Forenede Stater
    • North Carolina
      • Chapel Hill, North Carolina, Forenede Stater
    • Ohio
      • Columbus, Ohio, Forenede Stater
      • Mayfield, Ohio, Forenede Stater
      • Middleburg Heights, Ohio, Forenede Stater
    • Oklahoma
      • Tulsa, Oklahoma, Forenede Stater
    • Pennsylvania
      • Allentown, Pennsylvania, Forenede Stater
      • Duncansville, Pennsylvania, Forenede Stater
      • Wexford, Pennsylvania, Forenede Stater
    • South Carolina
      • Charleston, South Carolina, Forenede Stater
      • Greenville, South Carolina, Forenede Stater
    • Tennessee
      • Jackson, Tennessee, Forenede Stater
      • Nashville, Tennessee, Forenede Stater
    • Texas
      • Amarillo, Texas, Forenede Stater
      • Dallas, Texas, Forenede Stater
      • Fort Worth, Texas, Forenede Stater
      • Houston, Texas, Forenede Stater
      • Mesquite, Texas, Forenede Stater
      • Temple, Texas, Forenede Stater
      • Tyler, Texas, Forenede Stater
    • Virginia
      • Burke, Virginia, Forenede Stater
      • Reston, Virginia, Forenede Stater
    • Washington
      • Seattle, Washington, Forenede Stater
  • Frankrig
      • Bordeaux Cedex, Frankrig
      • Limoges, Frankrig
      • Montivilliers, Frankrig
      • Orleans, Frankrig
  • Holland
      • Alkmaar, Holland
  • Israel
      • Ashkelon, Israel
      • Beer Yaakov, Israel
      • Haifa, Israel
      • Kfar Saba, Israel
      • Ramat Gan, Israel
      • Rehovot, Israel
      • Tel-Aviv, Israel
  • Spanien
      • Madrid, Spanien
      • Oviedo, Spanien
      • Santiago De Compostela, Spanien
  • Tyskland
      • Frankfurt, Tyskland
      • Holdenfelde, Tyskland
      • Leipzig, Tyskland
      • Muenchen, Tyskland
      • München, Tyskland
      • Ratingen, Tyskland
  • Østrig
      • Graz-Eggenberg, Østrig
      • Wien, Østrig

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: 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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Centocor Ortho Biotech Services, L.L.C.

Samarbejdspartnere

Schering-Plough

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juli 2008

Primær færdiggørelse (Faktiske)

1. januar 2010

Studieafslutning (Faktiske)

1. juni 2010

Datoer for studieregistrering

Først indsendt

10. juli 2008

Først indsendt, der opfyldte QC-kriterier

11. juli 2008

Først opslået (Skøn)

14. juli 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

12. september 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. august 2013

Sidst verificeret

1. august 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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