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RESTART C0168Z05 Rheumatoid Arthritis Study

29 agosto 2013 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

203

Fase

  • Fase 4

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

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

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

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: Randomizzato
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Altro: 001
Infliximab3 mg/kg at week 0,2,6; Increase to 5mg/kg or 7 mg/kg based on EULAR response
Biologico: Infliximab
3 mg/kg at week 0,2,6; Increase to 5mg/kg or 7 mg/kg based on EULAR response

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percent of Patients Who Achieved a EULAR (The European League Against Rheumatism) Response at Week 10
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percent of Patients Who Acheived EULAR Response at Week 10 and Maintained Through Week 26 Without Infliximab Dose Increase
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: 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

Collaboratori e investigatori

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

Sponsor

Centocor Ortho Biotech Services, L.L.C.

Collaboratori

Schering-Plough

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.

Pubblicazioni generali

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 luglio 2008

Completamento primario (Effettivo)

1 gennaio 2010

Completamento dello studio (Effettivo)

1 giugno 2010

Date di iscrizione allo studio

Primo inviato

10 luglio 2008

Primo inviato che soddisfa i criteri di controllo qualità

11 luglio 2008

Primo Inserito (Stima)

14 luglio 2008

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

12 settembre 2013

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 agosto 2013

Ultimo verificato

1 agosto 2013

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CR013879
  • C0168Z05 (Altro identificatore: Centocor Ortho Biotech Services, L.L.C.)

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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