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Biomarkers of Anti-TNF-α Therapy Efficacy in Rheumatoid Arthritis to Define Unresponsive Patients (BATTER-UP)

6. juni 2014 oppdatert av: Biogen

Biomarkers of Anti-TNF-α Therapy Efficacy in Rheumatoid Arthritis to Define Unresponsive Patients (BATTER-UP)

The primary objective of this study was to validate the ability of an 8-gene biomarker set to differentiate between participants who met or did not meet European League Against Rheumatism (EULAR) Disease Activity Score (DAS)-28 Good Response criteria after treatment with anti-Tumor Necrosis Factor (TNF) therapy for 14 weeks in approximately 200 anti-TNF-naïve participants. The secondary objectives of this study was (i) to compare the behavior of the 8-gene marker set in participants who were anti-TNF naïve versus those who began their second anti-TNF treatment , (ii) to develop, maintain, and utilize a biorepository of serum, plasma, RNA, and deoxyribonucleic acid (DNA) samples for additional experiments and analyses and (iii) to discover novel genetic (DNA) predictors of response to anti-TNF therapy.

Studieoversikt

Status

Fullført

Forhold

Studietype

Observasjonsmessig

Registrering (Faktiske)

301

Kontakter og plasseringer

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

Studiesteder

  • Forente stater
    • California
      • Murietta, California, Forente stater
        • Research Site
    • Colorado
      • Longmont, Colorado, Forente stater
        • Research Site
    • Delaware
      • Lewes, Delaware, Forente stater
        • Research Site
    • Florida
      • Dunedin, Florida, Forente stater
        • Research Site
      • Ocala, Florida, Forente stater
        • Research Site
      • Orange Park, Florida, Forente stater
        • Research Site
    • Illinois
      • Morton Grove, Illinois, Forente stater
        • Research Site
    • Maryland
      • Baltimore, Maryland, Forente stater
        • Research Site
    • Massachusetts
      • Plymouth, Massachusetts, Forente stater
        • Research Site
    • Nevada
      • Las Vegas, Nevada, Forente stater
        • Research Site
      • Reno, Nevada, Forente stater
        • Research Site
    • New Jersey
      • Berkeley Heights, New Jersey, Forente stater
        • Research Site
      • Summit, New Jersey, Forente stater
        • Research Site
    • New York
      • Floral Park, New York, Forente stater
        • Research Site
      • Orchard Park, New York, Forente stater
        • Research Site
      • Smithtown, New York, Forente stater
        • Research Site
    • North Carolina
      • Raleigh, North Carolina, Forente stater
        • Research Site
      • Wilmington, North Carolina, Forente stater
        • Research Site
    • Ohio
      • Cincinnati, Ohio, Forente stater
        • Research Site
      • Mayfield Village, Ohio, Forente stater
        • Research Site
      • Middleburg Heights, Ohio, Forente stater
        • Research Site
    • Oklahoma
      • Edmund, Oklahoma, Forente stater
        • Research Site
    • Pennsylvania
      • Duncansville, Pennsylvania, Forente stater
        • Research Site
    • South Carolina
      • Mrytle Beach, South Carolina, Forente stater
        • Research Site
    • Texas
      • Dallas, Texas, Forente stater
        • Research Site
      • San Anotnio, Texas, Forente stater
        • Research Site
    • Virginia
      • Burke, Virginia, Forente stater
        • Research Site
    • Washington
      • Seattle, Washington, Forente stater
        • Research Site
      • Spokane, Washington, Forente stater
        • Research Site
    • Wisconsin
      • Franklin, Wisconsin, Forente stater
        • Research Site

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

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Participants who meet American College of Rheumatology (ACR) criteria for rheumatoid arthritis (RA) and who, in the opinion of their treating rheumatologist, are not adequately treated with existing therapy and should begin treatment with either an anti TNF agent for the first time or with a different anti-TNF agent.

Beskrivelse

Key Inclusion Criteria

To be eligible to participate in this study, candidates must meet the following eligibility criteria at the time of enrollment:

  • Are willing and able to provide informed consent..
  • Meet the ACR criteria for RA as determined by a rheumatologist who is board certified in Rheumatology or a member of the ACR.
  • Have 4 or more tender and 4 or more swollen joints out of 28 joints as assessed by their treating rheumatologist or a trained joint assessor.

  • Subjects are not taking any of the following treatments and/or have washed out for the minimum duration as defined below. If subjects are currently taking these treatments, must have been on a stable dosing regimen for the minimum duration as defined below:

    • Oral DMARDs (MTX, hydroxychloroquine, sulfasalazine, leflunomide, cyclosporine, azathioprine): on drug for at least 3 months and washed out or stable for at least 6 weeks prior to baseline sample collection.
    • Oral corticosteroids: washed out or stable AND ≤10 mg/day of prednisone equivalent for at least 4 weeks prior to baseline sample collection.
    • Intraarticular or parenteral corticosteroids: Washed out or stable for at least 4 weeks prior to baseline sample collection.
    • NSAIDs: Washed out or stable for at least 2 weeks prior to baseline sample collection.
  • Are about to start treatment with an anti-TNF agent approved for the treatment of RA for the first time OR Have not, in the opinion of the treating rheumatologist, achieved or maintained an adequate response to treatment with their first anti-TNF agent (any anti-TNF agent approved for the treatment of RA), and have been prescribed a different anti TNF agent. Subjects who switch for any reason other than lack of efficacy will be excluded.

Key Exclusion Criteria

Candidates will be excluded from study entry if any of the following exclusion criteria exist at the time of enrollment:

  • Any medical condition that would preclude safe use of an anti-TNF agent for at least 14 weeks.
  • Previous participation in the present study as a subject in the anti-TNF-naïve group.
  • Prior exposure to 2 or more anti-TNF agents.
  • Prior exposure to Orencia (abatacept, or CTLA4-Ig) and/or Rituxan (anti CD20), or other biologic therapy for RA or other diseases.

Note: Other protocol defined inclusion/exclusion criteria may apply.

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Validation of the ability of an 8-gene biomarker set to differentiate between participants who meet or do not meet EULAR DAS-28 Good response criteria after treatment with anti-TNF therapy
Tidsramme: 14 weeks
14 weeks

Sekundære resultatmål

Resultatmål
Tidsramme
Comparison of the behavior of the 8-gene marker set in participants who are anti-TNF naïve versus those who begin their second anti-TNF treatment
Tidsramme: 14 weeks
14 weeks
Development, maintenance, and utilization of a biorepository of serum, plasma, RNA, and deoxyribonucleic acid (DNA) samples for additional experiments and analyses.
Tidsramme: 14 weeks
14 weeks
Discovery of novel genetic (DNA) predictors of response to anti-TNF therapy.
Tidsramme: 14 weeks
14 weeks

Samarbeidspartnere og etterforskere

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

Sponsor

Biogen

Samarbeidspartnere

Crescendo Biosciences

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. juni 2010

Primær fullføring (Faktiske)

1. juli 2013

Studiet fullført (Faktiske)

1. juli 2013

Datoer for studieregistrering

Først innsendt

28. september 2010

Først innsendt som oppfylte QC-kriteriene

28. september 2010

Først lagt ut (Anslag)

29. september 2010

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

9. juni 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. juni 2014

Sist bekreftet

1. juni 2014

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 999RA002

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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