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

6. juni 2014 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

301

Kontakter og lokationer

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

Studiesteder

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

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

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

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

Samarbejdspartnere og efterforskere

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

Sponsor

Biogen

Samarbejdspartnere

Crescendo Biosciences

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. juni 2010

Primær færdiggørelse (Faktiske)

1. juli 2013

Studieafslutning (Faktiske)

1. juli 2013

Datoer for studieregistrering

Først indsendt

28. september 2010

Først indsendt, der opfyldte QC-kriterier

28. september 2010

Først opslået (Skøn)

29. september 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

9. juni 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. juni 2014

Sidst verificeret

1. juni 2014

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 999RA002

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 .

Kliniske forsøg med Gigt, reumatoid

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Peru

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner