- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01211678
Biomarkers of Anti-TNF-α Therapy Efficacy in Rheumatoid Arthritis to Define Unresponsive Patients (BATTER-UP)
Biomarkers of Anti-TNF-α Therapy Efficacy in Rheumatoid Arthritis to Define Unresponsive Patients (BATTER-UP)
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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California
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Murietta, California, Förenta staterna
- Research Site
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Colorado
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Longmont, Colorado, Förenta staterna
- Research Site
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Delaware
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Lewes, Delaware, Förenta staterna
- Research Site
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Florida
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Dunedin, Florida, Förenta staterna
- Research Site
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Ocala, Florida, Förenta staterna
- Research Site
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Orange Park, Florida, Förenta staterna
- Research Site
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Illinois
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Morton Grove, Illinois, Förenta staterna
- Research Site
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Maryland
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Baltimore, Maryland, Förenta staterna
- Research Site
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Massachusetts
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Plymouth, Massachusetts, Förenta staterna
- Research Site
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Nevada
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Las Vegas, Nevada, Förenta staterna
- Research Site
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Reno, Nevada, Förenta staterna
- Research Site
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New Jersey
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Berkeley Heights, New Jersey, Förenta staterna
- Research Site
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Summit, New Jersey, Förenta staterna
- Research Site
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New York
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Floral Park, New York, Förenta staterna
- Research Site
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Orchard Park, New York, Förenta staterna
- Research Site
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Smithtown, New York, Förenta staterna
- Research Site
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North Carolina
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Raleigh, North Carolina, Förenta staterna
- Research Site
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Wilmington, North Carolina, Förenta staterna
- Research Site
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Ohio
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Cincinnati, Ohio, Förenta staterna
- Research Site
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Mayfield Village, Ohio, Förenta staterna
- Research Site
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Middleburg Heights, Ohio, Förenta staterna
- Research Site
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Oklahoma
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Edmund, Oklahoma, Förenta staterna
- Research Site
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Pennsylvania
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Duncansville, Pennsylvania, Förenta staterna
- Research Site
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South Carolina
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Mrytle Beach, South Carolina, Förenta staterna
- Research Site
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Texas
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Dallas, Texas, Förenta staterna
- Research Site
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San Anotnio, Texas, Förenta staterna
- Research Site
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Virginia
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Burke, Virginia, Förenta staterna
- Research Site
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Washington
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Seattle, Washington, Förenta staterna
- Research Site
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Spokane, Washington, Förenta staterna
- Research Site
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Wisconsin
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Franklin, Wisconsin, Förenta staterna
- Research Site
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
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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
Tidsram: 14 weeks
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14 weeks
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Sekundära resultatmått
Resultatmått |
Tidsram |
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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
Tidsram: 14 weeks
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14 weeks
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Development, maintenance, and utilization of a biorepository of serum, plasma, RNA, and deoxyribonucleic acid (DNA) samples for additional experiments and analyses.
Tidsram: 14 weeks
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14 weeks
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Discovery of novel genetic (DNA) predictors of response to anti-TNF therapy.
Tidsram: 14 weeks
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14 weeks
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Samarbetspartners och utredare
Sponsor
Samarbetspartners
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 999RA002
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