- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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)
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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Murietta, California, Estados Unidos
- Research Site
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Colorado
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Longmont, Colorado, Estados Unidos
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Delaware
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Lewes, Delaware, Estados Unidos
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Florida
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Dunedin, Florida, Estados Unidos
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Ocala, Florida, Estados Unidos
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Orange Park, Florida, Estados Unidos
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Illinois
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Morton Grove, Illinois, Estados Unidos
- Research Site
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Maryland
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Baltimore, Maryland, Estados Unidos
- Research Site
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Massachusetts
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Plymouth, Massachusetts, Estados Unidos
- Research Site
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Nevada
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Las Vegas, Nevada, Estados Unidos
- Research Site
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Reno, Nevada, Estados Unidos
- Research Site
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New Jersey
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Berkeley Heights, New Jersey, Estados Unidos
- Research Site
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Summit, New Jersey, Estados Unidos
- Research Site
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New York
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Floral Park, New York, Estados Unidos
- Research Site
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Orchard Park, New York, Estados Unidos
- Research Site
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Smithtown, New York, Estados Unidos
- Research Site
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North Carolina
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Raleigh, North Carolina, Estados Unidos
- Research Site
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Wilmington, North Carolina, Estados Unidos
- Research Site
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Ohio
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Cincinnati, Ohio, Estados Unidos
- Research Site
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Mayfield Village, Ohio, Estados Unidos
- Research Site
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Middleburg Heights, Ohio, Estados Unidos
- Research Site
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Oklahoma
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Edmund, Oklahoma, Estados Unidos
- Research Site
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Pennsylvania
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Duncansville, Pennsylvania, Estados Unidos
- Research Site
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South Carolina
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Mrytle Beach, South Carolina, Estados Unidos
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Texas
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Dallas, Texas, Estados Unidos
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San Anotnio, Texas, Estados Unidos
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Virginia
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Burke, Virginia, Estados Unidos
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Washington
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Seattle, Washington, Estados Unidos
- Research Site
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Spokane, Washington, Estados Unidos
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Wisconsin
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Franklin, Wisconsin, Estados Unidos
- Research Site
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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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
Periodo de tiempo: 14 weeks
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14 weeks
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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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
Periodo de tiempo: 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.
Periodo de tiempo: 14 weeks
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14 weeks
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Discovery of novel genetic (DNA) predictors of response to anti-TNF therapy.
Periodo de tiempo: 14 weeks
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14 weeks
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 999RA002
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .