A Phase IIIB, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Comparative Study of Abatacept or Infliximab in Combination With Methotrexate in Controlling Disease Activity in Subjects With Rheumatoid Arthritis Having an Inadequate Clinical Response to Methotrexate

CompletadoFase 3ClinicalTrials.gov

ID: NCT00095147Tipo: INTERVENTIONALInicio: 1 de feb de 2005Fin estimado: 1 de jul de 2009

Traducción no disponible, mostrando original

Resumen

The purpose of this clinical research study is to learn if Abatacept or Infliximab in combination with Methotrexate demonstrate a greater reduction in disease activity over placebo.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

Diagnosis of Rheumatoid Arthritis
At least 3 months prior treatment with Methotrexate (MTX)
At least 10 swollen joints and 12 tender joints and C-Reactive Protein of at least 1 mg/dl
Washout required for other disease modifying anti-rheumatic drugs (DMARDS)

Criterios de exclusión

participants who have failed more than 3 DMARDs
participants previously treated with an approved biologic drug
History of cancer in the last 5 years
Severe or recurrent bacterial infection
Any previous or current medical conditions that are contraindications to the use of TNF blocking agents
Women of Child Bearing Potential

Intervenciones

drug

Abatacept (ABA) + Methotrexate (MTX), double-blind (DB)

Abatacept, intravenous (IV) Solution, Infusion, Depends on participant weight, Monthly, 12 months.

drug

Infliximab (INF) + MTX, DB

Infliximab, IV Solution, Infusion, Depends on participant weight, Every 2 Months, 12 months.

drug

Placebo (PLA) + MTX, DB

Placebo, IV Solution, Infusion, Depends on participant weight, Monthly, 6 months.

drug

PLA + MTX switched to ABA+ MTX, DB

Placebo=IV Solution, Infusion, Depends on participant weight, Monthly, 6 months. Abatacept=IV Solution, Infusion, Depends on participant weight, Monthly, 6 months

drug

ABA, open-label (OL)

Abatacept, IV solution, Infusion. Depends on participant weight, Monthly, 12+ months

Ubicaciones

Local Institution

Buenos Aires, Buenos Aires, Argentina

Local Institution

Capital Federal, Buenos Aires, Argentina

Local Institution

Quilmes, Buenos Aires, Argentina

Local Institution

Córdoba, Córdoba Province, Argentina

Local Institution

San Miguel de Tucumán, Tucumán Province, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

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