Randomized, Parallel, Double-Blind, Placebo-Controlled Trial To Evaluate The Efficacy And Safety Of SBI-087 In Seropositive Subjects With Active Rheumatoid Arthritis On A Stable Background Of Methotrexate

CompletadoFase 2ClinicalTrials.gov

ID: NCT01008852Tipo: INTERVENTIONALInicio: 1 de dic de 2009Fin estimado: 1 de jul de 2013

Traducción no disponible, mostrando original

Resumen

This study is designed to evaluate the safety and efficacy of a dose and dosage regimen of SBI-087 in seropositive patients with active Rheumatoid Arthritis, who are on a stable dose of methotrexate.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Meets the American College of Rheumatology (ACR) 1987 revised criteria for classification of Rheumatoid Arthritis (RA) for at least 6 months prior to screening
Active RA as defined by \>= 5 swollen and \>= 5 tender joints (28-joint count) and at least 1 of the following: C-reactive protein \>= 10 mg/L or Erythrocyte Sedimentation Rate \>= 28 mm/h
Must be seropositive as defined by a documented history of rheumatoid factor (RF) or anti-cyclic citrullinated peptide (anti-CCP) positivity
Must be receiving a stable route and dose of methotrexate (up to 25 mg weekly)

Criterios de exclusión

Any significant health problem other than rheumatoid arthritis
Any clinically significant laboratory abnormalities
Any prior use of B cell-depleting therapy

Intervenciones

drug

SBI-087

200 mg SC Day 1, 200 mg SC Day 15, Placebo Day 84 + Methotrexate

drug

SBI-087

200 mg SC Day 1, Placebo Day 15, 200 mg SC Day 84 + Methotrexate

drug

SBI-087

200 mg SC Day 1, 200 mg SC Day 15, 200 mg SC Day 84 + Methotrexate

drug

Placebo

Placebo Day 1, Placebo Day 15, Placebo Day 84 + Methotrexate

drug

SBI-087

200 mg SC Day 1, Placebo Day 15, Placebo Day 84 + Methotrexate

Ubicaciones

Pfizer Investigational Site

Buenos Aires, C.a.b.a., Argentina

Pfizer Investigational Site

C.a.b.a, Argentina

Pfizer Investigational Site

C.a.b.a, Argentina

Patrocinadores

PrincipalPfizer

ColaboradorEmergent Product Development Seattle LLC

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