Phase 3 Randomized, Double-blind Study Of The Efficacy And Safety Of 2 Doses Of Cp-690,550 Compared To Methotrexate In Methotrexate Navie Patients With Rheumatoid Arthritis

CompletadoFase 3ClinicalTrials.gov

ID: NCT01039688Tipo: INTERVENTIONALInicio: 1 de ene de 2010Fin estimado: 1 de mar de 2013

Traducción no disponible, mostrando original

Resumen

This study is designed to compare the effectiveness of the experimental drug, CP-690,550, to methotrexate in preventing joint damage and improving symptoms of rheumatoid arthritis. This study will also compare the safety of CP-690,550 with methotrexate.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 99 YearsSexo: ALL

Criterios de inclusión

Adults with moderate to severe RA (Rheumatoid Arthritis) who have not been treated with methotrexate.
Diagnosis of RA based on the American College of Rheumatology 1987 revised criteria.
Active disease as defined by both \>=6 tender or painful joints on motion and \>= 6 joints swollen; and either an erythrocyte sedimentation rate (ESR) \> 28 mm or a C-reactive protein (CRP) concentration \> 7 mg/dL

Criterios de exclusión

Blood dyscrasias including confirmed: Hemoglobin \<9 g/dL or Hematocrit \<30%; White blood cell count \<3.0 x 109/L; Absolute neutrophil count \<1.2 x 109/L; Platelet count \<100 x 109/L
History of any other rheumatic autoimmune disease other than Sjogren's syndrome
No malignancy or history of malignancy
History of infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator, within the 6 months prior to the first dose of study drug
No chronic liver disease, recent or active hepatitis or other contraindication to methotrexate therapy

Intervenciones

drug

CP-690,550

Oral tablets administered at a dose of 5 mg BID for 24 months

drug

CP-690,550

Oral tablets administered at a dose of 10 mg BID for 24 months

drug

Disease-modifying antirheumatic drug

Oral capsules,administered as 10 mg per week for 4 weeks titrated to 15 mg per week for 4 weeks, then titrated to 20 mg week for 24 months

Ubicaciones

OMI - Organización Médica de Investigación

Buenos Aires, Argentina

Saint Dennis Medical Group S.A.

Buenos Aires, Argentina

Consultorios Reumatológicos Pampa

Buenos Aires, Argentina

Patrocinadores

PrincipalPfizer

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