A Long-term, Open-label Follow-up Study Of Tofacitinib (Cp-690,550) For Treatment Of Rheumatoid Arthritis

CompletadoFase 3ClinicalTrials.gov

ID: NCT00413699Tipo: INTERVENTIONALInicio: 5 de feb de 2007Fin estimado: 26 de oct de 2017

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to determine the long-term effectiveness and safety of CP-690,550 for the treatment of rheumatoid arthritis. Subjects are eligible for this study only after participating in another "qualifying" study of CP-690,550 A sub-study will be conducted within the A3921024 study, this study will evaluate the immune response to pneumococcal and influenza vaccines in patients receiving CP-690,550

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Subjects who have participated in a randomized "qualifying" study of CP-690,550 for the treatment of rheumatoid arthritis
Vaccine sub-study visit
Subjects actively participating in Study A3921024 must have completed at least 3 months of continuous 10 mg BID CP-690,550 treatment in A3921024 as defined by \>80% compliance with prescribed dose consumption of CP-690,550 over the previous 3 months.

Criterios de exclusión

Serious medical conditions that would make treatment with CP-690,550 potentially unsafe
Vaccine sub-study visit
Any documented influenza or pneumococcal infection within the last 3 months prior to randomization in this study
Received any vaccine within 1 month prior to randomization in this study
Received an influenza vaccine within 6 months or a pneumococcal vaccine within 5 years of randomization in this study.

Intervenciones

drug

CP-690,550

5 mg PO BID open label; may increase to 10 mg PO BID to provide greater control of RA if no related AEs are present. May be off study drug temporarily for up to 28 days for mild to moderate AEs.

drug

CP-690,550

10 mg PO BID open label; may decrease to 5 mg PO BID for mild to moderate AEs. May be off study drug temporarily for up to 28 days for mild to moderate AEs.

Ubicaciones

OMI- Organizacion Medica de Investigacion

Buenos Aires, Buenos Aires F.D., Argentina

Centro de Investigaciones Reumatologicas y Osteologicas -CIRO

Buenos Aires, Buenos Aires F.D., Argentina

Hospital Sirio Libanes

Buenos Aires, Argentina

OMI - Organización Médica de Investigación

Buenos Aires, Argentina

Saint Dennis Medical Group S.A.

Buenos Aires, Argentina

Hospital Sirio Libanes

Buenos Aires, Argentina

Consultorios Reumatologicos Pampa

Buenos Aires, Argentina

Patrocinadores

PrincipalPfizer

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