(OSKIRA-X): A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium in the Treatment of Rheumatoid Arthritis

TerminadoFase 3ClinicalTrials.gov

ID: NCT01242514Tipo: INTERVENTIONALInicio: 1 de ene de 2011Fin estimado: 1 de ene de 2015

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to evaluate the long term safety and tolerability of fostamatinib in patients with rheumatoid arthritis (RA).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Patients who have successfully completed a qualifying study (D4300C00001, D4300C00002, D4300C00003 or D4300C00004) with fostamatinib
Patients who have participated in a qualifying study and who have been classified as non-responders due to pre-defined lack of efficacy at Week 12 (D4300C00001, D4300C00002, D4300C00003).

Criterios de exclusión

Premature withdrawal from the qualifying study (D4300C00001, D4300C00002, D4300C00003 and D4300C00004)
Females who are pregnant or breast feeding
Poorly controlled hypertension
Significant liver function test abnormalities or physical symptoms of hepatotoxicity
Significant infection
Gastrointestinal intolerance
Cancer

Intervenciones

drug

Fostamatinib

Fostamatinib 100mg twice daily

drug

Fostamatinib

Fostamatinib 150mg once daily

drug

Fostamatinib

Fostamatinib 100mg once daily

Ubicaciones

Research Site

Buenos Aires, Buenos Aires F.D., Argentina

Research Site

Ciudad Autonoma Bs As, CBA, Argentina

Research Site

Córdoba, CRD, Argentina

Research Site

San Juan, San Juan Province, Argentina

Research Site

Rosario, Santa Fe Province, Argentina

Research Site

San Miguel de Tucumán, TUC, Argentina

Research Site

Caba Buenos Aires, Argentina

Research Site

Ciudad Autonoma Bs As, Argentina

Research Site

Ciudad de Buenos Aires, Argentina

Research Site

Quilmes, Argentina

Patrocinadores

PrincipalAstraZeneca

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