(OSKIRA-1): A Phase III, Multi-centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate

CompletadoFase 3ClinicalTrials.gov

ID: NCT01197521Tipo: INTERVENTIONALInicio: 1 de sept de 2010Fin estimado: 1 de nov de 2012

Traducción no disponible, mostrando original

Resumen

The purpose of the study is to evaluate the effectiveness of two dosing regimens of fostamatinib compared to placebo, in patients with rheumatoid arthritis (RA) who are taking methotrexate but not responding. The study will last for 1 year.

Descripción detallada

Sub-study: Full title: Optional Genetic Research Date: 18 June 2010 Version: 1 Objectives: To collect and store, with appropriate consent ,DNA samples for future exploratory research into genes/genetic variation that may influence response (ie, absorption, distribution, metabolism and excretion, safety, tolerability and efficacy) to fostamatinib disodium and/or methotrexate; and/or susceptibility to, progression of and prognosis of RA

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Active rheumatoid arthritis (RA) diagnosed after the age of 16
Currently taking methotrexate
or more swollen joints and 6 or more tender/painful joints (from 28 joint count) and either Erythrocyte Sedimentation Rate (ESR) blood result of 28mm/h or more, or C-Reactive Protein (CRP) blood result of 10mg/L or more
At least one of the following: documented history of positive rheumatoid factor (blood test), current presence of rheumatoid factor (blood test), radiographic erosion within 12 months prior to study enrolment, presence of serum anti-cyclic citrullinated peptide antibodies (blood test)

Criterios de exclusión

Females who are pregnant or breast feeding
Poorly controlled hypertension
Liver disease or significant liver function test abnormalities
Certain inflammatory conditions (other than rheumatoid arthritis), connective tissue diseases or chronic pain disorders
Recent or significant cardiovascular disease
Significant active or recent infection including tuberculosis
Previous failure to respond to a TNF alpha antagonist, anakinra or previous treatment with other biological agent
Severe renal impairment
Neutropenia

Intervenciones

drug

fostamatinib

fostamatinib 100 mg twice daily

drug

fostamatinib

fostamatinib 100 mg twice daily/150 mg once daily

drug

placebo, fostamatinib

Placebo for 24 weeks followed by fostamatinib 100 mg twice daily

Ubicaciones

Research Site

Reading, Berkshire, Argentina

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, Argentina

Research Site

Quilmes, Argentina

Patrocinadores

PrincipalAstraZeneca

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