A Randomized, Parallel Group, Double-Blind, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of BMS-582949 Given Orally to Subjects With Rheumatoid Arthritis Having an Inadequate Response to Methotrexate

CompletadoFase 2ClinicalTrials.gov

ID: NCT00605735Tipo: INTERVENTIONALInicio: 1 de mar de 2008Fin estimado: 1 de sept de 2009

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to find out if 300 mg of BMS-582949 given once daily will be more effective than placebo after 12 weeks of treatment in subjects with rheumatoid arthritis who are also taking methotrexate

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Must have a diagnosis of RA for at least 6 months
Must be taking methotrexate for at least 3 months \& on a stable dose of 7.5-30 mg weekly) for 4 weeks before dosing with study medication
Must have at least 6 swollen and at least 8 tender joints
CRP above upper limit of normal or ESR \> 28 mm/hr
Must wash-out (stop taking) other immunosuppressant medications to treat RA (except for methotrexate) before dosing with study medication

Criterios de exclusión

Any infection including TB, HIV, Hepatitis B or C
Recent infection requiring antibiotics within 4 weeks
History of gastrointestinal disease (such as GERD, gastrointestinal ulcers, heartburn) requiring medical or surgical treatment within 3 months
Chronic use of proton pump inhibitors (such as Losec, Prilosec, Prevacid, Nexium), H2 blockers (such as Tagamet, Pepcid, Zantac, Axid) or antacids (such as Mylanta, Maalox)

Intervenciones

drug

BMS-582949

Tablets, Oral, 300 mg, once daily, 12 weeks

drug

Placebo

Tablets, Oral, placebo, once daily, 12 weeks

Ubicaciones

Local Institution

Buenos Aires, Buenos Aires, Argentina

Local Institution

Capital Federal, Buenos Aires, Argentina

Local Institution

Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

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