Phase 2, Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety/Pharmacokinetics of BMS-986142 in Subjects With Moderate to Severe Rheumatoid Arthritis With an Inadequate Response to Methotrexate With or Without TNF Inhibitors

CompletadoFase 2ClinicalTrials.gov

ID: NCT02638948Tipo: INTERVENTIONALInicio: 16 de feb de 2016Fin estimado: 3 de may de 2018

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to determine whether the study drug, BMS-986142, is safe and effective in treating moderate to severe rheumatoid arthritis in subjects with an inadequate response to methotrexate or methotrexate and up to 2 tumour necrosis factor (TNF) Inhibitors. Patients who qualify will be randomized to either one of 3 doses of BMS-986142 or placebo in 1:1:1 randomization for 12 weeks. Disease activity and safety will be assessed over the course of the study.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 120 YearsSexo: ALL

Criterios de inclusión

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Male and female age 18 and above
Diagnosed with active rheumatoid arthritis (RA) by standard criteria at least 16 weeks before screening, have functional ACR class I-III
Have an inadequate response to methotrexate
In addition to an inadequate response to methotrexate have an inadequate response or intolerance to 1 but not more than 2 TNF inhibitors
Have a minimum of 6 swollen and 6 tender joints (from 66/68 joint count)
Have hsCRP of ≥ 0.8 mg/dL (8mg/L) \[by central laboratory values\] or an ESR ≥ 28 mm/hr
Willing to use effective birth control for the entire length of the study

Criterios de exclusión

Diagnosed with juvenile Rheumatoid Arthritis
Have been treated with other biologic treatment than a TNF inhibitor
Active systemic bacterial, viral or fungal infection or evidence of prior or current Hepatitis B or C infection or HIV infection, latent bacterial, viral or fungal infections
Have been treated with Intramuscular or Intra-articular glucocorticosteroids within 4 weeks of randomization
Taking Oral steroids at dose above 10 mg/day of prednisone (or prednisone equivalents)
Have other autoimmune disease other than RA like lupus, multiple sclerosis
Have significant concurrent medical condition at the time of screening or baseline visit

Intervenciones

drug

BMS-986142

BMS986142 specific dose on specific days

drug

Placebo

Placebo of BMS-986142 specific dose on specific days

drug

Methotrexate

Methotrexate specific dose on specific days

Ubicaciones

Local Institution

Capital Federal, Buenos Aires, Argentina

Aprillus Asistencia e Investigacion

Capital Federal, Buenos Aires, Argentina

Instituto De Rehabilitacion Psicofisica

Buenos Aires, Argentina

Instituto Reumatologico Strusberg

Córdoba, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

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