A Randomized, Placebo-controlled Double-blind, Multicenter, Phase 2 Dose Ranging Study To Assess The Efficacy And Safety of CNTO 6785 In Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy

CompletadoFase 2ClinicalTrials.gov

ID: NCT01909427Tipo: INTERVENTIONALInicio: 1 de jun de 2013Fin estimado: 1 de may de 2015

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to assess the efficacy and safety of CNTO6785 in participants with active rheumatoid arthritis (RA) despite methotrexate (MTX) therapy.

Descripción detallada

This is a randomized (participants are assigned to treatment by chance), double-blind (participants and study personnel will not know which treatments are being given), placebo-controlled (a placebo appears identical to a study drug but has no active ingredients), multicenter study. The study will consist of 3 phases: a screening phase, a treatment phase, and a follow-up phase. Approximately 250 participants with active RA despite MTX therapy will be randomly assigned to receive placebo or CNTO 6785 during the double-blind treatment phase. The maximum period of active treatment will be 28 weeks. The maximum duration of study participation will be 44 weeks. Participant safety will be monitored throughout the study.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 80 YearsSexo: ALL

Criterios de inclusión

Have a diagnosis of rheumatoid arthritis (RA) (according to the revised 1987 criteria of the American Rheumatism Association) and have had RA for at least 6 months prior to the date of signing the informed consent at screening
Have active RA defined study as persistent disease activity with both of the following criteria: at least 6 swollen and 6 tender joints using a 66/68 joint count at the time of screening and at baseline; and serum C-reactive protein (CRP) ≥ 0.8 mg/dL at screening or erythrocyte sedimentation rate (ESR) ≥ 28 mm in the first hour at screening or baseline
Have been treated with and tolerated methotrexate (MTX) treatment at dosages from 7.5 to 25 mg/week, inclusive, for a minimum of 6 months prior to screening and must have a stable MTX dose for a minimum of 6 weeks prior to the first dosing with study agent

Criterios de exclusión

Has inflammatory diseases other than RA, that might confound the evaluation of the benefit of study agent therapy
Has a diagnosis of fibromyalgia
Has a recent history (within 12 months prior to screening) of uncontrolled, chronic disease including, but not limited to, pulmonary, psychiatric, and metabolic disturbances, cardiovascular, endocrine, neurological, hepatic, gastrointestinal, renal, hematological, or urological diseases that the investigator believes are clinically significant
At screening, the results of laboratory tests must meet protocol-specified criteria
Has ever received any approved or investigational biologic agent for a rheumatic indication

Intervenciones

drug

Placebo

Placebo subcutaneous injections (SC) every 4 weeks through Week 12

drug

CNTO 6785 200 mg

CNTO 6785 200 mg SC every 4 weeks from Week 16 through Week 28

drug

CNTO 6785 200 mg

CNTO 6785 200 mg SC every 4 weeks through Week 28

drug

CNTO 6785 100 mg

CNTO 6785 100 mg SC every 4 weeks through Week 28

drug

CNTO 6785 50 mg

CNTO 6785 50 mg SC every 4 weeks through Week 28

drug

CNTO 6785 15 mg

CNTO 6785 15 mg SC every 4 weeks through Week 28

drug

Methotrexate (MTX)

MTX at the same stable dose through Week 32, that participants were receiving prior to screening.

Ubicaciones

Buenos Aires, Argentina

Ciudad Autonoma Buenos Aires, Argentina

Córdoba, Argentina

La Capital, Argentina

San Juan, Argentina

Patrocinadores

PrincipalJanssen Research & Development, LLC

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

A Randomized, Placebo-controlled Double-blind, Multicente... | EligiMed