Este estudio tiene como objetivo evaluar la eficacia y seguridad de certolizumab pegol (CZP) en combinación con metotrexato (MTX) para inducir y mantener la respuesta clínica en el tratamiento de adultos DMARD-naïve (vírgenes de fármacos antirreumáticos modificadores de la enfermedad) con artritis reumatoide activa temprana.
Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml. Injections will be given subcutaneously. CZP 400 mg at Baseline, Week 2 and Week 4, followed by a maintenance dose of 200 mg every 2 Weeks until Week 50.
2 syringes Placebo at Baseline, Week 2 and Week 4, followed by 1 syringe Placebo every 2 Weeks.
The MTX treatment is to be initiated at a dose of 10 mg per Week (oral tablets at the strength of 2.5 mg/tablet). The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8. Patients who could not tolerate ≥ 15 mg/week MTX by Week 8 were withdrawn while the maximum tolerated dose per patient (optimized dose) was maintained to Week 52.
Buenos Aires, Argentina
Rosario, Argentina
San Juan, Argentina
San Miguel de Tucumán, Argentina