A PHASE 3, MULTI SITE, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, PARALLEL GROUP STUDY OF THE EFFICACY AND SAFETY OF 2 ORAL DOSES OF CP-690,550 AND 1 SUBCUTANEOUS DOSE OF ETANERCEPT IN SUBJECTS WIT...

Mise à jour : Il y a 5 ans
Référence : EUCTR2010-020004-30

A PHASE 3, MULTI SITE, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, PARALLEL GROUP STUDY OF THE EFFICACY AND SAFETY OF 2 ORAL DOSES OF CP-690,550 AND 1 SUBCUTANEOUS DOSE OF ETANERCEPT IN SUBJECTS WITH MODERATE TO SEVERE CHRONIC PLAQUE PSORIASIS

Femme et Homme

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Extrait

• To compare the efficacy of CP-690,550 (5 mg BID and 10 mg BID) versus etanercept (50 mg BIW) and placebo for the reduction in severity of plaque psoriasis after 12 weeks of treatment in subjects with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy; • Efficacy as measured by the Psoriasis Area and Severity Index 75 (PASI75) response, ie, the proportion of subjects achieving at least a 75% reduction in PASI relative to baseline; • Efficacy as measured by the Physician’s Global Assessment (PGA) response, ie, the proportion of subjects achieving a PGA of “clear” or “almost clear”; • To evaluate the safety and tolerability of CP-690,550 (5 mg BID and 10 mg BID) over 12 weeks of treatment in subjects with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.


Critère d'inclusion

  • Moderate To Severe Chronic Plaque Psoriasis