A 12-WEEK, PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED STUDY TO INVESTIGATE THE SAFETY, PHARMACOKINETICS, AND EFFICACY OF PH-797804, ADMINISTERED ORALLY ONCE DAILY IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS

Femme et Homme

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Extrait

The primary objective of this study is to evaluate the safety and tolerability of PH-797804 monotherapy in subjects with active RA on their current treatment regimen and having failed in the past at least 1 DMARD regimen. This will be accomplished in a 2-stage design, with an initial Safety/PK evaluation stage (Stage 1) in the first 50 treated subjects. A successful Stage 1 will launch the second stage (Stage 2) to complete the full enrollment of the study to evaluate the overall safety and tolerability of QD, oral PH-797804 versus placebo in all subjects through 12 weeks of treatment.

Critère d'inclusion

Treatment of rheumatoid arthritis (RA)

Liens

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Kusajili – Centralise les essais cliniques mondiaux

A 12-WEEK, PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED STUDY TO INVESTIGATE THE SAFETY, PHARMACOKINETICS, AND EFFICACY OF PH-797804, ADMINISTERED ORALLY ONCE DAILY IN SUBJECTS WITH ACTIVE RH...