drugset / Trial / NCT00833053

Dose Optimization of Infliximab in Moderate to Severe Plaque Psoriasis (Study P05315)

NCT00833053

Phase 3 Terminated 39 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupOpen-labelTreatment

Summary

Participants from an ongoing observational study (P05319) who have a limited (adequate but less than optimal) response to infliximab will be randomized to either increase the frequency of infliximab infusions from every 8 weeks to every 6 weeks, or to add weekly methotrexate to their current treatment plan. While receiving infliximab study treatment(s), patients in this study will attend regularly scheduled office visits for various clinical tests for safety and effectiveness evaluations.

Timeline

Start
2009-10
Primary completion
2011-04
Completion
2011-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Infliximab Monoclonal antibody 5 mg/kg Intravenous
Subject Methotrexate Small molecule 7.5 mg Oral

Indications