At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 23 enrolled
Drug / intervention
Infliximabbiological
Likely dose
Infliximab 5 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi Center, Open Label, Single-Arm Study to Evaluate the Efficacy of Infliximab Induction Therapy for Patients With Palmoplantar Psoriasis (PPP), Including the Pustular Form (PsPPP)
In Brief
A Phase 3 clinical trial evaluating Infliximab for Psoriasis. Completed, enrolled 23 participants.
Detailed Summary
Subjects with psoriasis will receive intravenous infliximab 5 mg/kg given over a 2-hour period at Weeks 0, 2, and 6 (induction therapy) to evaluate the efficacy of infliximab at Week 18. Subjects who achieved \>=75% improvement in Psoriasis Pustulosa Palmoplantaris Area and Severity Index (PPPASI) score at Week 8 AND had deterioration of PPPASI score of 50% from Week 8 until Week 12 were to receive an additional infusion at Week 12.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPsoriasis
Countries--
CollaboratorsCentocor, Inc.
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 2007
First PostedMay 2008
Primary CompletionFeb 2009
Study CompletionApr 2009
TodayJul 2026
First PostedMay 30, 2008
Enrollment StartDec 1, 2007
Primary CompletionFeb 1, 2009
Study CompletionApr 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 18.1 years ago
Interventions
Infliximabbiological
Intravenous infliximab 5 mg/kg given over a 2-hour period at Weeks 0, 2, and 6 and possibly at week 12.