CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 217 enrolled
Drug / intervention
infliximabbiological
Likely dose
Infliximab 5 mg/kg intravenous infusions at Weeks 0, 2, 6, 14, and 22AI-extracted
Key inclusion· 4
  • ✓Plaque psoriasis with inadequate response despite at least 4 months of etanercept therapy
  • ✓Psoriatic target lesions with PGA score >1 (minimal) at screening
  • ✓If on methotrexate at screening, must have received it for ≥3 months at stable dose ≤25 mg/week for ≥4 weeks prior to screening
  • ✓If on cyclosporine at screening, must have received it at stable dose ≤5 mg/kg daily for ≥4 weeks prior to screening
Key exclusion· 8
  • ✕Prior treatment with infliximab or adalimumab
  • ✕History of immediate hypersensitivity response (including anaphylaxis) to immunoglobulin products
  • ✕History of latent or active granulomatous infection, including tuberculosis, histoplasmosis, or coccidioidomycosis
  • ✕Concomitant diagnosis or any history of congestive heart failure

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00527072
NCT00527072Phase 3Completed
CompareCT.gov

A Multicenter, Open-label Study to Assess the Efficacy and Safety of Infliximab (REMICADE�) Therapy in Patients With Plaque Psoriasis Who Had an Inadequate Response to Etanercept (ENBREL�)

Centocor Ortho Biotech Services, L.L.C.·interventional·Posted Sep 10, 2007·Updated Sep 3, 2012

In Brief

A Phase 3 clinical trial evaluating infliximab for Psoriasis. Completed, enrolled 217 participants.

Detailed Summary

The purpose of this study is to test the safety and effectiveness of infliximab in patients with plaque psoriasis who have been receiving the drug etanercept for treatment of their plaque psoriasis for at least four months, without enough improvement in their psoriasis symptoms.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPsoriasis
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 10, 2007
Enrollment StartJul 1, 2007
Primary CompletionMay 1, 2009
Study CompletionOct 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 18.8 years ago

Interventions

infliximabbiological

Open-label 5 mg/kg infliximab infusions at Weeks 0, 2, 6, 14, and 22.