At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 115 enrolled
Drug / intervention
Infliximab + methotrexate (IFX + MTX) +1 moredrug
Likely dose
Infliximab + methotrexate (IFX + MTX) 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 Randomized, Multicenter, International, Open-label Study of Infliximab Plus Methotrexate Versus Methotrexate (MTX) Alone for the Treatment of MTX naïve Subjects With Active Psoriatic Arthritis
In Brief
A Phase 3 clinical trial evaluating Infliximab + methotrexate (IFX + MTX) and Methotrexate (MTX) for Arthritis, Psoriatic. Completed, enrolled 115 participants.
Detailed Summary
This study is undertaken to compare the efficacy and onset of action of infliximab plus methotrexate (IFX + MTX) versus methotrexate alone (MTX) in methotrexate naïve active psoriatic arthritis patients.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsArthritis, Psoriatic
Countries--
CollaboratorsIntegrated Therapeutics Group
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2006
First PostedAug 2006
Primary CompletionMar 2008
TodayJul 2026
First PostedAug 22, 2006
Enrollment StartMay 1, 2006
Primary CompletionMar 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 19.9 years ago
Interventions
Infliximab + methotrexate (IFX + MTX)drug
Infliximab 5 mg/kg infusion at Weeks 0, 2, 6, 14 and oral methotrexate 15 mg/week for 16 weeks. Methotrexate dose can be increased to 20 mg/week at week 6.
Methotrexate (MTX)drug
Oral methotrexate 15 mg/week for 15 weeks. Dose can be increased to 20 mg/week at Week 6.