CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 114 enrolled
Drug / intervention
Adalimumab +3 morebiological
Likely dose
Methotrexate 0.1 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.

Search/NCT01251614
NCT01251614Phase 3Completed
CompareCT.gov

A Multicenter, Randomized, Double-dummy, Double-blind Study Evaluating Two Doses of Adalimumab Versus Methotrexate (MTX) in Pediatric Subjects With Chronic Plaque Psoriasis (Ps)

AbbVie (prior sponsor, Abbott)·interventional·Posted Dec 2, 2010·Updated Sep 25, 2017

In Brief

A Phase 3 clinical trial evaluating Adalimumab, Methotrexate, and 2 other interventions for Plaque Psoriasis. Completed, enrolled 114 participants.

Detailed Summary

This study will compare how well adalimumab works versus methotrexate (MTX) in children with moderate to severe psoriasis in the short term. It will also study how safe and how well adalimumab works in the long term and how long disease response can be maintained after stopping therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPlaque Psoriasis
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 2, 2010
Enrollment StartDec 1, 2010
Primary CompletionDec 1, 2013
Study CompletionFeb 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 15.6 years ago

Interventions

Adalimumabbiological

Adalimumab by subcutaneous injection every other week (eow)

Methotrexatedrug

Methotrexate 0.1 mg/kg at Week 0 and up to 0.4 mg/kg per week (maximum dose of 25 mg/week) orally.

Placebo to Adalimumabbiological

A single subcutaneous loading dose at Week 0 followed by eow dosing beginning at Week 1.

Placebo to Methotrexatedrug

Orally once a week