At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 203 enrolled

Drug / intervention

Humira (adalimumab)biological

Likely dose

Humira (adalimumab) 80 mgfrom 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/NCT00513370

NCT00513370Phase 3Completed

Compare CT.gov

A Canadian Open-Label Access Program to Evaluate the Safety and the Effectiveness of Adalimumab When Added to Inadequate Therapy for the Treatment of Psoriasis

Abbott·interventional·Posted Aug 8, 2007·Updated Apr 11, 2011

In Brief

A Phase 3 clinical trial evaluating Humira (adalimumab) for Psoriasis. Completed, enrolled 203 participants across 27 sites.

Detailed Summary

To evaluate the safety profile, the effectiveness and the economic impact of adalimumab when used for the treatment of subjects with active plaque psoriasis who have not adequately responded to prior psoriasis therapy.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsPsoriasis

CountriesCanada

Collaborators--

Timeline

Phase 3CompletedFinished

20082009201020112012201320142015201620172018201920202021202220232024202520262027

First PostedAug 2007

Enrollment StartSep 2007

Primary CompletionSep 2008

TodayJul 2026

First PostedAug 8, 2007

Enrollment StartSep 1, 2007

Primary CompletionSep 1, 2008

TodayJul 2, 2026

Enrollment to primary: 1 yearPosted 18.9 years ago

Interventions

Humira (adalimumab)biological

Study drug will be provided as a sterile, preservative-free solution for subcutaneous injection, contained in a pre-filled syringe housed in a pen device (pre-filled pen). Loading dose of 80 mg of adalimumab subcutaneously (sc) at Baseline, and 40 mg of adalimumab sc at Week 1, followed by 40 mg of adalimumab sc every other week (eow) for 24 weeks.