CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 81 enrolled
Drug / intervention
Placebo +1 morebiological
Likely dose
Placebo 0.8 mlfrom 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/NCT00735787
NCT00735787Phase 4Completed
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Controlled Study of Humira in Subjects With Chronic Plaque Psoriasis of the Hands and/or Feet

Abbott·interventional·Posted Aug 15, 2008·Updated Nov 1, 2010

In Brief

A Phase 4 clinical trial evaluating Placebo and Adalimumab for Psoriasis. Completed, enrolled 81 participants across 17 sites in 2 countries.

Detailed Summary

Evaluate the efficacy and safety of a 16-week course of Humira (adalimumab) compared to placebo in adults with chronic plaque psoriasis of the hands and/or feet and the sustainability of response for 12 additional weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPsoriasis
CountriesCanada, United States
Collaborators--

Timeline

Phase 4CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 15, 2008
Enrollment StartAug 1, 2008
Primary CompletionSep 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 17.9 years ago

Interventions

Placebobiological

Loading dose of 2 placebo subcutaneous (SC) injections (0.8 ml) at Week 0 followed by 1 injection SC eow from Week 1 to Week 15.In second period of study, subjects who continued in the study received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.

Adalimumabbiological

Loading dose of 80 mg adalimumab SC (two 40 mg injections) followed by 40 mg adalimumab SC eow.