NCT Number: NCT00237887
Efficacy and Safety of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis
A Phase III, Multicenter Study of the Efficacy and Safety of Adalimumab Treatment in Subjects with Moderate to Severe Chronic Plaque Psoriasis
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Subject was age 18 or older and in good health (Investigator discretion) with a recent stable medical history.
- Subject had a clinical diagnosis of psoriasis for at least 6 months, had moderate to severe plaque psoriasis.
- Subject was able and willing to self-administer sc injections or had available qualified person(s) to administer sc injections
Exclusion criteria
- Subject had previously received anti-TNF therapy.
- Subject cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot avoid UVB or PUVA phototherapy
- Subject cannot avoid excessive sun exposure
- Subject is taking or requires oral or injectable corticosteroids
- Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
- Female subject who is pregnant or breast-feeding or considering becoming pregnant
Treatment and study plan
Primary outcomes
-
Proportion of subjects achieving clinical response at Week 16 relative to the Baseline (Week 0) PASI score
Time frame: Week 16
Secondary outcomes
-
Safety parameters
Sponsors and collaborators
Lead sponsor
Abbott
Industry
Registry information
Official study title
A Phase III, Multicenter Study of the Efficacy and Safety of Adalimumab Treatment in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Important dates
- Study start
- 2004
- First posted
- Oct 13, 2005
- Registry last updated
- Aug 29, 2007
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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