Efficacy and Safety of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Conditions

Psoriasis

Keywords

Psoriasis, adalimumab

Brief summary

A Phase III, Multicenter Study of the Efficacy and Safety of Adalimumab Treatment in Subjects with Moderate to Severe Chronic Plaque Psoriasis

Armstrong AW, Villanueva Quintero DG, Echeverría CM, Gu Y, Karunaratne M, Reyes Servín O.

2016-12-0128 citations

10.1007/s40257-016-0229-x

Adalimumab Efficacy in Patients with Psoriasis Who Received or Did Not Respond to Prior Systemic Therapy: A Pooled Post Hoc Analysis of Results from Three Double-Blind, Placebo-Controlled Clinical Trials.

Papp KA, Armstrong AW, Reich K, Karunaratne M, Valdecantos W.

2016-02-0120 citations

10.1007/s40257-015-0161-5

Adalimumab improves health-related quality of life in patients with moderate to severe plaque psoriasis compared with the United States general population norms: results from a randomized, controlled Phase III study.

Revicki DA, Menter A, Feldman S, Kimel M, Harnam N, Willian MK.

2008-10-0241 citations

10.1186/1477-7525-6-75

Adalimumab therapy for moderate to severe psoriasis: A randomized, controlled phase III trial.

Menter A, Tyring SK, Gordon K, Kimball AB, Leonardi CL, Langley RG, Strober BE, Kaul M, Gu Y, Okun M, Papp K.

2007-10-23596 citations

10.1016/j.jaad.2007.09.010

Interventions

DRUGadalimumab

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame
Proportion of subjects achieving clinical response at Week 16 relative to the Baseline (Week 0) PASI score	Week 16

Secondary

Measure	Time frame
Safety parameters	—

Outcome results

None listed