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

Conditions

Psoriasis

Brief summary

Study of the Safety and Efficacy of Adalimumab in Subjects with Moderate to Severe Chronic Plaque Psoriasis

Caitriona Ryan, Jeffrey M. Sobell, Craig L. Leonardi, Charles Lynde, M. Karunaratne et al. (7 authors)

American Journal of Clinical Dermatology2018-01-2732 citations

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

Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGplacebo for adalimumab

80 mg at Week 0 and 40 mg eow through Week 11

DRUGadalimumab

80 mg at Week 0 and 40 mg eow through Week 11

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* Diagnosis of moderate to severe chronic plaque psoriasis * Active psoriasis, despite topical therapies

Exclusion criteria

* Other active skin diseases or skin infections * Prior exposure to any anti-TNF therapy * Subject has other active skin diseases * Multiple concomitant therapy restrictions and/or washouts (topicals, UV, other systemic PS therapies) * Poorly controlled medical conditions * History of neurologic symptoms suggestive of central nervous system (CNS) demyelinating disease. * History of cancer or lymphoproliferative disease * History of active TB or listeriosis, or persistent chronic or active infections * Known to have immune deficiency or is immunocompromised * Clinically significant abnormal laboratory test results * Erythrodermic psoriasis or generalized pustular psoriasis

Design outcomes

Primary

Measure	Time frame
Psoriasis Area and Severity Index	Week 12
Adverse Events	Throughout Study Participation

Secondary

Measure	Time frame
Psoriasis Area and Severity Index	Week 1, 2, 4, 8, 12
DLQI, SF-36, Zung Depression Self-Rating Scale, EQ-5D	Week 12

Outcome results

None listed