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

Abbott

Status and phase: Completed; Phase 2

Conditions: Psoriasis

Treatments: Drug: adalimumab; Drug: placebo for adalimumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00645814

M02-528

Details and patient eligibility

About

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

Enrollment: 148 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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148 participants in 3 patient groups, including a placebo group

A

Placebo Comparator group

Treatment:

Drug: placebo for adalimumab

B

Active Comparator group

Treatment:

Drug: adalimumab

Drug: adalimumab

C

Active Comparator group

Treatment:

Drug: adalimumab

Drug: adalimumab