Extension Study of Two Dosing Schedules of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Phase 2CompletedNCT00645892

Abbott32 enrolled

Overview

Extension Study of Two Dosing Schedules of Adalimumab in Subjects with Moderate to Severe Chronic Plaque Psoriasis

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Psoriasis

Interventions

adalimumabDRUG

OL 80 mg at Weeks 0 and 1, 40 mg weekly Week 2 - Week 11, blinded 40 mg eow through Week 24

placebo for adalimumabDRUG

OL 80 mg at Weeks 0 and 1, 40 mg weekly Week 2 - Week 11, blinded placebo eow through Week 24

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subject participated and relapsed in prior PS study Exclusion Criteria: * 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

Outcomes

Primary Outcomes

Psoriasis Area and Severity Index

Time frame: Week 12

Adverse Events

Time frame: Throughout Study Participation

Secondary Outcomes

Psoriasis Area and Severity Index

Time frame: Week 12, Week 24

Physician's Global Assessment

Time frame: Week 12, Week 24

Data from ClinicalTrials.gov

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