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

Phase 2

Completed

• Conditions: Psoriasis
• Interventions: Drug: adalimumab

• Registration Number: NCT00646191
• Lead Sponsor: Abbott

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-03
• Primary Completion: 2004-06
• Status Verified: 2008-03
• Study First Submitted: 2008-03-26
• Study First Submitted QC: 2008-03-26
• Last Update Submitted: 2008-03-26
• Study First Posted: 2008-03-28
• Last Update Posted: 2008-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 137

Inclusion Criteria

• Subject completed prior PS study

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	adalimumab	-
B	adalimumab	-
C	adalimumab	-

Primary Outcome Measures

Name	Time	Method
Psoriasis Area and Severity Index	Week 12
Adverse Events	Throughout Study Participation

Secondary Outcome Measures

Name	Time	Method
Psoriasis Area and Severity Index	Week 0, 4, 8, 12, 16, 20, 24, 32, 40 and 48
DLQI, SF-36, Zung Depression Self-Rating Scale, EQ-5D, VAS	Week 12, 24 and 48
Physician's Global Assessment	Week 12, 16, 20, 24, 32, 40 and 48