Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis
- Registration Number
- NCT00645814
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 148
Inclusion Criteria
- Diagnosis of moderate to severe chronic plaque psoriasis
- Active psoriasis, despite topical therapies
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A placebo for 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 1, 2, 4, 8, 12 DLQI, SF-36, Zung Depression Self-Rating Scale, EQ-5D Week 12