Study of Two Dosing Schedules of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis
- Registration Number
- NCT00645905
- Lead Sponsor
- Abbott
- Brief Summary
Study of Two Dosing Schedules 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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A adalimumab - B placebo for adalimumab -
- Primary Outcome Measures
Name Time Method Psoriasis Area and Severity Index Week 12-Week 24 Adverse Events Throughout Study Participation
- Secondary Outcome Measures
Name Time Method Psoriasis Area and Severity Index Week 12, Week 24 through 360 days after last dose Physician's Global Assessment Week 12, Week 24 through 360 days after last dose