A phase IV open label study in moderate to severe chronic plaque psoriasis subjects transitioning from previous systemic antipsoriasis therapies (methotrexate, cyclosporine, retinoids or PUVA, NBUVB) to Raptiva 1 mg/kg/ week therapy.
Phase 4
Completed
- Conditions
- not found1000381610014982
- Registration Number
- NL-OMON31969
- Lead Sponsor
- Merck
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 120
Inclusion Criteria
Mature subjects with moderate to severe chronic plaque-type psoriasis who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including cyclosporine, methotrexate and PUVA and meet all eligibility criteria will be eligible for the study.
Subjects must be willing and able to comply with the study requirements and give their written, informed consent.
Exclusion Criteria
Subjects who have a contraindication to Raptiva, are participating in another clinical trial (except non-interventional studies, e.g. registries) or are experiencing an acute exacerbation of psoriasis at the time of screening will be excluded.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is safety, and will include all AEs, SAEs, and laboratory<br /><br>data (haematology and biochemistry) and urinalysis at all time points, divided<br /><br>by tapering and previous treatment. </p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary endpoint will be the efficacy of Raptiva after 12 weeks therapy,<br /><br>measured as the proportion of subjects who achieve an sPGA assessment of<br /><br>minimal or clear at Week 12 (Day 85).<br /><br>Tertiary endpoints will be the proportion of subjects with >=50% improvement of<br /><br>PASI score and the proportion of subjects with >=75% improvement of PASI score<br /><br>at Week 12 (Day 85) relative to Baseline and the median improvement of DLQI<br /><br>scores at Week 12 (Day 85) relative to Baseline. </p><br>