Efalizumab for Treatment of Patients With Moderate to Severe Psoriasis
NCT00442650 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL
Last updated 2016-11-21
Summary
Multicentre, open label, phase III study. Subjects with moderate to severe psoriasis were given efalizumab subcutaneously once per week for the 12-week treatment period. Assessments involved physical examination, disease activity assessments, clinical laboratory tests (haematology, blood chemistry and standard urinalysis), evaluation of the Psoriasis Area and Severity Index (PASI), the Physician's Global Assessment (PGA), the Patient's Global Psoriasis Assessment (PGPA), the SF-36 Health Survey and psoriatic body surface area (BSA). The 12-week treatment period was followed by a 12-week follow-up (FU) period, during which other antipsoriatic medications were allowed. The same assessments were also performed in the 12-week FU period.
Conditions
- Moderate to Severe Psoriasis
Interventions
- DRUG
-
Efalizumab
Sponsors & Collaborators
-
Merck KGaA, Darmstadt, Germany
lead INDUSTRY
Principal Investigators
-
Daiana Licu, MD · Merck Serono International SA
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-01-31
- Primary Completion
- 2005-12-31
- Completion
- 2005-12-31
Countries
- Switzerland
Study Locations
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