Moderate to severe chronic plaque psoriasis (PASI = 12) failing to respond to, or with a contraindication to, or intolerant to other systemic therapies including cyclosporine, methotrexate and Psoralen ultraviolet light A (PUVA) MedDRA version: 8.1 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris
Conditions
Interventions
Trade Name: Raptiva
Pharmaceutical Form: Concentrate for solution for injection
Sponsors
Serono GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult patient with moderate to severe chronic plaque psoriasis (PASI = 12) who has failed to respond to, or who has a contraindication to, or is intolerant to other systemic therapies including cyclosporine, methotrexate and Psoralen ultraviolet light A (PUVA) according to SmPC 2. 18 to 75 years old 3. Body weight max. 120 kg 4. Discontinuation of any systemic psoriasis treatment prior to commencement of the study treatment. An appropriate washout period is required for these agents (e.g. for cyclosporin, corticosteroids, methotrexate, retinoids, MMF, thioguanine, hydroxyurea, sirolimus, azathioprine, and 6-MP); and for any systemic immunosuppressive treatment applied for psoriasis. The specific wash out requirements must be followed for each systemic therapy and a wash out period of at least one month prior to receiving the first dose of study drug (SD 0) is required, if not indicated otherwise. Application of PUVA treatment must have been discontinued one month prior to receiving the first dose of study drug (SD 0); biologic agents must not have been applied within three months prior to receiving the first dose of study drug (SD 0) 5. Discontinuation of all high potency topical corticosteroid treatments for psoriasis at least 14 days prior to receiving the first dose of study drug (SD 0) 6. Discontinuation of any investigational drug or treatment prior to commencement of the study treatment. A washout period of two months is required for these agents prior to receiving the first dose of study drug (SD 0) 7. Treatment regimens of ß-blockers, ACE inhibitors, antimalarial drugs, quinidine, interferon, or lithium stable for at least 28 days prior to receiving the first dose of study drug (SD 0) 8. No required vaccination (e.g. tetanus, booster, influenza vaccine) at least 14 days prior to receiving the first dose of study drug (SD 0). 9. Willingness to hold sun exposure reasonably constant and to avoid use of tanning booths or other UV light sources during the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Guttate, erythrodermic or pustular psoriasis as sole or predominant form of psoriasis 2. History of severe allergic or anaphylactic reactions to humanised monoclonal antibodies 3. History of or ongoing uncontrolled bacterial, viral, fungal, or atypical mycobacterial infection 4. History of opportunistic infections (e.g., systemic fungal infections, parasites) 5. History of or ongoing active tuberculosis (TB) or other serious infections 6. History of clinically significant thrombocytopenia, bleeding disorders or a platelet count 14,000/L 20. Hepatic enzymes 3 times the upper limit of normal 21. Serum creatinine 2 times the upper limit of normal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate - whether the decrease in the adhesion of psoriatic neutrophils to Thy-1 is a first sign of a successful treatment before the clinical improvement can be observed, and - whether the failure of a significant decrease in the Thy-1-mediated adhesion during anti-psoriatic therapy is a predictor for patients who will not efficiently respond to the treatment ;Secondary Objective: To show efficacy of Raptiva in patients with moderate to severe plaque psoriasis To collect safety data for Raptiva in patients with moderate to severe plaque psoriasis;Primary end point(s): PASI 75 at week 12 Sensitivity and specificity of inhibition of Thy-1- mediated adhesion of neutrophils as a biomarker to identify PASI 75 responders | — |
Countries
Germany
Outcome results
None listed