Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously, -- AND who developed adverse events (AEs) corresponding to pre-specified newly diagnosed autoimmune disorders OR who developed severe thrombocytopenia. MedDRA version: 9.1 Level: LLT Classification code 10
Conditions
Sponsors
Merck Serono International S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1) Subject participating to Study 25878 currently treated or having been treated with efalizumab, with the last dose received within 6 weeks before inclusion in this trial. 2) Subject developing during the study 25878 either - A newly diagnosed autoimmune disease (suspected or confirmed) such as systemic lupus erythematosus, Wegener’s granulomatosis, antiphospholipid syndrome, Sjögren syndrome, rheumatoid arthritis, multiple sclerosis, diabetes type I, autoimmune uveoretinitis, autoimmune gut disorders such as Crohn disease or ulcerative colitis, autoimmune vasculitis, autoimmune hepatitis, autoimmune thyroiditis and other endocrine disorders, autoimmune haemolytic anaemia, pernicious anaemia, myasthenia gravis, Goodpasture’s syndrome, and Guillain-Barré syndrome, or - A severe thrombocytopenia defined as grade III or IV according to NCICTCAE criteria – i.e. platelet count =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Participation to any interventional clinical study (inclusion in other registry/ observational study is possible) 2) Administration of specific treatment for the current thrombocytopenia before inclusion in the study (e.g. glucocorticosteroids, plasmapheresis, platelet transfusion)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1) To assess the prevalence of anti-efalizumab positivity in two sub-populations of psoriatic subjects treated with Raptiva® in the framework of the CLEAREST study: - Subjects developing adverse events (AEs) corresponding to pre-specified newly diagnosed autoimmune disorders including (but not limited to) systemic lupus erythematosus, Wegener’s granulomatosis, antiphospholipid syndrome, Sjögren syndrome, rheumatoid arthritis, multiple sclerosis, Type I diabetes, auto-immune uveoretinitis, auto-immune gut disorders such as Crohn disease or ulcerative colitis, auto-immune vasculitis, auto-immune hepatitis, auto-immune thyroiditis and other endocrine disorders, auto-immune haemolytic anaemia, pernicious anaemia, myasthenia gravis, Goodpasture’s syndrome, Guillain-Barré syndrome. - Subjects developing severe thrombocytopenia (grade III or IV according to National Cancer Institute – Common Toxicity Criteria for Adverse Events – i.e. platelet count <50,000/mm3) ;Secondary Objective: - To investigate thrombocytopenia mechanism of action in subjects who develop severe thrombocytopenia (defined as platelet count <50,000/mm3) in the context of previous Raptiva® treatment in the framework of the CLEAREST study. For this secondary objective, a control group of psoriasis subjects without severe thrombocytopenia will be included. - To identify genetic profiles associated with drug-induced thrombocytopenia and autoimmune diseases.;Primary end point(s): Proportion of subjects with binding anti-efalizumab antibodies among subjects with newly diagnosed autoimmune disorders and proportion of subjects with binding antiefalizumab antibodies among subjects who develop severe thrombocytopenia. | — |
Countries
Austria, France, Germany, Netherlands, Portugal
Outcome results
None listed