Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of th...

Mise à jour : Il y a 4 ans
Référence : EUCTR2007-001377-28

Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™)

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Extrait

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)


Critère d'inclusion

  • 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