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).
- Conditions
- auto-immune diseasesthrombocytopenia1003553410003816
- Registration Number
- NL-OMON32149
- Lead Sponsor
- Serono
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 10
- 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.
- Subject developing during the study 25878 either:
* a newly diagnosed autoimmune disease (suspected or confirmed)
* a severe thrombocytopenia defined as grade III or IV according to NCI-CTCAE cirteria
- subject is willing and able to participate in the trial and has provided signed, informed consent.;For subjects of control group:
- subject is either currently treated with efalizumab or not (i.e. last dose of efalizumab received more than 6 weeks before study entry)
- Participation to any interventional clinical study (inclusion in other registry/observational study is possible).
- Administration of specific treatment for the current thrombocytopenia before inclusion in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Proportion of subjects with binding anti-efalizumab antibodies among subjects<br /><br>with newly diagnosed autoimmune disorders and proportion of subjects with<br /><br>binding anti-efalizumab antibodies among subjects who develop severe<br /><br>thrombocytopenia.</p><br>
- Secondary Outcome Measures
Name Time Method <p>In subjects developing severe thrombocytopenia and in subjects included in the<br /><br>control group:<br /><br>1. Quantification of the expression of CD11a on platelet membrane.<br /><br>2. Evaluation of efalizumab binding with platelet walls (via LFA-1 (CD11a) or<br /><br>other sites).<br /><br>3. Evaluation of platelet-surface-associated IgG (PSAIgG) and IgM<br /><br>4. Detection of drug-dependent platelet-reactive antibodies of the IgG or IgM<br /><br>class.<br /><br><br /><br>Differences in the distribution of specific genetic polymorphisms in clinically<br /><br>defined sub-groups based on drug-induced thrombocytopenia and autoimmune<br /><br>diseases compared to data from subjects treated with Raptiva® generated in<br /><br>other clinical studies that are stored in the Sponsor*s internal databases.</p><br>