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™) - CLEAREST™-TRAI

• Conditions: 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 newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia.; MedDRA version: 9.1Level: LLTClassification code 10061664Term: Autoimmune disorder; MedDRA version: 9.1Level: LLTClassification code 10025139Term: Lupus erythematosus systemic; MedDRA version: 9.1Level: LLTClassification code 10047888Term: Wegener's granulomatosis; MedDRA version: 9.1Level: LLTClassification code 10002817Term: Antiphospholipid syndrome; MedDRA version: 9.1Level: LLTClassification code 10040767Term: Sjogren's syndrome; MedDRA version: 9.1Level: LLTClassification code 10039073Term: Rheumatoid arthritis; MedDRA version: 9.1Level: LLTClassification code 10028245Term: Multiple sclerosis; MedDRA version: 9.1Level: LLTClassification code 10045228Term: Type I diabetes mellitus; MedDRA version: 9.1Level: LLTClassification code 10011401Term: Crohn's disease

• Registration Number: EUCTR2007-001377-28-NL
• Lead Sponsor: Merck Serono International S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05-29
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 92

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 < 50,000 mm3 - during routine monitoring
or for -cause laboratory evaluation
3) Subject is willing and able to participate in the trial and has provided signed, informed consent.
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In addition, for sites participating to the control group, control subjects will be included and must fulfil all the following criteria:
1) Subject participating to Study 25878
2) Absence of clinical signs of severe thrombocytopenia
3) Either currently treated with efalizumab or not (i.e. last dose of efalizumab received more than 6 weeks before study entry)
4) Subject is willing and able to participate in the trial and has provided signed, informed consent.

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

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified