EUCTR2007-001377-28-FR
Active, not recruiting
Phase 1
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
Merck Serono International S.A.0 sites0 target enrollmentFebruary 29, 2008
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Merck Serono International S.A.
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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,
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)
Outcomes
Primary Outcomes
Not specified
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Withdrawn
Phase 4
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).auto-immune diseasesthrombocytopenia1003553410003816NL-OMON32149Serono10
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Not Applicable
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™-TRAIAdult 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 disorderMedDRA version: 9.1Level: LLTClassification code 10025139Term: Lupus erythematosus systemicMedDRA version: 9.1Level: LLTClassification code 10047888Term: Wegener's granulomatosisMedDRA version: 9.1Level: LLTClassification code 10002817Term: Antiphospholipid syndromeMedDRA version: 9.1Level: LLTClassification code 10040767Term: Sjogren's syndromeMedDRA version: 9.1Level: LLTClassification code 10039073Term: Rheumatoid arthritisMedDRA version: 9.1Level: LLTClassification code 10028245Term: Multiple sclerosisMedDRA version: 9.1Level: LLTClassification code 10045228Term: Type I diabetes mellitusMedDRA version: 9.1Level: LLTClassification code 10011401Term: Crohn's diseaseMedDRA version: 9.1Level: LLTClassification code 10009900Term: Colitis ulcerativeMedDRA version: 9.1Level: LLTClassification code 10003827Term: Autoimmune hepatitisMedDRA version: 9.1Level: LLTClassification code 10049046Term: Autoimmune thyroiditisMedDRA version: 9.1Level: LLTClassification code 10003822Term: Autoimmune haemolytic anaemia NOSMedDRA version: 9.1Level: LLTClassification code 10034697Term: Pernicious anemiaMedDRA version: 9.1Level: LLTClassification code 10028417Term: Myasthenia gravisMedDRA version: 9.1Level: LLTClassification code 10018620Term: Goodpasture's syndromeMedDRA version: 9.1Level: LLTClassification code 10EUCTR2007-001377-28-ATMerck Serono International S.A.92
Active, not recruiting
Not Applicable
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™-TRAIAdult 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 disorderMedDRA version: 9.1Level: LLTClassification code 10025139Term: Lupus erythematosus systemicMedDRA version: 9.1Level: LLTClassification code 10047888Term: Wegener's granulomatosisMedDRA version: 9.1Level: LLTClassification code 10002817Term: Antiphospholipid syndromeMedDRA version: 9.1Level: LLTClassification code 10040767Term: Sjogren's syndromeMedDRA version: 9.1Level: LLTClassification code 10039073Term: Rheumatoid arthritisMedDRA version: 9.1Level: LLTClassification code 10028245Term: Multiple sclerosisMedDRA version: 9.1Level: LLTClassification code 10045228Term: Type I diabetes mellitusMedDRA version: 9.1Level: LLTClassification code 10011401Term: Crohn's diseaseMedDRA version: 9.1Level: LLTClassification code 10009900Term: Colitis ulcerativeMedDRA version: 9.1Level: LLTClassification code 10003827Term: Autoimmune hepatitisMedDRA version: 9.1Level: LLTClassification code 10049046Term: Autoimmune thyroiditisMedDRA version: 9.1Level: LLTClassification code 10003822Term: Autoimmune haemolytic anaemia NOSMedDRA version: 9.1Level: LLTClassification code 10034697Term: Pernicious anemiaMedDRA version: 9.1Level: LLTClassification code 10028417Term: Myasthenia gravisMedDRA version: 9.1Level: LLTClassification code 10018620Term: Goodpasture's syndromeMedDRA version: 9.1Level: LLTClassification code 10EUCTR2007-001377-28-DEMerck Serono International S.A.92