Status:
COMPLETED
Safety and Efficacy Study of Mepolizumab in Churg Strauss Syndrome
Lead Sponsor:
University Hospital Schleswig-Holstein
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Churg Strauss Syndrome
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
Churg-Strauss syndrome is a rare type of systemic vasculitis which occurs almost exclusively in patients with asthma and which is characterized by prominent blood and tissue eosinophilia. The disease ...
Eligibility Criteria
Inclusion
- informed consent
- documented history of Churg Strauss Syndrome
- active disease
- subjects must complete screening and baseline assessment
- stable corticosteroid dose of \> 12.5 mg prednisolone for at least one week
- treatment with cyclophosphamide (pulse or daily oral) or methotrexate or azathioprin or leflunomide in a stable dose for at least 4 weeks
- not pregnant or nursing
- negative pregnancy test and agree to practice birth control
Exclusion
- life threatening disease or other critical illness deemed inappropriate for inclusion in the study by the principal investigator
- treatment with other immunosuppressive agents within 4 weeks prior to randomisation
- corticosteroid pulse of \> 60 mg within the last three weeks prior to randomisation
- known secondary cause of eosinophilia
- no history or clinical features of vasculitis
- diagnosis of other primary systemic vasculitis
- currently active malignant disease
- abnormal laboratory values
- impaired cardiac function
- history of allergic reaction due to monoclonal antibodies
- prior treatment with anti-hIL-5 monoclonal antibody
- exposure to investigational drug within 30 days prior to randomisation
- positive pregnancy test
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00716651
Start Date
July 1 2008
Last Update
June 15 2012
Active Locations (1)
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1
University Hospital Schleswig Holstein, Rheumaklinik Bad Bramstetd
Bad Bramstedt, Schleswig-Holstein, Germany, 24576