Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-24 @ 11:57 PM
NCT ID:
NCT00716651
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00716651
Study Brief:
Protocol Section:
NCT00716651