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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT00527566 |
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Date of registration:
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07/09/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Mepolizumab As a Steroid-sparing Treatment Option in the Churg Strauss Syndrome
MATOCSS |
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Scientific title:
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Mepolizumab As a Steroid Sparing Treatment Option in the Churg Strauss Syndrome |
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Date of first enrolment:
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September 2007 |
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Target sample size:
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10 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00527566 |
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Study type:
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Interventional |
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Study design:
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Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Michael Wechsler, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Brigham and Women's Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age >18 years old
- Diagnosis of Churg Strauss Syndrome
- Maintained on stable corticosteroid dose of at least prednisone 10mg daily (or
equivalent) prior to enrollment in study
- If on cyclophosphamide, azathioprine or methotrexate, must be on a stable dose and be
able to maintain that dose for the duration of the study
Exclusion Criteria:
- Hypereosinophilic Syndrome
- Wegener's Granulomatosis
- Malignancy
- Parasitic Disease
- Pregnant or nursing
- If female and of child-bearing potential, must have negative pregnancy test prior to
each infusion of study medication and must adhere to acceptable method of
contraception (with <1% failure rate)
- Any other medical illness that precludes study involvement
Age minimum:
19 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Churg Strauss Syndrome
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Intervention(s)
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Biological: Mepolizumab
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Primary Outcome(s)
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Number of Participants With Indicated Side Effects
[Time Frame: Participants were followed for the duration of the study, approximately 44 weeks]
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Number of Participants Who Experienced Specific Symptoms
[Time Frame: 44 weeks]
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Secondary Outcome(s)
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Evaluate Overall Positive Change in Churg-Strauss Syndrome Via the Measures Outlined in Study Aims
[Time Frame: 20 weeks]
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Efficacy- Exacerbation Rate
[Time Frame: Treatment period (12 weeks)]
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Steroid Dosing During Trial
[Time Frame: 20 weeks]
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Secondary ID(s)
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2007-P-000012/1;BWH
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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