Ignite Creation Date:
2024-05-05 @ 6:40 PM
Last Modification Date:
2024-10-26 @ 9:36 AM
Study NCT ID:
NCT00527566
Status:
COMPLETED
Last Update Posted:
2017-03-22
First Post:
2007-09-07
Brief Title:
Mepolizumab As a Steroid-sparing Treatment Option in the Churg Strauss Syndrome
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
Mepolizumab As a Steroid Sparing Treatment Option in the Churg Strauss Syndrome
Status:
COMPLETED
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MATOCSS
Brief Summary:
The purpose of this study is to determine whether Mepolizumab a monoclonal antibody against interleukin-5 is a safe and well-tolerated therapy that will allow for steroid tapering in patients with steroid-dependent Churg-Strauss Syndrome CSS
Detailed Description:
Specific Aims
1 Document the safety of mepolizumab therapy in patients with CSS
2 Demonstrate the steroid sparing effect of mepolizumab therapy by decreasing corticosteroid dosage while using this anti-IL5 therapy
3 Demonstrate the efficacy of anti-IL5 therapy in improving the signs and symptoms of CSS by
1 Measuring serum markers of CSS disease activity including peripheral eosinophilia erythrocyte sedimentation rate anti- neutrophil cytoplasmic antigen C-reactive protein and IgE levels
2 Assessing the activity level of vasculitis via the Birmingham Vasculitis Activity Score
3 Evaluating asthmatic response via serial peak flow and FEV1 measurements as well as asthma symptom scores using the Juniper scale
4 Assessing changes in novel parameters such as fractional excretion of nitric oxide and IL-5 levels
1 Document the safety of mepolizumab therapy in patients with CSS
2 Demonstrate the steroid sparing effect of mepolizumab therapy by decreasing corticosteroid dosage while using this anti-IL5 therapy
3 Demonstrate the efficacy of anti-IL5 therapy in improving the signs and symptoms of CSS by
1 Measuring serum markers of CSS disease activity including peripheral eosinophilia erythrocyte sedimentation rate anti- neutrophil cytoplasmic antigen C-reactive protein and IgE levels
2 Assessing the activity level of vasculitis via the Birmingham Vasculitis Activity Score
3 Evaluating asthmatic response via serial peak flow and FEV1 measurements as well as asthma symptom scores using the Juniper scale
4 Assessing changes in novel parameters such as fractional excretion of nitric oxide and IL-5 levels
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None