Ignite Creation Date:
2025-12-24 @ 4:19 PM
Ignite Modification Date:
2025-12-29 @ 6:33 AM
Study NCT ID:
NCT00527566
Status:
COMPLETED
Last Update Posted:
2017-03-22
First Post:
2007-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Mepolizumab As a Steroid-sparing Treatment Option in the Churg Strauss Syndrome
Sponsor:
Brigham and Women's Hospital
Organization:
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:
False
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?: