Mepolizumab As a Steroid-Sparing Treatment Option in the Churg Strauss Syndrome (MATOCSS)
Recruitment status was Active, not recruiting
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).
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Mepolizumab As a Steroid Sparing Treatment Option in the Churg Strauss Syndrome|
- Safety and tolerability of mepolizumab [ Time Frame: 44 weeks ] [ Designated as safety issue: Yes ]
- Demonstrate the steroid sparing effect of mepolizumab [ Time Frame: 44 weeks ] [ Designated as safety issue: No ]
- Evaluate overall improvement in CSS via the measures outlined in Study Aims [ Time Frame: 44 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||September 2007|
|Estimated Study Completion Date:||August 2009|
|Estimated Primary Completion Date:||August 2009 (Final data collection date for primary outcome measure)|
Experimental: Single arm
Subjects will receive open-label mepolizumab
IV mepolizumab, 750 mg
Other Name: Anti IL-5
- Document the safety of mepolizumab therapy in patients with CSS.
- Demonstrate the steroid sparing effect of mepolizumab therapy by decreasing corticosteroid dosage while using this anti-IL5 therapy.
Demonstrate the efficacy of anti-IL5 therapy in improving the signs and symptoms of CSS by:
- Measuring serum markers of CSS disease activity, including: peripheral eosinophilia, erythrocyte sedimentation rate, anti- neutrophil cytoplasmic antigen, C-reactive protein and IgE levels.
- Assessing the activity level of vasculitis via the Birmingham Vasculitis Activity Score
- Evaluating asthmatic response via serial peak flow and FEV1 measurements as well as asthma symptom scores using the Juniper scale.
- Assessing changes in novel parameters such as fractional excretion of nitric oxide and IL-5 levels.
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Michael Wechsler, MD||Brigham and Women's Hospital|