Mepolizumab As a Steroid-Sparing Treatment Option in the Churg Strauss Syndrome (MATOCSS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Brigham and Women's Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00527566
First received: September 7, 2007
Last updated: April 16, 2009
Last verified: April 2009
  Purpose

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).


Condition Intervention Phase
Churg Strauss Syndrome
Biological: Mepolizumab
Phase 1
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Safety and tolerability of mepolizumab [ Time Frame: 44 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 10
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)
Arms Assigned Interventions
Experimental: Single arm
Subjects will receive open-label mepolizumab
Biological: Mepolizumab
IV mepolizumab, 750 mg
Other Name: Anti IL-5

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.
  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00527566

Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
GlaxoSmithKline
Investigators
Principal Investigator: Michael Wechsler, MD Brigham and Women's Hospital
  More Information

Publications:

Responsible Party: Michael E. Wechsler, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00527566     History of Changes
Other Study ID Numbers: 2007-P-000012/1;BWH
Study First Received: September 7, 2007
Last Updated: April 16, 2009
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
Churg Strauss Syndrome

Additional relevant MeSH terms:
Churg-Strauss Syndrome
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Systemic Vasculitis
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Granuloma
Lymphoproliferative Disorders
Lymphatic Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on August 19, 2014