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

Primary Purpose

Churg Strauss Syndrome

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Mepolizumab
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Churg Strauss Syndrome focused on measuring Churg Strauss Syndrome

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mepolizumab

Arm Description

Subjects will receive open-label mepolizumab

Outcomes

Primary Outcome Measures

Number of Participants With Indicated Side Effects
Side effects experienced by participants 1 to 2 days after Mepolizumab infusion.
Number of Participants Who Experienced Specific Symptoms
Number of participants who experienced specific symptoms during the trial.

Secondary Outcome Measures

Steroid Dosing During Trial
Evaluate Overall Positive Change in Churg-Strauss Syndrome Via the Measures Outlined in Study Aims
The Asthma Control Questionnaire (ACQ) was one measure used to assess the prevalence of asthma symptoms the participant was having during the study. It is a series of 7 questions assessing how often, over the past two weeks, the participant wakes up from their asthma, how bad their symptoms were, etc. The greater the prevalence of symptoms, the higher the score. Each of the 7 questions is scored 0-6. The total score is calculated by adding the individual question scores and dividing the sum by 7.
Efficacy- Exacerbation Rate
Quantified the exacerbation rate (total number of exacerbations per day) of the participants during treatment with mepolizumab and without treatment. Exacerbations were characterized as any worsening of clinical disease requiring an increase of systemic corticosteroid therapy (e.g. prednisone) for asthma, respiratory symptoms, or underlying vasculitis.

Full Information

First Posted
September 7, 2007
Last Updated
February 1, 2017
Sponsor
Brigham and Women's Hospital
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00527566
Brief Title
Mepolizumab As a Steroid-sparing Treatment Option in the Churg Strauss Syndrome
Acronym
MATOCSS
Official Title
Mepolizumab As a Steroid Sparing Treatment Option in the Churg Strauss Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Churg Strauss Syndrome
Keywords
Churg Strauss Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mepolizumab
Arm Type
Experimental
Arm Description
Subjects will receive open-label mepolizumab
Intervention Type
Biological
Intervention Name(s)
Mepolizumab
Other Intervention Name(s)
Anti IL-5
Intervention Description
IV mepolizumab, 750 mg
Primary Outcome Measure Information:
Title
Number of Participants With Indicated Side Effects
Description
Side effects experienced by participants 1 to 2 days after Mepolizumab infusion.
Time Frame
Participants were followed for the duration of the study, approximately 44 weeks
Title
Number of Participants Who Experienced Specific Symptoms
Description
Number of participants who experienced specific symptoms during the trial.
Time Frame
44 weeks
Secondary Outcome Measure Information:
Title
Steroid Dosing During Trial
Time Frame
20 weeks
Title
Evaluate Overall Positive Change in Churg-Strauss Syndrome Via the Measures Outlined in Study Aims
Description
The Asthma Control Questionnaire (ACQ) was one measure used to assess the prevalence of asthma symptoms the participant was having during the study. It is a series of 7 questions assessing how often, over the past two weeks, the participant wakes up from their asthma, how bad their symptoms were, etc. The greater the prevalence of symptoms, the higher the score. Each of the 7 questions is scored 0-6. The total score is calculated by adding the individual question scores and dividing the sum by 7.
Time Frame
20 weeks
Title
Efficacy- Exacerbation Rate
Description
Quantified the exacerbation rate (total number of exacerbations per day) of the participants during treatment with mepolizumab and without treatment. Exacerbations were characterized as any worsening of clinical disease requiring an increase of systemic corticosteroid therapy (e.g. prednisone) for asthma, respiratory symptoms, or underlying vasculitis.
Time Frame
Treatment period (12 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Wechsler, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15073927
Citation
Martin RM, Wilton LV, Mann RD. Prevalence of Churg-Strauss syndrome, vasculitis, eosinophilia and associated conditions: retrospective analysis of 58 prescription-event monitoring cohort studies. Pharmacoepidemiol Drug Saf. 1999 May;8(3):179-89. doi: 10.1002/(SICI)1099-1557(199905/06)8:33.0.CO;2-K.
Results Reference
background
PubMed Identifier
15940771
Citation
Harrold LR, Andrade SE, Go AS, Buist AS, Eisner M, Vollmer WM, Chan KA, Frazier EA, Weller PF, Wechsler ME, Yood RA, Davis KJ, Platt R. Incidence of Churg-Strauss syndrome in asthma drug users: a population-based perspective. J Rheumatol. 2005 Jun;32(6):1076-80.
Results Reference
background
PubMed Identifier
16126951
Citation
Hellmich B, Csernok E, Gross WL. Proinflammatory cytokines and autoimmunity in Churg-Strauss syndrome. Ann N Y Acad Sci. 2005 Jun;1051:121-31. doi: 10.1196/annals.1361.053.
Results Reference
background
PubMed Identifier
14699394
Citation
Garrett JK, Jameson SC, Thomson B, Collins MH, Wagoner LE, Freese DK, Beck LA, Boyce JA, Filipovich AH, Villanueva JM, Sutton SA, Assa'ad AH, Rothenberg ME. Anti-interleukin-5 (mepolizumab) therapy for hypereosinophilic syndromes. J Allergy Clin Immunol. 2004 Jan;113(1):115-9. doi: 10.1016/j.jaci.2003.10.049. Epub 2003 Dec 12.
Results Reference
background
PubMed Identifier
17157662
Citation
Stein ML, Collins MH, Villanueva JM, Kushner JP, Putnam PE, Buckmeier BK, Filipovich AH, Assa'ad AH, Rothenberg ME. Anti-IL-5 (mepolizumab) therapy for eosinophilic esophagitis. J Allergy Clin Immunol. 2006 Dec;118(6):1312-9. doi: 10.1016/j.jaci.2006.09.007. Epub 2006 Nov 7.
Results Reference
background
PubMed Identifier
14668459
Citation
Plotz SG, Simon HU, Darsow U, Simon D, Vassina E, Yousefi S, Hein R, Smith T, Behrendt H, Ring J. Use of an anti-interleukin-5 antibody in the hypereosinophilic syndrome with eosinophilic dermatitis. N Engl J Med. 2003 Dec 11;349(24):2334-9. doi: 10.1056/NEJMoa031261. No abstract available.
Results Reference
background
PubMed Identifier
12704348
Citation
Menzies-Gow A, Flood-Page P, Sehmi R, Burman J, Hamid Q, Robinson DS, Kay AB, Denburg J. Anti-IL-5 (mepolizumab) therapy induces bone marrow eosinophil maturational arrest and decreases eosinophil progenitors in the bronchial mucosa of atopic asthmatics. J Allergy Clin Immunol. 2003 Apr;111(4):714-9. doi: 10.1067/mai.2003.1382.
Results Reference
background
Available IPD and Supporting Information:
Available IPD/Information Type
Publication
Available IPD/Information URL
http://www.ncbi.nlm.nih.gov/pubmed/20513524
Available IPD/Information Identifier
PubMed ID: 20513524
Available IPD/Information Comments
Mepolizumab as a steroid-sparing treatment option in patients with Churg-Strauss syndrome. Kim S, Marigowda G, Oren E, Israel E, Wechsler ME. J Allergy Clin Immunol. 2010 Jun;125(6):1336-43. doi:10.1016/j.jaci.2010.03.028.

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Mepolizumab As a Steroid-sparing Treatment Option in the Churg Strauss Syndrome

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