NCT00527566|CompletedPhase 1/2Results
Mepolizumab As a Steroid-sparing Treatment Option in the Churg Strauss Syndrome
MATOCSS
Mepolizumab As a Steroid Sparing Treatment Option in the Churg Strauss Syndrome
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Sponsor study identifier
interventional
10
1 country
1
Study Start
September 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2009
Actual (reported)Study Completion
August 2009
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2009
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2007
Date type not reportedThis date has not been verified as actual or estimated.
September 7, 2007
Actual (reported)September 11, 2007
Actual (reported)August 2009
Actual (reported)August 2009
Actual (reported)March 22, 2017
Actual (reported)Number of Participants With Indicated Side Effects
Side effects experienced by participants 1 to 2 days after Mepolizumab infusion.
Participants were followed for the duration of the study, approximately 44 weeks
Number of Participants Who Experienced Specific Symptoms
Number of participants who experienced specific symptoms during the trial.
44 weeks
Steroid Dosing During Trial
20 weeks
Evaluate Overall Positive Change in Churg-Strauss Syndrome Via the Measures Outlined in Study Aims
20 weeks
Efficacy- Exacerbation Rate
Treatment period (12 weeks)
Subjects will receive open-label mepolizumab
IV mepolizumab, 750 mg
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
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.
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.
Michael Wechsler, MD
Brigham and Women's Hospital
10 participants (actual enrollment reported by the registry).
First Submitted
September 7, 2007
First Posted
September 11, 2007
Study Start
September 2007
Date type not reportedThis date has not been verified as actual or estimated.
Long-term Access Program (LAP) of Mepolizumab for Subjects Who Participated in Study MEA115921
Contact the study team to confirm eligibility.
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.
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.
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.
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.
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.
Primary Completion
August 2009
Actual (reported)Study Completion
August 2009
Actual (reported)Last Updated
March 22, 2017
Results First Posted
March 22, 2017
Record last verified: 2017-02
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Source: ClinicalTrials.gov.
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