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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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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).
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mepolizumab | Experimental | Subjects will receive open-label mepolizumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mepolizumab | Biological | IV mepolizumab, 750 mg |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Steroid Dosing During Trial | 20 weeks | |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Wechsler, MD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15073927 | Background | 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. | |
| 15940771 | Background |
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| ID | Type | URL | Comment |
|---|---|---|---|
| PubMed ID: 20513524 | Publication | View IPD |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mepolizumab | Intravenously infused 750 mg of mepolizumab 1x every 4 weeks for 16 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mepolizumab | Intravenously infused 750 mg of mepolizumab 1x every 4 weeks for 16 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Indicated Side Effects | Side effects experienced by participants 1 to 2 days after Mepolizumab infusion. | Posted | Number | Participants | Participants were followed for the duration of the study, approximately 44 weeks |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mepolizumab | Intravenously infused 750 mg of mepolizumab 1x every 4 weeks for 16 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fractured Hip | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Subject fell and broke hip. Event classified as serious, unexpected, and unrelated. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Wechsler | National Jewish Health | 617-285-4987 | wechslerm@NJHealth.org |
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| ID | Term |
|---|---|
| D015267 | Churg-Strauss Syndrome |
| ID | Term |
|---|---|
| D056648 | Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis |
| D056647 | Systemic Vasculitis |
| D014657 | Vasculitis |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C434107 | mepolizumab |
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| 20 weeks |
| 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. | Treatment period (12 weeks) |
| 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. |
| 16126951 | Background | 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. |
| 14699394 | Background | 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. |
| 17157662 | Background | 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. |
| 14668459 | Background | 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. |
| 12704348 | Background | 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. |
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. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Steroid Dosing During Trial | Posted | Mean | Full Range | Prednisone mg/day | 20 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Full Range | units on a scale | 20 weeks |
|
|
|
| Primary | Number of Participants Who Experienced Specific Symptoms | Number of participants who experienced specific symptoms during the trial. | Posted | Number | Participants | 44 weeks |
|
|
|
| Secondary | 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. | Posted | Number | Exacerbation rate (Exacerbations/day) | Treatment period (12 weeks) |
|
|
|
| 1 |
| 10 |
| 9 |
| 10 |
|
| Digestive System Issues | Gastrointestinal disorders | Non-systematic Assessment | Abdominal pain/diarrhea, gastroenteritis, gastroesophageal reflux |
|
| Churg-Strauss Syndrome Flair | Endocrine disorders | Non-systematic Assessment |
|
| Sinusitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Upper Respiratory Infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Wheezing and Shortness of Breath | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
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| D002318 | Cardiovascular Diseases |
| D006099 | Granuloma |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| Title | Measurements |
|---|---|
|
| Sinusitis |
|
| Arthritis |
|