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22444

Description

Study part: Eligibility Criteria Worksheet Screening Visit.A Phase 2 Multicenter, Double-blind, Placebo-controlled, Study to to Evaluate the Corticosteroid- sparing effects of Mepolizumab in Subjects with Hypereosinophilic Syndromes (HES) and Evaluate Efficacy and Safety of Mepolizumab in Controlling the Clinical Signs and Symptoms of subjects with HES Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Study ID: 100185, Clinical Study ID:MHE100185.

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Versions (1)
  1. 6/4/17 6/4/17 -
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GlaxoSmithKline

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June 4, 2017

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Creative Commons BY-NC 3.0
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    Eligibility Criteria Worksheet Screening Visit Mepolizumab HES NCT00086658

    English

    Eligibility Criteria Worksheet Screening Visit

    1 forms  
    INCLUSION CRITERIA
    Description

    INCLUSION CRITERIA

    Alias
    UMLS CUI-1
    C1512693
    1. Signed informed consent.
    Description

    Informed consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    2. Subjects with documented history of HES.
    Description

    HES is defined as: 1) peripheral blood eosinophilia (>1500 eosinophils/ μL) for at least 6 months, 2) signs and symptoms of organ system involvement or dysfunction that can be directly related to eosinophilia, 3) no evidence of parasitic, allergic, or other recognized causes of eosinophilia after comprehensive evaluation. Note: Subjects with sustained peripheral hypereosinophilia of >1500 eosinophils/μL for a duration of<6 months may be included if they meet the rest of the HES criteria accompanied by clear evidence of eosinophil tissue infiltration.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0262926
    UMLS CUI [1,2]
    C1540912
    3. Male or female, 18-75 years of age. A female subject is eligible to enter the study if she is: • Not pregnant or nursing • Of non-childbearing potential (i.e., women who had a hysterectomy, are post-menopausal which is defined as 1 year without menses, have both ovaries surgically removed, or have current documented tubule ligation); or • Of childbearing potential (i.e., women with functional ovaries and no documented impairment of oviductal or uterine function that would cause sterility). This category includes women with oligomenorrhoea [even severe], women who are perimenopausal or have just begun to menstruate. These women must have a negative serum pregnancy test at the Screening Visit, and agree to one of the following: 1). Complete abstinence from intercourse from 2 weeks prior to administration of the first dose of investigational product until 3 months after the last dose of investigational product; or 2). Consistent and correct use of one of the following acceptable methods of birth control for one month prior to the start of the investigation product and three months after the last dose: • Male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for the female subjects; • Implants of levonorgestrel; • Injectable progestogen; • Any intrauterine device (IUD) with a documented failure rate of less than 1% per year; • Oral contraceptives (either combined or progestogen only) • Double-barrier methods including diaphragm or condom with a spermicide.
    Description

    Gender; Age; Pregnancy; Childbearing Potential; Contraceptive methods

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0079399
    UMLS CUI [2]
    C0001779
    UMLS CUI [3]
    C0032961
    UMLS CUI [4]
    C3831118
    UMLS CUI [5]
    C0700589
    EXCLUSION CRITERIA
    Description

    EXCLUSION CRITERIA

    Alias
    UMLS CUI-1
    C0680251
    1. Subjects with life-threatening or other serious illness or clinical manifestation deemed inappropriate for inclusion in study per the principal investigator.
    Description

    Comorbidity

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0009488
    2. Known secondary causes of eosinophilia: drug eruption and parasitic infection occurring within a year prior to the Screening Visit, history of graft-versus host disease, bullous pemphigoid, cystic fibrosis, rheumatoid arthritis and human immunodeficiency virus (HIV) infection
    Description

    Secondary eosinophilia drug eruption parasitic infection graft-versus host disease

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0272194
    UMLS CUI [1,2]
    C0011609
    UMLS CUI [1,3]
    C0747256
    UMLS CUI [1,4]
    C0018133
    3. Known Churg-Strauss Syndrome
    Description

    Churg-Strauss Syndrome

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0008728
    4. Known Wegener's Granulomatosis
    Description

    Wegeners Granulomatosis

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3495801
    5. Known lymphoma, hematological malignancy, advanced and metastatic solid tumors and/or subjects who are under chemotherapy, radiotherapy or interleukin 2 treatment
    Description

    medical history malignant Neoplasms; Therapy chemotherapy radiotherapy Interleukin-2 therapy

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0262926
    UMLS CUI [1,2]
    C0006826
    UMLS CUI [2,1]
    C0087111
    UMLS CUI [2,2]
    C0392920
    UMLS CUI [2,3]
    C1522449
    UMLS CUI [2,4]
    C0199975
    6. Known history of allergic reaction to previous antibody therapy.
    Description

    Hypersensitivity antibody therapy

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0281176
    7. Prior treatment with an anti-hIL-5 monoclonal antibody.
    Description

    Therapy monoclonal antibody

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C0003250
    8. Use of an investigational drug within 30 days of entering the study (Screening Visit).
    Description

    Investigational drug

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0013230
    9. Recent history or suspicion of current drug abuse or alcohol abuse within the last 6 months.
    Description

    Substance use disorder

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0038586
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    Similar models

    Eligibility Criteria Worksheet Screening Visit

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    INCLUSION CRITERIA
    C1512693 (UMLS CUI-1)
    Informed consent
    Item
    1. Signed informed consent.
    boolean
    C0021430 (UMLS CUI [1])
    Medical history Hypereosinophilic Syndrome
    Item
    2. Subjects with documented history of HES.
    boolean
    C0262926 (UMLS CUI [1,1])
    C1540912 (UMLS CUI [1,2])
    Gender; Age; Pregnancy; Childbearing Potential; Contraceptive methods
    Item
    3. Male or female, 18-75 years of age. A female subject is eligible to enter the study if she is: • Not pregnant or nursing • Of non-childbearing potential (i.e., women who had a hysterectomy, are post-menopausal which is defined as 1 year without menses, have both ovaries surgically removed, or have current documented tubule ligation); or • Of childbearing potential (i.e., women with functional ovaries and no documented impairment of oviductal or uterine function that would cause sterility). This category includes women with oligomenorrhoea [even severe], women who are perimenopausal or have just begun to menstruate. These women must have a negative serum pregnancy test at the Screening Visit, and agree to one of the following: 1). Complete abstinence from intercourse from 2 weeks prior to administration of the first dose of investigational product until 3 months after the last dose of investigational product; or 2). Consistent and correct use of one of the following acceptable methods of birth control for one month prior to the start of the investigation product and three months after the last dose: • Male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for the female subjects; • Implants of levonorgestrel; • Injectable progestogen; • Any intrauterine device (IUD) with a documented failure rate of less than 1% per year; • Oral contraceptives (either combined or progestogen only) • Double-barrier methods including diaphragm or condom with a spermicide.
    boolean
    C0079399 (UMLS CUI [1])
    C0001779 (UMLS CUI [2])
    C0032961 (UMLS CUI [3])
    C3831118 (UMLS CUI [4])
    C0700589 (UMLS CUI [5])
    Item Group
    EXCLUSION CRITERIA
    C0680251 (UMLS CUI-1)
    Comorbidity
    Item
    1. Subjects with life-threatening or other serious illness or clinical manifestation deemed inappropriate for inclusion in study per the principal investigator.
    boolean
    C0009488 (UMLS CUI [1])
    Secondary eosinophilia drug eruption parasitic infection graft-versus host disease
    Item
    2. Known secondary causes of eosinophilia: drug eruption and parasitic infection occurring within a year prior to the Screening Visit, history of graft-versus host disease, bullous pemphigoid, cystic fibrosis, rheumatoid arthritis and human immunodeficiency virus (HIV) infection
    boolean
    C0272194 (UMLS CUI [1,1])
    C0011609 (UMLS CUI [1,2])
    C0747256 (UMLS CUI [1,3])
    C0018133 (UMLS CUI [1,4])
    Churg-Strauss Syndrome
    Item
    3. Known Churg-Strauss Syndrome
    boolean
    C0008728 (UMLS CUI [1])
    Wegeners Granulomatosis
    Item
    4. Known Wegener's Granulomatosis
    boolean
    C3495801 (UMLS CUI [1])
    medical history malignant Neoplasms; Therapy chemotherapy radiotherapy Interleukin-2 therapy
    Item
    5. Known lymphoma, hematological malignancy, advanced and metastatic solid tumors and/or subjects who are under chemotherapy, radiotherapy or interleukin 2 treatment
    boolean
    C0262926 (UMLS CUI [1,1])
    C0006826 (UMLS CUI [1,2])
    C0087111 (UMLS CUI [2,1])
    C0392920 (UMLS CUI [2,2])
    C1522449 (UMLS CUI [2,3])
    C0199975 (UMLS CUI [2,4])
    Hypersensitivity antibody therapy
    Item
    6. Known history of allergic reaction to previous antibody therapy.
    boolean
    C0020517 (UMLS CUI [1,1])
    C0281176 (UMLS CUI [1,2])
    Therapy monoclonal antibody
    Item
    7. Prior treatment with an anti-hIL-5 monoclonal antibody.
    boolean
    C0087111 (UMLS CUI [1,1])
    C0003250 (UMLS CUI [1,2])
    Investigational drug
    Item
    8. Use of an investigational drug within 30 days of entering the study (Screening Visit).
    boolean
    C0013230 (UMLS CUI [1])
    Substance use disorder
    Item
    9. Recent history or suspicion of current drug abuse or alcohol abuse within the last 6 months.
    boolean
    C0038586 (UMLS CUI [1])
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