ID

22444

Beschrijving

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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  1. 04-06-17 04-06-17 -
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GlaxoSmithKline

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4 juni 2017

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

Engels

Eligibility Criteria Worksheet Screening Visit

1 Formulieren  
INCLUSION CRITERIA
Beschrijving

INCLUSION CRITERIA

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

Informed consent

Datatype

boolean

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

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.

Datatype

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.
Beschrijving

Gender; Age; Pregnancy; Childbearing Potential; Contraceptive methods

Datatype

boolean

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

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.
Beschrijving

Comorbidity

Datatype

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
Beschrijving

Secondary eosinophilia drug eruption parasitic infection graft-versus host disease

Datatype

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
Beschrijving

Churg-Strauss Syndrome

Datatype

boolean

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

Wegeners Granulomatosis

Datatype

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
Beschrijving

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

Datatype

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.
Beschrijving

Hypersensitivity antibody therapy

Datatype

boolean

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

Therapy monoclonal antibody

Datatype

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).
Beschrijving

Investigational drug

Datatype

boolean

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

Substance use disorder

Datatype

boolean

Alias
UMLS CUI [1]
C0038586
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Similar models

Eligibility Criteria Worksheet Screening Visit

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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