ID

41819

Description

Effect of Adrenocorticotropin Injection With Weekly Interferon Beta in Patients With Relapsing Remitting Multiple Sclerosis (MS); ODM derived from: https://clinicaltrials.gov/show/NCT00986960

Link

https://clinicaltrials.gov/show/NCT00986960

Keywords

Versions (3)
  1. 1/21/21 1/21/21 - Ahmed Rafee, MD
  2. 1/22/21 1/22/21 - Ahmed Rafee, MD
  3. 1/22/21 1/22/21 - Sarah Riepenhausen
Copyright Holder

University at Buffalo

Uploaded on

January 22, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT00986960

English

Eligibility Multiple Sclerosis NCT00986960

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient diagnosed with ms according to mcdonald criteria
Description

patient diagnosed with ms according to mcdonald criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C0026769
UMLS CUI [1,2]
C0679228
age 18-65
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
have a rr disease course
Description

have a rr disease course

Data type

boolean

Alias
UMLS CUI [1,1]
C3808177
UMLS CUI [1,2]
C0026769
have edss scores 0-5.5
Description

have edss scores 0-5.5

Data type

boolean

Alias
UMLS CUI [1]
C0451246
have a disease duration <20 years
Description

have a disease duration <20 years

Data type

boolean

Alias
UMLS CUI [1,1]
C0872146
UMLS CUI [1,2]
C0026769
sub-optimal response to interferon beta-1a i.m. (avonex®) while being on therapy for at least 6 months defined as: presence of a documented relapse within the last 12 months OR the presence of at least one enhancing T1 Gd lesion on an MRI performed within previous 3 months
Description

sub-optimal response to interferon beta-1a i.m. (avonex®) while being on therapy for at least 6 months defined as: presence of a documented relapse within the last 12 months OR the presence of at least one enhancing T1 Gd lesion on an MRI performed within previous 3 months

Data type

boolean

Alias
UMLS CUI [1,1]
C0254119
UMLS CUI [1,2]
C0021492
UMLS CUI [1,3]
C2984009
UMLS CUI [1,4]
C0521982
UMLS CUI [1,5]
C0026769
UMLS CUI [1,6]
C0444921
UMLS CUI [2,1]
C0035020
UMLS CUI [2,2]
C0026769
UMLS CUI [2,3]
C0332185
UMLS CUI [2,4]
C1301725
UMLS CUI [3,1]
C1333400
UMLS CUI [3,2]
C0449788
signed informed consent
Description

signed informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
normal kidney functioning (creatinine clearance >59)
Description

normal kidney functioning (creatinine clearance >59)

Data type

boolean

Alias
UMLS CUI [1]
C0373595
none of the exclusion criteria
Description

none of the exclusion criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0444868
UMLS CUI [1,3]
C0332197
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
presence of relapse or steroid treatment within 60 days prior to study enrollment
Description

presence of relapse or steroid treatment within 60 days prior to study enrollment

Data type

boolean

Alias
UMLS CUI [1,1]
C0026769
UMLS CUI [1,2]
C0035020
UMLS CUI [1,3]
C0332185
UMLS CUI [2,1]
C0149783
UMLS CUI [2,2]
C0332185
presence of neutralizing antibodies to ifnβ-1a i.m. prior to study enrollment
Description

presence of neutralizing antibodies to ifnβ-1a i.m. prior to study enrollment

Data type

boolean

Alias
UMLS CUI [1,1]
C1997641
UMLS CUI [1,2]
C0332185
presence of optic neuritis within less than 6 months prior to study enrollment
Description

presence of optic neuritis within less than 6 months prior to study enrollment

Data type

boolean

Alias
UMLS CUI [1,1]
C0029134
UMLS CUI [1,2]
C0332185
diagnosis of osteoporosis (t score ≥2.5 sd)
Description

diagnosis of osteoporosis (t score ≥2.5 sd)

Data type

boolean

Alias
UMLS CUI [1]
C0029456
UMLS CUI [2]
C3854607
women who are pregnant, lactating or of childbearing age who do not consent to approved contraceptive use during the study.
Description

women who are pregnant, lactating or of childbearing age who do not consent to approved contraceptive use during the study.

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0558080
abnormal blood tests, performed during the screening visit including: hepatitis b or hepatitis c, alt or ast greater than two times the upper limit of normal, abnormal glucose fasting levels or already known diabetes
Description

abnormal blood tests, performed during the screening visit including: hepatitis b or hepatitis c, alt or ast greater than two times the upper limit of normal, abnormal glucose fasting levels or already known diabetes

Data type

boolean

Alias
UMLS CUI [1,1]
C0178913
UMLS CUI [1,2]
C0022885
UMLS CUI [1,3]
C0205161
UMLS CUI [1,4]
C1710032
UMLS CUI [2,1]
C0744837
UMLS CUI [2,2]
C0205161
UMLS CUI [3,1]
C0850489
UMLS CUI [3,2]
C0205161
UMLS CUI [4,1]
C0201836
UMLS CUI [4,2]
C0205161
UMLS CUI [5,1]
C0201899
UMLS CUI [5,2]
C0205161
UMLS CUI [6,1]
C0583513
UMLS CUI [6,2]
C0205161
UMLS CUI [7]
C0011849
history of depression while on ifnβ-1a i.m.
Description

history of depression while on ifnβ-1a i.m.

Data type

boolean

Alias
UMLS CUI [1,1]
C0205156
UMLS CUI [1,2]
C0262926
UMLS CUI [1,3]
C0011581
UMLS CUI [1,4]
C0041755
UMLS CUI [1,5]
C0254119
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Similar models

Eligibility Multiple Sclerosis NCT00986960

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
patient diagnosed with ms according to mcdonald criteria
Item
patient diagnosed with ms according to mcdonald criteria
boolean
C0026769 (UMLS CUI [1,1])
C0679228 (UMLS CUI [1,2])
Age
Item
age 18-65
boolean
C0001779 (UMLS CUI [1])
have a rr disease course
Item
have a rr disease course
boolean
C3808177 (UMLS CUI [1,1])
C0026769 (UMLS CUI [1,2])
have edss scores 0-5.5
Item
have edss scores 0-5.5
boolean
C0451246 (UMLS CUI [1])
have a disease duration <20 years
Item
have a disease duration <20 years
boolean
C0872146 (UMLS CUI [1,1])
C0026769 (UMLS CUI [1,2])
sub-optimal response to interferon beta-1a i.m. (avonex®) while being on therapy for at least 6 months defined as: presence of a documented relapse within the last 12 months OR the presence of at least one enhancing T1 Gd lesion on an MRI performed within previous 3 months
Item
sub-optimal response to interferon beta-1a i.m. (avonex®) while being on therapy for at least 6 months defined as: presence of a documented relapse within the last 12 months OR the presence of at least one enhancing T1 Gd lesion on an MRI performed within previous 3 months
boolean
C0254119 (UMLS CUI [1,1])
C0021492 (UMLS CUI [1,2])
C2984009 (UMLS CUI [1,3])
C0521982 (UMLS CUI [1,4])
C0026769 (UMLS CUI [1,5])
C0444921 (UMLS CUI [1,6])
C0035020 (UMLS CUI [2,1])
C0026769 (UMLS CUI [2,2])
C0332185 (UMLS CUI [2,3])
C1301725 (UMLS CUI [2,4])
C1333400 (UMLS CUI [3,1])
C0449788 (UMLS CUI [3,2])
signed informed consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
normal kidney functioning (creatinine clearance >59)
Item
normal kidney functioning (creatinine clearance >59)
boolean
C0373595 (UMLS CUI [1])
none of the exclusion criteria
Item
none of the exclusion criteria
boolean
C0680251 (UMLS CUI [1,1])
C0444868 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
presence of relapse or steroid treatment within 60 days prior to study enrollment
Item
presence of relapse or steroid treatment within 60 days prior to study enrollment
boolean
C0026769 (UMLS CUI [1,1])
C0035020 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
C0149783 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
presence of neutralizing antibodies to ifnβ-1a i.m. prior to study enrollment
Item
presence of neutralizing antibodies to ifnβ-1a i.m. prior to study enrollment
boolean
C1997641 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
presence of optic neuritis within less than 6 months prior to study enrollment
Item
presence of optic neuritis within less than 6 months prior to study enrollment
boolean
C0029134 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
diagnosis of osteoporosis (t score ≥2.5 sd)
Item
diagnosis of osteoporosis (t score ≥2.5 sd)
boolean
C0029456 (UMLS CUI [1])
C3854607 (UMLS CUI [2])
women who are pregnant, lactating or of childbearing age who do not consent to approved contraceptive use during the study.
Item
women who are pregnant, lactating or of childbearing age who do not consent to approved contraceptive use during the study.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0558080 (UMLS CUI [3,3])
abnormal blood tests, performed during the screening visit including: hepatitis b or hepatitis c, alt or ast greater than two times the upper limit of normal, abnormal glucose fasting levels or already known diabetes
Item
abnormal blood tests, performed during the screening visit including: hepatitis b or hepatitis c, alt or ast greater than two times the upper limit of normal, abnormal glucose fasting levels or already known diabetes
boolean
C0178913 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
C1710032 (UMLS CUI [1,4])
C0744837 (UMLS CUI [2,1])
C0205161 (UMLS CUI [2,2])
C0850489 (UMLS CUI [3,1])
C0205161 (UMLS CUI [3,2])
C0201836 (UMLS CUI [4,1])
C0205161 (UMLS CUI [4,2])
C0201899 (UMLS CUI [5,1])
C0205161 (UMLS CUI [5,2])
C0583513 (UMLS CUI [6,1])
C0205161 (UMLS CUI [6,2])
C0011849 (UMLS CUI [7])
history of depression while on ifnβ-1a i.m.
Item
history of depression while on ifnβ-1a i.m.
boolean
C0205156 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0011581 (UMLS CUI [1,3])
C0041755 (UMLS CUI [1,4])
C0254119 (UMLS CUI [1,5])
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