ID

36506

Description

Adrenocorticotropic Hormone (ACTH) Effects on Myelination in Subjects With MS; ODM derived from: https://clinicaltrials.gov/show/NCT02446886

Link

https://clinicaltrials.gov/show/NCT02446886

Keywords

Versions (1)
  1. 5/18/19 5/18/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 18, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT02446886

English

Eligibility Multiple Sclerosis NCT02446886

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with rrms or spms with new contrast-enhancing lesions who will start as part of their standard of care acth.
Description

Multiple Sclerosis, Relapsing-Remitting | Multiple Sclerosis, Secondary Progressive | Enhancing Lesion New | Standard of Care Corticotropin

Data type

boolean

Alias
UMLS CUI [1]
C0751967
UMLS CUI [2]
C0751965
UMLS CUI [3,1]
C3830314
UMLS CUI [3,2]
C0205314
UMLS CUI [4,1]
C2936643
UMLS CUI [4,2]
C0001655
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients having received oral or iv corticosteroids within one month prior to initial scan demonstrating contrast enhancing lesion
Description

Adrenal Cortex Hormones Oral | Adrenal Cortex Hormones Intravenous | Enhancing Lesion

Data type

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C1527415
UMLS CUI [2,1]
C0001617
UMLS CUI [2,2]
C1522726
UMLS CUI [3]
C3830314
patients with known or new allergy to acth
Description

Hypersensitivity Corticotropin

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0001655
patients being treated with natalizumab, rituximab, and cyclophosphamide
Description

natalizumab | rituximab | Cyclophosphamide

Data type

boolean

Alias
UMLS CUI [1]
C1172734
UMLS CUI [2]
C0393022
UMLS CUI [3]
C0010583
patients unwilling to have serial mri exams
Description

MRI Repeated Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C0024485
UMLS CUI [1,2]
C0205341
UMLS CUI [1,3]
C0558080
patients unable to undergo mri imaging because of having an artificial heart valve, metal plate, pin, or other metallic objects in their body or is unable to complete all the mri scans required for this study
Description

MRI Receive Unable | Heart Valve Prosthesis | Metal plate | Pins | Metallic Object Body | MRI scan Completion Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0024485
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C1299582
UMLS CUI [2]
C0018825
UMLS CUI [3]
C0013866
UMLS CUI [4]
C1168556
UMLS CUI [5,1]
C2826620
UMLS CUI [5,2]
C1318419
UMLS CUI [6,1]
C0024485
UMLS CUI [6,2]
C0205197
UMLS CUI [6,3]
C1299582
patients with acute or chronic renal disease in whom administration of gadolinium may pose risk of nephrogenic systemic fibrosis
Description

Kidney Disease | Chronic Kidney Disease | Gadolinium At risk Nephrogenic Systemic Fibrosis

Data type

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2]
C1561643
UMLS CUI [3,1]
C0016911
UMLS CUI [3,2]
C1444641
UMLS CUI [3,3]
C3888044
patients that are pregnant
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
premenopausal woman not willing to use at least one form of contraception
Description

Premenopausal state Contraceptive methods Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C0232969
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0558080
patients with a known history of diabetes mellitus
Description

Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1]
C0011849
patients with a known history of osteoporosis or bone density values in the osteoporosis range at screening
Description

Osteoporosis | Bone Density Range Osteoporosis

Data type

boolean

Alias
UMLS CUI [1]
C0029456
UMLS CUI [2,1]
C0005938
UMLS CUI [2,2]
C1514721
UMLS CUI [2,3]
C0029456
progressive neurological disorder other than rrms or spms
Description

Nervous system disorder Progressive | Exception Relapsing-Remitting Multiple Sclerosis | Exception Secondary Progressive Multiple Sclerosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0027765
UMLS CUI [1,2]
C0205329
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0751967
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0751965
clinically significant cardiovascular disease, including myocardial infarct within last 6 months, unstable ischemic heart disease, congestive heart failure, or angina
Description

Cardiovascular Disease | Myocardial Infarction | Myocardial Ischemia Unstable | Congestive heart failure | Angina Pectoris

Data type

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0027051
UMLS CUI [3,1]
C0151744
UMLS CUI [3,2]
C0443343
UMLS CUI [4]
C0018802
UMLS CUI [5]
C0002962
subjects on chronic steroid therapy for treatment of ms or other systematic disease
Description

Steroid therapy chronic Multiple Sclerosis | Steroid therapy chronic Systemic disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0149783
UMLS CUI [1,2]
C0205191
UMLS CUI [1,3]
C0026769
UMLS CUI [2,1]
C0149783
UMLS CUI [2,2]
C0205191
UMLS CUI [2,3]
C0442893
subject currently has a significant medical condition (other than ms) including the following: neurological, psychiatric, metabolic, hepatic, renal, hematological, pulmonary, cardiovascular (including uncontrolled hypertension), gastrointestinal, urological disorder, or central nervous system (cns) infection that would pose a risk to the subject if they were to participate in the study or that might confound the results of the study
Description

Medical condition Study Subject Participation Status At risk | Medical condition Interferes with Research results | Exception Multiple Sclerosis | Nervous system disorder | Mental disorder | Metabolic Disease | Liver disease | Kidney Disease | Hematological Disease | Lung disease | Cardiovascular Disease | Uncontrolled hypertension | Gastrointestinal Disease | Urologic Disease | Central Nervous System Infection

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1444641
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0683954
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0026769
UMLS CUI [4]
C0027765
UMLS CUI [5]
C0004936
UMLS CUI [6]
C0025517
UMLS CUI [7]
C0023895
UMLS CUI [8]
C0022658
UMLS CUI [9]
C0018939
UMLS CUI [10]
C0024115
UMLS CUI [11]
C0007222
UMLS CUI [12]
C1868885
UMLS CUI [13]
C0017178
UMLS CUI [14]
C0042075
UMLS CUI [15]
C0007684
o note: active medical conditions that are minor or well-controlled are not exclusionary if, in the judgment of the primary investigator, they do not affect risk or the subject or the study results.
Description

Medical condition Minor Eligible | Medical condition Well controlled Eligible

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205165
UMLS CUI [1,3]
C1548635
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C3853142
UMLS CUI [2,3]
C1548635
subject is unable to cooperate with any study procedures, unlikely to adhere to the study procedures and keep appointments, in the opinion of the investigator, or was planning to relocate during the study
Description

Protocol Compliance Unable | Protocol Compliance Unlikely | Relocation of home Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C0750558
UMLS CUI [3,1]
C2699029
UMLS CUI [3,2]
C1301732
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Similar models

Eligibility Multiple Sclerosis NCT02446886

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Sclerosis, Relapsing-Remitting | Multiple Sclerosis, Secondary Progressive | Enhancing Lesion New | Standard of Care Corticotropin
Item
patients with rrms or spms with new contrast-enhancing lesions who will start as part of their standard of care acth.
boolean
C0751967 (UMLS CUI [1])
C0751965 (UMLS CUI [2])
C3830314 (UMLS CUI [3,1])
C0205314 (UMLS CUI [3,2])
C2936643 (UMLS CUI [4,1])
C0001655 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
Adrenal Cortex Hormones Oral | Adrenal Cortex Hormones Intravenous | Enhancing Lesion
Item
patients having received oral or iv corticosteroids within one month prior to initial scan demonstrating contrast enhancing lesion
boolean
C0001617 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0001617 (UMLS CUI [2,1])
C1522726 (UMLS CUI [2,2])
C3830314 (UMLS CUI [3])
Hypersensitivity Corticotropin
Item
patients with known or new allergy to acth
boolean
C0020517 (UMLS CUI [1,1])
C0001655 (UMLS CUI [1,2])
natalizumab | rituximab | Cyclophosphamide
Item
patients being treated with natalizumab, rituximab, and cyclophosphamide
boolean
C1172734 (UMLS CUI [1])
C0393022 (UMLS CUI [2])
C0010583 (UMLS CUI [3])
MRI Repeated Unwilling
Item
patients unwilling to have serial mri exams
boolean
C0024485 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
MRI Receive Unable | Heart Valve Prosthesis | Metal plate | Pins | Metallic Object Body | MRI scan Completion Unable
Item
patients unable to undergo mri imaging because of having an artificial heart valve, metal plate, pin, or other metallic objects in their body or is unable to complete all the mri scans required for this study
boolean
C0024485 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0018825 (UMLS CUI [2])
C0013866 (UMLS CUI [3])
C1168556 (UMLS CUI [4])
C2826620 (UMLS CUI [5,1])
C1318419 (UMLS CUI [5,2])
C0024485 (UMLS CUI [6,1])
C0205197 (UMLS CUI [6,2])
C1299582 (UMLS CUI [6,3])
Kidney Disease | Chronic Kidney Disease | Gadolinium At risk Nephrogenic Systemic Fibrosis
Item
patients with acute or chronic renal disease in whom administration of gadolinium may pose risk of nephrogenic systemic fibrosis
boolean
C0022658 (UMLS CUI [1])
C1561643 (UMLS CUI [2])
C0016911 (UMLS CUI [3,1])
C1444641 (UMLS CUI [3,2])
C3888044 (UMLS CUI [3,3])
Pregnancy
Item
patients that are pregnant
boolean
C0032961 (UMLS CUI [1])
Premenopausal state Contraceptive methods Unwilling
Item
premenopausal woman not willing to use at least one form of contraception
boolean
C0232969 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
Diabetes Mellitus
Item
patients with a known history of diabetes mellitus
boolean
C0011849 (UMLS CUI [1])
Osteoporosis | Bone Density Range Osteoporosis
Item
patients with a known history of osteoporosis or bone density values in the osteoporosis range at screening
boolean
C0029456 (UMLS CUI [1])
C0005938 (UMLS CUI [2,1])
C1514721 (UMLS CUI [2,2])
C0029456 (UMLS CUI [2,3])
Nervous system disorder Progressive | Exception Relapsing-Remitting Multiple Sclerosis | Exception Secondary Progressive Multiple Sclerosis
Item
progressive neurological disorder other than rrms or spms
boolean
C0027765 (UMLS CUI [1,1])
C0205329 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0751967 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0751965 (UMLS CUI [3,2])
Cardiovascular Disease | Myocardial Infarction | Myocardial Ischemia Unstable | Congestive heart failure | Angina Pectoris
Item
clinically significant cardiovascular disease, including myocardial infarct within last 6 months, unstable ischemic heart disease, congestive heart failure, or angina
boolean
C0007222 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0151744 (UMLS CUI [3,1])
C0443343 (UMLS CUI [3,2])
C0018802 (UMLS CUI [4])
C0002962 (UMLS CUI [5])
Steroid therapy chronic Multiple Sclerosis | Steroid therapy chronic Systemic disease
Item
subjects on chronic steroid therapy for treatment of ms or other systematic disease
boolean
C0149783 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0026769 (UMLS CUI [1,3])
C0149783 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0442893 (UMLS CUI [2,3])
Medical condition Study Subject Participation Status At risk | Medical condition Interferes with Research results | Exception Multiple Sclerosis | Nervous system disorder | Mental disorder | Metabolic Disease | Liver disease | Kidney Disease | Hematological Disease | Lung disease | Cardiovascular Disease | Uncontrolled hypertension | Gastrointestinal Disease | Urologic Disease | Central Nervous System Infection
Item
subject currently has a significant medical condition (other than ms) including the following: neurological, psychiatric, metabolic, hepatic, renal, hematological, pulmonary, cardiovascular (including uncontrolled hypertension), gastrointestinal, urological disorder, or central nervous system (cns) infection that would pose a risk to the subject if they were to participate in the study or that might confound the results of the study
boolean
C3843040 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0683954 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0026769 (UMLS CUI [3,2])
C0027765 (UMLS CUI [4])
C0004936 (UMLS CUI [5])
C0025517 (UMLS CUI [6])
C0023895 (UMLS CUI [7])
C0022658 (UMLS CUI [8])
C0018939 (UMLS CUI [9])
C0024115 (UMLS CUI [10])
C0007222 (UMLS CUI [11])
C1868885 (UMLS CUI [12])
C0017178 (UMLS CUI [13])
C0042075 (UMLS CUI [14])
C0007684 (UMLS CUI [15])
Medical condition Minor Eligible | Medical condition Well controlled Eligible
Item
o note: active medical conditions that are minor or well-controlled are not exclusionary if, in the judgment of the primary investigator, they do not affect risk or the subject or the study results.
boolean
C3843040 (UMLS CUI [1,1])
C0205165 (UMLS CUI [1,2])
C1548635 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C3853142 (UMLS CUI [2,2])
C1548635 (UMLS CUI [2,3])
Protocol Compliance Unable | Protocol Compliance Unlikely | Relocation of home Planned
Item
subject is unable to cooperate with any study procedures, unlikely to adhere to the study procedures and keep appointments, in the opinion of the investigator, or was planning to relocate during the study
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C0750558 (UMLS CUI [2,2])
C2699029 (UMLS CUI [3,1])
C1301732 (UMLS CUI [3,2])
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