ID

37016

Description

Study to Explore the Onset of Efficacy on Magnetic Resonance Disease Activity of BG00012 (Dimethyl Fumarate) in Patients With Relapsing remitTing Multiple Sclerosis; ODM derived from: https://clinicaltrials.gov/show/NCT02472938

Link

https://clinicaltrials.gov/show/NCT02472938

Keywords

  1. 6/30/19 6/30/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 30, 2019

DOI

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License

Creative Commons BY 4.0

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Eligibility Relapsing Remitting Multiple Sclerosis NCT02472938

Eligibility Relapsing Remitting Multiple Sclerosis NCT02472938

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
to be eligible to participate in this study, candidates must meet all the following eligibility criteria atthe screening visit (v0)and at baseline (v1):
Description

Inclusion criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1550543
ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected information in accordance with local subject privacy regulations.
Description

Informed Consent | Authorization Use of Patient data

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0680281
UMLS CUI [2,2]
C1524063
UMLS CUI [2,3]
C2707520
patients with rrms (mcdonald criteria, 2010) who do not accept current injectable firstline dmts.
Description

Multiple Sclerosis, Relapsing-Remitting | Biological Response Modifier Therapy Rejected

Data type

boolean

Alias
UMLS CUI [1]
C0751967
UMLS CUI [2,1]
C0005527
UMLS CUI [2,2]
C1548437
age between 18 and 50 years at the time of informed consent.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
ms onset within one year before enrolment
Description

Onset of Multiple Sclerosis Recent

Data type

boolean

Alias
UMLS CUI [1,1]
C0332162
UMLS CUI [1,2]
C0026769
UMLS CUI [1,3]
C0332185
≥ 1 gd+ lesions at a brain mri scan performed within three months beforeenrolment.
Description

Gadolinium-Enhancing Lesion MRI scan brain

Data type

boolean

Alias
UMLS CUI [1,1]
C1333400
UMLS CUI [1,2]
C0412675
no previous disease modifying and/or immunosuppressive treatments for ms.
Description

Biological Response Modifier Therapy Absent Multiple Sclerosis | Therapeutic immunosuppression Absent Multiple Sclerosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0005527
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0026769
UMLS CUI [2,1]
C0021079
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0026769
must have a baseline edss between 0.0 and 5.0, inclusive. · women of childbearing potential (i.e. who are not post-menopausal for at least 1 year) and men must practice effective contraception (as defined by the investigator) during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment.
Description

EDSS | Childbearing Potential Contraceptive methods | Postmenopausal state Absent | Gender Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C0451246
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [3,1]
C0232970
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
candidates will be excluded from study entry if any of the following exclusion criteria exists at screening or baseline/randomization visit:
Description

Exclusion Criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1550543
primary progressive, secondary progressive, or progressive relapsing ms, as defined by lublin and reingold (lublin and reingold 1996)
Description

Multiple Sclerosis, Primary Progressive | Multiple Sclerosis, Secondary Progressive | Multiple Sclerosis, Progressive Relapsing

Data type

boolean

Alias
UMLS CUI [1]
C0751964
UMLS CUI [2]
C0751965
UMLS CUI [3]
C0393666
previous disease modifying and/or immunosuppressive treatments for ms, including tcell or t-cell receptor vaccination, any therapeutic monoclonal antibody, mitoxantrone, cyclophosphamide
Description

Biological Response Modifier Therapy Multiple Sclerosis | Therapeutic immunosuppression Multiple Sclerosis | T-Cell Vaccination | T-Cell Receptor Vaccination | Monoclonal Antibodies | Mitoxantrone | Cyclophosphamide

Data type

boolean

Alias
UMLS CUI [1,1]
C0005527
UMLS CUI [1,2]
C0026769
UMLS CUI [2,1]
C0021079
UMLS CUI [2,2]
C0026769
UMLS CUI [3,1]
C0039194
UMLS CUI [3,2]
C0042196
UMLS CUI [4,1]
C0034790
UMLS CUI [4,2]
C0042196
UMLS CUI [5]
C0003250
UMLS CUI [6]
C0026259
UMLS CUI [7]
C0010583
previous treatment with fumaderm®, dimethyl fumarate or other fumarates
Description

Fumaderm | dimethyl fumarate | Fumarates

Data type

boolean

Alias
UMLS CUI [1]
C0633802
UMLS CUI [2]
C0058218
UMLS CUI [3]
C0016801
history of malignancy (except basal cell carcinoma that has been completely excised prior to study enrollment)
Description

Malignant Neoplasms | Exception Complete excision Basal cell carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0015250
UMLS CUI [2,3]
C0007117
history of severe allergic or anaphylactic reactions or known drug hypersensitivity.known allergy/hypersensitivity to gadolinium.
Description

Allergic Reaction Severe | Anaphylaxis Severe | Drug Allergy | Hypersensitivity Gadolinium

Data type

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0002792
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0013182
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0016911
history of abnormal laboratory results indicative of any significant endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, renal, and/or other major disease that in the opinion of the investigator would preclude participation in a clinical trial.
Description

Laboratory test result abnormal | Endocrine System Diseases | Hematological Disease | Liver diseases | Immune System Diseases | Metabolic Diseases | Urologic Diseases | Kidney Diseases | Disease Major Study Subject Participation Status Excluded

Data type

boolean

Alias
UMLS CUI [1]
C0438215
UMLS CUI [2]
C0014130
UMLS CUI [3]
C0018939
UMLS CUI [4]
C0023895
UMLS CUI [5]
C0021053
UMLS CUI [6]
C0025517
UMLS CUI [7]
C0042075
UMLS CUI [8]
C0022658
UMLS CUI [9,1]
C0012634
UMLS CUI [9,2]
C0205164
UMLS CUI [9,3]
C2348568
UMLS CUI [9,4]
C0332196
uncontrolled intercurrent illness including, but not limited to: ongoing or active infection; symptomatic congestive heart failure; unstable angina pectoris; cardiac arrhythmia; serious or acute liver, kidney, or bone marrow dysfunction; uncontrolled diabetes; serious or acute psychiatric illness that would limit compliance with study requirements.
Description

Comorbidity Uncontrolled | Communicable Disease | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Liver di seases Serious | Liver diseases | Kidney Diseases | Bone Marrow Dysfunction | Diabetic - poor control | Mental disorders Serious | Mental disorders Limiting Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0009450
UMLS CUI [3]
C0742758
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0003811
UMLS CUI [6,1]
C0023895
UMLS CUI [6,2]
C0205404
UMLS CUI [7]
C0023895
UMLS CUI [8]
C0022658
UMLS CUI [9,1]
C0005953
UMLS CUI [9,2]
C3887504
UMLS CUI [10]
C0421258
UMLS CUI [11,1]
C0004936
UMLS CUI [11,2]
C0205404
UMLS CUI [12,1]
C0004936
UMLS CUI [12,2]
C0439801
UMLS CUI [12,3]
C0525058
history of or positive test result at screening for human immunodeficiency virus (hiv).positive for hepatitis c antibody and/or positive for hepatitis b surface antigen (hbsag) at screening.
Description

HIV Seropositivity | Hepatitis C antibody positive | Hepatitis B surface antigen positive

Data type

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0281863
UMLS CUI [3]
C0149709
history of drug or alcohol abuse (as defined by the investigator) within the 2 years prior to inclusion.
Description

Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0038586
an ms relapse that has occurred within the 30 days prior to inclusion (screening) and/or the subject has not stabilized from a previous relapse prior to inclusion.
Description

Multiple sclerosis relapse | Relapse Previous | Stabilization Lacking

Data type

boolean

Alias
UMLS CUI [1]
C0856120
UMLS CUI [2,1]
C0035020
UMLS CUI [2,2]
C0205156
UMLS CUI [3,1]
C1293130
UMLS CUI [3,2]
C0332268

Similar models

Eligibility Relapsing Remitting Multiple Sclerosis NCT02472938

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Inclusion criteria Fulfill
Item
to be eligible to participate in this study, candidates must meet all the following eligibility criteria atthe screening visit (v0)and at baseline (v1):
boolean
C1512693 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Informed Consent | Authorization Use of Patient data
Item
ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected information in accordance with local subject privacy regulations.
boolean
C0021430 (UMLS CUI [1])
C0680281 (UMLS CUI [2,1])
C1524063 (UMLS CUI [2,2])
C2707520 (UMLS CUI [2,3])
Multiple Sclerosis, Relapsing-Remitting | Biological Response Modifier Therapy Rejected
Item
patients with rrms (mcdonald criteria, 2010) who do not accept current injectable firstline dmts.
boolean
C0751967 (UMLS CUI [1])
C0005527 (UMLS CUI [2,1])
C1548437 (UMLS CUI [2,2])
Age
Item
age between 18 and 50 years at the time of informed consent.
boolean
C0001779 (UMLS CUI [1])
Onset of Multiple Sclerosis Recent
Item
ms onset within one year before enrolment
boolean
C0332162 (UMLS CUI [1,1])
C0026769 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
Gadolinium-Enhancing Lesion MRI scan brain
Item
≥ 1 gd+ lesions at a brain mri scan performed within three months beforeenrolment.
boolean
C1333400 (UMLS CUI [1,1])
C0412675 (UMLS CUI [1,2])
Biological Response Modifier Therapy Absent Multiple Sclerosis | Therapeutic immunosuppression Absent Multiple Sclerosis
Item
no previous disease modifying and/or immunosuppressive treatments for ms.
boolean
C0005527 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0026769 (UMLS CUI [1,3])
C0021079 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0026769 (UMLS CUI [2,3])
EDSS | Childbearing Potential Contraceptive methods | Postmenopausal state Absent | Gender Contraceptive methods
Item
must have a baseline edss between 0.0 and 5.0, inclusive. · women of childbearing potential (i.e. who are not post-menopausal for at least 1 year) and men must practice effective contraception (as defined by the investigator) during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment.
boolean
C0451246 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0232970 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0079399 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
Exclusion Criteria Fulfill
Item
candidates will be excluded from study entry if any of the following exclusion criteria exists at screening or baseline/randomization visit:
boolean
C0680251 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Multiple Sclerosis, Primary Progressive | Multiple Sclerosis, Secondary Progressive | Multiple Sclerosis, Progressive Relapsing
Item
primary progressive, secondary progressive, or progressive relapsing ms, as defined by lublin and reingold (lublin and reingold 1996)
boolean
C0751964 (UMLS CUI [1])
C0751965 (UMLS CUI [2])
C0393666 (UMLS CUI [3])
Biological Response Modifier Therapy Multiple Sclerosis | Therapeutic immunosuppression Multiple Sclerosis | T-Cell Vaccination | T-Cell Receptor Vaccination | Monoclonal Antibodies | Mitoxantrone | Cyclophosphamide
Item
previous disease modifying and/or immunosuppressive treatments for ms, including tcell or t-cell receptor vaccination, any therapeutic monoclonal antibody, mitoxantrone, cyclophosphamide
boolean
C0005527 (UMLS CUI [1,1])
C0026769 (UMLS CUI [1,2])
C0021079 (UMLS CUI [2,1])
C0026769 (UMLS CUI [2,2])
C0039194 (UMLS CUI [3,1])
C0042196 (UMLS CUI [3,2])
C0034790 (UMLS CUI [4,1])
C0042196 (UMLS CUI [4,2])
C0003250 (UMLS CUI [5])
C0026259 (UMLS CUI [6])
C0010583 (UMLS CUI [7])
Fumaderm | dimethyl fumarate | Fumarates
Item
previous treatment with fumaderm®, dimethyl fumarate or other fumarates
boolean
C0633802 (UMLS CUI [1])
C0058218 (UMLS CUI [2])
C0016801 (UMLS CUI [3])
Malignant Neoplasms | Exception Complete excision Basal cell carcinoma
Item
history of malignancy (except basal cell carcinoma that has been completely excised prior to study enrollment)
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0015250 (UMLS CUI [2,2])
C0007117 (UMLS CUI [2,3])
Allergic Reaction Severe | Anaphylaxis Severe | Drug Allergy | Hypersensitivity Gadolinium
Item
history of severe allergic or anaphylactic reactions or known drug hypersensitivity.known allergy/hypersensitivity to gadolinium.
boolean
C1527304 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0002792 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0013182 (UMLS CUI [3])
C0020517 (UMLS CUI [4,1])
C0016911 (UMLS CUI [4,2])
Laboratory test result abnormal | Endocrine System Diseases | Hematological Disease | Liver diseases | Immune System Diseases | Metabolic Diseases | Urologic Diseases | Kidney Diseases | Disease Major Study Subject Participation Status Excluded
Item
history of abnormal laboratory results indicative of any significant endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, renal, and/or other major disease that in the opinion of the investigator would preclude participation in a clinical trial.
boolean
C0438215 (UMLS CUI [1])
C0014130 (UMLS CUI [2])
C0018939 (UMLS CUI [3])
C0023895 (UMLS CUI [4])
C0021053 (UMLS CUI [5])
C0025517 (UMLS CUI [6])
C0042075 (UMLS CUI [7])
C0022658 (UMLS CUI [8])
C0012634 (UMLS CUI [9,1])
C0205164 (UMLS CUI [9,2])
C2348568 (UMLS CUI [9,3])
C0332196 (UMLS CUI [9,4])
Comorbidity Uncontrolled | Communicable Disease | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Liver di seases Serious | Liver diseases | Kidney Diseases | Bone Marrow Dysfunction | Diabetic - poor control | Mental disorders Serious | Mental disorders Limiting Protocol Compliance
Item
uncontrolled intercurrent illness including, but not limited to: ongoing or active infection; symptomatic congestive heart failure; unstable angina pectoris; cardiac arrhythmia; serious or acute liver, kidney, or bone marrow dysfunction; uncontrolled diabetes; serious or acute psychiatric illness that would limit compliance with study requirements.
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0742758 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0003811 (UMLS CUI [5])
C0023895 (UMLS CUI [6,1])
C0205404 (UMLS CUI [6,2])
C0023895 (UMLS CUI [7])
C0022658 (UMLS CUI [8])
C0005953 (UMLS CUI [9,1])
C3887504 (UMLS CUI [9,2])
C0421258 (UMLS CUI [10])
C0004936 (UMLS CUI [11,1])
C0205404 (UMLS CUI [11,2])
C0004936 (UMLS CUI [12,1])
C0439801 (UMLS CUI [12,2])
C0525058 (UMLS CUI [12,3])
HIV Seropositivity | Hepatitis C antibody positive | Hepatitis B surface antigen positive
Item
history of or positive test result at screening for human immunodeficiency virus (hiv).positive for hepatitis c antibody and/or positive for hepatitis b surface antigen (hbsag) at screening.
boolean
C0019699 (UMLS CUI [1])
C0281863 (UMLS CUI [2])
C0149709 (UMLS CUI [3])
Substance Use Disorders
Item
history of drug or alcohol abuse (as defined by the investigator) within the 2 years prior to inclusion.
boolean
C0038586 (UMLS CUI [1])
Multiple sclerosis relapse | Relapse Previous | Stabilization Lacking
Item
an ms relapse that has occurred within the 30 days prior to inclusion (screening) and/or the subject has not stabilized from a previous relapse prior to inclusion.
boolean
C0856120 (UMLS CUI [1])
C0035020 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C1293130 (UMLS CUI [3,1])
C0332268 (UMLS CUI [3,2])

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