ID

36484

Description

Comparison of Brain Atrophy Rates, Cognition, and Patient-Reported Outcomes in MS Patients Using Long-term Fingolimod and Glatiramer Acetate; ODM derived from: https://clinicaltrials.gov/show/NCT02307877

Link

https://clinicaltrials.gov/show/NCT02307877

Keywords

Versions (1)
  1. 5/17/19 5/17/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 17, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT02307877

English

Eligibility Multiple Sclerosis NCT02307877

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
must be able to provide written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
between 18-55 years of age at the time of informed consent.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
diagnosis of any form of ms as defined by the 2010 revised mcdonald criteria
Description

Multiple Sclerosis Type Any

Data type

boolean

Alias
UMLS CUI [1,1]
C0026769
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C1552551
currently taking fingolimod or glatiramer acetate for a minimum of two years at the time of the initial baseline visit
Description

fingolimod | glatiramer acetate

Data type

boolean

Alias
UMLS CUI [1]
C1699926
UMLS CUI [2]
C0289884
must be willing and able to comply with the protocol requirements for the duration of the study
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
-patients suffering from comorbidities that could confound the mri outcomes or are (relative) contraindicated to receive treatment with fingolimod such as diabetes, myocardial infarction, unstable angina, transient ischemic attack, decompensated heart failure, history of mobitz type ii 2nd or 3rd degree atrioventricular block or sick sinus syndrome, history of stroke, traumatic brain injury, encephalitis, and dementia (not related to ms).
Description

Comorbidity Interferes with MRI Result | Comorbidity Contraindicated Fingolimod | Diabetes Mellitus | Myocardial Infarction | Angina, Unstable | Transient Ischemic Attack | Decompensated cardiac failure | Mobitz type II atrioventricular block | Complete atrioventricular block | Sick Sinus Syndrome | Cerebrovascular accident | Traumatic Brain Injury | Encephalitis | Dementia Independent of Multiple Sclerosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0024485
UMLS CUI [1,4]
C1274040
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C1444657
UMLS CUI [2,3]
C1699926
UMLS CUI [3]
C0011849
UMLS CUI [4]
C0027051
UMLS CUI [5]
C0002965
UMLS CUI [6]
C0007787
UMLS CUI [7]
C0581377
UMLS CUI [8]
C0155700
UMLS CUI [9]
C0151517
UMLS CUI [10]
C0037052
UMLS CUI [11]
C0038454
UMLS CUI [12]
C0876926
UMLS CUI [13]
C0014038
UMLS CUI [14,1]
C0497327
UMLS CUI [14,2]
C0332291
UMLS CUI [14,3]
C0026769
systemic steroid used (oral or iv) within 30 days of the baseline visit.
Description

Systemic steroids Oral | Systemic steroids Intravenous

Data type

boolean

Alias
UMLS CUI [1,1]
C2825233
UMLS CUI [1,2]
C1527415
UMLS CUI [2,1]
C2825233
UMLS CUI [2,2]
C1522726
patients who were ever treated with chemotherapy.
Description

Chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0392920
patients ever having undergone cranial radiation, or intracranial surgery.
Description

Cranial Irradiation | Intracranial surgery

Data type

boolean

Alias
UMLS CUI [1]
C0079172
UMLS CUI [2]
C0745377
patients who are unable to tolerate an mri scan. -patient who is pregnant or breastfeeding or planning on pregnancy during the study period-
Description

MRI scan Receive Unable | Pregnancy | Breast Feeding | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C0024485
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C1299582
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0006147
UMLS CUI [4]
C0032992
patient who is decisionally challenged, illiterate or blind
Description

Handicap | Illiteracy | Blindness

Data type

boolean

Alias
UMLS CUI [1]
C0231172
UMLS CUI [2]
C0020899
UMLS CUI [3]
C0456909
patient is non-english speaking (as the pro instruments are only validated in english)
Description

Lacking Able to speak English Language

Data type

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C0564215
UMLS CUI [1,3]
C0376245
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Similar models

Eligibility Multiple Sclerosis NCT02307877

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
must be able to provide written informed consent
boolean
C0021430 (UMLS CUI [1])
Age
Item
between 18-55 years of age at the time of informed consent.
boolean
C0001779 (UMLS CUI [1])
Multiple Sclerosis Type Any
Item
diagnosis of any form of ms as defined by the 2010 revised mcdonald criteria
boolean
C0026769 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
fingolimod | glatiramer acetate
Item
currently taking fingolimod or glatiramer acetate for a minimum of two years at the time of the initial baseline visit
boolean
C1699926 (UMLS CUI [1])
C0289884 (UMLS CUI [2])
Protocol Compliance
Item
must be willing and able to comply with the protocol requirements for the duration of the study
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Comorbidity Interferes with MRI Result | Comorbidity Contraindicated Fingolimod | Diabetes Mellitus | Myocardial Infarction | Angina, Unstable | Transient Ischemic Attack | Decompensated cardiac failure | Mobitz type II atrioventricular block | Complete atrioventricular block | Sick Sinus Syndrome | Cerebrovascular accident | Traumatic Brain Injury | Encephalitis | Dementia Independent of Multiple Sclerosis
Item
-patients suffering from comorbidities that could confound the mri outcomes or are (relative) contraindicated to receive treatment with fingolimod such as diabetes, myocardial infarction, unstable angina, transient ischemic attack, decompensated heart failure, history of mobitz type ii 2nd or 3rd degree atrioventricular block or sick sinus syndrome, history of stroke, traumatic brain injury, encephalitis, and dementia (not related to ms).
boolean
C0009488 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0024485 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,4])
C0009488 (UMLS CUI [2,1])
C1444657 (UMLS CUI [2,2])
C1699926 (UMLS CUI [2,3])
C0011849 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
C0002965 (UMLS CUI [5])
C0007787 (UMLS CUI [6])
C0581377 (UMLS CUI [7])
C0155700 (UMLS CUI [8])
C0151517 (UMLS CUI [9])
C0037052 (UMLS CUI [10])
C0038454 (UMLS CUI [11])
C0876926 (UMLS CUI [12])
C0014038 (UMLS CUI [13])
C0497327 (UMLS CUI [14,1])
C0332291 (UMLS CUI [14,2])
C0026769 (UMLS CUI [14,3])
Systemic steroids Oral | Systemic steroids Intravenous
Item
systemic steroid used (oral or iv) within 30 days of the baseline visit.
boolean
C2825233 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C2825233 (UMLS CUI [2,1])
C1522726 (UMLS CUI [2,2])
Chemotherapy
Item
patients who were ever treated with chemotherapy.
boolean
C0392920 (UMLS CUI [1])
Cranial Irradiation | Intracranial surgery
Item
patients ever having undergone cranial radiation, or intracranial surgery.
boolean
C0079172 (UMLS CUI [1])
C0745377 (UMLS CUI [2])
MRI scan Receive Unable | Pregnancy | Breast Feeding | Pregnancy, Planned
Item
patients who are unable to tolerate an mri scan. -patient who is pregnant or breastfeeding or planning on pregnancy during the study period-
boolean
C0024485 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0032961 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
C0032992 (UMLS CUI [4])
Handicap | Illiteracy | Blindness
Item
patient who is decisionally challenged, illiterate or blind
boolean
C0231172 (UMLS CUI [1])
C0020899 (UMLS CUI [2])
C0456909 (UMLS CUI [3])
Lacking Able to speak English Language
Item
patient is non-english speaking (as the pro instruments are only validated in english)
boolean
C0332268 (UMLS CUI [1,1])
C0564215 (UMLS CUI [1,2])
C0376245 (UMLS CUI [1,3])
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