ID

30974

Description

Real-World Betaseron Health Economic Outcomes Study for Relapsing Forms of Multiple Sclerosis; ODM derived from: https://clinicaltrials.gov/show/NCT01158183

Link

https://clinicaltrials.gov/show/NCT01158183

Keywords

Versions (1)
  1. 7/8/18 7/8/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 8, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis, Relapsing-Remitting NCT01158183

English

Eligibility Multiple Sclerosis, Relapsing-Remitting NCT01158183

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
provides written informed consent to participate in the study
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
at least 18 but no more than 65 years old
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
documented clinical diagnosis of a relapsing form of multiple sclerosis or confirmed clinically isolated syndrome (cis)
Description

Multiple sclerosis relapse | Clinically isolated syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0856120
UMLS CUI [2]
C2921627
initiating betaseron therapy, or resuming betaseron after not having used it for at least three months
Description

Betaseron Initiation | Betaseron Reuse

Data type

boolean

Alias
UMLS CUI [1,1]
C0284968
UMLS CUI [1,2]
C1704686
UMLS CUI [2,1]
C0284968
UMLS CUI [2,2]
C2699072
willing and able to provide a valid e-mail address which will be in use for the duration of the study
Description

E-mail Address Use of

Data type

boolean

Alias
UMLS CUI [1,1]
C1705961
UMLS CUI [1,2]
C1524063
willing and able to complete study questionnaires via the internet
Description

Clinical Trial Subject Questionnaire Completion Internet

Data type

boolean

Alias
UMLS CUI [1,1]
C3890411
UMLS CUI [1,2]
C0205197
UMLS CUI [1,3]
C0282111
has reliable internet access for the duration of the study
Description

Availability of Internet Access

Data type

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C0282111
UMLS CUI [1,3]
C0444454
completes the baseline patient questionnaire
Description

Complete Patient Questionnaire Baseline

Data type

boolean

Alias
UMLS CUI [1,1]
C4289751
UMLS CUI [1,2]
C1442488
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
kurtzke expanded disability status scale (edss) score greater than 6.0
Description

EDSS

Data type

boolean

Alias
UMLS CUI [1]
C0451246
cognitive dysfunction that, in the investigator's judgment, raises doubts about the study participant's ability to provide informed consent or accurately complete the monthly patient questionnaire
Description

Impaired cognition Informed Consent Unlikely | Impaired cognition Complete Patient Questionnaire Unlikely

Data type

boolean

Alias
UMLS CUI [1,1]
C0338656
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C0750558
UMLS CUI [2,1]
C0338656
UMLS CUI [2,2]
C4289751
UMLS CUI [2,3]
C0750558
any use of betaseron within the three months prior to study entry
Description

Betaseron Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C0284968
UMLS CUI [1,2]
C0205156
inability to read, write, or speak the english language
Description

Lacking Able to read English Language | Lacking Able to write English Language | Lacking Able to speak English Language

Data type

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C0586740
UMLS CUI [1,3]
C0376245
UMLS CUI [2,1]
C0332268
UMLS CUI [2,2]
C0584993
UMLS CUI [2,3]
C0376245
UMLS CUI [3,1]
C0332268
UMLS CUI [3,2]
C0564215
UMLS CUI [3,3]
C0376245
illness or disease other than multiple sclerosis that the investigator believes is likely to cause the patient's death or incapacity within twelve months
Description

Illness Causing Patient Death | Disease Causing Patient Death | Illness Causing Patient Incapacity | Disease Causing Patient Incapacity | Exception Multiple Sclerosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0678227
UMLS CUI [1,3]
C0030705
UMLS CUI [1,4]
C0011065
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0678227
UMLS CUI [2,3]
C0030705
UMLS CUI [2,4]
C0011065
UMLS CUI [3,1]
C0221423
UMLS CUI [3,2]
C0678227
UMLS CUI [3,3]
C0030705
UMLS CUI [3,4]
C3176592
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C0678227
UMLS CUI [4,3]
C0030705
UMLS CUI [4,4]
C3176592
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0026769
any severe, uncontrolled illness or condition that the investigator believes could dominate the patient's quality of life
Description

Illness Severe Uncontrolled | Condition Severe Uncontrolled | Impact Patient Quality of life

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0205318
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C0205318
UMLS CUI [3,1]
C4049986
UMLS CUI [3,2]
C0030705
UMLS CUI [3,3]
C0034380
coexistent autoimmune disease such as rheumatoid arthritis, lupus, or psoriasis that is likely to be exacerbated by treatment with interferon
Description

Autoimmune Disease | Rheumatoid Arthritis | Lupus Erythematosus | Psoriasis | Exacerbation Due to Interferon

Data type

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2]
C0003873
UMLS CUI [3]
C0409974
UMLS CUI [4]
C0033860
UMLS CUI [5,1]
C4086268
UMLS CUI [5,2]
C0678226
UMLS CUI [5,3]
C3652465
current use of any immunosuppressive medication
Description

Immunosuppressive Agents

Data type

boolean

Alias
UMLS CUI [1]
C0021081
previous participation in a multiple sclerosis (ms) clinical trial within the three months prior to study entry
Description

Study Subject Participation Status | Multiple Sclerosis

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0026769
previous use of monoclonal antibodies treating ms within the three months prior to study entry
Description

Monoclonal Antibodies Multiple Sclerosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0003250
UMLS CUI [1,2]
C0026769
current use of any secondary treatment for multiple sclerosis other than the episodic use of steroids during relapses or exacerbations
Description

Therapeutic procedure Secondary Multiple Sclerosis | Exception Steroids Relapse | Exception Steroids Exacerbation

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0175668
UMLS CUI [1,3]
C0026769
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0038317
UMLS CUI [2,3]
C0035020
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0038317
UMLS CUI [3,3]
C4086268
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Similar models

Eligibility Multiple Sclerosis, Relapsing-Remitting NCT01158183

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
provides written informed consent to participate in the study
boolean
C0021430 (UMLS CUI [1])
Age
Item
at least 18 but no more than 65 years old
boolean
C0001779 (UMLS CUI [1])
Multiple sclerosis relapse | Clinically isolated syndrome
Item
documented clinical diagnosis of a relapsing form of multiple sclerosis or confirmed clinically isolated syndrome (cis)
boolean
C0856120 (UMLS CUI [1])
C2921627 (UMLS CUI [2])
Betaseron Initiation | Betaseron Reuse
Item
initiating betaseron therapy, or resuming betaseron after not having used it for at least three months
boolean
C0284968 (UMLS CUI [1,1])
C1704686 (UMLS CUI [1,2])
C0284968 (UMLS CUI [2,1])
C2699072 (UMLS CUI [2,2])
E-mail Address Use of
Item
willing and able to provide a valid e-mail address which will be in use for the duration of the study
boolean
C1705961 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
Clinical Trial Subject Questionnaire Completion Internet
Item
willing and able to complete study questionnaires via the internet
boolean
C3890411 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0282111 (UMLS CUI [1,3])
Availability of Internet Access
Item
has reliable internet access for the duration of the study
boolean
C0470187 (UMLS CUI [1,1])
C0282111 (UMLS CUI [1,2])
C0444454 (UMLS CUI [1,3])
Complete Patient Questionnaire Baseline
Item
completes the baseline patient questionnaire
boolean
C4289751 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
EDSS
Item
kurtzke expanded disability status scale (edss) score greater than 6.0
boolean
C0451246 (UMLS CUI [1])
Impaired cognition Informed Consent Unlikely | Impaired cognition Complete Patient Questionnaire Unlikely
Item
cognitive dysfunction that, in the investigator's judgment, raises doubts about the study participant's ability to provide informed consent or accurately complete the monthly patient questionnaire
boolean
C0338656 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0750558 (UMLS CUI [1,3])
C0338656 (UMLS CUI [2,1])
C4289751 (UMLS CUI [2,2])
C0750558 (UMLS CUI [2,3])
Betaseron Previous
Item
any use of betaseron within the three months prior to study entry
boolean
C0284968 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Lacking Able to read English Language | Lacking Able to write English Language | Lacking Able to speak English Language
Item
inability to read, write, or speak the english language
boolean
C0332268 (UMLS CUI [1,1])
C0586740 (UMLS CUI [1,2])
C0376245 (UMLS CUI [1,3])
C0332268 (UMLS CUI [2,1])
C0584993 (UMLS CUI [2,2])
C0376245 (UMLS CUI [2,3])
C0332268 (UMLS CUI [3,1])
C0564215 (UMLS CUI [3,2])
C0376245 (UMLS CUI [3,3])
Illness Causing Patient Death | Disease Causing Patient Death | Illness Causing Patient Incapacity | Disease Causing Patient Incapacity | Exception Multiple Sclerosis
Item
illness or disease other than multiple sclerosis that the investigator believes is likely to cause the patient's death or incapacity within twelve months
boolean
C0221423 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C0030705 (UMLS CUI [1,3])
C0011065 (UMLS CUI [1,4])
C0012634 (UMLS CUI [2,1])
C0678227 (UMLS CUI [2,2])
C0030705 (UMLS CUI [2,3])
C0011065 (UMLS CUI [2,4])
C0221423 (UMLS CUI [3,1])
C0678227 (UMLS CUI [3,2])
C0030705 (UMLS CUI [3,3])
C3176592 (UMLS CUI [3,4])
C0012634 (UMLS CUI [4,1])
C0678227 (UMLS CUI [4,2])
C0030705 (UMLS CUI [4,3])
C3176592 (UMLS CUI [4,4])
C1705847 (UMLS CUI [5,1])
C0026769 (UMLS CUI [5,2])
Illness Severe Uncontrolled | Condition Severe Uncontrolled | Impact Patient Quality of life
Item
any severe, uncontrolled illness or condition that the investigator believes could dominate the patient's quality of life
boolean
C0221423 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0205318 (UMLS CUI [2,3])
C4049986 (UMLS CUI [3,1])
C0030705 (UMLS CUI [3,2])
C0034380 (UMLS CUI [3,3])
Autoimmune Disease | Rheumatoid Arthritis | Lupus Erythematosus | Psoriasis | Exacerbation Due to Interferon
Item
coexistent autoimmune disease such as rheumatoid arthritis, lupus, or psoriasis that is likely to be exacerbated by treatment with interferon
boolean
C0004364 (UMLS CUI [1])
C0003873 (UMLS CUI [2])
C0409974 (UMLS CUI [3])
C0033860 (UMLS CUI [4])
C4086268 (UMLS CUI [5,1])
C0678226 (UMLS CUI [5,2])
C3652465 (UMLS CUI [5,3])
Immunosuppressive Agents
Item
current use of any immunosuppressive medication
boolean
C0021081 (UMLS CUI [1])
Study Subject Participation Status | Multiple Sclerosis
Item
previous participation in a multiple sclerosis (ms) clinical trial within the three months prior to study entry
boolean
C2348568 (UMLS CUI [1])
C0026769 (UMLS CUI [2])
Monoclonal Antibodies Multiple Sclerosis
Item
previous use of monoclonal antibodies treating ms within the three months prior to study entry
boolean
C0003250 (UMLS CUI [1,1])
C0026769 (UMLS CUI [1,2])
Therapeutic procedure Secondary Multiple Sclerosis | Exception Steroids Relapse | Exception Steroids Exacerbation
Item
current use of any secondary treatment for multiple sclerosis other than the episodic use of steroids during relapses or exacerbations
boolean
C0087111 (UMLS CUI [1,1])
C0175668 (UMLS CUI [1,2])
C0026769 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0038317 (UMLS CUI [2,2])
C0035020 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0038317 (UMLS CUI [3,2])
C4086268 (UMLS CUI [3,3])
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