ID

36504

Beschreibung

Comparison of Rebif Compared to Tecifdera on Six-month Outcomes in Patients With Relapsing-remitting MS; ODM derived from: https://clinicaltrials.gov/show/NCT02419638

Link

https://clinicaltrials.gov/show/NCT02419638

Stichworte

Versionen (2)
  1. 17.05.19 17.05.19 -
  2. 20.09.21 20.09.21 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

17. Mai 2019

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT02419638

Englisch

Eligibility Multiple Sclerosis NCT02419638

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. male and female subjects aged 18-65 years old, inclusive.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
2. a diagnosis of ms as defined by the mcdonald 2010 criteria for ms.
Beschreibung

Multiple Sclerosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0026769
3. relapsing form of ms, defined as at least one relapse in the prior 5 years.
Beschreibung

Multiple sclerosis relapse | Relapse Quantity

Datentyp

boolean

Alias
UMLS CUI [1]
C0856120
UMLS CUI [2,1]
C0035020
UMLS CUI [2,2]
C1265611
4. expanded disability status scale (edss) score of 0 to 5.5, inclusive.
Beschreibung

EDSS

Datentyp

boolean

Alias
UMLS CUI [1]
C0451246
5. english language skills adequate for the completion of questionnaires and cognitive measures.
Beschreibung

Language skills English | Questionnaires Completion | Tests Cognitive Completion

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1145677
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0034394
UMLS CUI [2,2]
C0205197
UMLS CUI [3,1]
C0392366
UMLS CUI [3,2]
C1516691
UMLS CUI [3,3]
C0205197
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. subjects with progressive ms.
Beschreibung

Progressive multiple sclerosis

Datentyp

boolean

Alias
UMLS CUI [1]
C1095979
2. subjects with a contraindications for standard treatment with rebif or tecfidera including gi disease, needle phobia, liver disease.
Beschreibung

Medical contraindication Rebif | Medical contraindication Tecfidera | Gastrointestinal Disease | Needle phobia | Liver disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0752980
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C3556178
UMLS CUI [3]
C0017178
UMLS CUI [4]
C0338906
UMLS CUI [5]
C0023895
3. subjects treated with:
Beschreibung

Therapeutic procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C0087111
high dose intravenous immunoglobulin within 2 months prior to study entry
Beschreibung

Intravenous Immunoglobulins High dose

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0085297
UMLS CUI [1,2]
C0444956
natalizumab within 3 months prior to study entry
Beschreibung

natalizumab

Datentyp

boolean

Alias
UMLS CUI [1]
C1172734
immunosuppressive/immunomodulatory medications including cyclophosphamide, mitoxantrone, azathioprine, methotrexate, rituximab, ofatumumab, ocrelizumab, or alemtuzumab at any time.
Beschreibung

Immunosuppressive Agents | Biological Response Modifiers | Cyclophosphamide | Mitoxantrone | Azathioprine | Methotrexate | rituximab | ofatumumab | ocrelizumab | alemtuzumab

Datentyp

boolean

Alias
UMLS CUI [1]
C0021081
UMLS CUI [2]
C0005525
UMLS CUI [3]
C0010583
UMLS CUI [4]
C0026259
UMLS CUI [5]
C0004482
UMLS CUI [6]
C0025677
UMLS CUI [7]
C0393022
UMLS CUI [8]
C1832027
UMLS CUI [9]
C1882138
UMLS CUI [10]
C0383429
4. subjects with absolute lymphocyte count < 800 cells (mm3).
Beschreibung

Absolute lymphocyte count

Datentyp

boolean

Alias
UMLS CUI [1]
C3544087
5. subjects with any of the following neurologic/psychiatric disorder:
Beschreibung

Nervous system disorder | Mental disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0027765
UMLS CUI [2]
C0004936
severe depression during the past 12 months before screening;
Beschreibung

Severe depression

Datentyp

boolean

Alias
UMLS CUI [1]
C0588008
history of substance abuse (treatment or alcohol) or any other factor (i.e., serious psychiatric condition) that may interfere with the subject's ability to cooperate and comply with the study procedures;
Beschreibung

Substance Use Disorders | Factor Interferes with Compliance behavior | Mental condition Serious Interferes with Compliance behavior | Factor Interferes with Protocol Compliance | Mental condition Serious Interferes with Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2,1]
C1521761
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C1321605
UMLS CUI [3,1]
C3840291
UMLS CUI [3,2]
C0205404
UMLS CUI [3,3]
C0521102
UMLS CUI [3,4]
C1321605
UMLS CUI [4,1]
C1521761
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0525058
UMLS CUI [5,1]
C3840291
UMLS CUI [5,2]
C0205404
UMLS CUI [5,3]
C0521102
UMLS CUI [5,4]
C0525058
6. subjects unable to undergo mri scans, including claustrophobia or history of hypersensitivity to gadolinium-dtpa.
Beschreibung

MRI scan Receive Unable | Claustrophobia | Hypersensitivity Gadolinium DTPA

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0024485
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C1299582
UMLS CUI [2]
C0008909
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0060933
7. pregnant or nursing females, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hcg laboratory test.
Beschreibung

Pregnancy | HCG pregnancy test Positive | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0546577
UMLS CUI [2,2]
C1514241
UMLS CUI [3]
C0006147
8. female subjects of childbearing potential, defined as all females physiologically capable of becoming pregnant, unless they agree to abstinence or, if sexually active, the use of contraception.
Beschreibung

Childbearing Potential | Childbearing Potential Sexual Abstinence | Childbearing Potential Sexually active Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0036899
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0241028
UMLS CUI [3,3]
C0700589
9. history of hypersensitivity to any of the study treatments or to treatments of similar chemical classes.
Beschreibung

Hypersensitivity Investigational Therapy | Hypersensitivity Therapy Similar

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0949266
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0087111
UMLS CUI [2,3]
C2348205
10. subjects with abnormal liver function test (lft) levels
Beschreibung

Liver function tests abnormal

Datentyp

boolean

Alias
UMLS CUI [1]
C0151766
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Ähnliche Modelle

Eligibility Multiple Sclerosis NCT02419638

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. male and female subjects aged 18-65 years old, inclusive.
boolean
C0001779 (UMLS CUI [1])
Multiple Sclerosis
Item
2. a diagnosis of ms as defined by the mcdonald 2010 criteria for ms.
boolean
C0026769 (UMLS CUI [1])
Multiple sclerosis relapse | Relapse Quantity
Item
3. relapsing form of ms, defined as at least one relapse in the prior 5 years.
boolean
C0856120 (UMLS CUI [1])
C0035020 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
EDSS
Item
4. expanded disability status scale (edss) score of 0 to 5.5, inclusive.
boolean
C0451246 (UMLS CUI [1])
Language skills English | Questionnaires Completion | Tests Cognitive Completion
Item
5. english language skills adequate for the completion of questionnaires and cognitive measures.
boolean
C1145677 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0034394 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
C0392366 (UMLS CUI [3,1])
C1516691 (UMLS CUI [3,2])
C0205197 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
Progressive multiple sclerosis
Item
1. subjects with progressive ms.
boolean
C1095979 (UMLS CUI [1])
Medical contraindication Rebif | Medical contraindication Tecfidera | Gastrointestinal Disease | Needle phobia | Liver disease
Item
2. subjects with a contraindications for standard treatment with rebif or tecfidera including gi disease, needle phobia, liver disease.
boolean
C1301624 (UMLS CUI [1,1])
C0752980 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C3556178 (UMLS CUI [2,2])
C0017178 (UMLS CUI [3])
C0338906 (UMLS CUI [4])
C0023895 (UMLS CUI [5])
Therapeutic procedure
Item
3. subjects treated with:
boolean
C0087111 (UMLS CUI [1])
Intravenous Immunoglobulins High dose
Item
high dose intravenous immunoglobulin within 2 months prior to study entry
boolean
C0085297 (UMLS CUI [1,1])
C0444956 (UMLS CUI [1,2])
natalizumab
Item
natalizumab within 3 months prior to study entry
boolean
C1172734 (UMLS CUI [1])
Immunosuppressive Agents | Biological Response Modifiers | Cyclophosphamide | Mitoxantrone | Azathioprine | Methotrexate | rituximab | ofatumumab | ocrelizumab | alemtuzumab
Item
immunosuppressive/immunomodulatory medications including cyclophosphamide, mitoxantrone, azathioprine, methotrexate, rituximab, ofatumumab, ocrelizumab, or alemtuzumab at any time.
boolean
C0021081 (UMLS CUI [1])
C0005525 (UMLS CUI [2])
C0010583 (UMLS CUI [3])
C0026259 (UMLS CUI [4])
C0004482 (UMLS CUI [5])
C0025677 (UMLS CUI [6])
C0393022 (UMLS CUI [7])
C1832027 (UMLS CUI [8])
C1882138 (UMLS CUI [9])
C0383429 (UMLS CUI [10])
Absolute lymphocyte count
Item
4. subjects with absolute lymphocyte count < 800 cells (mm3).
boolean
C3544087 (UMLS CUI [1])
Nervous system disorder | Mental disorders
Item
5. subjects with any of the following neurologic/psychiatric disorder:
boolean
C0027765 (UMLS CUI [1])
C0004936 (UMLS CUI [2])
Severe depression
Item
severe depression during the past 12 months before screening;
boolean
C0588008 (UMLS CUI [1])
Substance Use Disorders | Factor Interferes with Compliance behavior | Mental condition Serious Interferes with Compliance behavior | Factor Interferes with Protocol Compliance | Mental condition Serious Interferes with Protocol Compliance
Item
history of substance abuse (treatment or alcohol) or any other factor (i.e., serious psychiatric condition) that may interfere with the subject's ability to cooperate and comply with the study procedures;
boolean
C0038586 (UMLS CUI [1])
C1521761 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C1321605 (UMLS CUI [2,3])
C3840291 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C0521102 (UMLS CUI [3,3])
C1321605 (UMLS CUI [3,4])
C1521761 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
C3840291 (UMLS CUI [5,1])
C0205404 (UMLS CUI [5,2])
C0521102 (UMLS CUI [5,3])
C0525058 (UMLS CUI [5,4])
MRI scan Receive Unable | Claustrophobia | Hypersensitivity Gadolinium DTPA
Item
6. subjects unable to undergo mri scans, including claustrophobia or history of hypersensitivity to gadolinium-dtpa.
boolean
C0024485 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0008909 (UMLS CUI [2])
C0020517 (UMLS CUI [3,1])
C0060933 (UMLS CUI [3,2])
Pregnancy | HCG pregnancy test Positive | Breast Feeding
Item
7. pregnant or nursing females, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hcg laboratory test.
boolean
C0032961 (UMLS CUI [1])
C0546577 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C0006147 (UMLS CUI [3])
Childbearing Potential | Childbearing Potential Sexual Abstinence | Childbearing Potential Sexually active Contraceptive methods
Item
8. female subjects of childbearing potential, defined as all females physiologically capable of becoming pregnant, unless they agree to abstinence or, if sexually active, the use of contraception.
boolean
C3831118 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0036899 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0241028 (UMLS CUI [3,2])
C0700589 (UMLS CUI [3,3])
Hypersensitivity Investigational Therapy | Hypersensitivity Therapy Similar
Item
9. history of hypersensitivity to any of the study treatments or to treatments of similar chemical classes.
boolean
C0020517 (UMLS CUI [1,1])
C0949266 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C2348205 (UMLS CUI [2,3])
Liver function tests abnormal
Item
10. subjects with abnormal liver function test (lft) levels
boolean
C0151766 (UMLS CUI [1])
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