ID

44610

Description

ODM derived from http://clinicaltrials.gov/show/NCT01064401

Link

http://clinicaltrials.gov/show/NCT01064401

Keywords

Versions (3)
  1. 12/7/13 12/7/13 - Martin Dugas
  2. 4/17/14 4/17/14 - Julian Varghese
  3. 9/27/21 9/27/21 -
Uploaded on

September 27, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility DRKS00000438 NCT01064401 Relapsing Remitting Multiple Sclerosis

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age 18 Years to 55 Years
Description

age 18 Years to 55 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Informed Consent
Description

Must be 18 to 55 years of age, inclusive, at the time of consent

Data type

boolean

Alias
UMLS CUI 2011AA
C0021430
Must have a confirmed diagnosis of RRMS, and a cranial MRI demonstrating lesion(s) consistent with MS
Description

Must have a confirmed diagnosis of RRMS, and a cranial MRI demonstrating lesion(s) consistent with MS

Data type

boolean

Alias
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0751967
SNOMED CT 2011_0131
426373005
MedDRA 14.1
10063399
UMLS CUI 2011AA
C0881827
LOINC Version 232
24590-2
UMLS CUI 2011AA
C0221198
SNOMED CT 2011_0131
49755003
UMLS CUI 2011AA
C0332290
SNOMED CT 2011_0131
385433004
UMLS CUI 2011AA
C0026769
SNOMED CT 2011_0131
24700007
MedDRA 14.1
10028245
LOINC Version 232
MTHU020805
ICD-10-CM Version 2010
G35
ICD-9-CM Version 2011
340
Must have a baseline EDSS between 0.0 and 5.0, inclusive
Description

Must have a baseline EDSS between 0.0 and 5.0, inclusive

Data type

boolean

Alias
UMLS CUI 2011AA
C1442488
UMLS CUI 2011AA
C0451246
SNOMED CT 2011_0131
273554001
Male subjects and female subjects of childbearing potential must be willing to practice effective contraception during the study and be willing and able to continue contraception for 4 months after their last dose of study treatment
Description

Male subjects and female subjects of childbearing potential must be willing to practice effective contraception during the study and be willing and able to continue contraception for 4 months after their last dose of study treatment

Data type

boolean

Alias
UMLS CUI 2011AA
C0086582
SNOMED CT 2011_0131
248153007
HL7 V3 2006_05
M
UMLS CUI 2011AA
C0086287
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0600109
SNOMED CT 2011_0131
225466006
UMLS CUI 2011AA
C0085732
SNOMED CT 2011_0131
371150009
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Known intolerance, contraindication to, or history of non compliance with Avonex 30 mcg
Description

Known intolerance, contraindication to, or history of non compliance with Avonex 30 mcg

Data type

boolean

Alias
UMLS CUI 2011AA
C1744706
UMLS CUI 2011AA
C1301624
SNOMED CT 2011_0131
397745006
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0457432
SNOMED CT 2011_0131
258143003
UMLS CUI 2011AA
C0982234
History of treatment with Dac HYP
Description

History of treatment with Dac HYP

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0663182
SNOMED CT 2011_0131
386977009
History of neoplastic disease
Description

History of malignancy

Data type

boolean

Alias
UMLS CUI 2011AA
C0006826
LOINC Version 232
MTHU034770
History of severe allergic or anaphylactic reactions
Description

History of severe allergic or anaphylactic reactions

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
UMLS CUI 2011AA
C1527304
SNOMED CT 2011_0131
421668005
MedDRA 14.1
10001718
ICD-10-CM Version 2010
T78.40
UMLS CUI 2011AA
C0002792
SNOMED CT 2011_0131
39579001
MedDRA 14.1
10002199
ICD-10-CM Version 2010
T78.2
CTCAE 1105E
E11254
Known hypersensitivity to study drugs or their excipients
Description

Known hypersensitivity to study drugs or their excipients

Data type

boolean

Alias
UMLS CUI 2011AA
C0020517
SNOMED CT 2011_0131
418634005
ICD-10-CM Version 2010
T78.40
UMLS CUI 2011AA
C0304229
SNOMED CT 2011_0131
902003
UMLS CUI 2011AA
C0015237
SNOMED CT 2011_0131
360215002
History of abnormal laboratory results indicative of any significant disease
Description

History of abnormal laboratory results indicative of any significant disease

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0438215
SNOMED CT 2011_0131
165346000
MedDRA 14.1
10023547
UMLS CUI 2011AA
CL335836
UMLS CUI 2011AA
C0750502
SNOMED CT 2011_0131
386134007
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
History of human immunodeficiency virus (HIV) or other immunodeficient conditions
Description

History of human immunodeficiency virus (HIV) or other immunodeficient conditions

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0019682
SNOMED CT 2011_0131
19030005
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
CL414853
UMLS CUI 2011AA
C0348080
SNOMED CT 2011_0131
260905004
HL7 V3 2006_05
COND
History of drug or alcohol abuse (as defined by the Investigator) within the 2 years prior to randomization
Description

History of drug or alcohol abuse (as defined by the Investigator) within the 2 years prior to randomization

Data type

boolean

Alias
UMLS CUI 2011AA
C0085762
History of seizure disorder or unexplained blackouts OR history of a seizure within 6 months prior to Baseline
Description

History of seizure disorder or unexplained blackouts OR history of a seizure within 6 months prior to Baseline

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0852425
MedDRA 14.1
10039912
UMLS CUI 2011AA
C0312422
SNOMED CT 2011_0131
418648005
MedDRA 14.1
10004982
ICD-10-CM Version 2010
R55
ICD-9-CM Version 2011
780.2
UMLS CUI 2011AA
C0681841
LOINC Version 232
MTHU013812
UMLS CUI 2011AA
C0686905
SNOMED CT 2011_0131
397854000
History of suicidal ideation or an episode of clinically severe depression (as determined by the Investigator) within 3 months prior to Day 1
Description

History of suicidal ideation or an episode of clinically severe depression (as determined by the Investigator) within 3 months prior to Day 1

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0424000
SNOMED CT 2011_0131
6471006
MedDRA 14.1
10042458
ICD-9-CM Version 2011
V62.84
CTCAE 1105E
E12964
UMLS CUI 2011AA
C0332189
SNOMED CT 2011_0131
272128006
UMLS CUI 2011AA
C0588008
SNOMED CT 2011_0131
310497006
An MS relapse that has occurred within the 50 days prior to randomization AND/OR the subject has not stabilized from a previous relapse prior to randomization
Description

An MS relapse that has occurred within the 50 days prior to randomization AND/OR the subject has not stabilized from a previous relapse prior to randomization

Data type

boolean

Alias
UMLS CUI 2011AA
C0751967
SNOMED CT 2011_0131
426373005
MedDRA 14.1
10063399
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C1293130
SNOMED CT 2011_0131
115979005
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
C0035020
SNOMED CT 2011_0131
263855007
Known history of, or positive screening test result for hepatitis C virus or hepatitis B virus
Description

Known history of, or positive screening test result for hepatitis C virus or hepatitis B virus

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0220847
SNOMED CT 2011_0131
62944002
MedDRA 14.1
10019752
UMLS CUI 2011AA
C0019169
SNOMED CT 2011_0131
81665004
UMLS CUI 2011AA
C1409616
UMLS CUI 2011AA
C1112419
MedDRA 14.1
10057394
UMLS CUI 2011AA
C0856706
MedDRA 14.1
10019738
Varicella or herpes zoster virus infection or any severe viral infection within 6 weeks before screening
Description

Varicella or herpes zoster virus infection or any severe viral infection within 6 weeks before screening

Data type

boolean

Alias
UMLS CUI 2011AA
C0008049
SNOMED CT 2011_0131
38907003
MedDRA 14.1
10046980
ICD-10-CM Version 2010
B01
ICD-9-CM Version 2011
52
UMLS CUI 2011AA
C0019360
SNOMED CT 2011_0131
4740000
MedDRA 14.1
10019974
ICD-10-CM Version 2010
B02
ICD-9-CM Version 2011
53
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
UMLS CUI 2011AA
C0042769
SNOMED CT 2011_0131
34014006
MedDRA 14.1
10047461
ICD-10-CM Version 2010
B34.9
Exposure to varicella zoster virus within 21 days before screening
Description

Exposure to varicella zoster virus within 21 days before screening

Data type

boolean

Alias
UMLS CUI 2011AA
C0332157
SNOMED CT 2011_0131
24932003
UMLS CUI 2011AA
C0042338
SNOMED CT 2011_0131
19551004
LOINC Version 232
MTHU002144
UMLS CUI 2011AA
C0205449
SNOMED CT 2011_0131
421291004
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1409616
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age 18 Years to 55 Years
Item
age 18 Years to 55 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Must be 18 to 55 years of age, inclusive, at the time of consent
Item
Informed Consent
boolean
C0021430 (UMLS CUI 2011AA)
Must have a confirmed diagnosis of RRMS, and a cranial MRI demonstrating lesion(s) consistent with MS
Item
Must have a confirmed diagnosis of RRMS, and a cranial MRI demonstrating lesion(s) consistent with MS
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0751967 (UMLS CUI 2011AA)
426373005 (SNOMED CT 2011_0131)
10063399 (MedDRA 14.1)
C0881827 (UMLS CUI 2011AA)
24590-2 (LOINC Version 232)
C0221198 (UMLS CUI 2011AA)
49755003 (SNOMED CT 2011_0131)
C0332290 (UMLS CUI 2011AA)
385433004 (SNOMED CT 2011_0131)
C0026769 (UMLS CUI 2011AA)
24700007 (SNOMED CT 2011_0131)
10028245 (MedDRA 14.1)
MTHU020805 (LOINC Version 232)
G35 (ICD-10-CM Version 2010)
340 (ICD-9-CM Version 2011)
Must have a baseline EDSS between 0.0 and 5.0, inclusive
Item
Must have a baseline EDSS between 0.0 and 5.0, inclusive
boolean
C1442488 (UMLS CUI 2011AA)
C0451246 (UMLS CUI 2011AA)
273554001 (SNOMED CT 2011_0131)
Male subjects and female subjects of childbearing potential must be willing to practice effective contraception during the study and be willing and able to continue contraception for 4 months after their last dose of study treatment
Item
Male subjects and female subjects of childbearing potential must be willing to practice effective contraception during the study and be willing and able to continue contraception for 4 months after their last dose of study treatment
boolean
C0086582 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0600109 (UMLS CUI 2011AA)
225466006 (SNOMED CT 2011_0131)
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Known intolerance, contraindication to, or history of non compliance with Avonex 30 mcg
Item
Known intolerance, contraindication to, or history of non compliance with Avonex 30 mcg
boolean
C1744706 (UMLS CUI 2011AA)
C1301624 (UMLS CUI 2011AA)
397745006 (SNOMED CT 2011_0131)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0457432 (UMLS CUI 2011AA)
258143003 (SNOMED CT 2011_0131)
C0982234 (UMLS CUI 2011AA)
History of treatment with Dac HYP
Item
History of treatment with Dac HYP
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0663182 (UMLS CUI 2011AA)
386977009 (SNOMED CT 2011_0131)
History of malignancy
Item
History of neoplastic disease
boolean
C0006826 (UMLS CUI 2011AA)
MTHU034770 (LOINC Version 232)
History of severe allergic or anaphylactic reactions
Item
History of severe allergic or anaphylactic reactions
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C1527304 (UMLS CUI 2011AA)
421668005 (SNOMED CT 2011_0131)
10001718 (MedDRA 14.1)
T78.40 (ICD-10-CM Version 2010)
C0002792 (UMLS CUI 2011AA)
39579001 (SNOMED CT 2011_0131)
10002199 (MedDRA 14.1)
T78.2 (ICD-10-CM Version 2010)
E11254 (CTCAE 1105E)
Known hypersensitivity to study drugs or their excipients
Item
Known hypersensitivity to study drugs or their excipients
boolean
C0020517 (UMLS CUI 2011AA)
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0304229 (UMLS CUI 2011AA)
902003 (SNOMED CT 2011_0131)
C0015237 (UMLS CUI 2011AA)
360215002 (SNOMED CT 2011_0131)
History of abnormal laboratory results indicative of any significant disease
Item
History of abnormal laboratory results indicative of any significant disease
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0438215 (UMLS CUI 2011AA)
165346000 (SNOMED CT 2011_0131)
10023547 (MedDRA 14.1)
CL335836 (UMLS CUI 2011AA)
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
History of human immunodeficiency virus (HIV) or other immunodeficient conditions
Item
History of human immunodeficiency virus (HIV) or other immunodeficient conditions
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0019682 (UMLS CUI 2011AA)
19030005 (SNOMED CT 2011_0131)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
CL414853 (UMLS CUI 2011AA)
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
History of drug or alcohol abuse (as defined by the Investigator) within the 2 years prior to randomization
Item
History of drug or alcohol abuse (as defined by the Investigator) within the 2 years prior to randomization
boolean
C0085762 (UMLS CUI 2011AA)
History of seizure disorder or unexplained blackouts OR history of a seizure within 6 months prior to Baseline
Item
History of seizure disorder or unexplained blackouts OR history of a seizure within 6 months prior to Baseline
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0852425 (UMLS CUI 2011AA)
10039912 (MedDRA 14.1)
C0312422 (UMLS CUI 2011AA)
418648005 (SNOMED CT 2011_0131)
10004982 (MedDRA 14.1)
R55 (ICD-10-CM Version 2010)
780.2 (ICD-9-CM Version 2011)
C0681841 (UMLS CUI 2011AA)
MTHU013812 (LOINC Version 232)
C0686905 (UMLS CUI 2011AA)
397854000 (SNOMED CT 2011_0131)
History of suicidal ideation or an episode of clinically severe depression (as determined by the Investigator) within 3 months prior to Day 1
Item
History of suicidal ideation or an episode of clinically severe depression (as determined by the Investigator) within 3 months prior to Day 1
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0424000 (UMLS CUI 2011AA)
6471006 (SNOMED CT 2011_0131)
10042458 (MedDRA 14.1)
V62.84 (ICD-9-CM Version 2011)
E12964 (CTCAE 1105E)
C0332189 (UMLS CUI 2011AA)
272128006 (SNOMED CT 2011_0131)
C0588008 (UMLS CUI 2011AA)
310497006 (SNOMED CT 2011_0131)
An MS relapse that has occurred within the 50 days prior to randomization AND/OR the subject has not stabilized from a previous relapse prior to randomization
Item
An MS relapse that has occurred within the 50 days prior to randomization AND/OR the subject has not stabilized from a previous relapse prior to randomization
boolean
C0751967 (UMLS CUI 2011AA)
426373005 (SNOMED CT 2011_0131)
10063399 (MedDRA 14.1)
C1518422 (UMLS CUI 2011AA)
C1293130 (UMLS CUI 2011AA)
115979005 (SNOMED CT 2011_0131)
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C0035020 (UMLS CUI 2011AA)
263855007 (SNOMED CT 2011_0131)
Known history of, or positive screening test result for hepatitis C virus or hepatitis B virus
Item
Known history of, or positive screening test result for hepatitis C virus or hepatitis B virus
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0220847 (UMLS CUI 2011AA)
62944002 (SNOMED CT 2011_0131)
10019752 (MedDRA 14.1)
C0019169 (UMLS CUI 2011AA)
81665004 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
C1112419 (UMLS CUI 2011AA)
10057394 (MedDRA 14.1)
C0856706 (UMLS CUI 2011AA)
10019738 (MedDRA 14.1)
Varicella or herpes zoster virus infection or any severe viral infection within 6 weeks before screening
Item
Varicella or herpes zoster virus infection or any severe viral infection within 6 weeks before screening
boolean
C0008049 (UMLS CUI 2011AA)
38907003 (SNOMED CT 2011_0131)
10046980 (MedDRA 14.1)
B01 (ICD-10-CM Version 2010)
52 (ICD-9-CM Version 2011)
C0019360 (UMLS CUI 2011AA)
4740000 (SNOMED CT 2011_0131)
10019974 (MedDRA 14.1)
B02 (ICD-10-CM Version 2010)
53 (ICD-9-CM Version 2011)
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0042769 (UMLS CUI 2011AA)
34014006 (SNOMED CT 2011_0131)
10047461 (MedDRA 14.1)
B34.9 (ICD-10-CM Version 2010)
Exposure to varicella zoster virus within 21 days before screening
Item
Exposure to varicella zoster virus within 21 days before screening
boolean
C0332157 (UMLS CUI 2011AA)
24932003 (SNOMED CT 2011_0131)
C0042338 (UMLS CUI 2011AA)
19551004 (SNOMED CT 2011_0131)
MTHU002144 (LOINC Version 232)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
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