ID

44715

Description

ODM derived from http://clinicaltrials.gov/show/NCT01285401

Link

http://clinicaltrials.gov/show/NCT01285401

Keywords

Versions (3)
  1. 2/28/13 2/28/13 - Martin Dugas
  2. 4/19/14 4/19/14 - 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 NCT01285401 Relapsing-Remitting Multiple Sclerosis

German English

Eligibility

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

Inclusion Criteria

age 18 Years to 50 Years
Description

age 18 Years to 50 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Diagnosis of a relapsing-remitting form of MS
Description

Diagnosis of a relapsing-remitting form of MS

Data type

boolean

Alias
UMLS CUI 1
C0011900
UMLS CUI 1*2
C0751967
Brain and/or spinal MRI with findings typical of MS
Description

Brain and/or spinal MRI with findings typical of MS

Data type

boolean

Alias
UMLS CUI 2011AA
C0881827
LOINC Version 232
24590-2
UMLS CUI 2011AA
C0177803
SNOMED CT 2011_0131
241645008
UMLS CUI 2011AA
C0243095
UMLS CUI 2011AA
CL381509
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
A first clinical event prior to Screening.
Description

A first clinical event prior to Screening.

Data type

boolean

Alias
UMLS CUI 2011AA
C2981444
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1409616
Active disease diagnosis
Description

Disease activity

Data type

boolean

Alias
UMLS CUI 2011AA
C2707252
LOINC Version 232
MTHU031865
EDSS score of <= 4.0 at Screening.
Description

EDSS score of <= 4.0 at Screening.

Data type

boolean

Alias
UMLS CUI 2011AA
C0451246
SNOMED CT 2011_0131
273554001
UMLS CUI 2011AA
C1409616
Currently treated with interferon-beta-1a (tiw) sc
Description

Currently treated with interferon-beta-1a (tiw) sc

Data type

boolean

Alias
UMLS CUI 2011AA
C2827774
UMLS CUI 2011AA
C0254119
SNOMED CT 2011_0131
108749003
UMLS CUI 2011AA
C0556987
SNOMED CT 2011_0131
229804006
UMLS CUI 2011AA
C0443315
SNOMED CT 2011_0131
263887005
Willingness and ability to comply with the protocol
Description

Willingness and ability to comply with the protocol

Data type

boolean

Alias
UMLS CUI 2011AA
C0600109
SNOMED CT 2011_0131
225466006
UMLS CUI 2011AA
C0085732
SNOMED CT 2011_0131
371150009
UMLS CUI 2011AA
C0525058
Written informed consent
Description

Written informed consent

Data type

boolean

Alias
UMLS CUI 2011AA
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Pregnancy and lactation period
Description

Pregnancy and lactation period

Data type

boolean

Alias
UMLS CUI 2011AA
C0032961
SNOMED CT 2011_0131
289908002
MedDRA 14.1
10036556
LOINC Version 232
MTHU035048
UMLS CUI 2011AA
C0006147
MedDRA 14.1
10006247
UMLS CUI 2011AA
C1948053
Any disease other than MS that could better explain signs and symptoms.
Description

Any disease other than MS that could better explain signs and symptoms.

Data type

boolean

Alias
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
UMLS CUI 2011AA
C1550462
HL7 V3 2006_05
B
UMLS CUI 2011AA
C0681841
LOINC Version 232
MTHU013812
UMLS CUI 2011AA
C0037088
SNOMED CT 2011_0131
404684003
UMLS CUI 2011AA
CL411789
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
Complete transverse myelitis or bilateral optic neuritis.
Description

Complete transverse myelitis or bilateral optic neuritis.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205197
SNOMED CT 2011_0131
255594003
UMLS CUI 2011AA
C0026976
SNOMED CT 2011_0131
16631009
MedDRA 14.1
10028527
UMLS CUI 2011AA
C0861152
MedDRA 14.1
10004571
Currently receiving or use at any time of monoclonal antibodies, mitoxantrone, cytotoxic or immunosuppressive therapy (excluding systemic steroids and adrenocorticotrophic hormone [ACTH]), B cell modulating therapies (e.g. RituxiMab or BelimuMab), total lymphoid irradiation or bone marrow transplantation.
Description

Currently receiving or use at any time of monoclonal antibodies, mitoxantrone, cytotoxic or immunosuppressive therapy (excluding systemic steroids and adrenocorticotrophic hormone [ACTH]), B cell modulating therapies (e.g. RituxiMab or BelimuMab), total lymphoid irradiation or bone marrow transplantation.

Data type

boolean

Alias
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
C0003250
SNOMED CT 2011_0131
49616005
UMLS CUI 2011AA
C0026259
SNOMED CT 2011_0131
386913001
UMLS CUI 2011AA
C0004561
SNOMED CT 2011_0131
112130006
LOINC Version 232
MTHU002435
UMLS CUI 2011AA
CL421192
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0732355
SNOMED CT 2011_0131
386919002
UMLS CUI 2011AA
C1723401
SNOMED CT 2011_0131
449043000
UMLS CUI 2011AA
C1519560
UMLS CUI 2011AA
C0005961
SNOMED CT 2011_0131
23719005
MedDRA 14.1
10061730
ICD-9-CM Version 2011
41.00
UMLS CUI 2011AA
C0677881
UMLS CUI 2011AA
C0021079
SNOMED CT 2011_0131
86553008
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C2911187
ICD-10-CM Version 2010
Z79.52
UMLS CUI 2011AA
C0001655
SNOMED CT 2011_0131
40789008
LOINC Version 232
MTHU003098
Use of any cytokine or anti-cytokine therapy, intravenous immunoglobulin, plasmapheresis, or any investigational drug or experimental procedure
Description

Use of any cytokine or anti-cytokine therapy, intravenous immunoglobulin, plasmapheresis, or any investigational drug or experimental procedure

Data type

boolean

Alias
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
C0199974
SNOMED CT 2011_0131
84501003
MedDRA 14.1
10011824
UMLS CUI 2011AA
C0281178
UMLS CUI 2011AA
C0085297
SNOMED CT 2011_0131
350344000
HL7 V3 2006_05
87
UMLS CUI 2011AA
C0032134
SNOMED CT 2011_0131
20720000
MedDRA 14.1
10035486
ICD-9-CM Version 2011
99.71
UMLS CUI 2011AA
C0013230
UMLS CUI 2011AA
C1517586
UMLS CUI 2011AA
C2700391
Use of oral or systemic corticosteroids or ACTH
Description

Use of oral or systemic corticosteroids or ACTH

Data type

boolean

Alias
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
C1527415
SNOMED CT 2011_0131
26643006
HL7 V3 2006_05
_OralRoute
UMLS CUI 2011AA
C0205373
SNOMED CT 2011_0131
31099001
UMLS CUI 2011AA
C0001617
SNOMED CT 2011_0131
79440004
UMLS CUI 2011AA
C0001655
SNOMED CT 2011_0131
40789008
LOINC Version 232
MTHU003098
Have abnormalities of Vitamin D related hormonal system other than low dietary intake or decreased sun exposure, i.e. primary hyperparathyroidism or granulomatous disorders.
Description

Have abnormalities of Vitamin D related hormonal system other than low dietary intake or decreased sun exposure, i.e. primary hyperparathyroidism or granulomatous disorders.

Data type

boolean

Alias
UMLS CUI 2011AA
C1704258
UMLS CUI 2011AA
C0042866
SNOMED CT 2011_0131
30178006
UMLS CUI 2011AA
C0699792
SNOMED CT 2011_0131
263498003
UMLS CUI 2011AA
C0014136
SNOMED CT 2011_0131
113331007
LOINC Version 232
MTHU001408
UMLS CUI 2011AA
C0221002
SNOMED CT 2011_0131
36348003
MedDRA 14.1
10020707
ICD-10-CM Version 2010
E21.0
ICD-9-CM Version 2011
252.01
UMLS CUI 2011AA
C0740451
SNOMED CT 2011_0131
128561003
MedDRA 14.1
10018701
Have an urine calcium/creatinine (mmol/mmol) ratio > 1.0 or hypercalcaemia
Description

Have an urine calcium/creatinine (mmol/mmol) ratio > 1.0 or hypercalcaemia

Data type

boolean

Alias
UMLS CUI 2011AA
C1142058
SNOMED CT 2011_0131
413011003
MedDRA 14.1
10058624
UMLS CUI 2011AA
C0020437
SNOMED CT 2011_0131
66931009
MedDRA 14.1
10020583
ICD-10-CM Version 2010
E83.52
ICD-9-CM Version 2011
275.42
CTCAE 1105E
E12270
Are taking medications that influence Vitamin D metabolism other than corticosteroids, e.g., phenytoin, barbiturates, thiazide diuretics and cardiac glycosides.
Description

Are taking medications that influence Vitamin D metabolism other than corticosteroids, e.g., phenytoin, barbiturates, thiazide diuretics and cardiac glycosides.

Data type

boolean

Alias
UMLS CUI 2011AA
C1512806
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C0814606
UMLS CUI 2011AA
C0042866
SNOMED CT 2011_0131
30178006
UMLS CUI 2011AA
C0025519
SNOMED CT 2011_0131
47722004
UMLS CUI 2011AA
C0031507
SNOMED CT 2011_0131
40556005
LOINC Version 232
MTHU002993
UMLS CUI 2011AA
C0004745
SNOMED CT 2011_0131
60978003
LOINC Version 232
MTHU001340
UMLS CUI 2011AA
C0012802
SNOMED CT 2011_0131
45518007
UMLS CUI 2011AA
C0007158
SNOMED CT 2011_0131
33589008
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0001617
SNOMED CT 2011_0131
79440004
Are taking > 400 IU (10 microg) of Vitamin D supplement daily.
Description

Are taking > 400 IU (10 microg) of Vitamin D supplement daily.

Data type

boolean

Alias
UMLS CUI 2011AA
C2732464
SNOMED CT 2011_0131
444069008
UMLS CUI 2011AA
C0439453
SNOMED CT 2011_0131
258997004
UMLS CUI 2011AA
C0332173
SNOMED CT 2011_0131
69620002
Have conditions with increased susceptibility to hypercalcaemia, e.g., known arrhythmia or heart disease, treatment with Digitalis, or Hydrochlorothiazide and those who suffer from nephrolithiasis.
Description

Have conditions with increased susceptibility to hypercalcaemia, e.g., known arrhythmia or heart disease, treatment with Digitalis, or Hydrochlorothiazide and those who suffer from nephrolithiasis.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205217
HL7 V3 2006_05
U
UMLS CUI 2011AA
C1264642
SNOMED CT 2011_0131
118588007
UMLS CUI 2011AA
C0020437
SNOMED CT 2011_0131
66931009
MedDRA 14.1
10020583
ICD-10-CM Version 2010
E83.52
ICD-9-CM Version 2011
275.42
CTCAE 1105E
E12270
UMLS CUI 2011AA
C0003811
SNOMED CT 2011_0131
44808001
MedDRA 14.1
10003119
ICD-9-CM Version 2011
427.9
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0304520
SNOMED CT 2011_0131
91307002
UMLS CUI 2011AA
C0020261
SNOMED CT 2011_0131
387525002
LOINC Version 232
MTHU016732
UMLS CUI 2011AA
C0392525
SNOMED CT 2011_0131
95570007
MedDRA 14.1
10029148
ICD-10-CM Version 2010
N20.0
Have inadequate liver function
Description

Have inadequate liver function

Data type

boolean

Alias
UMLS CUI 2011AA
C0205412
SNOMED CT 2011_0131
71978007
UMLS CUI 2011AA
C0232741
SNOMED CT 2011_0131
79036002
Moderate to severe renal impairment
Description

Moderate to severe renal impairment

Data type

boolean

Alias
UMLS CUI 2011AA
C1299393
SNOMED CT 2011_0131
371924009
UMLS CUI 2011AA
C1565489
SNOMED CT 2011_0131
236423003
MedDRA 14.1
10062237
Inadequate bone marrow reserve
Description

Inadequate bone marrow reserve

Data type

boolean

Alias
UMLS CUI 2011AA
C0205412
SNOMED CT 2011_0131
71978007
UMLS CUI 2011AA
C0005953
SNOMED CT 2011_0131
14016003
LOINC Version 232
MTHU016536
UMLS CUI 2011AA
C2347957
History or presence of serious or acute heart disease such as uncontrolled cardiac dysrhythmia or arrhythmia, uncontrolled angina pectoris, cardiomyopathy, or uncontrolled congestive heart failure (NYHA class 3 or 4).
Description

History or presence of serious or acute heart disease such as uncontrolled cardiac dysrhythmia or arrhythmia, uncontrolled angina pectoris, cardiomyopathy, or uncontrolled congestive heart failure (NYHA class 3 or 4).

Data type

boolean

Alias
UMLS CUI 2011AA
C0018799
SNOMED CT 2011_0131
56265001
MedDRA 14.1
10061024
ICD-10-CM Version 2010
I51.9
ICD-9-CM Version 2011
429.9
UMLS CUI 2011AA
C0205318
SNOMED CT 2011_0131
19032002
UMLS CUI 2011AA
C0494598
ICD-10-CM Version 2010
I49
CTCAE 1105E
MTHU117243
UMLS CUI 2011AA
C0003811
SNOMED CT 2011_0131
44808001
MedDRA 14.1
10003119
ICD-9-CM Version 2011
427.9
UMLS CUI 2011AA
C0002962
SNOMED CT 2011_0131
194828000
MedDRA 14.1
10002383
ICD-10-CM Version 2010
I20
ICD-9-CM Version 2011
413
UMLS CUI 2011AA
CL411823
SNOMED CT 2011_0131
85898001
MedDRA 14.1
10007636
ICD-10-CM Version 2010
I42.9
ICD-9-CM Version 2011
425
UMLS CUI 2011AA
C0018802
SNOMED CT 2011_0131
42343007
MedDRA 14.1
10007559
LOINC Version 232
MTHU020787
ICD-10-CM Version 2010
I50.9
ICD-9-CM Version 2011
428.0
UMLS CUI 2011AA
C1319795
SNOMED CT 2011_0131
420913000
MedDRA 14.1
10064081
UMLS CUI 2011AA
C1319796
SNOMED CT 2011_0131
422293003
MedDRA 14.1
10064082
History or presence of severe depression, history of suicide attempt, or current suicidal ideation.
Description

History or presence of severe depression, history of suicide attempt, or current suicidal ideation.

Data type

boolean

Alias
UMLS CUI 2011AA
C0588008
SNOMED CT 2011_0131
310497006
UMLS CUI 2011AA
C2911479
ICD-10-CM Version 2010
Z91.5
UMLS CUI 2011AA
C0521116
SNOMED CT 2011_0131
15240007
UMLS CUI 2011AA
C0424000
SNOMED CT 2011_0131
6471006
MedDRA 14.1
10042458
ICD-9-CM Version 2011
V62.84
CTCAE 1105E
E12964
Epilepsy or seizures not adequately controlled by treatment.
Description

Epilepsy or seizures not adequately controlled by treatment.

Data type

boolean

Alias
UMLS CUI 2011AA
C0014544
SNOMED CT 2011_0131
84757009
MedDRA 14.1
10015037
LOINC Version 232
MTHU020586
ICD-10-CM Version 2010
G40.9
ICD-9-CM Version 2011
345.9
UMLS CUI 2011AA
C0036572
SNOMED CT 2011_0131
91175000
MedDRA 14.1
10039910
ICD-9-CM Version 2011
780.39
UMLS CUI 2011AA
C0205412
SNOMED CT 2011_0131
71978007
UMLS CUI 2011AA
C2587213
SNOMED CT 2011_0131
31509003
UMLS CUI 2011AA
C0039798
Current or past alcohol or drug abuse.
Description

Current or past alcohol or drug abuse.

Data type

boolean

Alias
UMLS CUI 2011AA
C0521116
SNOMED CT 2011_0131
15240007
UMLS CUI 2011AA
C1444637
SNOMED CT 2011_0131
410513005
UMLS CUI 2011AA
C0085762
SNOMED CT 2011_0131
15167005
MedDRA 14.1
10001584
LOINC Version 232
LP36309-0
ICD-10-CM Version 2010
F10.1
ICD-9-CM Version 2011
305.0
UMLS CUI 2011AA
C0013146
SNOMED CT 2011_0131
26416006
MedDRA 14.1
10013654
LOINC Version 232
LP36310-8
ICD-9-CM Version 2011
305.90
Any major medical or psychiatric illness (such as psychosis, bipolar disorder) that in the opinion of the Investigator could create undue risk to the subject or could affect adherence with the trial protocol.
Description

Any major medical or psychiatric illness (such as psychosis, bipolar disorder) that in the opinion of the Investigator could create undue risk to the subject or could affect adherence with the trial protocol.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205164
SNOMED CT 2011_0131
255603008
UMLS CUI 2011AA
C0221423
SNOMED CT 2011_0131
39104002
MedDRA 14.1
10040658
ICD-10-CM Version 2010
R69
UMLS CUI 2011AA
C0004936
SNOMED CT 2011_0131
74732009
MedDRA 14.1
10037174
ICD-10-CM Version 2010
F99
ICD-9-CM Version 2011
290-319.99
UMLS CUI 2011AA
C0033975
SNOMED CT 2011_0131
69322001
MedDRA 14.1
10061920
ICD-9-CM Version 2011
290-299.99
CTCAE 1105E
E12954
UMLS CUI 2011AA
C0005586
SNOMED CT 2011_0131
13746004
MedDRA 14.1
10057667
LOINC Version 232
MTHU026189
ICD-10-CM Version 2010
F31
ICD-9-CM Version 2011
296.80
UMLS CUI 2011AA
C1883420
UMLS CUI 2011AA
C0035647
SNOMED CT 2011_0131
30207005
HL7 V3 2006_05
RSK
UMLS CUI 2011AA
C0681850
UMLS CUI 2011AA
C0392760
SNOMED CT 2011_0131
247591002
UMLS CUI 2011AA
C0525058
Known contra-indication to treatment with vitamin D
Description

Known contra-indication to treatment with vitamin D

Data type

boolean

Alias
UMLS CUI 2011AA
C1301624
SNOMED CT 2011_0131
397745006
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0042866
SNOMED CT 2011_0131
30178006
Known hypersensitivity to interferon or its excipient(s)
Description

Known hypersensitivity to interferon or its excipient(s)

Data type

boolean

Alias
UMLS CUI 2011AA
C0020517
SNOMED CT 2011_0131
418634005
ICD-10-CM Version 2010
T78.40
UMLS CUI 2011AA
C0021747
SNOMED CT 2011_0131
49327004
LOINC Version 232
MTHU021353
UMLS CUI 2011AA
C0015237
SNOMED CT 2011_0131
360215002
Known hypersensitivity to gadolinium.
Description

Known hypersensitivity to gadolinium.

Data type

boolean

Alias
UMLS CUI 2011AA
C0020517
SNOMED CT 2011_0131
418634005
ICD-10-CM Version 2010
T78.40
UMLS CUI 2011AA
C0016911
SNOMED CT 2011_0131
58281002
LOINC Version 232
MTHU024403
Any other condition that would prevent the subject from undergoing an MRI scan.
Description

Any other condition that would prevent the subject from undergoing an MRI scan.

Data type

boolean

Alias
UMLS CUI 2011AA
C0348080
SNOMED CT 2011_0131
260905004
HL7 V3 2006_05
COND
UMLS CUI 2011AA
CL414898
UMLS CUI 2011AA
C0681850
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C0917711
Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from such.
Description

Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from such.

Data type

boolean

Alias
UMLS CUI 2011AA
C0037088
SNOMED CT 2011_0131
404684003
UMLS CUI 2011AA
C0750491
SNOMED CT 2011_0131
415684004
UMLS CUI 2011AA
C0162534
SNOMED CT 2011_0131
230284004
MedDRA 14.1
10036760
ICD-10-CM Version 2010
A81.9
UMLS CUI 2011AA
CL414906
UMLS CUI 2011AA
C0086282
SNOMED CT 2011_0131
303071001
HL7 V3 2006_05
FAMMEMB
Positive HIV, hepatitis C, or hepatitis B (HBsAg and HBc antibody) serology (test performed at screening).
Description

Positive HIV, hepatitis C, or hepatitis B (HBsAg and HBc antibody) serology (test performed at screening).

Data type

boolean

Alias
UMLS CUI 2011AA
C0019699
SNOMED CT 2011_0131
165816005
MedDRA 14.1
10020188
ICD-10-CM Version 2010
Z21
UMLS CUI 2011AA
C1112419
MedDRA 14.1
10057394
UMLS CUI 2011AA
C0856706
MedDRA 14.1
10019738
UMLS CUI 2011AA
C0149709
SNOMED CT 2011_0131
165806002
MedDRA 14.1
10019742
UMLS CUI 2011AA
C0262506
MedDRA 14.1
10071344
Legal incapacity or limited legal capacity.
Description

Legal incapacity or limited legal capacity.

Data type

boolean

Alias
UMLS CUI 2011AA
C1705492
UMLS CUI 2011AA
CL414906
UMLS CUI 2011AA
C0439801
SNOMED CT 2011_0131
255469002
UMLS CUI 2011AA
C0683673
Another current autoimmune disease, except diabetes.
Description

Another current autoimmune disease, except diabetes.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0521116
SNOMED CT 2011_0131
15240007
UMLS CUI 2011AA
C0004364
SNOMED CT 2011_0131
85828009
MedDRA 14.1
10061664
ICD-10-CM Version 2010
M30-M36
CTCAE 1105E
E11258
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C0011849
SNOMED CT 2011_0131
191044006
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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
age 18 Years to 50 Years
Item
age 18 Years to 50 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Diagnosis of a relapsing-remitting form of MS
Item
Diagnosis of a relapsing-remitting form of MS
boolean
C0011900 (UMLS CUI 1)
C0751967 (UMLS CUI 1*2)
Brain and/or spinal MRI with findings typical of MS
Item
Brain and/or spinal MRI with findings typical of MS
boolean
C0881827 (UMLS CUI 2011AA)
24590-2 (LOINC Version 232)
C0177803 (UMLS CUI 2011AA)
241645008 (SNOMED CT 2011_0131)
C0243095 (UMLS CUI 2011AA)
CL381509 (UMLS CUI 2011AA)
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)
A first clinical event prior to Screening.
Item
A first clinical event prior to Screening.
boolean
C2981444 (UMLS CUI 2011AA)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
Disease activity
Item
Active disease diagnosis
boolean
C2707252 (UMLS CUI 2011AA)
MTHU031865 (LOINC Version 232)
EDSS score of <= 4.0 at Screening.
Item
EDSS score of <= 4.0 at Screening.
boolean
C0451246 (UMLS CUI 2011AA)
273554001 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
Currently treated with interferon-beta-1a (tiw) sc
Item
Currently treated with interferon-beta-1a (tiw) sc
boolean
C2827774 (UMLS CUI 2011AA)
C0254119 (UMLS CUI 2011AA)
108749003 (SNOMED CT 2011_0131)
C0556987 (UMLS CUI 2011AA)
229804006 (SNOMED CT 2011_0131)
C0443315 (UMLS CUI 2011AA)
263887005 (SNOMED CT 2011_0131)
Willingness and ability to comply with the protocol
Item
Willingness and ability to comply with the protocol
boolean
C0600109 (UMLS CUI 2011AA)
225466006 (SNOMED CT 2011_0131)
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C0525058 (UMLS CUI 2011AA)
Written informed consent
Item
Written informed consent
boolean
C0021430 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
Pregnancy and lactation period
Item
Pregnancy and lactation period
boolean
C0032961 (UMLS CUI 2011AA)
289908002 (SNOMED CT 2011_0131)
10036556 (MedDRA 14.1)
MTHU035048 (LOINC Version 232)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
C1948053 (UMLS CUI 2011AA)
Any disease other than MS that could better explain signs and symptoms.
Item
Any disease other than MS that could better explain signs and symptoms.
boolean
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C1550462 (UMLS CUI 2011AA)
B (HL7 V3 2006_05)
C0681841 (UMLS CUI 2011AA)
MTHU013812 (LOINC Version 232)
C0037088 (UMLS CUI 2011AA)
404684003 (SNOMED CT 2011_0131)
CL411789 (UMLS CUI 2011AA)
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)
Complete transverse myelitis or bilateral optic neuritis.
Item
Complete transverse myelitis or bilateral optic neuritis.
boolean
C0205197 (UMLS CUI 2011AA)
255594003 (SNOMED CT 2011_0131)
C0026976 (UMLS CUI 2011AA)
16631009 (SNOMED CT 2011_0131)
10028527 (MedDRA 14.1)
C0861152 (UMLS CUI 2011AA)
10004571 (MedDRA 14.1)
Currently receiving or use at any time of monoclonal antibodies, mitoxantrone, cytotoxic or immunosuppressive therapy (excluding systemic steroids and adrenocorticotrophic hormone [ACTH]), B cell modulating therapies (e.g. RituxiMab or BelimuMab), total lymphoid irradiation or bone marrow transplantation.
Item
Currently receiving or use at any time of monoclonal antibodies, mitoxantrone, cytotoxic or immunosuppressive therapy (excluding systemic steroids and adrenocorticotrophic hormone [ACTH]), B cell modulating therapies (e.g. RituxiMab or BelimuMab), total lymphoid irradiation or bone marrow transplantation.
boolean
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0003250 (UMLS CUI 2011AA)
49616005 (SNOMED CT 2011_0131)
C0026259 (UMLS CUI 2011AA)
386913001 (SNOMED CT 2011_0131)
C0004561 (UMLS CUI 2011AA)
112130006 (SNOMED CT 2011_0131)
MTHU002435 (LOINC Version 232)
CL421192 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C0732355 (UMLS CUI 2011AA)
386919002 (SNOMED CT 2011_0131)
C1723401 (UMLS CUI 2011AA)
449043000 (SNOMED CT 2011_0131)
C1519560 (UMLS CUI 2011AA)
C0005961 (UMLS CUI 2011AA)
23719005 (SNOMED CT 2011_0131)
10061730 (MedDRA 14.1)
41.00 (ICD-9-CM Version 2011)
C0677881 (UMLS CUI 2011AA)
C0021079 (UMLS CUI 2011AA)
86553008 (SNOMED CT 2011_0131)
CL411789 (UMLS CUI 2011AA)
C2911187 (UMLS CUI 2011AA)
Z79.52 (ICD-10-CM Version 2010)
C0001655 (UMLS CUI 2011AA)
40789008 (SNOMED CT 2011_0131)
MTHU003098 (LOINC Version 232)
Use of any cytokine or anti-cytokine therapy, intravenous immunoglobulin, plasmapheresis, or any investigational drug or experimental procedure
Item
Use of any cytokine or anti-cytokine therapy, intravenous immunoglobulin, plasmapheresis, or any investigational drug or experimental procedure
boolean
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0199974 (UMLS CUI 2011AA)
84501003 (SNOMED CT 2011_0131)
10011824 (MedDRA 14.1)
C0281178 (UMLS CUI 2011AA)
C0085297 (UMLS CUI 2011AA)
350344000 (SNOMED CT 2011_0131)
87 (HL7 V3 2006_05)
C0032134 (UMLS CUI 2011AA)
20720000 (SNOMED CT 2011_0131)
10035486 (MedDRA 14.1)
99.71 (ICD-9-CM Version 2011)
C0013230 (UMLS CUI 2011AA)
C1517586 (UMLS CUI 2011AA)
C2700391 (UMLS CUI 2011AA)
Use of oral or systemic corticosteroids or ACTH
Item
Use of oral or systemic corticosteroids or ACTH
boolean
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C1527415 (UMLS CUI 2011AA)
26643006 (SNOMED CT 2011_0131)
_OralRoute (HL7 V3 2006_05)
C0205373 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
C0001617 (UMLS CUI 2011AA)
79440004 (SNOMED CT 2011_0131)
C0001655 (UMLS CUI 2011AA)
40789008 (SNOMED CT 2011_0131)
MTHU003098 (LOINC Version 232)
Have abnormalities of Vitamin D related hormonal system other than low dietary intake or decreased sun exposure, i.e. primary hyperparathyroidism or granulomatous disorders.
Item
Have abnormalities of Vitamin D related hormonal system other than low dietary intake or decreased sun exposure, i.e. primary hyperparathyroidism or granulomatous disorders.
boolean
C1704258 (UMLS CUI 2011AA)
C0042866 (UMLS CUI 2011AA)
30178006 (SNOMED CT 2011_0131)
C0699792 (UMLS CUI 2011AA)
263498003 (SNOMED CT 2011_0131)
C0014136 (UMLS CUI 2011AA)
113331007 (SNOMED CT 2011_0131)
MTHU001408 (LOINC Version 232)
C0221002 (UMLS CUI 2011AA)
36348003 (SNOMED CT 2011_0131)
10020707 (MedDRA 14.1)
E21.0 (ICD-10-CM Version 2010)
252.01 (ICD-9-CM Version 2011)
C0740451 (UMLS CUI 2011AA)
128561003 (SNOMED CT 2011_0131)
10018701 (MedDRA 14.1)
Have an urine calcium/creatinine (mmol/mmol) ratio > 1.0 or hypercalcaemia
Item
Have an urine calcium/creatinine (mmol/mmol) ratio > 1.0 or hypercalcaemia
boolean
C1142058 (UMLS CUI 2011AA)
413011003 (SNOMED CT 2011_0131)
10058624 (MedDRA 14.1)
C0020437 (UMLS CUI 2011AA)
66931009 (SNOMED CT 2011_0131)
10020583 (MedDRA 14.1)
E83.52 (ICD-10-CM Version 2010)
275.42 (ICD-9-CM Version 2011)
E12270 (CTCAE 1105E)
Are taking medications that influence Vitamin D metabolism other than corticosteroids, e.g., phenytoin, barbiturates, thiazide diuretics and cardiac glycosides.
Item
Are taking medications that influence Vitamin D metabolism other than corticosteroids, e.g., phenytoin, barbiturates, thiazide diuretics and cardiac glycosides.
boolean
C1512806 (UMLS CUI 2011AA)
C0013227 (UMLS CUI 2011AA)
C0814606 (UMLS CUI 2011AA)
C0042866 (UMLS CUI 2011AA)
30178006 (SNOMED CT 2011_0131)
C0025519 (UMLS CUI 2011AA)
47722004 (SNOMED CT 2011_0131)
C0031507 (UMLS CUI 2011AA)
40556005 (SNOMED CT 2011_0131)
MTHU002993 (LOINC Version 232)
C0004745 (UMLS CUI 2011AA)
60978003 (SNOMED CT 2011_0131)
MTHU001340 (LOINC Version 232)
C0012802 (UMLS CUI 2011AA)
45518007 (SNOMED CT 2011_0131)
C0007158 (UMLS CUI 2011AA)
33589008 (SNOMED CT 2011_0131)
CL411789 (UMLS CUI 2011AA)
C0001617 (UMLS CUI 2011AA)
79440004 (SNOMED CT 2011_0131)
Are taking > 400 IU (10 microg) of Vitamin D supplement daily.
Item
Are taking > 400 IU (10 microg) of Vitamin D supplement daily.
boolean
C2732464 (UMLS CUI 2011AA)
444069008 (SNOMED CT 2011_0131)
C0439453 (UMLS CUI 2011AA)
258997004 (SNOMED CT 2011_0131)
C0332173 (UMLS CUI 2011AA)
69620002 (SNOMED CT 2011_0131)
Have conditions with increased susceptibility to hypercalcaemia, e.g., known arrhythmia or heart disease, treatment with Digitalis, or Hydrochlorothiazide and those who suffer from nephrolithiasis.
Item
Have conditions with increased susceptibility to hypercalcaemia, e.g., known arrhythmia or heart disease, treatment with Digitalis, or Hydrochlorothiazide and those who suffer from nephrolithiasis.
boolean
C0205217 (UMLS CUI 2011AA)
U (HL7 V3 2006_05)
C1264642 (UMLS CUI 2011AA)
118588007 (SNOMED CT 2011_0131)
C0020437 (UMLS CUI 2011AA)
66931009 (SNOMED CT 2011_0131)
10020583 (MedDRA 14.1)
E83.52 (ICD-10-CM Version 2010)
275.42 (ICD-9-CM Version 2011)
E12270 (CTCAE 1105E)
C0003811 (UMLS CUI 2011AA)
44808001 (SNOMED CT 2011_0131)
10003119 (MedDRA 14.1)
427.9 (ICD-9-CM Version 2011)
C0039798 (UMLS CUI 2011AA)
C0304520 (UMLS CUI 2011AA)
91307002 (SNOMED CT 2011_0131)
C0020261 (UMLS CUI 2011AA)
387525002 (SNOMED CT 2011_0131)
MTHU016732 (LOINC Version 232)
C0392525 (UMLS CUI 2011AA)
95570007 (SNOMED CT 2011_0131)
10029148 (MedDRA 14.1)
N20.0 (ICD-10-CM Version 2010)
Have inadequate liver function
Item
Have inadequate liver function
boolean
C0205412 (UMLS CUI 2011AA)
71978007 (SNOMED CT 2011_0131)
C0232741 (UMLS CUI 2011AA)
79036002 (SNOMED CT 2011_0131)
Moderate to severe renal impairment
Item
Moderate to severe renal impairment
boolean
C1299393 (UMLS CUI 2011AA)
371924009 (SNOMED CT 2011_0131)
C1565489 (UMLS CUI 2011AA)
236423003 (SNOMED CT 2011_0131)
10062237 (MedDRA 14.1)
Inadequate bone marrow reserve
Item
Inadequate bone marrow reserve
boolean
C0205412 (UMLS CUI 2011AA)
71978007 (SNOMED CT 2011_0131)
C0005953 (UMLS CUI 2011AA)
14016003 (SNOMED CT 2011_0131)
MTHU016536 (LOINC Version 232)
C2347957 (UMLS CUI 2011AA)
History or presence of serious or acute heart disease such as uncontrolled cardiac dysrhythmia or arrhythmia, uncontrolled angina pectoris, cardiomyopathy, or uncontrolled congestive heart failure (NYHA class 3 or 4).
Item
History or presence of serious or acute heart disease such as uncontrolled cardiac dysrhythmia or arrhythmia, uncontrolled angina pectoris, cardiomyopathy, or uncontrolled congestive heart failure (NYHA class 3 or 4).
boolean
C0018799 (UMLS CUI 2011AA)
56265001 (SNOMED CT 2011_0131)
10061024 (MedDRA 14.1)
I51.9 (ICD-10-CM Version 2010)
429.9 (ICD-9-CM Version 2011)
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C0494598 (UMLS CUI 2011AA)
I49 (ICD-10-CM Version 2010)
MTHU117243 (CTCAE 1105E)
C0003811 (UMLS CUI 2011AA)
44808001 (SNOMED CT 2011_0131)
10003119 (MedDRA 14.1)
427.9 (ICD-9-CM Version 2011)
C0002962 (UMLS CUI 2011AA)
194828000 (SNOMED CT 2011_0131)
10002383 (MedDRA 14.1)
I20 (ICD-10-CM Version 2010)
413 (ICD-9-CM Version 2011)
CL411823 (UMLS CUI 2011AA)
85898001 (SNOMED CT 2011_0131)
10007636 (MedDRA 14.1)
I42.9 (ICD-10-CM Version 2010)
425 (ICD-9-CM Version 2011)
C0018802 (UMLS CUI 2011AA)
42343007 (SNOMED CT 2011_0131)
10007559 (MedDRA 14.1)
MTHU020787 (LOINC Version 232)
I50.9 (ICD-10-CM Version 2010)
428.0 (ICD-9-CM Version 2011)
C1319795 (UMLS CUI 2011AA)
420913000 (SNOMED CT 2011_0131)
10064081 (MedDRA 14.1)
C1319796 (UMLS CUI 2011AA)
422293003 (SNOMED CT 2011_0131)
10064082 (MedDRA 14.1)
History or presence of severe depression, history of suicide attempt, or current suicidal ideation.
Item
History or presence of severe depression, history of suicide attempt, or current suicidal ideation.
boolean
C0588008 (UMLS CUI 2011AA)
310497006 (SNOMED CT 2011_0131)
C2911479 (UMLS CUI 2011AA)
Z91.5 (ICD-10-CM Version 2010)
C0521116 (UMLS CUI 2011AA)
15240007 (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)
Epilepsy or seizures not adequately controlled by treatment.
Item
Epilepsy or seizures not adequately controlled by treatment.
boolean
C0014544 (UMLS CUI 2011AA)
84757009 (SNOMED CT 2011_0131)
10015037 (MedDRA 14.1)
MTHU020586 (LOINC Version 232)
G40.9 (ICD-10-CM Version 2010)
345.9 (ICD-9-CM Version 2011)
C0036572 (UMLS CUI 2011AA)
91175000 (SNOMED CT 2011_0131)
10039910 (MedDRA 14.1)
780.39 (ICD-9-CM Version 2011)
C0205412 (UMLS CUI 2011AA)
71978007 (SNOMED CT 2011_0131)
C2587213 (UMLS CUI 2011AA)
31509003 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
Current or past alcohol or drug abuse.
Item
Current or past alcohol or drug abuse.
boolean
C0521116 (UMLS CUI 2011AA)
15240007 (SNOMED CT 2011_0131)
C1444637 (UMLS CUI 2011AA)
410513005 (SNOMED CT 2011_0131)
C0085762 (UMLS CUI 2011AA)
15167005 (SNOMED CT 2011_0131)
10001584 (MedDRA 14.1)
LP36309-0 (LOINC Version 232)
F10.1 (ICD-10-CM Version 2010)
305.0 (ICD-9-CM Version 2011)
C0013146 (UMLS CUI 2011AA)
26416006 (SNOMED CT 2011_0131)
10013654 (MedDRA 14.1)
LP36310-8 (LOINC Version 232)
305.90 (ICD-9-CM Version 2011)
Any major medical or psychiatric illness (such as psychosis, bipolar disorder) that in the opinion of the Investigator could create undue risk to the subject or could affect adherence with the trial protocol.
Item
Any major medical or psychiatric illness (such as psychosis, bipolar disorder) that in the opinion of the Investigator could create undue risk to the subject or could affect adherence with the trial protocol.
boolean
C0205164 (UMLS CUI 2011AA)
255603008 (SNOMED CT 2011_0131)
C0221423 (UMLS CUI 2011AA)
39104002 (SNOMED CT 2011_0131)
10040658 (MedDRA 14.1)
R69 (ICD-10-CM Version 2010)
C0004936 (UMLS CUI 2011AA)
74732009 (SNOMED CT 2011_0131)
10037174 (MedDRA 14.1)
F99 (ICD-10-CM Version 2010)
290-319.99 (ICD-9-CM Version 2011)
C0033975 (UMLS CUI 2011AA)
69322001 (SNOMED CT 2011_0131)
10061920 (MedDRA 14.1)
290-299.99 (ICD-9-CM Version 2011)
E12954 (CTCAE 1105E)
C0005586 (UMLS CUI 2011AA)
13746004 (SNOMED CT 2011_0131)
10057667 (MedDRA 14.1)
MTHU026189 (LOINC Version 232)
F31 (ICD-10-CM Version 2010)
296.80 (ICD-9-CM Version 2011)
C1883420 (UMLS CUI 2011AA)
C0035647 (UMLS CUI 2011AA)
30207005 (SNOMED CT 2011_0131)
RSK (HL7 V3 2006_05)
C0681850 (UMLS CUI 2011AA)
C0392760 (UMLS CUI 2011AA)
247591002 (SNOMED CT 2011_0131)
C0525058 (UMLS CUI 2011AA)
Known contra-indication to treatment with vitamin D
Item
Known contra-indication to treatment with vitamin D
boolean
C1301624 (UMLS CUI 2011AA)
397745006 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0042866 (UMLS CUI 2011AA)
30178006 (SNOMED CT 2011_0131)
Known hypersensitivity to interferon or its excipient(s)
Item
Known hypersensitivity to interferon or its excipient(s)
boolean
C0020517 (UMLS CUI 2011AA)
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0021747 (UMLS CUI 2011AA)
49327004 (SNOMED CT 2011_0131)
MTHU021353 (LOINC Version 232)
C0015237 (UMLS CUI 2011AA)
360215002 (SNOMED CT 2011_0131)
Known hypersensitivity to gadolinium.
Item
Known hypersensitivity to gadolinium.
boolean
C0020517 (UMLS CUI 2011AA)
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0016911 (UMLS CUI 2011AA)
58281002 (SNOMED CT 2011_0131)
MTHU024403 (LOINC Version 232)
Any other condition that would prevent the subject from undergoing an MRI scan.
Item
Any other condition that would prevent the subject from undergoing an MRI scan.
boolean
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
CL414898 (UMLS CUI 2011AA)
C0681850 (UMLS CUI 2011AA)
C1514756 (UMLS CUI 2011AA)
C0917711 (UMLS CUI 2011AA)
Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from such.
Item
Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from such.
boolean
C0037088 (UMLS CUI 2011AA)
404684003 (SNOMED CT 2011_0131)
C0750491 (UMLS CUI 2011AA)
415684004 (SNOMED CT 2011_0131)
C0162534 (UMLS CUI 2011AA)
230284004 (SNOMED CT 2011_0131)
10036760 (MedDRA 14.1)
A81.9 (ICD-10-CM Version 2010)
CL414906 (UMLS CUI 2011AA)
C0086282 (UMLS CUI 2011AA)
303071001 (SNOMED CT 2011_0131)
FAMMEMB (HL7 V3 2006_05)
Positive HIV, hepatitis C, or hepatitis B (HBsAg and HBc antibody) serology (test performed at screening).
Item
Positive HIV, hepatitis C, or hepatitis B (HBsAg and HBc antibody) serology (test performed at screening).
boolean
C0019699 (UMLS CUI 2011AA)
165816005 (SNOMED CT 2011_0131)
10020188 (MedDRA 14.1)
Z21 (ICD-10-CM Version 2010)
C1112419 (UMLS CUI 2011AA)
10057394 (MedDRA 14.1)
C0856706 (UMLS CUI 2011AA)
10019738 (MedDRA 14.1)
C0149709 (UMLS CUI 2011AA)
165806002 (SNOMED CT 2011_0131)
10019742 (MedDRA 14.1)
C0262506 (UMLS CUI 2011AA)
10071344 (MedDRA 14.1)
Legal incapacity or limited legal capacity.
Item
Legal incapacity or limited legal capacity.
boolean
C1705492 (UMLS CUI 2011AA)
CL414906 (UMLS CUI 2011AA)
C0439801 (UMLS CUI 2011AA)
255469002 (SNOMED CT 2011_0131)
C0683673 (UMLS CUI 2011AA)
Another current autoimmune disease, except diabetes.
Item
Another current autoimmune disease, except diabetes.
boolean
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0521116 (UMLS CUI 2011AA)
15240007 (SNOMED CT 2011_0131)
C0004364 (UMLS CUI 2011AA)
85828009 (SNOMED CT 2011_0131)
10061664 (MedDRA 14.1)
M30-M36 (ICD-10-CM Version 2010)
E11258 (CTCAE 1105E)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0011849 (UMLS CUI 2011AA)
191044006 (SNOMED CT 2011_0131)
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