Visit 1 (Screening) Part 1/2, DIMAT-MS, Relapsing Remitting Multiple Sclerosis DRKS00008037 NCT02461069

Study documentation part: Visits 1 (Screening), Study week -4 to 0 Study Details: A 24-week, multicenter, exploratory, two arm study to assess the effect of Dimethyl fumarate on ImmuneModulatory Action on T cells in patients with relapsing remitting Multiple Sclerosis. Principal Investigator PD Dr. Luisa Klotz, University Hospital Münster EudraCT - No.: 2014-003481-25. Clinical Trial No.r: NCT02461069.

Visit 1 (Screening) Part 1/2, DIMAT-MS, Relapsing Remitting Multiple Sclerosis NCT02461069

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administration and Instructions for CRF Completion
Patient Study ID
Item
Subject ID
text
C2348585 (UMLS CUI [1])
Patient Name
Item
Patient Name (initials acceptable)
text
C1299487 (UMLS CUI [1])
Instructions for CRF Completion
Item
text
C1516308 (UMLS CUI [1,1])
C1442085 (UMLS CUI [1,2])
Date of written Informed Consent
Item
Date of written Informed Consent
date
Item Group
Demographic Data
Age
Item
Age
integer
C0001779 (UMLS CUI [1])
Item
Sex
integer
C0150831 (UMLS CUI [1])
Code List
Sex
CL Item
male (m)
CL Item
female (f)
Item Group
Blood pregnancy test
Blood Pregnancy Test done, specify test date
Item
Blood Pregnancy Test done, specify test date
date
C0850355 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Result:
Item
text
C0427777 (UMLS CUI [1])
Item
Blood pregnancy test not done, reason:
text
C0850355 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Code List
Blood pregnancy test not done, reason:
CL Item
male participant (male participant)
CL Item
female participant with no childbearing potential (female participant with no childbearing potential)
CL Item
other: (other:)
Item Group
Testing for JC virus antibodies
JC virus antibodies test done, specify test date:
Item
date
C3511565 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Result:
text
C3511565 (UMLS CUI [1,1])
C2346633 (UMLS CUI [1,2])
Code List
Result:
CL Item
positive (1)
CL Item
negative (2)
JC virus antibodies test not done, reason
Item
JC virus antibodies test not done, reason
text
C3511565 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Item Group
Medical History
Medical History Description: Please state diagnosis, if known
Item
Medical History Description: Please state diagnosis, if known
text
C0011900 (UMLS CUI [1])
Start Date
Item
Start Date
date
C2826738 (UMLS CUI [1])
End Date
Item
End Date
date
C2826747 (UMLS CUI [1])
Item
Ongoing at Start of Study
text
C2826680 (UMLS CUI [1])
Code List
Ongoing at Start of Study
CL Item
NO (N)
CL Item
YES (Y)
Item Group
MS Medical History
Date of MS diagnosis
Item
Date of MS diagnosis
date
C0026769 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Date of MS diagnosis unknown
Item
Date of MS diagnosis unknown
boolean
C0026769 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0439673 (UMLS CUI [1,4])
Date of first MS symptoms
Item
Date of first MS symptoms
date
C0026769 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
Date of first MS symptoms unknown
Item
Date of first MS symptoms unknown
boolean
C0026769 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,3])
Number of relapses since MS diagnosis
Item
Number of relapses since MS diagnosis
integer
C0856120 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Number of relapses since MS diagnosis unknown
Item
Number of relapses since MS diagnosis unknown
text
C0856120 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,3])
Number of relapses in the last 12 months
Item
Number of relapses in the last 12 months
text
C0856120 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Number of relapses in the last 12 months unknown
Item
Number of relapses in the last 12 months unknown
boolean
C0856120 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,3])
Onset date of most recent relapse
Item
Onset date of most recent relapse
date
C0856120 (UMLS CUI [1,1])
C1513491 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,3])
Onset date of most recent relapse unknown
Item
Onset date of most recent relapse unknown
text
C0856120 (UMLS CUI [1,1])
C1513491 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,3])
C0439673 (UMLS CUI [1,4])
Item
Active substance/nondrug therapy
integer
C1254351 (UMLS CUI [1])
C0599938 (UMLS CUI [2])
Code List
Active substance/nondrug therapy
CL Item
1 Alemtuzumab (1)
CL Item
2 Azathioprine (2)
CL Item
3 Cyclophosphamide (3)
CL Item
4 Dimethyl fumarate  (4)
CL Item
5 Fingolimod (5)
CL Item
6 Glatiramer acetate (6)
CL Item
7 Immunoglobulins (7)
CL Item
8 Interferon beta (8)
CL Item
9 Methylprednisolone* (9)
CL Item
10 Mitoxantrone (10)
CL Item
11 Natalizumab (11)
CL Item
12 Rituximab (12)
CL Item
13 Teriflunomide (13)
CL Item
14 Other active substance (14)
CL Item
15 Physiotherapy (15)
CL Item
16 Plasmapheresis (16)
CL Item
17 Other Non-drug therapy (17)
Treatment of MS relapse
Item
Treatment of MS relapse
boolean
C0856120 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
TreatmentStartDate
Item
Start Date
date
C0087111 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
TreatmentEndDate
Item
End Date
date
C0087111 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
ongoingtreatment
Item
ongoing
boolean
C0087111 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])

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