ID

36505

Description

Tecfidera Slow-titration Study; ODM derived from: https://clinicaltrials.gov/show/NCT02428231

Link

https://clinicaltrials.gov/show/NCT02428231

Keywords

Versions (1)
  1. 5/18/19 5/18/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 18, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT02428231

English

Eligibility Multiple Sclerosis NCT02428231

1 forms  
Criteria
Description

Criteria

diagnosis of ms consistent with locally labeled indication for dimethyl fumarate
Description

Multiple Sclerosis | Indication Dimethyl fumarate

Data type

boolean

Alias
UMLS CUI [1]
C0026769
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0058218
no prior treatment with dimethyl fumarate
Description

Dimethyl fumarate Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0058218
UMLS CUI [1,2]
C0332197
female subjects of childbearing potential who are not surgically sterile must practice effective contraception during their participation in the study
Description

Childbearing Potential Female Sterilization Absent | Childbearing Potential Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0015787
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
have had a recent complete blood count (cbc), including lymphocyte count, that does not preclude participation in the study
Description

Complete Blood Count | Lymphocyte Count

Data type

boolean

Alias
UMLS CUI [1]
C0009555
UMLS CUI [2]
C0200635
key exclusion criteria:
Description

Exclusion Criteria Main

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
have a recent history or ongoing gi illness (e.g., peptic ulcer, irritable bowel syndrome) or any other current condition with gi signs and symptoms (e.g., nausea, vomiting, abdominal pain, or diarrhea) that may interfere with assessment of study endpoints
Description

Gastrointestinal Disease | Peptic Ulcer | Irritable Bowel Syndrome | Digestive Signs and Symptoms Interfere with Assessment End Point | Nausea | Vomiting | Abdominal Pain | Diarrhea

Data type

boolean

Alias
UMLS CUI [1]
C0017178
UMLS CUI [2]
C0030920
UMLS CUI [3]
C0022104
UMLS CUI [4,1]
C0037089
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C1516048
UMLS CUI [4,4]
C2349179
UMLS CUI [5]
C0027497
UMLS CUI [6]
C0042963
UMLS CUI [7]
C0000737
UMLS CUI [8]
C0011991
have other comorbid conditions that preclude participation in the study
Description

Comorbidity Study Subject Participation Status Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0332196
participant is pregnant, breastfeeding, or planning a pregnancy during the study period
Description

Pregnancy | Breast Feeding | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
are receiving concomitant disease-modifying therapies for ms including, but not limited to, natalizumab, ifn-β, glatiramer acetate, fingolimod, alemtuzumab, teriflunomide, or laquinimod at screening
Description

Disease Modification Therapy Multiple Sclerosis | natalizumab | Interferon-beta | glatiramer acetate | fingolimod | alemtuzumab | teriflunomide | laquinimod

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C3840684
UMLS CUI [1,3]
C0087111
UMLS CUI [1,4]
C0026769
UMLS CUI [2]
C1172734
UMLS CUI [3]
C0015980
UMLS CUI [4]
C0289884
UMLS CUI [5]
C1699926
UMLS CUI [6]
C0383429
UMLS CUI [7]
C1718383
UMLS CUI [8]
C1260208
history of severe allergic or anaphylactic reactions or known drug hypersensitivity
Description

Allergic Reaction Severe | Anaphylaxis Severe | Drug Allergy

Data type

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0002792
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0013182
note: other protocol defined inclusion/exclusion criteria may apply
Description

Eligibility Criteria Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Multiple Sclerosis NCT02428231

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Multiple Sclerosis | Indication Dimethyl fumarate
Item
diagnosis of ms consistent with locally labeled indication for dimethyl fumarate
boolean
C0026769 (UMLS CUI [1])
C3146298 (UMLS CUI [2,1])
C0058218 (UMLS CUI [2,2])
Dimethyl fumarate Absent
Item
no prior treatment with dimethyl fumarate
boolean
C0058218 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Childbearing Potential Female Sterilization Absent | Childbearing Potential Contraceptive methods
Item
female subjects of childbearing potential who are not surgically sterile must practice effective contraception during their participation in the study
boolean
C3831118 (UMLS CUI [1,1])
C0015787 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Complete Blood Count | Lymphocyte Count
Item
have had a recent complete blood count (cbc), including lymphocyte count, that does not preclude participation in the study
boolean
C0009555 (UMLS CUI [1])
C0200635 (UMLS CUI [2])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Gastrointestinal Disease | Peptic Ulcer | Irritable Bowel Syndrome | Digestive Signs and Symptoms Interfere with Assessment End Point | Nausea | Vomiting | Abdominal Pain | Diarrhea
Item
have a recent history or ongoing gi illness (e.g., peptic ulcer, irritable bowel syndrome) or any other current condition with gi signs and symptoms (e.g., nausea, vomiting, abdominal pain, or diarrhea) that may interfere with assessment of study endpoints
boolean
C0017178 (UMLS CUI [1])
C0030920 (UMLS CUI [2])
C0022104 (UMLS CUI [3])
C0037089 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C1516048 (UMLS CUI [4,3])
C2349179 (UMLS CUI [4,4])
C0027497 (UMLS CUI [5])
C0042963 (UMLS CUI [6])
C0000737 (UMLS CUI [7])
C0011991 (UMLS CUI [8])
Comorbidity Study Subject Participation Status Excluded
Item
have other comorbid conditions that preclude participation in the study
boolean
C0009488 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
participant is pregnant, breastfeeding, or planning a pregnancy during the study period
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Disease Modification Therapy Multiple Sclerosis | natalizumab | Interferon-beta | glatiramer acetate | fingolimod | alemtuzumab | teriflunomide | laquinimod
Item
are receiving concomitant disease-modifying therapies for ms including, but not limited to, natalizumab, ifn-β, glatiramer acetate, fingolimod, alemtuzumab, teriflunomide, or laquinimod at screening
boolean
C0012634 (UMLS CUI [1,1])
C3840684 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0026769 (UMLS CUI [1,4])
C1172734 (UMLS CUI [2])
C0015980 (UMLS CUI [3])
C0289884 (UMLS CUI [4])
C1699926 (UMLS CUI [5])
C0383429 (UMLS CUI [6])
C1718383 (UMLS CUI [7])
C1260208 (UMLS CUI [8])
Allergic Reaction Severe | Anaphylaxis Severe | Drug Allergy
Item
history of severe allergic or anaphylactic reactions or known drug hypersensitivity
boolean
C1527304 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0002792 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0013182 (UMLS CUI [3])
Eligibility Criteria Study Protocol
Item
note: other protocol defined inclusion/exclusion criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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