ID

37017

Description

Management Of The Infusion-Associated Reactions In RRMS Patients Treated With LEMTRADA; ODM derived from: https://clinicaltrials.gov/show/NCT02205489

Link

https://clinicaltrials.gov/show/NCT02205489

Keywords

Versions (1)
  1. 6/30/19 6/30/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 30, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Relapsing-remitting Multiple Sclerosis NCT02205489

English

Eligibility Relapsing-remitting Multiple Sclerosis NCT02205489

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult rrms patients who will be initiating treatment with lemtrada according to local approved label.
Description

Multiple Sclerosis, Relapsing-Remitting | Adult | Start time Lemtrada

Data type

boolean

Alias
UMLS CUI [1]
C0751967
UMLS CUI [2]
C0001675
UMLS CUI [3,1]
C1301880
UMLS CUI [3,2]
C3860145
signed written informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previously treated with lemtrada.
Description

Prior Therapy Lemtrada

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C3860145
contraindications to lemtrada according to the labeling in the country.
Description

Medical contraindication Lemtrada

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C3860145
any known contraindications to the symptomatic therapy used in the infusion management guidance based on their local approved label.
Description

Medical contraindication Therapy Symptomatic

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0231220
currently participating in another investigational interventional study.
Description

Study Subject Participation Status | Interventional Study Investigational

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C3274035
UMLS CUI [2,2]
C1517586
any technical/administrative reason that makes it impossible to enroll the patient in the study.
Description

Technical Problem Study Subject Participation Status Excluded | Factor Administrative Study Subject Participation Status Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C1710348
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0332196
UMLS CUI [2,1]
C1521761
UMLS CUI [2,2]
C3845829
UMLS CUI [2,3]
C2348568
UMLS CUI [2,4]
C0332196
patient is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.
Description

Persons Involved Completion of clinical trial | Research Personnel | Research Personnel Relative

Data type

boolean

Alias
UMLS CUI [1,1]
C0027361
UMLS CUI [1,2]
C1314939
UMLS CUI [1,3]
C2732579
UMLS CUI [2]
C0035173
UMLS CUI [3,1]
C0035173
UMLS CUI [3,2]
C0080103
patient who has withdrawn consent before enrollment (starting from signed informed consent form).
Description

Consent Withdrawn

Data type

boolean

Alias
UMLS CUI [1]
C1707492
despite screening of the patient, enrolment is stopped at the study level.
Description

Enrollment Discontinued

Data type

boolean

Alias
UMLS CUI [1,1]
C1516879
UMLS CUI [1,2]
C1444662
woman of childbearing potential not protected by highly-effective method(s) of birth control (as defined in a local protocol amendment in case of specific local requirement) and/or who are unwilling or unable to be tested for pregnancy.
Description

Childbearing Potential Contraceptive methods Absent | Childbearing Potential Pregnancy Test Unwilling | Childbearing Potential Pregnancy Test Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0032976
UMLS CUI [2,3]
C0558080
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0032976
UMLS CUI [3,3]
C1299582
pregnancy (defined as positive beta human chorionic gonadotropin (β-hcg) blood test), breast feeding.
Description

Pregnancy | Hematologic Test Beta HCG positive | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0018941
UMLS CUI [2,2]
C0813152
UMLS CUI [3]
C0006147
known infection with latent tuberculosis or active tuberculosis.
Description

Latent Tuberculosis | Tuberculosis

Data type

boolean

Alias
UMLS CUI [1]
C1609538
UMLS CUI [2]
C0041296
known infection with hepatitis b, hepatitis c.
Description

Hepatitis B | Hepatitis C

Data type

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Description

Study Subject Participation Status | Considerations Additional

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0518609
UMLS CUI [2,2]
C1524062
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Similar models

Eligibility Relapsing-remitting Multiple Sclerosis NCT02205489

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Sclerosis, Relapsing-Remitting | Adult | Start time Lemtrada
Item
adult rrms patients who will be initiating treatment with lemtrada according to local approved label.
boolean
C0751967 (UMLS CUI [1])
C0001675 (UMLS CUI [2])
C1301880 (UMLS CUI [3,1])
C3860145 (UMLS CUI [3,2])
Informed Consent
Item
signed written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Prior Therapy Lemtrada
Item
previously treated with lemtrada.
boolean
C1514463 (UMLS CUI [1,1])
C3860145 (UMLS CUI [1,2])
Medical contraindication Lemtrada
Item
contraindications to lemtrada according to the labeling in the country.
boolean
C1301624 (UMLS CUI [1,1])
C3860145 (UMLS CUI [1,2])
Medical contraindication Therapy Symptomatic
Item
any known contraindications to the symptomatic therapy used in the infusion management guidance based on their local approved label.
boolean
C1301624 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0231220 (UMLS CUI [1,3])
Study Subject Participation Status | Interventional Study Investigational
Item
currently participating in another investigational interventional study.
boolean
C2348568 (UMLS CUI [1])
C3274035 (UMLS CUI [2,1])
C1517586 (UMLS CUI [2,2])
Technical Problem Study Subject Participation Status Excluded | Factor Administrative Study Subject Participation Status Excluded
Item
any technical/administrative reason that makes it impossible to enroll the patient in the study.
boolean
C1710348 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C1521761 (UMLS CUI [2,1])
C3845829 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C0332196 (UMLS CUI [2,4])
Persons Involved Completion of clinical trial | Research Personnel | Research Personnel Relative
Item
patient is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.
boolean
C0027361 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])
C0035173 (UMLS CUI [2])
C0035173 (UMLS CUI [3,1])
C0080103 (UMLS CUI [3,2])
Consent Withdrawn
Item
patient who has withdrawn consent before enrollment (starting from signed informed consent form).
boolean
C1707492 (UMLS CUI [1])
Enrollment Discontinued
Item
despite screening of the patient, enrolment is stopped at the study level.
boolean
C1516879 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
Childbearing Potential Contraceptive methods Absent | Childbearing Potential Pregnancy Test Unwilling | Childbearing Potential Pregnancy Test Unable
Item
woman of childbearing potential not protected by highly-effective method(s) of birth control (as defined in a local protocol amendment in case of specific local requirement) and/or who are unwilling or unable to be tested for pregnancy.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0032976 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
C3831118 (UMLS CUI [3,1])
C0032976 (UMLS CUI [3,2])
C1299582 (UMLS CUI [3,3])
Pregnancy | Hematologic Test Beta HCG positive | Breast Feeding
Item
pregnancy (defined as positive beta human chorionic gonadotropin (β-hcg) blood test), breast feeding.
boolean
C0032961 (UMLS CUI [1])
C0018941 (UMLS CUI [2,1])
C0813152 (UMLS CUI [2,2])
C0006147 (UMLS CUI [3])
Latent Tuberculosis | Tuberculosis
Item
known infection with latent tuberculosis or active tuberculosis.
boolean
C1609538 (UMLS CUI [1])
C0041296 (UMLS CUI [2])
Hepatitis B | Hepatitis C
Item
known infection with hepatitis b, hepatitis c.
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
Study Subject Participation Status | Considerations Additional
Item
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
boolean
C2348568 (UMLS CUI [1])
C0518609 (UMLS CUI [2,1])
C1524062 (UMLS CUI [2,2])
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