ID

37017

Beschrijving

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

Trefwoorden

Versies (1)
  1. 30-06-19 30-06-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

30 juni 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Relapsing-remitting Multiple Sclerosis NCT02205489

Engels

Eligibility Relapsing-remitting Multiple Sclerosis NCT02205489

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

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

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

Datatype

boolean

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

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
previously treated with lemtrada.
Beschrijving

Prior Therapy Lemtrada

Datatype

boolean

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

Medical contraindication Lemtrada

Datatype

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.
Beschrijving

Medical contraindication Therapy Symptomatic

Datatype

boolean

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

Study Subject Participation Status | Interventional Study Investigational

Datatype

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.
Beschrijving

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

Datatype

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.
Beschrijving

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

Datatype

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).
Beschrijving

Consent Withdrawn

Datatype

boolean

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

Enrollment Discontinued

Datatype

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.
Beschrijving

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

Datatype

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.
Beschrijving

Pregnancy | Hematologic Test Beta HCG positive | Breast Feeding

Datatype

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.
Beschrijving

Latent Tuberculosis | Tuberculosis

Datatype

boolean

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

Hepatitis B | Hepatitis C

Datatype

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.
Beschrijving

Study Subject Participation Status | Considerations Additional

Datatype

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 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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