ID

42663

Beskrivning

Study to Evaluate Fatigue in Participants With Relapsing Remitting Multiple Sclerosis When Treated With Dimethyl Fumarate; ODM derived from: https://clinicaltrials.gov/show/NCT02090348

Länk

https://clinicaltrials.gov/show/NCT02090348

Nyckelord

Versioner (2)
  1. 2015-11-20 2015-11-20 -
  2. 2021-09-17 2021-09-17 -
Uppladdad den

17 september 2021

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Relapsing-Remitting Multiple Sclerosis NCT02090348

Engelsk

Eligibility Relapsing-Remitting Multiple Sclerosis NCT02090348

1 Formulär  
Criteria
Beskrivning

Criteria

have a confirmed diagnosis of rrms and satisfies the therapeutic indication as described in the local label.
Beskrivning

Relapsing-Remitting Multiple Sclerosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0751967
have a stable edss (as assessed by the investigator) and been on the same (type and dosage) standard of care (soc) first-line treatment for at least 6 months.
Beskrivning

Expanded Disability Status Scale

Datatyp

boolean

Alias
UMLS CUI [1]
C0451246
if taking antidepressants, amphetamine, modafinil, or fampridine (fampyra), subject must be assessed as having been clinically stable for at least 3 months prior to the baseline visit.
Beskrivning

Clinically stable

Datatyp

boolean

Alias
UMLS CUI [1]
C0205360
fsmc total score ≥43 (mild fatigue) at baseline.
Beskrivning

Fatigue Scale for Motor and Cognitive Functions (FSMC)

Datatyp

boolean

Alias
UMLS CUI [1]
C2733557
as perceived by the investigator, have the ability to comply with all requirements of the study protocol.
Beskrivning

Ability to comply with all requirements of the study protocol

Datatyp

boolean

Alias
UMLS CUI [1]
C1321605
key exclusion criteria:
Beskrivning

Exclusion Criteria

Datatyp

boolean

Alias
UMLS CUI [1]
C0680251
diagnosis of major depression, as identified by the investigator.
Beskrivning

Major depression

Datatyp

boolean

Alias
UMLS CUI [1]
C1269683
diagnosis of primary progressive, secondary progressive, or progressive relapsing multiple sclerosis.
Beskrivning

Relapsing Multiple Sclerosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0751967
UMLS CUI [2]
C0393666
UMLS CUI [3]
C0393664
history of malignancy (except for basal cell carcinoma that had been completely excised prior to study entry), severe allergic or anaphylactic reactions or known drug hypersensitivity, abnormal laboratory results indicative of any significant disease, and/or a major disease that would preclude participation in a clinical trial.
Beskrivning

History of malignancy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0009488
UMLS CUI [1,3]
C0439801
treatment of ms relapse within 90 days prior to study enrollment.
Beskrivning

Multiple sclerosis relapse

Datatyp

boolean

Alias
UMLS CUI [1]
C0856120
history of a positive test result for human immunodeficiency virus, hepatitis c virus antibody, or hepatitis b virus (defined as positive for hepatitis b surface antigen or hepatitis b core antibody.
Beskrivning

History of a positive infection

Datatyp

boolean

Alias
UMLS CUI [1]
C0019682
UMLS CUI [2]
C0166049
UMLS CUI [3]
C0149708
impaired hepatic or renal function, as perceived by the investigator.
Beskrivning

Impaired hepatic or renal function

Datatyp

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C3279454
any prior treatment with dmf (or other fumarate derivative), total lymphoid irradiation, cladribine, fingolimod, t cell or t-cell receptor vaccination, or any therapeutic monoclonal antibody.
Beskrivning

Any prior treatment with dmf

Datatyp

boolean

Alias
UMLS CUI [1]
C0012426
UMLS CUI [2]
C0024230
current enrollment in any other clinical studies.
Beskrivning

Current enrollment in any other clinical studies

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
known to suffer from narcolepsy or another significant sleep disorder.
Beskrivning

Narcolepsy

Datatyp

boolean

Alias
UMLS CUI [1]
C0027404
UMLS CUI [2]
C0851578
comorbidity that may have an impact on fatigue.
Beskrivning

Comorbidity

Datatyp

boolean

Alias
UMLS CUI [1]
C0009488
other unspecified reasons that, in the opinion of the investigator or biogen idec, make the subject unsuitable for enrollment.
Beskrivning

Unsuitable for enrollment.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0009488
UMLS CUI [1,3]
C0439801
note: other protocol-defined inclusion/exclusion criteria may apply
Beskrivning

Inclusion/exclusion criteria

Datatyp

boolean

Alias
UMLS CUI [1]
C2827031
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Similar models

Eligibility Relapsing-Remitting Multiple Sclerosis NCT02090348

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Relapsing-Remitting Multiple Sclerosis
Item
have a confirmed diagnosis of rrms and satisfies the therapeutic indication as described in the local label.
boolean
C0751967 (UMLS CUI [1])
Expanded Disability Status Scale
Item
have a stable edss (as assessed by the investigator) and been on the same (type and dosage) standard of care (soc) first-line treatment for at least 6 months.
boolean
C0451246 (UMLS CUI [1])
Clinically stable
Item
if taking antidepressants, amphetamine, modafinil, or fampridine (fampyra), subject must be assessed as having been clinically stable for at least 3 months prior to the baseline visit.
boolean
C0205360 (UMLS CUI [1])
Fatigue Scale for Motor and Cognitive Functions (FSMC)
Item
fsmc total score ≥43 (mild fatigue) at baseline.
boolean
C2733557 (UMLS CUI [1])
Ability to comply with all requirements of the study protocol
Item
as perceived by the investigator, have the ability to comply with all requirements of the study protocol.
boolean
C1321605 (UMLS CUI [1])
Exclusion Criteria
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1])
Major depression
Item
diagnosis of major depression, as identified by the investigator.
boolean
C1269683 (UMLS CUI [1])
Relapsing Multiple Sclerosis
Item
diagnosis of primary progressive, secondary progressive, or progressive relapsing multiple sclerosis.
boolean
C0751967 (UMLS CUI [1])
C0393666 (UMLS CUI [2])
C0393664 (UMLS CUI [3])
History of malignancy
Item
history of malignancy (except for basal cell carcinoma that had been completely excised prior to study entry), severe allergic or anaphylactic reactions or known drug hypersensitivity, abnormal laboratory results indicative of any significant disease, and/or a major disease that would preclude participation in a clinical trial.
boolean
C0525058 (UMLS CUI [1,1])
C0009488 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
Multiple sclerosis relapse
Item
treatment of ms relapse within 90 days prior to study enrollment.
boolean
C0856120 (UMLS CUI [1])
History of a positive infection
Item
history of a positive test result for human immunodeficiency virus, hepatitis c virus antibody, or hepatitis b virus (defined as positive for hepatitis b surface antigen or hepatitis b core antibody.
boolean
C0019682 (UMLS CUI [1])
C0166049 (UMLS CUI [2])
C0149708 (UMLS CUI [3])
Impaired hepatic or renal function
Item
impaired hepatic or renal function, as perceived by the investigator.
boolean
C0086565 (UMLS CUI [1])
C3279454 (UMLS CUI [2])
Any prior treatment with dmf
Item
any prior treatment with dmf (or other fumarate derivative), total lymphoid irradiation, cladribine, fingolimod, t cell or t-cell receptor vaccination, or any therapeutic monoclonal antibody.
boolean
C0012426 (UMLS CUI [1])
C0024230 (UMLS CUI [2])
Current enrollment in any other clinical studies
Item
current enrollment in any other clinical studies.
boolean
C2348568 (UMLS CUI [1])
Narcolepsy
Item
known to suffer from narcolepsy or another significant sleep disorder.
boolean
C0027404 (UMLS CUI [1])
C0851578 (UMLS CUI [2])
Comorbidity
Item
comorbidity that may have an impact on fatigue.
boolean
C0009488 (UMLS CUI [1])
Unsuitable for enrollment.
Item
other unspecified reasons that, in the opinion of the investigator or biogen idec, make the subject unsuitable for enrollment.
boolean
C0525058 (UMLS CUI [1,1])
C0009488 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
Inclusion/exclusion criteria
Item
note: other protocol-defined inclusion/exclusion criteria may apply
boolean
C2827031 (UMLS CUI [1])
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