ID

37014

Description

Transition to Peginterferon Beta-1a (BIIB017) From Subcutaneous Interferon Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT02234869

Link

https://clinicaltrials.gov/show/NCT02234869

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 Multiple Sclerosis NCT02234869

English

Eligibility Relapsing Multiple Sclerosis NCT02234869

1 forms  
Criteria
Description

Criteria

must have a confirmed diagnosis of relapsing multiple sclerosis (rms), as defined by mcdonald criteria.
Description

Multiple sclerosis relapse

Data type

boolean

Alias
UMLS CUI [1]
C0856120
an expanded disability status scale (edss) score between 0 and 5.0.
Description

EDSS

Data type

boolean

Alias
UMLS CUI [1]
C0451246
on continual treatment for ≥6 months with a single standard-of-care subcutaneous (sc) interferon beta (ifn-β) therapy, including ifn β-1b 0.25 mg sc every other day or ifn
Description

Standard of Care | Interferon-beta Subcutaneous | Interferon beta-1b Subcutaneous Dosage

Data type

boolean

Alias
UMLS CUI [1]
C2936643
UMLS CUI [2,1]
C0015980
UMLS CUI [2,2]
C1522438
UMLS CUI [3,1]
C0244713
UMLS CUI [3,2]
C1522438
UMLS CUI [3,3]
C0178602
β-1a 44 μg sc 3 times weekly, and from a clinical perspective be able to continue this therapy (i.e., no significant untoward events attributed to ifn therapy that would preclude continuation of the existing ifn therapy).
Description

Interferon beta-1a Subcutaneous Dosage

Data type

boolean

Alias
UMLS CUI [1,1]
C0254119
UMLS CUI [1,2]
C1522438
UMLS CUI [1,3]
C0178602
a candidate for change to biib017 therapy (candidacy for therapy change is determined by the treating physician; however, it is recommended to exclude patients with high disease activity and who are candidates for escalation therapy according to local guidelines).
Description

Change Peginterferon beta-1a

Data type

boolean

Alias
UMLS CUI [1,1]
C0392747
UMLS CUI [1,2]
C3848580
patients who are randomized to their current standard-of-care ifn-β therapy for the first 6 months of the study must be willing to receive their treatment via the formulation provided in the study (i.e., rebif 44 μg in a prefilled syringe or betaferon/betaseron 0.25 mg in single-use vials of lyophilized powder accompanied by a prefilled single-use diluent syringe).
Description

Standard of Care | Interferon-beta | Rebif Dosage | Betaferon Dosage | Betaseron Dosage

Data type

boolean

Alias
UMLS CUI [1]
C2936643
UMLS CUI [2]
C0015980
UMLS CUI [3,1]
C0752980
UMLS CUI [3,2]
C0178602
UMLS CUI [4,1]
C0592527
UMLS CUI [4,2]
C0178602
UMLS CUI [5,1]
C0284968
UMLS CUI [5,2]
C0178602
key exclusion criteria:
Description

Exclusion Criteria Main

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
primary progressive, secondary progressive, or progressive relapsing ms.
Description

Multiple Sclerosis, Primary Progressive | Multiple Sclerosis, Secondary Progressive | Multiple Sclerosis, Progressive Relapsing

Data type

boolean

Alias
UMLS CUI [1]
C0751964
UMLS CUI [2]
C0751965
UMLS CUI [3]
C0393666
history of inadequate response to sc ifn therapy (as determined by the treating physician).
Description

Interferon Subcutaneous | Response Inadequate

Data type

boolean

Alias
UMLS CUI [1,1]
C3652465
UMLS CUI [1,2]
C1522438
UMLS CUI [2,1]
C1704632
UMLS CUI [2,2]
C0205412
history of severe allergic or anaphylactic reactions or known hypersensitivity to study drug or its excipients. - known allergy to any component of the biib017 formulation.
Description

Allergic Reaction Severe | Anaphylaxis Severe | Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drug Excipient | Hypersensitivity Peginterferon beta-1a Component

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 [3,1]
C0020517
UMLS CUI [3,2]
C0013230
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0013230
UMLS CUI [4,3]
C0015237
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C3848580
UMLS CUI [5,3]
C1705248
history of any clinically significant (as determined by the investigator) cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major disease that would preclude participation in a clinical study.
Description

Heart Disease | Endocrine System Diseases | Hematological Disease | Liver diseases | Immune System Diseases | Metabolic Diseases | Urologic Diseases | Lung diseases | Nervous system disorder | Dermatologic disorders | Mental disorders | Kidney Diseases | Disease Major Study Subject Participation Status Excluded

Data type

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0014130
UMLS CUI [3]
C0018939
UMLS CUI [4]
C0023895
UMLS CUI [5]
C0021053
UMLS CUI [6]
C0025517
UMLS CUI [7]
C0042075
UMLS CUI [8]
C0024115
UMLS CUI [9]
C0027765
UMLS CUI [10]
C0037274
UMLS CUI [11]
C0004936
UMLS CUI [12]
C0022658
UMLS CUI [13,1]
C0012634
UMLS CUI [13,2]
C0205164
UMLS CUI [13,3]
C2348568
UMLS CUI [13,4]
C0332196
history of hypersensitivity or intolerance to acetaminophen, ibuprofen, naproxen, or aspirin that would preclude use of at least one of these during the study.
Description

Allergy to acetaminophen | Intolerance to Acetaminophen | Ibuprofen allergy | Intolerance to Ibuprofen | Naproxen allergy | Intolerance to Naproxen | Aspirin allergy | Intolerance to Aspirin

Data type

boolean

Alias
UMLS CUI [1]
C0570513
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0000970
UMLS CUI [3]
C0020741
UMLS CUI [4,1]
C1744706
UMLS CUI [4,2]
C0020740
UMLS CUI [5]
C0570551
UMLS CUI [6,1]
C1744706
UMLS CUI [6,2]
C0027396
UMLS CUI [7]
C0004058
UMLS CUI [8,1]
C1744706
UMLS CUI [8,2]
C0004057
an ms relapse that has occurred within the 50 days prior to randomization and/or lack of stabilization from a previous relapse prior to randomization.
Description

Multiple sclerosis relapse | Relapse Previous | Stabilization Lacking

Data type

boolean

Alias
UMLS CUI [1]
C0856120
UMLS CUI [2,1]
C0035020
UMLS CUI [2,2]
C0205156
UMLS CUI [3,1]
C1293130
UMLS CUI [3,2]
C0332268
any previous treatment with biib017.
Description

Peginterferon beta-1a Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C3848580
UMLS CUI [1,2]
C0205156
treatment with other agents for ms.
Description

Pharmacotherapy Other Multiple Sclerosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0026769
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 Relapsing Multiple Sclerosis NCT02234869

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Multiple sclerosis relapse
Item
must have a confirmed diagnosis of relapsing multiple sclerosis (rms), as defined by mcdonald criteria.
boolean
C0856120 (UMLS CUI [1])
EDSS
Item
an expanded disability status scale (edss) score between 0 and 5.0.
boolean
C0451246 (UMLS CUI [1])
Standard of Care | Interferon-beta Subcutaneous | Interferon beta-1b Subcutaneous Dosage
Item
on continual treatment for ≥6 months with a single standard-of-care subcutaneous (sc) interferon beta (ifn-β) therapy, including ifn β-1b 0.25 mg sc every other day or ifn
boolean
C2936643 (UMLS CUI [1])
C0015980 (UMLS CUI [2,1])
C1522438 (UMLS CUI [2,2])
C0244713 (UMLS CUI [3,1])
C1522438 (UMLS CUI [3,2])
C0178602 (UMLS CUI [3,3])
Interferon beta-1a Subcutaneous Dosage
Item
β-1a 44 μg sc 3 times weekly, and from a clinical perspective be able to continue this therapy (i.e., no significant untoward events attributed to ifn therapy that would preclude continuation of the existing ifn therapy).
boolean
C0254119 (UMLS CUI [1,1])
C1522438 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
Change Peginterferon beta-1a
Item
a candidate for change to biib017 therapy (candidacy for therapy change is determined by the treating physician; however, it is recommended to exclude patients with high disease activity and who are candidates for escalation therapy according to local guidelines).
boolean
C0392747 (UMLS CUI [1,1])
C3848580 (UMLS CUI [1,2])
Standard of Care | Interferon-beta | Rebif Dosage | Betaferon Dosage | Betaseron Dosage
Item
patients who are randomized to their current standard-of-care ifn-β therapy for the first 6 months of the study must be willing to receive their treatment via the formulation provided in the study (i.e., rebif 44 μg in a prefilled syringe or betaferon/betaseron 0.25 mg in single-use vials of lyophilized powder accompanied by a prefilled single-use diluent syringe).
boolean
C2936643 (UMLS CUI [1])
C0015980 (UMLS CUI [2])
C0752980 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0592527 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0284968 (UMLS CUI [5,1])
C0178602 (UMLS CUI [5,2])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Multiple Sclerosis, Primary Progressive | Multiple Sclerosis, Secondary Progressive | Multiple Sclerosis, Progressive Relapsing
Item
primary progressive, secondary progressive, or progressive relapsing ms.
boolean
C0751964 (UMLS CUI [1])
C0751965 (UMLS CUI [2])
C0393666 (UMLS CUI [3])
Interferon Subcutaneous | Response Inadequate
Item
history of inadequate response to sc ifn therapy (as determined by the treating physician).
boolean
C3652465 (UMLS CUI [1,1])
C1522438 (UMLS CUI [1,2])
C1704632 (UMLS CUI [2,1])
C0205412 (UMLS CUI [2,2])
Allergic Reaction Severe | Anaphylaxis Severe | Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drug Excipient | Hypersensitivity Peginterferon beta-1a Component
Item
history of severe allergic or anaphylactic reactions or known hypersensitivity to study drug or its excipients. - known allergy to any component of the biib017 formulation.
boolean
C1527304 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0002792 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0013230 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0013230 (UMLS CUI [4,2])
C0015237 (UMLS CUI [4,3])
C0020517 (UMLS CUI [5,1])
C3848580 (UMLS CUI [5,2])
C1705248 (UMLS CUI [5,3])
Heart Disease | Endocrine System Diseases | Hematological Disease | Liver diseases | Immune System Diseases | Metabolic Diseases | Urologic Diseases | Lung diseases | Nervous system disorder | Dermatologic disorders | Mental disorders | Kidney Diseases | Disease Major Study Subject Participation Status Excluded
Item
history of any clinically significant (as determined by the investigator) cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major disease that would preclude participation in a clinical study.
boolean
C0018799 (UMLS CUI [1])
C0014130 (UMLS CUI [2])
C0018939 (UMLS CUI [3])
C0023895 (UMLS CUI [4])
C0021053 (UMLS CUI [5])
C0025517 (UMLS CUI [6])
C0042075 (UMLS CUI [7])
C0024115 (UMLS CUI [8])
C0027765 (UMLS CUI [9])
C0037274 (UMLS CUI [10])
C0004936 (UMLS CUI [11])
C0022658 (UMLS CUI [12])
C0012634 (UMLS CUI [13,1])
C0205164 (UMLS CUI [13,2])
C2348568 (UMLS CUI [13,3])
C0332196 (UMLS CUI [13,4])
Allergy to acetaminophen | Intolerance to Acetaminophen | Ibuprofen allergy | Intolerance to Ibuprofen | Naproxen allergy | Intolerance to Naproxen | Aspirin allergy | Intolerance to Aspirin
Item
history of hypersensitivity or intolerance to acetaminophen, ibuprofen, naproxen, or aspirin that would preclude use of at least one of these during the study.
boolean
C0570513 (UMLS CUI [1])
C1744706 (UMLS CUI [2,1])
C0000970 (UMLS CUI [2,2])
C0020741 (UMLS CUI [3])
C1744706 (UMLS CUI [4,1])
C0020740 (UMLS CUI [4,2])
C0570551 (UMLS CUI [5])
C1744706 (UMLS CUI [6,1])
C0027396 (UMLS CUI [6,2])
C0004058 (UMLS CUI [7])
C1744706 (UMLS CUI [8,1])
C0004057 (UMLS CUI [8,2])
Multiple sclerosis relapse | Relapse Previous | Stabilization Lacking
Item
an ms relapse that has occurred within the 50 days prior to randomization and/or lack of stabilization from a previous relapse prior to randomization.
boolean
C0856120 (UMLS CUI [1])
C0035020 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C1293130 (UMLS CUI [3,1])
C0332268 (UMLS CUI [3,2])
Peginterferon beta-1a Previous
Item
any previous treatment with biib017.
boolean
C3848580 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Pharmacotherapy Other Multiple Sclerosis
Item
treatment with other agents for ms.
boolean
C0013216 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0026769 (UMLS CUI [1,3])
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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