ID

22925

Descrição

Safety Study in Relapsing-remitting Multiple Sclerosis (RRMS) Patients Receiving Betaferon or Rebif; ODM derived from: https://clinicaltrials.gov/show/NCT00317941

Link

https://clinicaltrials.gov/show/NCT00317941

Palavras-chave

Versões (1)
  1. 16/06/2017 16/06/2017 -
Transferido a

16 de junho de 2017

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Relapsing-remitting Multiple Sclerosis NCT00317941

Inglês

Eligibility Relapsing-remitting Multiple Sclerosis NCT00317941

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
males or females
Descrição

Gender

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0079399
age >= 18 years old
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
patients after a first demyelinating event suggestive of ms (only for betaferon) as well as patients with a definite diagnosis of rrms (betaferon et rebif)
Descrição

Demyelinating disorder First Suggestive of Multiple Sclerosis | Betaferon | Multiple Sclerosis, Relapsing-Remitting | Rebif

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0947925
UMLS CUI [1,2]
C0205435
UMLS CUI [1,3]
C0332299
UMLS CUI [1,4]
C0026769
UMLS CUI [2]
C0592527
UMLS CUI [3]
C0751967
UMLS CUI [4]
C0752980
first justified prescription of one interferon beta by subcutaneous route (as described in summary of product characteristics [smpc] of betaferon or rebif)
Descrição

Interferon-beta Subcutaneous Firstly | Betaferon | Rebif

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0015980
UMLS CUI [1,2]
C1522438
UMLS CUI [1,3]
C1279901
UMLS CUI [2]
C0592527
UMLS CUI [3]
C0752980
females of child-bearing potential must agree to practice adequate contraceptive methods over the duration of the study (not applicable for men)
Descrição

Childbearing Potential Contraceptive methods

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
patient can follow and comply with all study procedures of the trial protocol
Descrição

Protocol Compliance

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0525058
laboratory evaluations (i.e., evaluation of hepatic enzyme gamma-gt, full blood count and differential white blood cell count [wbc]) must be available and the results must be normal.
Descrição

Laboratory data interpretation | Evaluation Liver enzyme Gamma glutamyl transferase measurement | Complete Blood Count | Differential white blood cell count procedure | Normal Laboratory Test Result

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0262707
UMLS CUI [2,1]
C1261322
UMLS CUI [2,2]
C0443764
UMLS CUI [2,3]
C0202035
UMLS CUI [3]
C0009555
UMLS CUI [4]
C0162401
UMLS CUI [5]
C0438214
written informed consent
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
any contraindication to the prescription of betaferon or rebif, as described in the smpc of products:
Descrição

Medical contraindication Betaferon | Medical contraindication Rebif

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0592527
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0752980
pregnancy or lactation
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
known hypersensitivity to natural or recombinant interferon beta, to mannitol, to human albumin or any other excipients used
Descrição

Hypersensitivity Interferon-beta | Hypersensitivity Recombinant Interferon Beta | Mannitol allergy | Hypersensitivity Albumin Human | Hypersensitivity Excipient

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0015980
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0751599
UMLS CUI [3]
C0571922
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0304925
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0015237
history of severe depression or suicide attempt or current suicidal ideation.
Descrição

Severe depression | Suicide attempt | Feeling suicidal

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0588008
UMLS CUI [2]
C0038663
UMLS CUI [3]
C0424000
patient with decompensated liver disease
Descrição

Decompensated liver disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C4075847
epilepsy not adequately controlled by treatment
Descrição

Epilepsy control poor

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1278398
patient previously included in this study.
Descrição

Study Subject Participation Status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
patient previously treated by sub-cutaneous route with either betaferon or rebif.
Descrição

Betaferon Subcutaneous | Rebif Subcutaneous

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0592527
UMLS CUI [1,2]
C1522438
UMLS CUI [2,1]
C0752980
UMLS CUI [2,2]
C1522438
participation in any clinical trial within the past 30 days involving the investigational drug intake.
Descrição

Study Subject Participation Status | Investigational New Drugs

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
medical, psychiatric or other conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol or to complete the study.
Descrição

Medical condition compromises Comprehension Patient Information | Medical condition compromises Informed Consent | Medical condition compromises Protocol Compliance | Medical condition compromises Clinical Trial Completion | Mental disorder compromises Comprehension Patient Information | Mental disorder compromises Informed Consent | Mental disorder compromises Protocol Compliance | Mental disorder compromises Clinical Trial Completion | Condition compromises Comprehension Patient Information | Condition compromises Informed Consent | Condition compromises Protocol Compliance | Condition compromises Clinical Trial Completion

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2945640
UMLS CUI [1,3]
C0162340
UMLS CUI [1,4]
C1955348
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C2945640
UMLS CUI [2,3]
C0021430
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C2945640
UMLS CUI [3,3]
C0525058
UMLS CUI [4,1]
C3843040
UMLS CUI [4,2]
C2945640
UMLS CUI [4,3]
C0008976
UMLS CUI [4,4]
C0205197
UMLS CUI [5,1]
C0004936
UMLS CUI [5,2]
C2945640
UMLS CUI [5,3]
C0162340
UMLS CUI [5,4]
C1955348
UMLS CUI [6,1]
C0004936
UMLS CUI [6,2]
C2945640
UMLS CUI [6,3]
C0021430
UMLS CUI [7,1]
C0004936
UMLS CUI [7,2]
C2945640
UMLS CUI [7,3]
C0525058
UMLS CUI [8,1]
C0004936
UMLS CUI [8,2]
C2945640
UMLS CUI [8,3]
C0008976
UMLS CUI [8,4]
C0205197
UMLS CUI [9,1]
C0348080
UMLS CUI [9,2]
C2945640
UMLS CUI [9,3]
C0162340
UMLS CUI [9,4]
C1955348
UMLS CUI [10,1]
C0348080
UMLS CUI [10,2]
C2945640
UMLS CUI [10,3]
C0021430
UMLS CUI [11,1]
C0348080
UMLS CUI [11,2]
C2945640
UMLS CUI [11,3]
C0525058
UMLS CUI [12,1]
C0348080
UMLS CUI [12,2]
C2945640
UMLS CUI [12,3]
C0008976
UMLS CUI [12,4]
C0205197
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Similar models

Eligibility Relapsing-remitting Multiple Sclerosis NCT00317941

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Gender
Item
males or females
boolean
C0079399 (UMLS CUI [1])
Age
Item
age >= 18 years old
boolean
C0001779 (UMLS CUI [1])
Demyelinating disorder First Suggestive of Multiple Sclerosis | Betaferon | Multiple Sclerosis, Relapsing-Remitting | Rebif
Item
patients after a first demyelinating event suggestive of ms (only for betaferon) as well as patients with a definite diagnosis of rrms (betaferon et rebif)
boolean
C0947925 (UMLS CUI [1,1])
C0205435 (UMLS CUI [1,2])
C0332299 (UMLS CUI [1,3])
C0026769 (UMLS CUI [1,4])
C0592527 (UMLS CUI [2])
C0751967 (UMLS CUI [3])
C0752980 (UMLS CUI [4])
Interferon-beta Subcutaneous Firstly | Betaferon | Rebif
Item
first justified prescription of one interferon beta by subcutaneous route (as described in summary of product characteristics [smpc] of betaferon or rebif)
boolean
C0015980 (UMLS CUI [1,1])
C1522438 (UMLS CUI [1,2])
C1279901 (UMLS CUI [1,3])
C0592527 (UMLS CUI [2])
C0752980 (UMLS CUI [3])
Childbearing Potential Contraceptive methods
Item
females of child-bearing potential must agree to practice adequate contraceptive methods over the duration of the study (not applicable for men)
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Protocol Compliance
Item
patient can follow and comply with all study procedures of the trial protocol
boolean
C0525058 (UMLS CUI [1])
Laboratory data interpretation | Evaluation Liver enzyme Gamma glutamyl transferase measurement | Complete Blood Count | Differential white blood cell count procedure | Normal Laboratory Test Result
Item
laboratory evaluations (i.e., evaluation of hepatic enzyme gamma-gt, full blood count and differential white blood cell count [wbc]) must be available and the results must be normal.
boolean
C0262707 (UMLS CUI [1])
C1261322 (UMLS CUI [2,1])
C0443764 (UMLS CUI [2,2])
C0202035 (UMLS CUI [2,3])
C0009555 (UMLS CUI [3])
C0162401 (UMLS CUI [4])
C0438214 (UMLS CUI [5])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Medical contraindication Betaferon | Medical contraindication Rebif
Item
any contraindication to the prescription of betaferon or rebif, as described in the smpc of products:
boolean
C1301624 (UMLS CUI [1,1])
C0592527 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0752980 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
pregnancy or lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Hypersensitivity Interferon-beta | Hypersensitivity Recombinant Interferon Beta | Mannitol allergy | Hypersensitivity Albumin Human | Hypersensitivity Excipient
Item
known hypersensitivity to natural or recombinant interferon beta, to mannitol, to human albumin or any other excipients used
boolean
C0020517 (UMLS CUI [1,1])
C0015980 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0751599 (UMLS CUI [2,2])
C0571922 (UMLS CUI [3])
C0020517 (UMLS CUI [4,1])
C0304925 (UMLS CUI [4,2])
C0020517 (UMLS CUI [5,1])
C0015237 (UMLS CUI [5,2])
Severe depression | Suicide attempt | Feeling suicidal
Item
history of severe depression or suicide attempt or current suicidal ideation.
boolean
C0588008 (UMLS CUI [1])
C0038663 (UMLS CUI [2])
C0424000 (UMLS CUI [3])
Decompensated liver disease
Item
patient with decompensated liver disease
boolean
C4075847 (UMLS CUI [1])
Epilepsy control poor
Item
epilepsy not adequately controlled by treatment
boolean
C1278398 (UMLS CUI [1])
Study Subject Participation Status
Item
patient previously included in this study.
boolean
C2348568 (UMLS CUI [1])
Betaferon Subcutaneous | Rebif Subcutaneous
Item
patient previously treated by sub-cutaneous route with either betaferon or rebif.
boolean
C0592527 (UMLS CUI [1,1])
C1522438 (UMLS CUI [1,2])
C0752980 (UMLS CUI [2,1])
C1522438 (UMLS CUI [2,2])
Study Subject Participation Status | Investigational New Drugs
Item
participation in any clinical trial within the past 30 days involving the investigational drug intake.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Medical condition compromises Comprehension Patient Information | Medical condition compromises Informed Consent | Medical condition compromises Protocol Compliance | Medical condition compromises Clinical Trial Completion | Mental disorder compromises Comprehension Patient Information | Mental disorder compromises Informed Consent | Mental disorder compromises Protocol Compliance | Mental disorder compromises Clinical Trial Completion | Condition compromises Comprehension Patient Information | Condition compromises Informed Consent | Condition compromises Protocol Compliance | Condition compromises Clinical Trial Completion
Item
medical, psychiatric or other conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol or to complete the study.
boolean
C3843040 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C0162340 (UMLS CUI [1,3])
C1955348 (UMLS CUI [1,4])
C3843040 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C2945640 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
C3843040 (UMLS CUI [4,1])
C2945640 (UMLS CUI [4,2])
C0008976 (UMLS CUI [4,3])
C0205197 (UMLS CUI [4,4])
C0004936 (UMLS CUI [5,1])
C2945640 (UMLS CUI [5,2])
C0162340 (UMLS CUI [5,3])
C1955348 (UMLS CUI [5,4])
C0004936 (UMLS CUI [6,1])
C2945640 (UMLS CUI [6,2])
C0021430 (UMLS CUI [6,3])
C0004936 (UMLS CUI [7,1])
C2945640 (UMLS CUI [7,2])
C0525058 (UMLS CUI [7,3])
C0004936 (UMLS CUI [8,1])
C2945640 (UMLS CUI [8,2])
C0008976 (UMLS CUI [8,3])
C0205197 (UMLS CUI [8,4])
C0348080 (UMLS CUI [9,1])
C2945640 (UMLS CUI [9,2])
C0162340 (UMLS CUI [9,3])
C1955348 (UMLS CUI [9,4])
C0348080 (UMLS CUI [10,1])
C2945640 (UMLS CUI [10,2])
C0021430 (UMLS CUI [10,3])
C0348080 (UMLS CUI [11,1])
C2945640 (UMLS CUI [11,2])
C0525058 (UMLS CUI [11,3])
C0348080 (UMLS CUI [12,1])
C2945640 (UMLS CUI [12,2])
C0008976 (UMLS CUI [12,3])
C0205197 (UMLS CUI [12,4])
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