ID

37010

Beschreibung

Effectiveness of Rebif® in Clinically Isolated Syndrome and Relapsing Multiple Sclerosis Using RebiSmart™ (PROCEED); ODM derived from: https://clinicaltrials.gov/show/NCT02254304

Link

https://clinicaltrials.gov/show/NCT02254304

Stichworte

Versionen (1)
  1. 29.06.19 29.06.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

29. Juni 2019

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Relapsing Multiple Sclerosis NCT02254304

Englisch

Eligibility Relapsing Multiple Sclerosis NCT02254304

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
male and female subjects between 18 to 65 years of age
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
female subjects must be neither pregnant nor breast-feeding and must lack child-bearing potential as defined in the protocol
Beschreibung

Gender | Pregnancy Absent | Breast Feeding Absent | Childbearing Potential Lacking

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0006147
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0332268
subjects diagnosed with cis or rms according to the revised mcdonald criteria (2010)
Beschreibung

Clinically isolated syndrome | Multiple sclerosis relapse

Datentyp

boolean

Alias
UMLS CUI [1]
C2921627
UMLS CUI [2]
C0856120
treatment-naive subjects or subjects treated with rebif® multi-dose injected by rebismart™ for no longer than 6 weeks prior to baseline visit
Beschreibung

Therapy naive | Rebif Injectable Product Dose multiple | Other Coding

Datentyp

boolean

Alias
UMLS CUI [1]
C0919936
UMLS CUI [2,1]
C3232239
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0439064
UMLS CUI [3]
C3846158
subjects that are able to self-inject with rebismart™ (in the opinion of the physician)
Beschreibung

Injection Self Injector | Other Coding

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1533685
UMLS CUI [1,2]
C0036588
UMLS CUI [1,3]
C0181342
UMLS CUI [2]
C3846158
subjects with expanded disability status scale (edss) score less than (<) 6 (inclusive) at baseline
Beschreibung

EDSS

Datentyp

boolean

Alias
UMLS CUI [1]
C0451246
signed informed consent and subject data collection form
Beschreibung

Informed Consent | Data Collection Consent Form

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0010995
UMLS CUI [2,2]
C0009797
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects experiencing a relapse within 30 days before baseline
Beschreibung

Relapse

Datentyp

boolean

Alias
UMLS CUI [1]
C0035020
participation in other studies within 30 days before baseline
Beschreibung

Study Subject Participation Status

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
received any ms therapy within 6 months prior to study enrolment (for example, other disease-modifying drugs: immunomodulatory, immunosuppressive agents or combination therapy) with the exception of rebif® multi-dose injected by rebismart™
Beschreibung

Therapy Multiple Sclerosis | Biological Response Modifiers | Immunomodulators | Immunosuppressive Agents | Combined Modality Therapy | Exception Rebif Dose multiple

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0026769
UMLS CUI [2]
C0005525
UMLS CUI [3]
C1527392
UMLS CUI [4]
C0021081
UMLS CUI [5]
C0009429
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C3232239
UMLS CUI [6,3]
C0178602
UMLS CUI [6,4]
C0439064
any visual or physical impairment that precludes the subject from self-injecting the treatment using the rebismart™
Beschreibung

Visual Impairment Excludes Injection Self | Physical impairment Excludes Injection Self

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3665347
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C1533685
UMLS CUI [1,4]
C0036588
UMLS CUI [2,1]
C0231171
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C1533685
UMLS CUI [2,4]
C0036588
pregnancy and breast-feeding
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
serious or acute heart disease such as uncontrolled cardiac dysrhythmias, uncontrolled angina pectoris, cardiomyopathy, or uncontrolled congestive heart failure, as per investigator opinion
Beschreibung

Heart Disease Serious | Heart Disease | Cardiac Arrhythmia Uncontrolled | Angina Pectoris Uncontrolled | Cardiomyopathy | Congestive heart failure Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C0018799
UMLS CUI [3,1]
C0003811
UMLS CUI [3,2]
C0205318
UMLS CUI [4,1]
C0002962
UMLS CUI [4,2]
C0205318
UMLS CUI [5]
C0878544
UMLS CUI [6,1]
C0018802
UMLS CUI [6,2]
C0205318
current or past (within the last 2 years) history of alcohol or drug abuse
Beschreibung

Substance Use Disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
have any contra-indications to treatment with interferon beta-1a according to summary of product characteristics
Beschreibung

Medical contraindication Interferon beta-1a

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0254119
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Ähnliche Modelle

Eligibility Relapsing Multiple Sclerosis NCT02254304

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male and female subjects between 18 to 65 years of age
boolean
C0001779 (UMLS CUI [1])
Gender | Pregnancy Absent | Breast Feeding Absent | Childbearing Potential Lacking
Item
female subjects must be neither pregnant nor breast-feeding and must lack child-bearing potential as defined in the protocol
boolean
C0079399 (UMLS CUI [1])
C0032961 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0006147 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C3831118 (UMLS CUI [4,1])
C0332268 (UMLS CUI [4,2])
Clinically isolated syndrome | Multiple sclerosis relapse
Item
subjects diagnosed with cis or rms according to the revised mcdonald criteria (2010)
boolean
C2921627 (UMLS CUI [1])
C0856120 (UMLS CUI [2])
Therapy naive | Rebif Injectable Product Dose multiple | Other Coding
Item
treatment-naive subjects or subjects treated with rebif® multi-dose injected by rebismart™ for no longer than 6 weeks prior to baseline visit
boolean
C0919936 (UMLS CUI [1])
C3232239 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0439064 (UMLS CUI [2,3])
C3846158 (UMLS CUI [3])
Injection Self Injector | Other Coding
Item
subjects that are able to self-inject with rebismart™ (in the opinion of the physician)
boolean
C1533685 (UMLS CUI [1,1])
C0036588 (UMLS CUI [1,2])
C0181342 (UMLS CUI [1,3])
C3846158 (UMLS CUI [2])
EDSS
Item
subjects with expanded disability status scale (edss) score less than (<) 6 (inclusive) at baseline
boolean
C0451246 (UMLS CUI [1])
Informed Consent | Data Collection Consent Form
Item
signed informed consent and subject data collection form
boolean
C0021430 (UMLS CUI [1])
C0010995 (UMLS CUI [2,1])
C0009797 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Relapse
Item
subjects experiencing a relapse within 30 days before baseline
boolean
C0035020 (UMLS CUI [1])
Study Subject Participation Status
Item
participation in other studies within 30 days before baseline
boolean
C2348568 (UMLS CUI [1])
Therapy Multiple Sclerosis | Biological Response Modifiers | Immunomodulators | Immunosuppressive Agents | Combined Modality Therapy | Exception Rebif Dose multiple
Item
received any ms therapy within 6 months prior to study enrolment (for example, other disease-modifying drugs: immunomodulatory, immunosuppressive agents or combination therapy) with the exception of rebif® multi-dose injected by rebismart™
boolean
C0087111 (UMLS CUI [1,1])
C0026769 (UMLS CUI [1,2])
C0005525 (UMLS CUI [2])
C1527392 (UMLS CUI [3])
C0021081 (UMLS CUI [4])
C0009429 (UMLS CUI [5])
C1705847 (UMLS CUI [6,1])
C3232239 (UMLS CUI [6,2])
C0178602 (UMLS CUI [6,3])
C0439064 (UMLS CUI [6,4])
Visual Impairment Excludes Injection Self | Physical impairment Excludes Injection Self
Item
any visual or physical impairment that precludes the subject from self-injecting the treatment using the rebismart™
boolean
C3665347 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C1533685 (UMLS CUI [1,3])
C0036588 (UMLS CUI [1,4])
C0231171 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C1533685 (UMLS CUI [2,3])
C0036588 (UMLS CUI [2,4])
Pregnancy | Breast Feeding
Item
pregnancy and breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Heart Disease Serious | Heart Disease | Cardiac Arrhythmia Uncontrolled | Angina Pectoris Uncontrolled | Cardiomyopathy | Congestive heart failure Uncontrolled
Item
serious or acute heart disease such as uncontrolled cardiac dysrhythmias, uncontrolled angina pectoris, cardiomyopathy, or uncontrolled congestive heart failure, as per investigator opinion
boolean
C0018799 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0018799 (UMLS CUI [2])
C0003811 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0002962 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C0878544 (UMLS CUI [5])
C0018802 (UMLS CUI [6,1])
C0205318 (UMLS CUI [6,2])
Substance Use Disorders
Item
current or past (within the last 2 years) history of alcohol or drug abuse
boolean
C0038586 (UMLS CUI [1])
Medical contraindication Interferon beta-1a
Item
have any contra-indications to treatment with interferon beta-1a according to summary of product characteristics
boolean
C1301624 (UMLS CUI [1,1])
C0254119 (UMLS CUI [1,2])
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