ID

30968

Description

Safety, Tolerability and Adherence With Rebif® New Formulation in Real Life Settings (STAR); ODM derived from: https://clinicaltrials.gov/show/NCT01080027

Link

https://clinicaltrials.gov/show/NCT01080027

Keywords

Versions (2)
  1. 7/8/18 7/8/18 -
  2. 7/8/18 7/8/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 8, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis, Relapsing Remitting NCT01080027

English

Eligibility Multiple Sclerosis, Relapsing Remitting NCT01080027

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects with a diagnosis of rrms according to the mc donald criteria(2005)
Description

Multiple Sclerosis, Relapsing-Remitting

Data type

boolean

Alias
UMLS CUI [1]
C0751967
18 to 60 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
expanded disability status scale (edss) < 6
Description

EDSS

Data type

boolean

Alias
UMLS CUI [1]
C0451246
naïve subjects or subjects treated with rebif® new formulation for no more than 6 weeks prior to enrollment
Description

Therapy naive | Rebif Formulation New

Data type

boolean

Alias
UMLS CUI [1]
C0919936
UMLS CUI [2,1]
C0752980
UMLS CUI [2,2]
C0524527
UMLS CUI [2,3]
C0205314
subjects who have given written informed consent to participate in the study
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
primary progressive or secondary progressive ms
Description

Multiple Sclerosis, Primary Progressive | Multiple Sclerosis, Secondary Progressive

Data type

boolean

Alias
UMLS CUI [1]
C0751964
UMLS CUI [2]
C0751965
subjects previously administered ifn beta-1a (including rebif®) or ifn beta-1b or glatiramer acetate or any other immunomodulatory or immunosuppressive agents or any other ms therapy in the past with the exception of rebif® new formulation for no more than 6 weeks prior to enrollment
Description

Interferon beta-1a | Rebif | Interferon beta-1b | glatiramer acetate | Biological Response Modifiers | Immunosuppressive Agents | Therapeutic procedure Multiple Sclerosis | Exception Rebif Formulation New

Data type

boolean

Alias
UMLS CUI [1]
C0254119
UMLS CUI [2]
C0752980
UMLS CUI [3]
C0244713
UMLS CUI [4]
C0289884
UMLS CUI [5]
C0005525
UMLS CUI [6]
C0021081
UMLS CUI [7,1]
C0087111
UMLS CUI [7,2]
C0026769
UMLS CUI [8,1]
C1705847
UMLS CUI [8,2]
C0752980
UMLS CUI [8,3]
C0524527
UMLS CUI [8,4]
C0205314
subjects receiving oral or systemic corticosteroids or adrenocorticotrophic hormone within 30 days of visit 1 (prior to enrolment)
Description

Adrenal Cortex Hormones Oral | CORTICOSTEROIDS FOR SYSTEMIC USE | ACTH

Data type

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C1527415
UMLS CUI [2]
C3653708
UMLS CUI [3]
C0001655
history of any chronic pain syndrome
Description

Chronic pain syndrome

Data type

boolean

Alias
UMLS CUI [1]
C1298685
known allergy to ifn or its excipients
Description

Hypersensitivity Interferon | Hypersensitivity Interferon Excipient

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C3652465
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C3652465
UMLS CUI [2,3]
C0015237
serious or acute heart disease such as uncontrolled cardiac dysrhythmias, uncontrolled angina pectoris, cardiomyopathy, or uncontrolled congestive heart failure
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2,1]
C0003811
UMLS CUI [2,2]
C0205318
UMLS CUI [3,1]
C0002962
UMLS CUI [3,2]
C0205318
UMLS CUI [4]
C0878544
UMLS CUI [5,1]
C0018802
UMLS CUI [5,2]
C0205318
inadequate liver function, defined by a alanine aminotransferase (alt) > 3 x upper limit of normal (uln), or alkaline phosphatase > 2 x uln, or total bilirubin > 2 x uln if associated with any elevation of alt or alkaline phosphatase
Description

Liver function Inadequate | Alanine aminotransferase increased | Alkaline phosphatase raised | Elevated total bilirubin

Data type

boolean

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C0205412
UMLS CUI [2]
C0151905
UMLS CUI [3]
C0151849
UMLS CUI [4]
C0741494
inadequate bone marrow reserve, defined as a white blood cell count less than 0.5 x lower limit of normal
Description

Few mature neutrophils in the bone marrow | White blood cell count decreased

Data type

boolean

Alias
UMLS CUI [1]
C2748959
UMLS CUI [2]
C0750394
current or past (within the last 2 years) history of alcohol or drug abuse
Description

Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0038586
contra-indications to ifn beta-1a
Description

Medical contraindication Interferon beta-1a

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0254119
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Similar models

Eligibility Multiple Sclerosis, Relapsing Remitting NCT01080027

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Sclerosis, Relapsing-Remitting
Item
subjects with a diagnosis of rrms according to the mc donald criteria(2005)
boolean
C0751967 (UMLS CUI [1])
Age
Item
18 to 60 years of age
boolean
C0001779 (UMLS CUI [1])
EDSS
Item
expanded disability status scale (edss) < 6
boolean
C0451246 (UMLS CUI [1])
Therapy naive | Rebif Formulation New
Item
naïve subjects or subjects treated with rebif® new formulation for no more than 6 weeks prior to enrollment
boolean
C0919936 (UMLS CUI [1])
C0752980 (UMLS CUI [2,1])
C0524527 (UMLS CUI [2,2])
C0205314 (UMLS CUI [2,3])
Informed Consent
Item
subjects who have given written informed consent to participate in the study
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Multiple Sclerosis, Primary Progressive | Multiple Sclerosis, Secondary Progressive
Item
primary progressive or secondary progressive ms
boolean
C0751964 (UMLS CUI [1])
C0751965 (UMLS CUI [2])
Interferon beta-1a | Rebif | Interferon beta-1b | glatiramer acetate | Biological Response Modifiers | Immunosuppressive Agents | Therapeutic procedure Multiple Sclerosis | Exception Rebif Formulation New
Item
subjects previously administered ifn beta-1a (including rebif®) or ifn beta-1b or glatiramer acetate or any other immunomodulatory or immunosuppressive agents or any other ms therapy in the past with the exception of rebif® new formulation for no more than 6 weeks prior to enrollment
boolean
C0254119 (UMLS CUI [1])
C0752980 (UMLS CUI [2])
C0244713 (UMLS CUI [3])
C0289884 (UMLS CUI [4])
C0005525 (UMLS CUI [5])
C0021081 (UMLS CUI [6])
C0087111 (UMLS CUI [7,1])
C0026769 (UMLS CUI [7,2])
C1705847 (UMLS CUI [8,1])
C0752980 (UMLS CUI [8,2])
C0524527 (UMLS CUI [8,3])
C0205314 (UMLS CUI [8,4])
Adrenal Cortex Hormones Oral | CORTICOSTEROIDS FOR SYSTEMIC USE | ACTH
Item
subjects receiving oral or systemic corticosteroids or adrenocorticotrophic hormone within 30 days of visit 1 (prior to enrolment)
boolean
C0001617 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C3653708 (UMLS CUI [2])
C0001655 (UMLS CUI [3])
Chronic pain syndrome
Item
history of any chronic pain syndrome
boolean
C1298685 (UMLS CUI [1])
Hypersensitivity Interferon | Hypersensitivity Interferon Excipient
Item
known allergy to ifn or its excipients
boolean
C0020517 (UMLS CUI [1,1])
C3652465 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C3652465 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
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
boolean
C0018799 (UMLS CUI [1])
C0003811 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0002962 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0878544 (UMLS CUI [4])
C0018802 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
Liver function Inadequate | Alanine aminotransferase increased | Alkaline phosphatase raised | Elevated total bilirubin
Item
inadequate liver function, defined by a alanine aminotransferase (alt) > 3 x upper limit of normal (uln), or alkaline phosphatase > 2 x uln, or total bilirubin > 2 x uln if associated with any elevation of alt or alkaline phosphatase
boolean
C0232741 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
C0151905 (UMLS CUI [2])
C0151849 (UMLS CUI [3])
C0741494 (UMLS CUI [4])
Few mature neutrophils in the bone marrow | White blood cell count decreased
Item
inadequate bone marrow reserve, defined as a white blood cell count less than 0.5 x lower limit of normal
boolean
C2748959 (UMLS CUI [1])
C0750394 (UMLS CUI [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
contra-indications to ifn beta-1a
boolean
C1301624 (UMLS CUI [1,1])
C0254119 (UMLS CUI [1,2])
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