ID

31974

Beskrivning

Study to Characterize Demographics, Compliance, Tolerability and Safety in Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis Prescribed Adalimumab (Humira®) as Part of Routine Clinical Care; ODM derived from: https://clinicaltrials.gov/show/NCT01163916

Länk

https://clinicaltrials.gov/show/NCT01163916

Nyckelord

Versioner (1)
  1. 2018-10-09 2018-10-09 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

9 oktober 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT01163916

Engelsk

Eligibility Rheumatoid Arthritis NCT01163916

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients for whom adalimumab therapy is indicated according to product label and who meet the following criteria:
Beskrivning

Indication Adalimumab

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C1122087
patients who are newly prescribed adalimumab therapy (no prior history of treatment with adalimumab) including patients with infliximab treatment history.
Beskrivning

Adalimumab prescribed newly | infliximab

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1122087
UMLS CUI [1,2]
C0278329
UMLS CUI [1,3]
C0750546
UMLS CUI [2]
C0666743
patients who completed abbott sponsored interventional trials and are continuing treatment with commercial adalimumab thereafter.
Beskrivning

Clinical Trials Specified Completed | adalimumab

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0205369
UMLS CUI [1,3]
C0205197
UMLS CUI [2]
C1122087
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
the following patients will not be included in the study:
Beskrivning

Patients Excluded

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0332196
patients who are being treated or will be treated with drugs at risk of interactions with adalimumab.
Beskrivning

Pharmaceutical Preparations At risk Interactions Adalimumab

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C0687133
UMLS CUI [1,4]
C1122087
hypersensitivity to adalimumab
Beskrivning

Hypersensitivity Adalimumab

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1122087
pregnancy
Beskrivning

Pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
lactation
Beskrivning

Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0006147
age below 18
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
infectious diseases including tuberculosis
Beskrivning

Communicable Diseases | Tuberculosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0041296
patients currently participating in another clinical trial.
Beskrivning

Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Rheumatoid Arthritis NCT01163916

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Indication Adalimumab
Item
patients for whom adalimumab therapy is indicated according to product label and who meet the following criteria:
boolean
C3146298 (UMLS CUI [1,1])
C1122087 (UMLS CUI [1,2])
Adalimumab prescribed newly | infliximab
Item
patients who are newly prescribed adalimumab therapy (no prior history of treatment with adalimumab) including patients with infliximab treatment history.
boolean
C1122087 (UMLS CUI [1,1])
C0278329 (UMLS CUI [1,2])
C0750546 (UMLS CUI [1,3])
C0666743 (UMLS CUI [2])
Clinical Trials Specified Completed | adalimumab
Item
patients who completed abbott sponsored interventional trials and are continuing treatment with commercial adalimumab thereafter.
boolean
C0008976 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C1122087 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Patients Excluded
Item
the following patients will not be included in the study:
boolean
C0030705 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
Pharmaceutical Preparations At risk Interactions Adalimumab
Item
patients who are being treated or will be treated with drugs at risk of interactions with adalimumab.
boolean
C0013227 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0687133 (UMLS CUI [1,3])
C1122087 (UMLS CUI [1,4])
Hypersensitivity Adalimumab
Item
hypersensitivity to adalimumab
boolean
C0020517 (UMLS CUI [1,1])
C1122087 (UMLS CUI [1,2])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Breast Feeding
Item
lactation
boolean
C0006147 (UMLS CUI [1])
Age
Item
age below 18
boolean
C0001779 (UMLS CUI [1])
Communicable Diseases | Tuberculosis
Item
infectious diseases including tuberculosis
boolean
C0009450 (UMLS CUI [1])
C0041296 (UMLS CUI [2])
Study Subject Participation Status
Item
patients currently participating in another clinical trial.
boolean
C2348568 (UMLS CUI [1])
Tillbaka till toppen 

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