ID

15878

Beschrijving

Psoriatic Arthritis Treated With Liraglutide Therapy: a QUality of Life and Efficacy Study; ODM derived from: https://clinicaltrials.gov/show/NCT02472717

Link

https://clinicaltrials.gov/show/NCT02472717

Trefwoorden

Versies (1)
  1. 17-06-16 17-06-16 -
Geüploaded op

17 juni 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Psoriatic Arthritis NCT02472717

Engels

Eligibility Psoriatic Arthritis NCT02472717

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with active psoriatic arthritis (3 tender and swollen joints) meeting caspar study group criteria
Beschrijving

Arthritis, Psoriatic | Joint tenderness | Joint swelling

Datatype

boolean

Alias
UMLS CUI [1]
C0003872
UMLS CUI [2]
C0240094
UMLS CUI [3]
C0152031
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
bmi > 35 kg/m2
Beschrijving

Body mass index

Datatype

boolean

Alias
UMLS CUI [1]
C1305855
uncontrolled diabetes, hba1c > 10.5%
Beschrijving

DIABETES MELLITUS UNCONTROLLED | Glycosylated hemoglobin A

Datatype

boolean

Alias
UMLS CUI [1]
C0743131
UMLS CUI [2]
C0019018
current biological treatment for any inflammatory disorder within the past three months
Beschrijving

Biological treatment Inflammatory disorder

Datatype

boolean

Alias
UMLS CUI [1,1]
C1531518
UMLS CUI [1,2]
C1290884
renal dysfunction (egfr < 50 ml/min/1.73m or macroalbuminuria >300mg)
Beschrijving

Renal dysfunction | Estimated Glomerular Filtration Rate | Macroalbuminuria

Datatype

boolean

Alias
UMLS CUI [1]
C3279454
UMLS CUI [2]
C3811844
UMLS CUI [3]
C1654921
hepatic dysfunction (ast (aspartate aminotransferase), alt (alanine aminotransferase), total bilirubin > 3 times upper limit of normal)
Beschrijving

Liver Dysfunction | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Bilirubin, total measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201836
UMLS CUI [4]
C0201913
history of pancreatitis or personal or family history of medullary thyroid cancer, c-cell hyperplasia, or men-2 syndrome
Beschrijving

Pancreatitis | Medullary carcinoma of thyroid | C-cell hyperplasia | Multiple Endocrine Neoplasia Type 2a

Datatype

boolean

Alias
UMLS CUI [1]
C0030305
UMLS CUI [2]
C0238462
UMLS CUI [3]
C0342190
UMLS CUI [4]
C0025268
current pregnancy or current breast feeding
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
use of dpp-4 (dipeptidyl peptidase-4 inhibitor) or glp-1 receptor agonist within 2 months (washout is permitted)
Beschrijving

Dipeptidyl Peptidase-4 Inhibitor | GLP-1 Receptor Agonist | Washout

Datatype

boolean

Alias
UMLS CUI [1]
C3537225
UMLS CUI [2]
C2917359
UMLS CUI [3]
C1710661
drug or alcohol dependence
Beschrijving

Substance Dependence

Datatype

boolean

Alias
UMLS CUI [1]
C0038580
resting tachycardia > 100 bpm or conduction abnormalities associated with tachycardia
Beschrijving

TACHYCARDIA REST | Cardiac conduction abnormalities Associated with Tachycardia

Datatype

boolean

Alias
UMLS CUI [1]
C0749248
UMLS CUI [2,1]
C1842820
UMLS CUI [2,2]
C0332281
UMLS CUI [2,3]
C0039231
current enrollment in any other clinical trial
Beschrijving

Study Subject Participation Status

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
symptomatic gastroparesis
Beschrijving

Gastroparesis Symptomatic

Datatype

boolean

Alias
UMLS CUI [1,1]
C0152020
UMLS CUI [1,2]
C0231220
concomitant serious medical conditions
Beschrijving

concomitant conditions Serious

Datatype

boolean

Alias
UMLS CUI [1,1]
C0243086
UMLS CUI [1,2]
C0205404
all medication for the treatment of psoriatic arthritis such as mtx (methotrexate) < 25 mg, lfn (leflunomide) < 20 mg, and nsaids (non-steroidal anti-inflammatory drugs) will have been used at stable doses for at least 4 weeks, having been initiated at least 3 months prior to study start (8 weeks before screening, 4 weeks before baseline) for mtx and lfn and at least 4 weeks for nsaids
Beschrijving

Therapeutic procedure Arthritis, Psoriatic | Pharmaceutical Preparations Dosage Stable status | Methotrexate | leflunomide | Anti-Inflammatory Agents, Non-Steroidal

Datatype

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0003872
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
UMLS CUI [3]
C0025677
UMLS CUI [4]
C0063041
UMLS CUI [5]
C0003211
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Similar models

Eligibility Psoriatic Arthritis NCT02472717

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Arthritis, Psoriatic | Joint tenderness | Joint swelling
Item
patients with active psoriatic arthritis (3 tender and swollen joints) meeting caspar study group criteria
boolean
C0003872 (UMLS CUI [1])
C0240094 (UMLS CUI [2])
C0152031 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Body mass index
Item
bmi > 35 kg/m2
boolean
C1305855 (UMLS CUI [1])
DIABETES MELLITUS UNCONTROLLED | Glycosylated hemoglobin A
Item
uncontrolled diabetes, hba1c > 10.5%
boolean
C0743131 (UMLS CUI [1])
C0019018 (UMLS CUI [2])
Biological treatment Inflammatory disorder
Item
current biological treatment for any inflammatory disorder within the past three months
boolean
C1531518 (UMLS CUI [1,1])
C1290884 (UMLS CUI [1,2])
Renal dysfunction | Estimated Glomerular Filtration Rate | Macroalbuminuria
Item
renal dysfunction (egfr < 50 ml/min/1.73m or macroalbuminuria >300mg)
boolean
C3279454 (UMLS CUI [1])
C3811844 (UMLS CUI [2])
C1654921 (UMLS CUI [3])
Liver Dysfunction | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Bilirubin, total measurement
Item
hepatic dysfunction (ast (aspartate aminotransferase), alt (alanine aminotransferase), total bilirubin > 3 times upper limit of normal)
boolean
C0086565 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201913 (UMLS CUI [4])
Pancreatitis | Medullary carcinoma of thyroid | C-cell hyperplasia | Multiple Endocrine Neoplasia Type 2a
Item
history of pancreatitis or personal or family history of medullary thyroid cancer, c-cell hyperplasia, or men-2 syndrome
boolean
C0030305 (UMLS CUI [1])
C0238462 (UMLS CUI [2])
C0342190 (UMLS CUI [3])
C0025268 (UMLS CUI [4])
Pregnancy | Breast Feeding
Item
current pregnancy or current breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Dipeptidyl Peptidase-4 Inhibitor | GLP-1 Receptor Agonist | Washout
Item
use of dpp-4 (dipeptidyl peptidase-4 inhibitor) or glp-1 receptor agonist within 2 months (washout is permitted)
boolean
C3537225 (UMLS CUI [1])
C2917359 (UMLS CUI [2])
C1710661 (UMLS CUI [3])
Substance Dependence
Item
drug or alcohol dependence
boolean
C0038580 (UMLS CUI [1])
TACHYCARDIA REST | Cardiac conduction abnormalities Associated with Tachycardia
Item
resting tachycardia > 100 bpm or conduction abnormalities associated with tachycardia
boolean
C0749248 (UMLS CUI [1])
C1842820 (UMLS CUI [2,1])
C0332281 (UMLS CUI [2,2])
C0039231 (UMLS CUI [2,3])
Study Subject Participation Status
Item
current enrollment in any other clinical trial
boolean
C2348568 (UMLS CUI [1])
Gastroparesis Symptomatic
Item
symptomatic gastroparesis
boolean
C0152020 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
concomitant conditions Serious
Item
concomitant serious medical conditions
boolean
C0243086 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Therapeutic procedure Arthritis, Psoriatic | Pharmaceutical Preparations Dosage Stable status | Methotrexate | leflunomide | Anti-Inflammatory Agents, Non-Steroidal
Item
all medication for the treatment of psoriatic arthritis such as mtx (methotrexate) < 25 mg, lfn (leflunomide) < 20 mg, and nsaids (non-steroidal anti-inflammatory drugs) will have been used at stable doses for at least 4 weeks, having been initiated at least 3 months prior to study start (8 weeks before screening, 4 weeks before baseline) for mtx and lfn and at least 4 weeks for nsaids
boolean
C0087111 (UMLS CUI [1,1])
C0003872 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0025677 (UMLS CUI [3])
C0063041 (UMLS CUI [4])
C0003211 (UMLS CUI [5])
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