ID

42477

Beskrivning

PALACE 2: Efficacy and Safety Study of Apremilast to Treat Active Psoriatic Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT01212757

Länk

https://clinicaltrials.gov/show/NCT01212757

Nyckelord

Versioner (1)
  1. 2021-07-17 2021-07-17 -
Rättsinnehavare

Amgen

Uppladdad den

17 juli 2021

DOI

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Licens

Creative Commons BY-NC 4.0
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Eligibility Psoriatic Arthritis NCT01212757

Engelsk

Eligibility Psoriatic Arthritis NCT01212757

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
males or females, aged ≥ 18 years at time of consent.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
have a diagnosis of psoriatic arthritis (psa, by any criteria) of ≥ 6 months duration.
Beskrivning

Diagnosis od psoriatic arthritis, duration

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003872
UMLS CUI [1,2]
C0449238
meet the classification criteria for psoriatic arthritis (caspar) psa at time of screening.
Beskrivning

Classification criteria for psoriatic arthritis (caspar) psa.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003872
UMLS CUI [1,2]
C0008902
UMLS CUI [1,3]
C1550543
must have been inadequately treated by disease-modifying antirheumatic drugs (dmards)
Beskrivning

Treatment procedure, inadequate, disease-modifying antirheumatic drugs

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0242708
UMLS CUI [1,3]
C0205412
may not have axial involvement alone
Beskrivning

Not only axial involvement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0475264
UMLS CUI [1,2]
C0205131
UMLS CUI [1,3]
C1548966
UMLS CUI [1,4]
C0332197
concurrent treatment allowed with methotrexate, leflunomide, or sulfasalazine
Beskrivning

Concurrent treatment allowed with methotrexate, leflunomide, or sulfasalazine

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0025677
UMLS CUI [1,2]
C2347852
UMLS CUI [2,1]
C0063041
UMLS CUI [2,2]
C2347852
UMLS CUI [3,1]
C0036078
UMLS CUI [3,2]
C2347852
have ≥ 3 swollen and ≥ 3 tender joints.
Beskrivning

Swollen joints quantity, Tender joints quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0152031
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0240094
UMLS CUI [1,4]
C1265611
males & females must use contraception
Beskrivning

Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1]
C0700589
stable dose of nonsteroidal anti-inflammatory drugs (nsaids), narcotics and low dose oral corticosteroids allowed.
Beskrivning

Stable dose of nonsteroidal anti-inflammatory drugs (nsaids), narcotics and low dose oral corticosteroids allowed.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003211
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C0027415
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
UMLS CUI [3,1]
C0038317
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0445550
UMLS CUI [3,4]
C1527415
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or breast feeding.
Beskrivning

Pregnancy | Breast feeding.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
history of allergy to any component of the investigational product.
Beskrivning

History of allergy to any component of the investigational product.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0020517
UMLS CUI [1,3]
C1705248
UMLS CUI [1,4]
C0304229
hepatitis b surface antigen and/or hepatitis c antibody positive at screening.
Beskrivning

Hepatitis B surface antigen positive | Hepatitis C antibody positive at screening.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0201477
UMLS CUI [1,2]
C1446409
UMLS CUI [2,1]
C0201487
UMLS CUI [2,2]
C1446409
therapeutic failure on > 3 agents for psa or > 1 biologic tumor necrosis factor (tnf) blocker
Beskrivning

Therapeutic failure on > 3 agents for psa | Therapeutic failure of > 1 biologic tumor necrosis factor (tnf) blocker

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0162643
UMLS CUI [1,2]
C0003872
UMLS CUI [1,3]
C0013227
UMLS CUI [1,4]
C1265611
UMLS CUI [2,1]
C0162643
UMLS CUI [2,2]
C0281481
UMLS CUI [2,3]
C1265611
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Similar models

Eligibility Psoriatic Arthritis NCT01212757

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
males or females, aged ≥ 18 years at time of consent.
boolean
C0001779 (UMLS CUI [1])
Diagnosis od psoriatic arthritis, duration
Item
have a diagnosis of psoriatic arthritis (psa, by any criteria) of ≥ 6 months duration.
boolean
C0003872 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Classification criteria for psoriatic arthritis (caspar) psa.
Item
meet the classification criteria for psoriatic arthritis (caspar) psa at time of screening.
boolean
C0003872 (UMLS CUI [1,1])
C0008902 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Treatment procedure, inadequate, disease-modifying antirheumatic drugs
Item
must have been inadequately treated by disease-modifying antirheumatic drugs (dmards)
boolean
C0087111 (UMLS CUI [1,1])
C0242708 (UMLS CUI [1,2])
C0205412 (UMLS CUI [1,3])
Not only axial involvement
Item
may not have axial involvement alone
boolean
C0475264 (UMLS CUI [1,1])
C0205131 (UMLS CUI [1,2])
C1548966 (UMLS CUI [1,3])
C0332197 (UMLS CUI [1,4])
Concurrent treatment allowed with methotrexate, leflunomide, or sulfasalazine
Item
concurrent treatment allowed with methotrexate, leflunomide, or sulfasalazine
boolean
C0025677 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0063041 (UMLS CUI [2,1])
C2347852 (UMLS CUI [2,2])
C0036078 (UMLS CUI [3,1])
C2347852 (UMLS CUI [3,2])
Swollen joints quantity, Tender joints quantity
Item
have ≥ 3 swollen and ≥ 3 tender joints.
boolean
C0152031 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0240094 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
Contraceptive methods
Item
males & females must use contraception
boolean
C0700589 (UMLS CUI [1])
Stable dose of nonsteroidal anti-inflammatory drugs (nsaids), narcotics and low dose oral corticosteroids allowed.
Item
stable dose of nonsteroidal anti-inflammatory drugs (nsaids), narcotics and low dose oral corticosteroids allowed.
boolean
C0003211 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0027415 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0038317 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0445550 (UMLS CUI [3,3])
C1527415 (UMLS CUI [3,4])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast feeding.
Item
pregnant or breast feeding.
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
History of allergy to any component of the investigational product.
Item
history of allergy to any component of the investigational product.
boolean
C0262926 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C1705248 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
Hepatitis B surface antigen positive | Hepatitis C antibody positive at screening.
Item
hepatitis b surface antigen and/or hepatitis c antibody positive at screening.
boolean
C0201477 (UMLS CUI [1,1])
C1446409 (UMLS CUI [1,2])
C0201487 (UMLS CUI [2,1])
C1446409 (UMLS CUI [2,2])
Therapeutic failure on > 3 agents for psa | Therapeutic failure of > 1 biologic tumor necrosis factor (tnf) blocker
Item
therapeutic failure on > 3 agents for psa or > 1 biologic tumor necrosis factor (tnf) blocker
boolean
C0162643 (UMLS CUI [1,1])
C0003872 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
C0162643 (UMLS CUI [2,1])
C0281481 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
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