ID

42477

Description

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

Link

https://clinicaltrials.gov/show/NCT01212757

Keywords

  1. 7/17/21 7/17/21 -
Copyright Holder

Amgen

Uploaded on

July 17, 2021

DOI

To request one please log in.

License

Creative Commons BY-NC 4.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Psoriatic Arthritis NCT01212757

Eligibility Psoriatic Arthritis NCT01212757

Inclusion Criteria
Description

Inclusion Criteria

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

Age

Data type

boolean

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

Diagnosis od psoriatic arthritis, duration

Data type

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.
Description

Classification criteria for psoriatic arthritis (caspar) psa.

Data type

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)
Description

Treatment procedure, inadequate, disease-modifying antirheumatic drugs

Data type

boolean

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

Not only axial involvement

Data type

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
Description

Concurrent treatment allowed with methotrexate, leflunomide, or sulfasalazine

Data type

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.
Description

Swollen joints quantity, Tender joints quantity

Data type

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
Description

Contraceptive methods

Data type

boolean

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

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

Data type

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
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or breast feeding.
Description

Pregnancy | Breast feeding.

Data type

boolean

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

History of allergy to any component of the investigational product.

Data type

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.
Description

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

Data type

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
Description

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

Data type

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

Similar models

Eligibility Psoriatic Arthritis NCT01212757

Name
Type
Description | Question | Decode (Coded Value)
Data type
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])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial