ID

44747

Descrição

Efficacy and Safety Study of Apremilast to Treat Active Psoriatic Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT01172938

Link

https://clinicaltrials.gov/show/NCT01172938

Palavras-chave

Versões (1)
  1. 10/11/2021 10/11/2021 -
Titular dos direitos

Biogen

Transferido a

10 de novembro de 2021

DOI

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Licença

Creative Commons BY-NC 4.0
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Eligibility Psoriatic Arthritis NCT01172938

Inglês

Eligibility Psoriatic Arthritis NCT01172938

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

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

males or females, aged ≥ 18 years at time of consent.

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0086582
UMLS CUI [1,2]
C0001779
UMLS CUI [1,3]
C0347984
UMLS CUI [1,4]
C0021430
UMLS CUI [2,1]
C0086287
UMLS CUI [2,2]
C0001779
UMLS CUI [2,3]
C0347984
UMLS CUI [2,4]
C0021430
have a diagnosis of psoriatic arthritis (psa, by any criteria) of ≥ 6 months duration.
Descrição

diagnosis of psoriatic arthritis (psa, by any criteria) of ≥ 6 months duration.

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0003872
UMLS CUI [1,2]
C0011900
UMLS CUI [1,3]
C0243161
UMLS CUI [1,4]
C0449238
meet the classification criteria for psoriatic arthritis (caspar) at time of screening.
Descrição

meet the classification criteria for psoriatic arthritis (caspar) at time of screening.

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0003872
UMLS CUI [1,2]
C0008902
UMLS CUI [1,3]
C1550543
UMLS CUI [1,4]
C0347984
UMLS CUI [1,5]
C0220908
must have been inadequately treated by disease-modifying antirheumatic drugs (dmards)
Descrição

inadequately treated by disease-modifying antirheumatic drugs

Tipo de dados

boolean

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

may not have axial involvement alone

Tipo de dados

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
Descrição

concurrent treatment allowed with methotrexate, leflunomide, or sulfasalazine

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0025677
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0205420
UMLS CUI [1,4]
C0683607
UMLS CUI [2,1]
C0063041
UMLS CUI [2,2]
C0087111
UMLS CUI [2,3]
C0205420
UMLS CUI [2,4]
C0683607
UMLS CUI [3,1]
C0036078
UMLS CUI [3,2]
C0087111
UMLS CUI [3,3]
C0205420
UMLS CUI [3,4]
C0683607
have ≥ 3 swollen and ≥ 3 tender joints.
Descrição

have ≥ 3 swollen and ≥ 3 tender joints.

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0451521
UMLS CUI [2]
C0451530
males & females must use contraception
Descrição

males & females must use contraception

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0086582
UMLS CUI [1,2]
C0420837
UMLS CUI [2,1]
C0086287
UMLS CUI [2,2]
C0420837
stable dose of nonsteroidal anti-inflammatory drugs (nsaids), narcotics and low dose oral corticosteroids allowed.
Descrição

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

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0003211
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [1,4]
C0683607
UMLS CUI [2,1]
C0027415
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
UMLS CUI [2,4]
C0683607
UMLS CUI [3,1]
C0038317
UMLS CUI [3,2]
C0445550
UMLS CUI [3,3]
C1527415
UMLS CUI [3,4]
C0178602
UMLS CUI [3,5]
C0205360
UMLS CUI [3,6]
C0683607
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or breast feeding.
Descrição

pregnant or breast feeding.

Tipo de dados

boolean

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

history of allergy to any component of the investigational product.

Tipo de dados

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.
Descrição

hepatitis b surface antigen and/or hepatitis c antibody positive at screening.

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0149709
UMLS CUI [1,2]
C0220908
UMLS CUI [2,1]
C0281863
UMLS CUI [2,2]
C0220908
therapeutic failure on > 3 agents for psa or > 1 biologic tumor necrosis factor (tnf) blocker
Descrição

therapeutic failure on > 3 agents for psa or > 1 biologic tumor necrosis factor (tnf) blocker

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0162643
UMLS CUI [1,2]
C0003872
UMLS CUI [1,3]
C0013227
UMLS CUI [1,4]
C0750480
UMLS CUI [2,1]
C0162643
UMLS CUI [2,2]
C0281481
UMLS CUI [2,3]
C0750480
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Similar models

Eligibility Psoriatic Arthritis NCT01172938

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
males or females, aged ≥ 18 years at time of consent.
Item
males or females, aged ≥ 18 years at time of consent.
boolean
C0086582 (UMLS CUI [1,1])
C0001779 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C0021430 (UMLS CUI [1,4])
C0086287 (UMLS CUI [2,1])
C0001779 (UMLS CUI [2,2])
C0347984 (UMLS CUI [2,3])
C0021430 (UMLS CUI [2,4])
diagnosis of psoriatic arthritis (psa, by any criteria) of ≥ 6 months duration.
Item
have a diagnosis of psoriatic arthritis (psa, by any criteria) of ≥ 6 months duration.
boolean
C0003872 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
C0449238 (UMLS CUI [1,4])
meet the classification criteria for psoriatic arthritis (caspar) at time of screening.
Item
meet the classification criteria for psoriatic arthritis (caspar) at time of screening.
boolean
C0003872 (UMLS CUI [1,1])
C0008902 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
C0347984 (UMLS CUI [1,4])
C0220908 (UMLS CUI [1,5])
inadequately treated by 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])
may not have axial involvement alone
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])
C0087111 (UMLS CUI [1,2])
C0205420 (UMLS CUI [1,3])
C0683607 (UMLS CUI [1,4])
C0063041 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0205420 (UMLS CUI [2,3])
C0683607 (UMLS CUI [2,4])
C0036078 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C0205420 (UMLS CUI [3,3])
C0683607 (UMLS CUI [3,4])
have ≥ 3 swollen and ≥ 3 tender joints.
Item
have ≥ 3 swollen and ≥ 3 tender joints.
boolean
C0451521 (UMLS CUI [1])
C0451530 (UMLS CUI [2])
males & females must use contraception
Item
males & females must use contraception
boolean
C0086582 (UMLS CUI [1,1])
C0420837 (UMLS CUI [1,2])
C0086287 (UMLS CUI [2,1])
C0420837 (UMLS CUI [2,2])
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])
C0683607 (UMLS CUI [1,4])
C0027415 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0683607 (UMLS CUI [2,4])
C0038317 (UMLS CUI [3,1])
C0445550 (UMLS CUI [3,2])
C1527415 (UMLS CUI [3,3])
C0178602 (UMLS CUI [3,4])
C0205360 (UMLS CUI [3,5])
C0683607 (UMLS CUI [3,6])
Item Group
C0680251 (UMLS CUI)
pregnant or breast feeding.
Item
pregnant or breast feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [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 and/or hepatitis c antibody positive at screening.
Item
hepatitis b surface antigen and/or hepatitis c antibody positive at screening.
boolean
C0149709 (UMLS CUI [1,1])
C0220908 (UMLS CUI [1,2])
C0281863 (UMLS CUI [2,1])
C0220908 (UMLS CUI [2,2])
therapeutic failure on > 3 agents for psa or > 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])
C0750480 (UMLS CUI [1,4])
C0162643 (UMLS CUI [2,1])
C0281481 (UMLS CUI [2,2])
C0750480 (UMLS CUI [2,3])
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