ID

42334

Descripción

Prevalence and Incidence of Articular Symptoms and Signs Related to Psoriatic Arthritis in Patients With Psoriasis Severe or Moderate With Adalimumab Treatment; ODM derived from: https://clinicaltrials.gov/show/NCT01316224

Link

https://clinicaltrials.gov/show/NCT01316224

Palabras clave

Versiones (2)
  1. 2021-06-15 2021-06-15 -
  2. 2021-06-15 2021-06-15 -
Titular de derechos de autor

AbbVie (prior sponsor, Abbott)

Subido en

15 juni 2021

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Psoriatic Arthritis in Psoriasis NCT01316224

Inglés

Eligibility Psoriatic Arthritis in Psoriasis NCT01316224

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
participant has a documented clinical diagnosis of psoriasis, as determined by participant interview of his/her medical history and confirmation of diagnosis through physical examination by the investigator
Descripción

Psoriasis medical history interview | physical examination

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0033860
UMLS CUI [1,2]
C0262926
UMLS CUI [1,3]
C0021822
UMLS CUI [2,1]
C0033860
UMLS CUI [2,2]
C0031809
participant has indication of psoriasis systemic therapy
Descripción

Indication of psoriasis systemic therapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0033860
UMLS CUI [1,2]
C1515119
UMLS CUI [1,3]
C3146298
if female, participant is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing one of the following methods of birth control: condoms, sponge, foams, jellies, diaphragm or intrauterine device (iud)
Descripción

Childbearing potential absent | postmenopausal | female sterilization (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) | childbearing potential contraceptive methods | condoms | contraceptive sponge | vaginal foam | contraceptive vaginal gel | diaphragm | iud

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0332197
UMLS CUI [2]
C0232970
UMLS CUI [3]
C0015787
UMLS CUI [4]
C0589114
UMLS CUI [5]
C0278321
UMLS CUI [6]
C0020699
UMLS CUI [7,1]
C3831118
UMLS CUI [7,2]
C0700589
UMLS CUI [8]
C0677582
UMLS CUI [9]
C0183461
UMLS CUI [10]
C0042254
UMLS CUI [11,1]
C0009871
UMLS CUI [11,2]
C0042257
UMLS CUI [12]
C0042241
UMLS CUI [13]
C0021900
contraceptives (oral or parenteral) for three months (90 days) prior to study drug administration
Descripción

Recent intake of oral contraceptives | recent parenteral contraceptives

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009905
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C0700589
UMLS CUI [2,2]
C1518896
UMLS CUI [2,3]
C0332185
a vasectomized partner
Descripción

Partner had vasectomy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0420842
total abstinence from sexual intercourse
Descripción

Sexual Abstinence

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0036899
able and willing to give written informed consent and comply with the requirements of the study protocol
Descripción

Able to give informed consent | willing to give informed consent | compliance with study protocol

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0085732
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0600109
UMLS CUI [3]
C0525058
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
participants who have active infections
Descripción

Active infection

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205177
participants enrolled in another study or clinical trial
Descripción

Participation in another study or clinical trial

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
any condition that according to the criteria of the participating investigator represents an obstacle for study conduction and/or participants to an unacceptable risk
Descripción

Condition interfering with study conduction | condition causing patient risk

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2732579
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C1444641
UMLS CUI [2,3]
C1113679
history of active tuberculosis (tb), histoplasmosis or listeriosis
Descripción

History of active tuberculosis | histoplasmosis | listeriosis

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0151332
UMLS CUI [1,2]
C0262926
UMLS CUI [2,1]
C0019655
UMLS CUI [2,2]
C0262926
UMLS CUI [3,1]
C0023860
UMLS CUI [3,2]
C0262926
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Similar models

Eligibility Psoriatic Arthritis in Psoriasis NCT01316224

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Psoriasis medical history interview | physical examination
Item
participant has a documented clinical diagnosis of psoriasis, as determined by participant interview of his/her medical history and confirmation of diagnosis through physical examination by the investigator
boolean
C0033860 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0021822 (UMLS CUI [1,3])
C0033860 (UMLS CUI [2,1])
C0031809 (UMLS CUI [2,2])
Indication of psoriasis systemic therapy
Item
participant has indication of psoriasis systemic therapy
boolean
C0033860 (UMLS CUI [1,1])
C1515119 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,3])
Childbearing potential absent | postmenopausal | female sterilization (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) | childbearing potential contraceptive methods | condoms | contraceptive sponge | vaginal foam | contraceptive vaginal gel | diaphragm | iud
Item
if female, participant is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing one of the following methods of birth control: condoms, sponge, foams, jellies, diaphragm or intrauterine device (iud)
boolean
C3831118 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0232970 (UMLS CUI [2])
C0015787 (UMLS CUI [3])
C0589114 (UMLS CUI [4])
C0278321 (UMLS CUI [5])
C0020699 (UMLS CUI [6])
C3831118 (UMLS CUI [7,1])
C0700589 (UMLS CUI [7,2])
C0677582 (UMLS CUI [8])
C0183461 (UMLS CUI [9])
C0042254 (UMLS CUI [10])
C0009871 (UMLS CUI [11,1])
C0042257 (UMLS CUI [11,2])
C0042241 (UMLS CUI [12])
C0021900 (UMLS CUI [13])
Recent intake of oral contraceptives | recent parenteral contraceptives
Item
contraceptives (oral or parenteral) for three months (90 days) prior to study drug administration
boolean
C0009905 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0700589 (UMLS CUI [2,1])
C1518896 (UMLS CUI [2,2])
C0332185 (UMLS CUI [2,3])
Partner had vasectomy
Item
a vasectomized partner
boolean
C0420842 (UMLS CUI [1])
Sexual Abstinence
Item
total abstinence from sexual intercourse
boolean
C0036899 (UMLS CUI [1])
Able to give informed consent | willing to give informed consent | compliance with study protocol
Item
able and willing to give written informed consent and comply with the requirements of the study protocol
boolean
C0021430 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0600109 (UMLS CUI [2,2])
C0525058 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Active infection
Item
participants who have active infections
boolean
C0009450 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
Participation in another study or clinical trial
Item
participants enrolled in another study or clinical trial
boolean
C2348568 (UMLS CUI [1])
Condition interfering with study conduction | condition causing patient risk
Item
any condition that according to the criteria of the participating investigator represents an obstacle for study conduction and/or participants to an unacceptable risk
boolean
C0348080 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C1113679 (UMLS CUI [2,3])
History of active tuberculosis | histoplasmosis | listeriosis
Item
history of active tuberculosis (tb), histoplasmosis or listeriosis
boolean
C0151332 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0019655 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
C0023860 (UMLS CUI [3,1])
C0262926 (UMLS CUI [3,2])
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