ID

40512

Description

An Open-Label Extension of the Dose Finding Study (DSC/08/2357/36) in Patients With Poly Juvenile Idiopathic Arthritis (JIA); ODM derived from: https://clinicaltrials.gov/show/NCT01557452

Link

https://clinicaltrials.gov/show/NCT01557452

Keywords

Versions (1)
  1. 4/29/20 4/29/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 29, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Juvenile Idiopathic Arthritis NCT01557452

English

Eligibility Juvenile Idiopathic Arthritis NCT01557452

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects who had successfully completed the previous dose finding study and were fully compliant to the inclusion/exclusion criteria described in the previous dsc/08/2357/36
Description

Clinical Trial Specified Completed | Eligibility Criteria Specified Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0205369
UMLS CUI [1,3]
C0205197
UMLS CUI [2,1]
C1516637
UMLS CUI [2,2]
C0205369
UMLS CUI [2,3]
C1550543
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with fever related to jia or other systemic features of jia during 12 months before entering the study
Description

Fever Relationship Juvenile arthritis | Feature Systemic Juvenile arthritis

Data type

boolean

Alias
UMLS CUI [1,1]
C0015967
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C3495559
UMLS CUI [2,1]
C2348519
UMLS CUI [2,2]
C0205373
UMLS CUI [2,3]
C3495559
active bacterial or mycotic infection requiring antimicrobial treatment
Description

Bacterial Infections Requirement Antibiotic therapy | Mycoses Requirement Antibiotic therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0004623
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0338237
UMLS CUI [2,1]
C0026946
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0338237
episode of macrophage activation syndrome over the last 6 months
Description

Episode of Macrophage Activation Syndrome

Data type

boolean

Alias
UMLS CUI [1,1]
C0332189
UMLS CUI [1,2]
C1096155
baseline prolongation of qt/qtc interval, use of concomitant medications that prolong the qt/qtc interval or history of additional risk factors for tdp.
Description

Prolonged QT interval | Prolonged QTc interval | Pharmaceutical Preparations Causing Prolonged QT interval | Pharmaceutical Preparations Causing Prolonged QTc interval | Risk factors Additional Torsades de Pointes

Data type

boolean

Alias
UMLS CUI [1]
C0151878
UMLS CUI [2]
C1560305
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C0678227
UMLS CUI [3,3]
C0151878
UMLS CUI [4,1]
C0013227
UMLS CUI [4,2]
C0678227
UMLS CUI [4,3]
C1560305
UMLS CUI [5,1]
C0035648
UMLS CUI [5,2]
C1524062
UMLS CUI [5,3]
C0040479
clinically significant cardiovascular disease
Description

Cardiovascular Disease

Data type

boolean

Alias
UMLS CUI [1]
C0007222
clinically significant illness i.e. any condition that in the opinion of the investigator places the patient to unacceptable risk for adverse outcome if he/she were to participate in the study
Description

Illness Study Subject Participation Status At risk | Condition Study Subject Participation Status At risk

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1444641
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C1444641
psychiatric illness/social situation that would limit compliance with study medication and protocol requirements
Description

Mental disorders Limiting Medication Compliance | Social situation Limiting Medication Compliance | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C3489773
UMLS CUI [2,1]
C0748872
UMLS CUI [2,2]
C0439801
UMLS CUI [2,3]
C3489773
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C0439801
UMLS CUI [3,3]
C0525058
UMLS CUI [4,1]
C0748872
UMLS CUI [4,2]
C0439801
UMLS CUI [4,3]
C0525058
inherited metabolic diseases
Description

Metabolic Diseases Hereditary

Data type

boolean

Alias
UMLS CUI [1,1]
C0025517
UMLS CUI [1,2]
C0439660
presence of malignancy
Description

Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0006826
pregnancy or lactation
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
positive blood test for hiv
Description

Hematologic Test Positive HIV

Data type

boolean

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C1514241
UMLS CUI [1,3]
C0019682
active ebv infection, active b and/or c hepatitis
Description

Epstein-Barr Virus Infection | Hepatitis B | Hepatitis C

Data type

boolean

Alias
UMLS CUI [1]
C0149678
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
platelet count <100x10(9)/l
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
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Similar models

Eligibility Juvenile Idiopathic Arthritis NCT01557452

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Clinical Trial Specified Completed | Eligibility Criteria Specified Fulfill
Item
subjects who had successfully completed the previous dose finding study and were fully compliant to the inclusion/exclusion criteria described in the previous dsc/08/2357/36
boolean
C0008976 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C1516637 (UMLS CUI [2,1])
C0205369 (UMLS CUI [2,2])
C1550543 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Fever Relationship Juvenile arthritis | Feature Systemic Juvenile arthritis
Item
patients with fever related to jia or other systemic features of jia during 12 months before entering the study
boolean
C0015967 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C3495559 (UMLS CUI [1,3])
C2348519 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C3495559 (UMLS CUI [2,3])
Bacterial Infections Requirement Antibiotic therapy | Mycoses Requirement Antibiotic therapy
Item
active bacterial or mycotic infection requiring antimicrobial treatment
boolean
C0004623 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0338237 (UMLS CUI [1,3])
C0026946 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0338237 (UMLS CUI [2,3])
Episode of Macrophage Activation Syndrome
Item
episode of macrophage activation syndrome over the last 6 months
boolean
C0332189 (UMLS CUI [1,1])
C1096155 (UMLS CUI [1,2])
Prolonged QT interval | Prolonged QTc interval | Pharmaceutical Preparations Causing Prolonged QT interval | Pharmaceutical Preparations Causing Prolonged QTc interval | Risk factors Additional Torsades de Pointes
Item
baseline prolongation of qt/qtc interval, use of concomitant medications that prolong the qt/qtc interval or history of additional risk factors for tdp.
boolean
C0151878 (UMLS CUI [1])
C1560305 (UMLS CUI [2])
C0013227 (UMLS CUI [3,1])
C0678227 (UMLS CUI [3,2])
C0151878 (UMLS CUI [3,3])
C0013227 (UMLS CUI [4,1])
C0678227 (UMLS CUI [4,2])
C1560305 (UMLS CUI [4,3])
C0035648 (UMLS CUI [5,1])
C1524062 (UMLS CUI [5,2])
C0040479 (UMLS CUI [5,3])
Cardiovascular Disease
Item
clinically significant cardiovascular disease
boolean
C0007222 (UMLS CUI [1])
Illness Study Subject Participation Status At risk | Condition Study Subject Participation Status At risk
Item
clinically significant illness i.e. any condition that in the opinion of the investigator places the patient to unacceptable risk for adverse outcome if he/she were to participate in the study
boolean
C0221423 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C1444641 (UMLS CUI [2,3])
Mental disorders Limiting Medication Compliance | Social situation Limiting Medication Compliance | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance
Item
psychiatric illness/social situation that would limit compliance with study medication and protocol requirements
boolean
C0004936 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C3489773 (UMLS CUI [1,3])
C0748872 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C3489773 (UMLS CUI [2,3])
C0004936 (UMLS CUI [3,1])
C0439801 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
C0748872 (UMLS CUI [4,1])
C0439801 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
Metabolic Diseases Hereditary
Item
inherited metabolic diseases
boolean
C0025517 (UMLS CUI [1,1])
C0439660 (UMLS CUI [1,2])
Malignant Neoplasms
Item
presence of malignancy
boolean
C0006826 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnancy or lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Hematologic Test Positive HIV
Item
positive blood test for hiv
boolean
C0018941 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C0019682 (UMLS CUI [1,3])
Epstein-Barr Virus Infection | Hepatitis B | Hepatitis C
Item
active ebv infection, active b and/or c hepatitis
boolean
C0149678 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
Platelet Count measurement
Item
platelet count <100x10(9)/l
boolean
C0032181 (UMLS CUI [1])
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