ID

40595

Description

Extension Study Evaluating the Safety and Efficacy of Subcutaneous RoActemra/Actemra Administration in Patients With Systemic and Polyarticular-Course Juvenile Idiopathic Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT02165345

Link

https://clinicaltrials.gov/show/NCT02165345

Keywords

Versions (1)
  1. 4/30/20 4/30/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 30, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Juvenile Idiopathic Arthritis NCT02165345

English

Eligibility Juvenile Idiopathic Arthritis NCT02165345

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
completion of either of the jigsaw studies, study wa28117 (for patients with pcjia) or study wa28118 (for patients with sjia)
Description

Clinical Trial Specified Completed | Clinical Trial Polyarticular juvenile idiopathic arthritis | Clinical Trial SJIA

Data type

boolean

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0205369
UMLS CUI [1,3]
C0205197
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C4521004
UMLS CUI [3,1]
C0008976
UMLS CUI [3,2]
C1384600
adequate disease control with the use of sc roactemra/actemra, as assessed by the investigator
Description

Disorder control RoActemra Subcutaneous | Disorder control Actemra Subcutaneous

Data type

boolean

Alias
UMLS CUI [1,1]
C0920467
UMLS CUI [1,2]
C3272237
UMLS CUI [1,3]
C1522438
UMLS CUI [2,1]
C0920467
UMLS CUI [2,2]
C2740854
UMLS CUI [2,3]
C1522438
written informed consent for study participation obtained from the patient (for patients >/= 18 years old) or the patient's parents or guardian, with assent as appropriate by the patient, depending on the level of the patient's understanding
Description

Informed Consent | Age | Informed Consent Parent | Informed Consent Guardian

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0001779
UMLS CUI [3,1]
C0021430
UMLS CUI [3,2]
C0030551
UMLS CUI [4,1]
C0021430
UMLS CUI [4,2]
C1274041
for patients of reproductive potential: use of effective contraception as defined by the study protocol
Description

Females & males of reproductive potential Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
therapy with biologic agents (except roactemra/actemra) in the period between completion of the jigsaw study and screening for the current study
Description

Biological agents | Exception RoActemra | Exception Actemra

Data type

boolean

Alias
UMLS CUI [1]
C0005515
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C3272237
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C2740854
concurrent treatment with dmards (including mtx), nsaids, and oral corticosteroids is permitted at the discretion of the investigator
Description

DMARDs allowed | Methotrexate allowed | NSAIDs allowed | Adrenal Cortex Hormones Oral allowed

Data type

boolean

Alias
UMLS CUI [1,1]
C0242708
UMLS CUI [1,2]
C0683607
UMLS CUI [2,1]
C0025677
UMLS CUI [2,2]
C0683607
UMLS CUI [3,1]
C0003211
UMLS CUI [3,2]
C0683607
UMLS CUI [4,1]
C0001617
UMLS CUI [4,2]
C1527415
UMLS CUI [4,3]
C0683607
use of live or attenuated vaccines and immunosuppressants, such as cyclosporine and cyclophosphamide, is prohibited
Description

Vaccines, Attenuated | Immunosuppressive Agents | Cyclosporine | Cyclophosphamide

Data type

boolean

Alias
UMLS CUI [1]
C0042211
UMLS CUI [2]
C0021081
UMLS CUI [3]
C0010592
UMLS CUI [4]
C0010583
pregnancy or breast-feeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
any significant concurrent medical or surgical conditions or findings that would jeopardize the patient's safety or ability to complete the study, including but not limited to disease of the nervous, renal, hepatic, cardiac, pulmonary, gastric, or endocrine system or any infection
Description

Comorbidity At risk Patient safety | Operative Surgical Procedures At risk Patient safety | Finding At risk Patient safety | Comorbidity Completion of clinical trial At risk | Operative Surgical Procedures Completion of clinical trial At risk | Finding Completion of clinical trial At risk | Nervous system disorder | Kidney Disease | Liver disease | Heart Disease | Lung disease | Stomach Disease | Endocrine System Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C1113679
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C1444641
UMLS CUI [2,3]
C1113679
UMLS CUI [3,1]
C0243095
UMLS CUI [3,2]
C1444641
UMLS CUI [3,3]
C1113679
UMLS CUI [4,1]
C0009488
UMLS CUI [4,2]
C2732579
UMLS CUI [4,3]
C1444641
UMLS CUI [5,1]
C0543467
UMLS CUI [5,2]
C2732579
UMLS CUI [5,3]
C1444641
UMLS CUI [6,1]
C0243095
UMLS CUI [6,2]
C2732579
UMLS CUI [6,3]
C1444641
UMLS CUI [7]
C0027765
UMLS CUI [8]
C0022658
UMLS CUI [9]
C0023895
UMLS CUI [10]
C0018799
UMLS CUI [11]
C0024115
UMLS CUI [12]
C0038354
UMLS CUI [13]
C0014130
history of alcohol, drug, or chemical abuse within 6 months prior to screening
Description

Substance Use Disorders | Chemical abuse

Data type

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0851847
history of atypical tuberculosis (tb) or active tb requiring treatment within 2 years prior to screening
Description

Tuberculosis Atypical | Tuberculosis Treatment required for

Data type

boolean

Alias
UMLS CUI [1,1]
C0041296
UMLS CUI [1,2]
C0205182
UMLS CUI [2,1]
C0041296
UMLS CUI [2,2]
C0332121
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Similar models

Eligibility Juvenile Idiopathic Arthritis NCT02165345

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Clinical Trial Specified Completed | Clinical Trial Polyarticular juvenile idiopathic arthritis | Clinical Trial SJIA
Item
completion of either of the jigsaw studies, study wa28117 (for patients with pcjia) or study wa28118 (for patients with sjia)
boolean
C0008976 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C0008976 (UMLS CUI [2,1])
C4521004 (UMLS CUI [2,2])
C0008976 (UMLS CUI [3,1])
C1384600 (UMLS CUI [3,2])
Disorder control RoActemra Subcutaneous | Disorder control Actemra Subcutaneous
Item
adequate disease control with the use of sc roactemra/actemra, as assessed by the investigator
boolean
C0920467 (UMLS CUI [1,1])
C3272237 (UMLS CUI [1,2])
C1522438 (UMLS CUI [1,3])
C0920467 (UMLS CUI [2,1])
C2740854 (UMLS CUI [2,2])
C1522438 (UMLS CUI [2,3])
Informed Consent | Age | Informed Consent Parent | Informed Consent Guardian
Item
written informed consent for study participation obtained from the patient (for patients >/= 18 years old) or the patient's parents or guardian, with assent as appropriate by the patient, depending on the level of the patient's understanding
boolean
C0021430 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0021430 (UMLS CUI [3,1])
C0030551 (UMLS CUI [3,2])
C0021430 (UMLS CUI [4,1])
C1274041 (UMLS CUI [4,2])
Females & males of reproductive potential Contraceptive methods
Item
for patients of reproductive potential: use of effective contraception as defined by the study protocol
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Biological agents | Exception RoActemra | Exception Actemra
Item
therapy with biologic agents (except roactemra/actemra) in the period between completion of the jigsaw study and screening for the current study
boolean
C0005515 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C3272237 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C2740854 (UMLS CUI [3,2])
DMARDs allowed | Methotrexate allowed | NSAIDs allowed | Adrenal Cortex Hormones Oral allowed
Item
concurrent treatment with dmards (including mtx), nsaids, and oral corticosteroids is permitted at the discretion of the investigator
boolean
C0242708 (UMLS CUI [1,1])
C0683607 (UMLS CUI [1,2])
C0025677 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
C0003211 (UMLS CUI [3,1])
C0683607 (UMLS CUI [3,2])
C0001617 (UMLS CUI [4,1])
C1527415 (UMLS CUI [4,2])
C0683607 (UMLS CUI [4,3])
Vaccines, Attenuated | Immunosuppressive Agents | Cyclosporine | Cyclophosphamide
Item
use of live or attenuated vaccines and immunosuppressants, such as cyclosporine and cyclophosphamide, is prohibited
boolean
C0042211 (UMLS CUI [1])
C0021081 (UMLS CUI [2])
C0010592 (UMLS CUI [3])
C0010583 (UMLS CUI [4])
Pregnancy | Breast Feeding
Item
pregnancy or breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Comorbidity At risk Patient safety | Operative Surgical Procedures At risk Patient safety | Finding At risk Patient safety | Comorbidity Completion of clinical trial At risk | Operative Surgical Procedures Completion of clinical trial At risk | Finding Completion of clinical trial At risk | Nervous system disorder | Kidney Disease | Liver disease | Heart Disease | Lung disease | Stomach Disease | Endocrine System Disease
Item
any significant concurrent medical or surgical conditions or findings that would jeopardize the patient's safety or ability to complete the study, including but not limited to disease of the nervous, renal, hepatic, cardiac, pulmonary, gastric, or endocrine system or any infection
boolean
C0009488 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C0543467 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C1113679 (UMLS CUI [2,3])
C0243095 (UMLS CUI [3,1])
C1444641 (UMLS CUI [3,2])
C1113679 (UMLS CUI [3,3])
C0009488 (UMLS CUI [4,1])
C2732579 (UMLS CUI [4,2])
C1444641 (UMLS CUI [4,3])
C0543467 (UMLS CUI [5,1])
C2732579 (UMLS CUI [5,2])
C1444641 (UMLS CUI [5,3])
C0243095 (UMLS CUI [6,1])
C2732579 (UMLS CUI [6,2])
C1444641 (UMLS CUI [6,3])
C0027765 (UMLS CUI [7])
C0022658 (UMLS CUI [8])
C0023895 (UMLS CUI [9])
C0018799 (UMLS CUI [10])
C0024115 (UMLS CUI [11])
C0038354 (UMLS CUI [12])
C0014130 (UMLS CUI [13])
Substance Use Disorders | Chemical abuse
Item
history of alcohol, drug, or chemical abuse within 6 months prior to screening
boolean
C0038586 (UMLS CUI [1])
C0851847 (UMLS CUI [2])
Tuberculosis Atypical | Tuberculosis Treatment required for
Item
history of atypical tuberculosis (tb) or active tb requiring treatment within 2 years prior to screening
boolean
C0041296 (UMLS CUI [1,1])
C0205182 (UMLS CUI [1,2])
C0041296 (UMLS CUI [2,1])
C0332121 (UMLS CUI [2,2])
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