ID

37148

Description

ACP-196 Versus Placebo in Subjects With Rheumatoid Arthritis on Background Methotrexate; ODM derived from: https://clinicaltrials.gov/show/NCT02387762

Link

https://clinicaltrials.gov/show/NCT02387762

Keywords

Versions (1)
  1. 7/4/19 7/4/19 -
Copyright Holder

See clinicaltrials.gov

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July 4, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT02387762

English

Eligibility Rheumatoid Arthritis NCT02387762

1 forms  
Criteria
Description

Criteria

diagnosis of ra according to the 2010 acr/eular classification criteria .
Description

Rheumatoid Arthritis

Data type

boolean

Alias
UMLS CUI [1]
C0003873
must be on a stable mtx dose (7.5 to 25 mg/week)
Description

Methotrexate Dosage Stable U/week

Data type

boolean

Alias
UMLS CUI [1,1]
C0025677
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [1,4]
C0560588
subjects must be able to read and understand the consent form, complete the study-related procedures, and communicate with the study staff.
Description

Able to read Consent Form | Comprehension Consent Form | Interventional procedure Completion | Able to communicate Research Personnel

Data type

boolean

Alias
UMLS CUI [1,1]
C0586740
UMLS CUI [1,2]
C0009797
UMLS CUI [2,1]
C0162340
UMLS CUI [2,2]
C0009797
UMLS CUI [3,1]
C0184661
UMLS CUI [3,2]
C0205197
UMLS CUI [4,1]
C2364293
UMLS CUI [4,2]
C0035173
are willing and able to adhere to the study visit schedule, and understand and comply with other protocol requirements.
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
main exclusion criteria:
Description

Exclusion Criteria Main

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for ≥ 5 years.
Description

Malignant Neoplasms | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix | Exception Cancer Other Free of Duration

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C1707251
UMLS CUI [5,3]
C0332296
UMLS CUI [5,4]
C0449238
a life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of acp-196, or put the study outcomes at undue risk.
Description

Life threatening illness compromises Patient safety | Medical condition compromises Patient safety | Organ system Dysfunction compromises Patient safety | Life threatening illness Interferes with ACP-196 Absorption | Medical condition Interferes with ACP-196 Absorption | Organ system Dysfunction Interferes with ACP-196 Absorption | Life threatening illness Interferes with ACP-196 Metabolism | Medical condition Interferes with ACP-196 Metabolism | Organ system Dysfunction Interferes with ACP-196 Metabolism | Life threatening illness Research results At risk | Medical condition Research results At risk | Organ system Dysfunction Research results At risk

Data type

boolean

Alias
UMLS CUI [1,1]
C3846017
UMLS CUI [1,2]
C2945640
UMLS CUI [1,3]
C1113679
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C2945640
UMLS CUI [2,3]
C1113679
UMLS CUI [3,1]
C0460002
UMLS CUI [3,2]
C3887504
UMLS CUI [3,3]
C2945640
UMLS CUI [3,4]
C1113679
UMLS CUI [4,1]
C3846017
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C3827171
UMLS CUI [4,4]
C0237442
UMLS CUI [5,1]
C3843040
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C3827171
UMLS CUI [5,4]
C0237442
UMLS CUI [6,1]
C0460002
UMLS CUI [6,2]
C3887504
UMLS CUI [6,3]
C0521102
UMLS CUI [6,4]
C3827171
UMLS CUI [6,5]
C0237442
UMLS CUI [7,1]
C3846017
UMLS CUI [7,2]
C0521102
UMLS CUI [7,3]
C3827171
UMLS CUI [7,4]
C0025519
UMLS CUI [8,1]
C3843040
UMLS CUI [8,2]
C0521102
UMLS CUI [8,3]
C3827171
UMLS CUI [8,4]
C0025519
UMLS CUI [9,1]
C0460002
UMLS CUI [9,2]
C3887504
UMLS CUI [9,3]
C0521102
UMLS CUI [9,4]
C3827171
UMLS CUI [9,5]
C0025519
UMLS CUI [10,1]
C3846017
UMLS CUI [10,2]
C0683954
UMLS CUI [10,3]
C1444641
UMLS CUI [11,1]
C3843040
UMLS CUI [11,2]
C0683954
UMLS CUI [11,3]
C1444641
UMLS CUI [12,1]
C0460002
UMLS CUI [12,2]
C3887504
UMLS CUI [12,3]
C0683954
UMLS CUI [12,4]
C1444641
subjects who have taken any investigational drug within the previous 30 days before randomization.
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
use of all other synthetic disease-modifying antirheumatic drugs (dmards) such as but not limited to leflunomide, azathioprine, cyclosporine, penicillamine or gold salts within 8 weeks of randomization.
Description

DMARDs synthetic | leflunomide | Azathioprine | Cyclosporine | Penicillamine | Gold salt

Data type

boolean

Alias
UMLS CUI [1,1]
C0242708
UMLS CUI [1,2]
C1883254
UMLS CUI [2]
C0063041
UMLS CUI [3]
C0004482
UMLS CUI [4]
C0010592
UMLS CUI [5]
C0030817
UMLS CUI [6]
C0302210
use of etanercept, anakinra, tofacitinib within 4 weeks of randomization.
Description

Etanercept | anakinra | tofacitinib

Data type

boolean

Alias
UMLS CUI [1]
C0717758
UMLS CUI [2]
C0245109
UMLS CUI [3]
C2930696
use of abatacept, humira, infliximab, or tocilizumab within 8 weeks of randomization.
Description

abatacept | Humira | infliximab | tocilizumab

Data type

boolean

Alias
UMLS CUI [1]
C1619966
UMLS CUI [2]
C1171255
UMLS CUI [3]
C0666743
UMLS CUI [4]
C1609165
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Similar models

Eligibility Rheumatoid Arthritis NCT02387762

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Rheumatoid Arthritis
Item
diagnosis of ra according to the 2010 acr/eular classification criteria .
boolean
C0003873 (UMLS CUI [1])
Methotrexate Dosage Stable U/week
Item
must be on a stable mtx dose (7.5 to 25 mg/week)
boolean
C0025677 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0560588 (UMLS CUI [1,4])
Able to read Consent Form | Comprehension Consent Form | Interventional procedure Completion | Able to communicate Research Personnel
Item
subjects must be able to read and understand the consent form, complete the study-related procedures, and communicate with the study staff.
boolean
C0586740 (UMLS CUI [1,1])
C0009797 (UMLS CUI [1,2])
C0162340 (UMLS CUI [2,1])
C0009797 (UMLS CUI [2,2])
C0184661 (UMLS CUI [3,1])
C0205197 (UMLS CUI [3,2])
C2364293 (UMLS CUI [4,1])
C0035173 (UMLS CUI [4,2])
Protocol Compliance
Item
are willing and able to adhere to the study visit schedule, and understand and comply with other protocol requirements.
boolean
C0525058 (UMLS CUI [1])
Exclusion Criteria Main
Item
main exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Malignant Neoplasms | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix | Exception Cancer Other Free of Duration
Item
prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for ≥ 5 years.
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C1707251 (UMLS CUI [5,2])
C0332296 (UMLS CUI [5,3])
C0449238 (UMLS CUI [5,4])
Life threatening illness compromises Patient safety | Medical condition compromises Patient safety | Organ system Dysfunction compromises Patient safety | Life threatening illness Interferes with ACP-196 Absorption | Medical condition Interferes with ACP-196 Absorption | Organ system Dysfunction Interferes with ACP-196 Absorption | Life threatening illness Interferes with ACP-196 Metabolism | Medical condition Interferes with ACP-196 Metabolism | Organ system Dysfunction Interferes with ACP-196 Metabolism | Life threatening illness Research results At risk | Medical condition Research results At risk | Organ system Dysfunction Research results At risk
Item
a life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of acp-196, or put the study outcomes at undue risk.
boolean
C3846017 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C1113679 (UMLS CUI [2,3])
C0460002 (UMLS CUI [3,1])
C3887504 (UMLS CUI [3,2])
C2945640 (UMLS CUI [3,3])
C1113679 (UMLS CUI [3,4])
C3846017 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C3827171 (UMLS CUI [4,3])
C0237442 (UMLS CUI [4,4])
C3843040 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C3827171 (UMLS CUI [5,3])
C0237442 (UMLS CUI [5,4])
C0460002 (UMLS CUI [6,1])
C3887504 (UMLS CUI [6,2])
C0521102 (UMLS CUI [6,3])
C3827171 (UMLS CUI [6,4])
C0237442 (UMLS CUI [6,5])
C3846017 (UMLS CUI [7,1])
C0521102 (UMLS CUI [7,2])
C3827171 (UMLS CUI [7,3])
C0025519 (UMLS CUI [7,4])
C3843040 (UMLS CUI [8,1])
C0521102 (UMLS CUI [8,2])
C3827171 (UMLS CUI [8,3])
C0025519 (UMLS CUI [8,4])
C0460002 (UMLS CUI [9,1])
C3887504 (UMLS CUI [9,2])
C0521102 (UMLS CUI [9,3])
C3827171 (UMLS CUI [9,4])
C0025519 (UMLS CUI [9,5])
C3846017 (UMLS CUI [10,1])
C0683954 (UMLS CUI [10,2])
C1444641 (UMLS CUI [10,3])
C3843040 (UMLS CUI [11,1])
C0683954 (UMLS CUI [11,2])
C1444641 (UMLS CUI [11,3])
C0460002 (UMLS CUI [12,1])
C3887504 (UMLS CUI [12,2])
C0683954 (UMLS CUI [12,3])
C1444641 (UMLS CUI [12,4])
Investigational New Drugs
Item
subjects who have taken any investigational drug within the previous 30 days before randomization.
boolean
C0013230 (UMLS CUI [1])
DMARDs synthetic | leflunomide | Azathioprine | Cyclosporine | Penicillamine | Gold salt
Item
use of all other synthetic disease-modifying antirheumatic drugs (dmards) such as but not limited to leflunomide, azathioprine, cyclosporine, penicillamine or gold salts within 8 weeks of randomization.
boolean
C0242708 (UMLS CUI [1,1])
C1883254 (UMLS CUI [1,2])
C0063041 (UMLS CUI [2])
C0004482 (UMLS CUI [3])
C0010592 (UMLS CUI [4])
C0030817 (UMLS CUI [5])
C0302210 (UMLS CUI [6])
Etanercept | anakinra | tofacitinib
Item
use of etanercept, anakinra, tofacitinib within 4 weeks of randomization.
boolean
C0717758 (UMLS CUI [1])
C0245109 (UMLS CUI [2])
C2930696 (UMLS CUI [3])
abatacept | Humira | infliximab | tocilizumab
Item
use of abatacept, humira, infliximab, or tocilizumab within 8 weeks of randomization.
boolean
C1619966 (UMLS CUI [1])
C1171255 (UMLS CUI [2])
C0666743 (UMLS CUI [3])
C1609165 (UMLS CUI [4])
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