ID

40420

Description

A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Assess Clinical Efficacy of NNC0114-0006 in Subjects With Active Rheumatoid Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT01647451

Link

https://clinicaltrials.gov/show/NCT01647451

Keywords

Versions (1)
  1. 4/19/20 4/19/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 19, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Inflammation NCT01647451

English

Eligibility Inflammation NCT01647451

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
a diagnosis of ra meeting the 2010 acr (american college of rheumatology) classification criteria, obtained at least 6 months prior to dosing with the trial product. (if the diagnosis was made prior to 2010, a diagnosis meeting the 1987 acr classification criteria is acceptable)
Description

Rheumatoid Arthritis Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0449238
active ra characterised by das28-crp (disease activity score based on 28 joints and c-reactive protein) equal to or above 4.5 and at least five tender and five swollen joints (can be the same joints) of the 28 joint count
Description

Rheumatoid Arthritis Disease activity score DAS28 | C-reactive protein measurement | Tender 28 joint count | Swollen 28 joint count

Data type

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C4481729
UMLS CUI [2]
C0201657
UMLS CUI [3]
C2711398
UMLS CUI [4]
C2711873
concomitant treatment with mtx above or equal to 15 mg/week for at least 4 months prior to screening, with stable dose of between or equal to 15 mg/week and 25 mg/week for at least 6 weeks prior to screening (mtx doses between 7.5 and 12.5 mg/week are allowed, if patient had intolerance to 15 mg/week)
Description

Methotrexate Dose Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0025677
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
biologic naïve subjects or subjects having been treated with biologics for ra (biologic experienced) provided they meet one of the following criteria: a. reason for discontinuation of biologic therapy was intolerance (e.g., unable to receive recommended doses or achieve adequate treatment duration because of drug related side effects), b. discontinued biologic therapy for other reasons than lack of efficacy (primary or secondary failure) or intolerance (e.g., drug holiday)
Description

Biological agents Absent | Biological agents Rheumatoid Arthritis | Criteria Fulfill | Intolerance to Biological agents | Biological agents Discontinued | Etiology Except Lack of Efficacy

Data type

boolean

Alias
UMLS CUI [1,1]
C0005515
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0005515
UMLS CUI [2,2]
C0003873
UMLS CUI [3,1]
C0243161
UMLS CUI [3,2]
C1550543
UMLS CUI [4,1]
C1744706
UMLS CUI [4,2]
C0005515
UMLS CUI [5,1]
C0005515
UMLS CUI [5,2]
C1444662
UMLS CUI [6,1]
C0015127
UMLS CUI [6,2]
C0332300
UMLS CUI [6,3]
C0235828
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
body mass index (bmi) below or equal to 18.0 or above or equal to 38.0 kg/m^2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
subjects with rheumatic autoimmune disease other than ra, or significant systemic involvement secondary to ra (including but not limited to vasculitis, pulmonary fibrosis, or felty's syndrome). subjects with secondary sjögren's syndrome or stable hypothyroidism are eligible
Description

Autoimmune Disease Rheumatic | Exception Rheumatoid Arthritis | Involvement Systemic Secondary to Rheumatoid Arthritis | Vasculitis | Pulmonary Fibrosis | Felty Syndrome | Sjogren's Syndrome Secondary Eligible | Hypothyroidism Stable Eligible

Data type

boolean

Alias
UMLS CUI [1,1]
C0004364
UMLS CUI [1,2]
C0035435
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0003873
UMLS CUI [3,1]
C1314939
UMLS CUI [3,2]
C0205373
UMLS CUI [3,3]
C0175668
UMLS CUI [3,4]
C0003873
UMLS CUI [4]
C0042384
UMLS CUI [5]
C0034069
UMLS CUI [6]
C0015773
UMLS CUI [7,1]
C1527336
UMLS CUI [7,2]
C0175668
UMLS CUI [7,3]
C1548635
UMLS CUI [8,1]
C0020676
UMLS CUI [8,2]
C0205360
UMLS CUI [8,3]
C1548635
any active or ongoing bacterial infections within 4 weeks prior to randomisation, unless treated and resolved with appropriate therapy (e.g., simple urinary tract infection)
Description

Bacterial Infections | Exception resolved | Urinary tract infection Simple

Data type

boolean

Alias
UMLS CUI [1]
C0004623
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1514893
UMLS CUI [3,1]
C0042029
UMLS CUI [3,2]
C0205352
any history of recurrent infections or conditions predisposing to chronic infections (e.g., bronchiectasis, chronic osteomyelitis)
Description

Recurrent infections | Condition predisposing Chronic infectious disease | Bronchiectasis | Chronic osteomyelitis

Data type

boolean

Alias
UMLS CUI [1]
C0239998
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0231203
UMLS CUI [2,3]
C0151317
UMLS CUI [3]
C0006267
UMLS CUI [4]
C0008707
history of severe systemic fungal infection within the past 12 months prior to screening unless treated and resolved with appropriate therapy
Description

Systemic mycosis Severe | Exception resolved

Data type

boolean

Alias
UMLS CUI [1,1]
C0553576
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1514893
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Similar models

Eligibility Inflammation NCT01647451

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Rheumatoid Arthritis Duration
Item
a diagnosis of ra meeting the 2010 acr (american college of rheumatology) classification criteria, obtained at least 6 months prior to dosing with the trial product. (if the diagnosis was made prior to 2010, a diagnosis meeting the 1987 acr classification criteria is acceptable)
boolean
C0003873 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Rheumatoid Arthritis Disease activity score DAS28 | C-reactive protein measurement | Tender 28 joint count | Swollen 28 joint count
Item
active ra characterised by das28-crp (disease activity score based on 28 joints and c-reactive protein) equal to or above 4.5 and at least five tender and five swollen joints (can be the same joints) of the 28 joint count
boolean
C0003873 (UMLS CUI [1,1])
C4481729 (UMLS CUI [1,2])
C0201657 (UMLS CUI [2])
C2711398 (UMLS CUI [3])
C2711873 (UMLS CUI [4])
Methotrexate Dose Stable
Item
concomitant treatment with mtx above or equal to 15 mg/week for at least 4 months prior to screening, with stable dose of between or equal to 15 mg/week and 25 mg/week for at least 6 weeks prior to screening (mtx doses between 7.5 and 12.5 mg/week are allowed, if patient had intolerance to 15 mg/week)
boolean
C0025677 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Biological agents Absent | Biological agents Rheumatoid Arthritis | Criteria Fulfill | Intolerance to Biological agents | Biological agents Discontinued | Etiology Except Lack of Efficacy
Item
biologic naïve subjects or subjects having been treated with biologics for ra (biologic experienced) provided they meet one of the following criteria: a. reason for discontinuation of biologic therapy was intolerance (e.g., unable to receive recommended doses or achieve adequate treatment duration because of drug related side effects), b. discontinued biologic therapy for other reasons than lack of efficacy (primary or secondary failure) or intolerance (e.g., drug holiday)
boolean
C0005515 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0005515 (UMLS CUI [2,1])
C0003873 (UMLS CUI [2,2])
C0243161 (UMLS CUI [3,1])
C1550543 (UMLS CUI [3,2])
C1744706 (UMLS CUI [4,1])
C0005515 (UMLS CUI [4,2])
C0005515 (UMLS CUI [5,1])
C1444662 (UMLS CUI [5,2])
C0015127 (UMLS CUI [6,1])
C0332300 (UMLS CUI [6,2])
C0235828 (UMLS CUI [6,3])
Item Group
C0680251 (UMLS CUI)
Body mass index
Item
body mass index (bmi) below or equal to 18.0 or above or equal to 38.0 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Autoimmune Disease Rheumatic | Exception Rheumatoid Arthritis | Involvement Systemic Secondary to Rheumatoid Arthritis | Vasculitis | Pulmonary Fibrosis | Felty Syndrome | Sjogren's Syndrome Secondary Eligible | Hypothyroidism Stable Eligible
Item
subjects with rheumatic autoimmune disease other than ra, or significant systemic involvement secondary to ra (including but not limited to vasculitis, pulmonary fibrosis, or felty's syndrome). subjects with secondary sjögren's syndrome or stable hypothyroidism are eligible
boolean
C0004364 (UMLS CUI [1,1])
C0035435 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0003873 (UMLS CUI [2,2])
C1314939 (UMLS CUI [3,1])
C0205373 (UMLS CUI [3,2])
C0175668 (UMLS CUI [3,3])
C0003873 (UMLS CUI [3,4])
C0042384 (UMLS CUI [4])
C0034069 (UMLS CUI [5])
C0015773 (UMLS CUI [6])
C1527336 (UMLS CUI [7,1])
C0175668 (UMLS CUI [7,2])
C1548635 (UMLS CUI [7,3])
C0020676 (UMLS CUI [8,1])
C0205360 (UMLS CUI [8,2])
C1548635 (UMLS CUI [8,3])
Bacterial Infections | Exception resolved | Urinary tract infection Simple
Item
any active or ongoing bacterial infections within 4 weeks prior to randomisation, unless treated and resolved with appropriate therapy (e.g., simple urinary tract infection)
boolean
C0004623 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1514893 (UMLS CUI [2,2])
C0042029 (UMLS CUI [3,1])
C0205352 (UMLS CUI [3,2])
Recurrent infections | Condition predisposing Chronic infectious disease | Bronchiectasis | Chronic osteomyelitis
Item
any history of recurrent infections or conditions predisposing to chronic infections (e.g., bronchiectasis, chronic osteomyelitis)
boolean
C0239998 (UMLS CUI [1])
C0348080 (UMLS CUI [2,1])
C0231203 (UMLS CUI [2,2])
C0151317 (UMLS CUI [2,3])
C0006267 (UMLS CUI [3])
C0008707 (UMLS CUI [4])
Systemic mycosis Severe | Exception resolved
Item
history of severe systemic fungal infection within the past 12 months prior to screening unless treated and resolved with appropriate therapy
boolean
C0553576 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C1514893 (UMLS CUI [2,2])
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