ID

36157

Description

A Trial Investigating the Mechanism of Action of NNC0109-0012 (Anti-IL-20 mAb) Through Synovial Biopsies in Subjects With Rheumatoid Arthritis and an Inadequate Response to Methotrexate; ODM derived from: https://clinicaltrials.gov/show/NCT02097264

Link

https://clinicaltrials.gov/show/NCT02097264

Keywords

Versions (1)
  1. 4/18/19 4/18/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 18, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Inflammation NCT02097264

English

Eligibility Inflammation NCT02097264

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female age at least 18 and below or equal to 75 years at the time of signing informed consent
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
a diagnosis of ra at least 6 months prior to screening visit, according to the american college of rheumatology (eular/acr 2010 criteria) or by standard criteria (acr 1987) if diagnosis was made earlier than 2010
Description

Rheumatoid Arthritis Disease length

Data type

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0872146
subjects with acr global functional status of 1 to 3
Description

ACR Criteria for Improvement in Rheumatoid Arthritis Functional Status

Data type

boolean

Alias
UMLS CUI [1,1]
C3273740
UMLS CUI [1,2]
C0598463
active ra, characterised by: das28 (disease activity score 28) (crp (c-reactive protein)) above 4.5 and equal to or above 6 tender and equal to or above 6 swollen joints based on a 66/68 joint count
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0003873
UMLS CUI [2]
C4481729
UMLS CUI [3]
C0201657
UMLS CUI [4]
C0451530
UMLS CUI [5]
C0451521
active synovitis in at least two joints of the wrist and metacarpophalangeal joints, as assessed by high frequency power doppler ultrasound scan at screening and randomisation
Description

Synovitis wrist Joints Quantity | Synovitis Metacarpophalangeal joints Quantity | High frequency Doppler Ultrasound

Data type

boolean

Alias
UMLS CUI [1,1]
C1868955
UMLS CUI [1,2]
C0022417
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0039103
UMLS CUI [2,2]
C0025525
UMLS CUI [2,3]
C1265611
UMLS CUI [3,1]
C0205212
UMLS CUI [3,2]
C0162481
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects with arthritis due to other autoimmune diseases than ra
Description

Arthritis Due to Autoimmune Diseases | Exception Rheumatoid Arthritis

Data type

boolean

Alias
UMLS CUI [1,1]
C0003864
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0004364
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0003873
body weight above 90.0 kg
Description

Body Weight

Data type

boolean

Alias
UMLS CUI [1]
C0005910
history of or current inflammatory joint disease other than ra (e.g. gout, psoriatic or reactive arthritis, lyme disease, juvenile idiopathic arthritis, excluding secondary sjogren syndrome and hypothyroidism)
Description

Inflammatory joint disease | Exception Rheumatoid Arthritis | Gout | Arthritis, Psoriatic | Arthritis, Reactive | Lyme Disease | Juvenile arthritis | Exception Sjogren's Syndrome Secondary | Exception Hypothyroidism

Data type

boolean

Alias
UMLS CUI [1]
C0683381
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0003873
UMLS CUI [3]
C0018099
UMLS CUI [4]
C0003872
UMLS CUI [5]
C0085435
UMLS CUI [6]
C0024198
UMLS CUI [7]
C3495559
UMLS CUI [8,1]
C1705847
UMLS CUI [8,2]
C1527336
UMLS CUI [8,3]
C0175668
UMLS CUI [9,1]
C1705847
UMLS CUI [9,2]
C0020676
any active or on-going bacterial infections within 4 weeks prior to screening visit, unless treated and resolved with appropriate therapy or any history of recurrent infections or conditions predisposing to chronic infections (e.g., bronchiectasis, chronic osteomyelitis)
Description

Bacterial Infections | Exception Bacterial Infections resolved | Recurrent infections | Condition predisposing Chronic infectious disease | Bronchiectasis | Chronic osteomyelitis

Data type

boolean

Alias
UMLS CUI [1]
C0004623
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0004623
UMLS CUI [2,3]
C1514893
UMLS CUI [3]
C0239998
UMLS CUI [4,1]
C0348080
UMLS CUI [4,2]
C0231203
UMLS CUI [4,3]
C0151317
UMLS CUI [5]
C0006267
UMLS CUI [6]
C0008707
subjects with malignancy within the previous 5 years with the exception of adequately treated and cured basal or squamous cell carcinoma of the skin or cervical carcinoma in situ occurring more than 12 months prior to screening visit
Description

Malignant Neoplasms | Exception Basal cell carcinoma Treated Cured | Exception Squamous cell carcinoma of skin Treated Cured | Exception Carcinoma in situ of uterine cervix

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 [2,4]
C1880198
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [3,3]
C1522326
UMLS CUI [3,4]
C1880198
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
female who is pregnant, breast feeding, intends to become pregnant or is of childbearing potential, not willing to use two highly effective contraceptive methods (adequate highlyeffective contraceptive measures are defined as established use of oral, injected or implanted hormonal methods of contraception, sterilisation, intrauterine device or intrauterine system) one of which has to be a barrier method a barrier method of contraception (e.g. condom with spermicidal foam/gel/film/cream), for at least 16 weeks (approximately 5 half-lives) following the last dose of trial medication
Description

Pregnancy | Breast Feeding | Pregnancy, Planned | Childbearing Potential Contraceptive methods Quantity Unwilling | Contraceptives, Oral, Hormonal | Injectable contraception Hormonal | Contraceptive implant Hormonal | Female Sterilization | Intrauterine Devices | Intrauterine System Contraception | Contraception, Barrier | Female Condoms | Spermicidal foam/jelly/cream/film/suppository

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0700589
UMLS CUI [4,3]
C1265611
UMLS CUI [4,4]
C0558080
UMLS CUI [5]
C0009907
UMLS CUI [6,1]
C1262153
UMLS CUI [6,2]
C0458083
UMLS CUI [7,1]
C1657106
UMLS CUI [7,2]
C0458083
UMLS CUI [8]
C0015787
UMLS CUI [9]
C0021900
UMLS CUI [10,1]
C4293370
UMLS CUI [10,2]
C0700589
UMLS CUI [11]
C0004764
UMLS CUI [12]
C0221829
UMLS CUI [13]
C3843415
male subjects who are sexually active and not surgically sterilised, who or whose partner are unwilling to use two different forms of highly effective contraception, one of which has to be a barrier method a barrier method of contraception (e.g. condom with spermicidal foam/gel/film/cream) for the duration of the trial and for at least 16 weeks (approximately 5 half-lives) following the last dose of trial medication
Description

Gender Sexually active Contraceptive methods Unwilling | Male sterilization Absent | Partner Contraceptive methods Unwilling | Contraception, Barrier | Condoms, Male | Spermicidal foam/jelly/cream/film/suppository

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0241028
UMLS CUI [1,3]
C0700589
UMLS CUI [1,4]
C0558080
UMLS CUI [2,1]
C0024559
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0682323
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0558080
UMLS CUI [4]
C0004764
UMLS CUI [5]
C0009653
UMLS CUI [6]
C3843415
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Similar models

Eligibility Inflammation NCT02097264

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female age at least 18 and below or equal to 75 years at the time of signing informed consent
boolean
C0001779 (UMLS CUI [1])
Rheumatoid Arthritis Disease length
Item
a diagnosis of ra at least 6 months prior to screening visit, according to the american college of rheumatology (eular/acr 2010 criteria) or by standard criteria (acr 1987) if diagnosis was made earlier than 2010
boolean
C0003873 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
ACR Criteria for Improvement in Rheumatoid Arthritis Functional Status
Item
subjects with acr global functional status of 1 to 3
boolean
C3273740 (UMLS CUI [1,1])
C0598463 (UMLS CUI [1,2])
Rheumatoid Arthritis | Disease activity score DAS28 | C-reactive protein measurement | Tender joint count | Swollen joint count
Item
active ra, characterised by: das28 (disease activity score 28) (crp (c-reactive protein)) above 4.5 and equal to or above 6 tender and equal to or above 6 swollen joints based on a 66/68 joint count
boolean
C0003873 (UMLS CUI [1])
C4481729 (UMLS CUI [2])
C0201657 (UMLS CUI [3])
C0451530 (UMLS CUI [4])
C0451521 (UMLS CUI [5])
Synovitis wrist Joints Quantity | Synovitis Metacarpophalangeal joints Quantity | High frequency Doppler Ultrasound
Item
active synovitis in at least two joints of the wrist and metacarpophalangeal joints, as assessed by high frequency power doppler ultrasound scan at screening and randomisation
boolean
C1868955 (UMLS CUI [1,1])
C0022417 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0039103 (UMLS CUI [2,1])
C0025525 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0205212 (UMLS CUI [3,1])
C0162481 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Arthritis Due to Autoimmune Diseases | Exception Rheumatoid Arthritis
Item
subjects with arthritis due to other autoimmune diseases than ra
boolean
C0003864 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0004364 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0003873 (UMLS CUI [2,2])
Body Weight
Item
body weight above 90.0 kg
boolean
C0005910 (UMLS CUI [1])
Inflammatory joint disease | Exception Rheumatoid Arthritis | Gout | Arthritis, Psoriatic | Arthritis, Reactive | Lyme Disease | Juvenile arthritis | Exception Sjogren's Syndrome Secondary | Exception Hypothyroidism
Item
history of or current inflammatory joint disease other than ra (e.g. gout, psoriatic or reactive arthritis, lyme disease, juvenile idiopathic arthritis, excluding secondary sjogren syndrome and hypothyroidism)
boolean
C0683381 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0003873 (UMLS CUI [2,2])
C0018099 (UMLS CUI [3])
C0003872 (UMLS CUI [4])
C0085435 (UMLS CUI [5])
C0024198 (UMLS CUI [6])
C3495559 (UMLS CUI [7])
C1705847 (UMLS CUI [8,1])
C1527336 (UMLS CUI [8,2])
C0175668 (UMLS CUI [8,3])
C1705847 (UMLS CUI [9,1])
C0020676 (UMLS CUI [9,2])
Bacterial Infections | Exception Bacterial Infections resolved | Recurrent infections | Condition predisposing Chronic infectious disease | Bronchiectasis | Chronic osteomyelitis
Item
any active or on-going bacterial infections within 4 weeks prior to screening visit, unless treated and resolved with appropriate therapy or any history of recurrent infections or conditions predisposing to chronic infections (e.g., bronchiectasis, chronic osteomyelitis)
boolean
C0004623 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0004623 (UMLS CUI [2,2])
C1514893 (UMLS CUI [2,3])
C0239998 (UMLS CUI [3])
C0348080 (UMLS CUI [4,1])
C0231203 (UMLS CUI [4,2])
C0151317 (UMLS CUI [4,3])
C0006267 (UMLS CUI [5])
C0008707 (UMLS CUI [6])
Malignant Neoplasms | Exception Basal cell carcinoma Treated Cured | Exception Squamous cell carcinoma of skin Treated Cured | Exception Carcinoma in situ of uterine cervix
Item
subjects with malignancy within the previous 5 years with the exception of adequately treated and cured basal or squamous cell carcinoma of the skin or cervical carcinoma in situ occurring more than 12 months prior to screening visit
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1880198 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1880198 (UMLS CUI [3,4])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
Pregnancy | Breast Feeding | Pregnancy, Planned | Childbearing Potential Contraceptive methods Quantity Unwilling | Contraceptives, Oral, Hormonal | Injectable contraception Hormonal | Contraceptive implant Hormonal | Female Sterilization | Intrauterine Devices | Intrauterine System Contraception | Contraception, Barrier | Female Condoms | Spermicidal foam/jelly/cream/film/suppository
Item
female who is pregnant, breast feeding, intends to become pregnant or is of childbearing potential, not willing to use two highly effective contraceptive methods (adequate highlyeffective contraceptive measures are defined as established use of oral, injected or implanted hormonal methods of contraception, sterilisation, intrauterine device or intrauterine system) one of which has to be a barrier method a barrier method of contraception (e.g. condom with spermicidal foam/gel/film/cream), for at least 16 weeks (approximately 5 half-lives) following the last dose of trial medication
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
C0558080 (UMLS CUI [4,4])
C0009907 (UMLS CUI [5])
C1262153 (UMLS CUI [6,1])
C0458083 (UMLS CUI [6,2])
C1657106 (UMLS CUI [7,1])
C0458083 (UMLS CUI [7,2])
C0015787 (UMLS CUI [8])
C0021900 (UMLS CUI [9])
C4293370 (UMLS CUI [10,1])
C0700589 (UMLS CUI [10,2])
C0004764 (UMLS CUI [11])
C0221829 (UMLS CUI [12])
C3843415 (UMLS CUI [13])
Gender Sexually active Contraceptive methods Unwilling | Male sterilization Absent | Partner Contraceptive methods Unwilling | Contraception, Barrier | Condoms, Male | Spermicidal foam/jelly/cream/film/suppository
Item
male subjects who are sexually active and not surgically sterilised, who or whose partner are unwilling to use two different forms of highly effective contraception, one of which has to be a barrier method a barrier method of contraception (e.g. condom with spermicidal foam/gel/film/cream) for the duration of the trial and for at least 16 weeks (approximately 5 half-lives) following the last dose of trial medication
boolean
C0079399 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
C0558080 (UMLS CUI [1,4])
C0024559 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0682323 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0558080 (UMLS CUI [3,3])
C0004764 (UMLS CUI [4])
C0009653 (UMLS CUI [5])
C3843415 (UMLS CUI [6])
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