ID

40421

Description

A Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0215-0384 Administered to Subjects With Moderate to Severe Rheumatoid Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT01955603

Link

https://clinicaltrials.gov/show/NCT01955603

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 NCT01955603

English

Eligibility Inflammation NCT01955603

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female, age between 18 and 75 years (both years inclusive), for russia only: age between 18-65 years (both years inclusive)
Description

Age | Relationship Russia

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0439849
UMLS CUI [2,2]
C0035970
moderate to severe ra, confirmed by a disease activity score based on 28 joints and c-reactive protein (das28 (crp)) equal to or above 4.5 and a minimum of five tender and five swollen joints based on a 28 joint count (a joint can score as both tender and swollen)
Description

Rheumatoid Arthritis Moderate | Rheumatoid Arthritis Severe | 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]
C0205081
UMLS CUI [2,1]
C0003873
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C4481729
UMLS CUI [4]
C0201657
UMLS CUI [5]
C2711398
UMLS CUI [6]
C2711873
mtx (10-25 mg/week both inclusive) for at least 16 weeks, with an unchanged dose for at least 6 weeks prior to screening and until randomisation
Description

Methotrexate Dose unchanged U/week

Data type

boolean

Alias
UMLS CUI [1,1]
C0025677
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0442739
UMLS CUI [1,4]
C0560588
females who are not of child-bearing potential must have been post-menopausal for at least 1 year confirmed by follicle-stimulating hormone (fsh) equal to or above 26.7 u/l or be surgically sterile
Description

Gender Childbearing Potential Absent | Postmenopausal state | Follicle stimulating hormone measurement | Female Sterilization

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C3831118
UMLS CUI [1,3]
C0332197
UMLS CUI [2]
C0232970
UMLS CUI [3]
C0202022
UMLS CUI [4]
C0015787
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
past or current inflammatory joint disease other than ra (e.g. gout [crystal proven], psoriatic arthritis, juvenile idiopathic arthritis, reactive arthritis or lyme disease
Description

Inflammatory joint disease | Exception Rheumatoid Arthritis | Gout | Arthritis, Psoriatic | Juvenile arthritis | Arthritis, Reactive | Lyme Disease

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]
C3495559
UMLS CUI [6]
C0085435
UMLS CUI [7]
C0024198
any active or ongoing chronic infectious disease (e.g. chronic osteomyelitis, chronic pyelonephritis) within 4 weeks prior to randomisation
Description

Chronic infectious disease | Chronic osteomyelitis | Chronic pyelonephritis

Data type

boolean

Alias
UMLS CUI [1]
C0151317
UMLS CUI [2]
C0008707
UMLS CUI [3]
C0085697
clinically significant cardiac or cardiovascular disease
Description

Heart Disease | Cardiovascular Disease

Data type

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0007222
past or current malignancy
Description

Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0006826
evaluation of tuberculosis screening indicative of latent or active tuberculosis (tb)
Description

Indication Latent Tuberculosis | Indication Tuberculosis

Data type

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C1609538
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0041296
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Similar models

Eligibility Inflammation NCT01955603

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | Relationship Russia
Item
male or female, age between 18 and 75 years (both years inclusive), for russia only: age between 18-65 years (both years inclusive)
boolean
C0001779 (UMLS CUI [1])
C0439849 (UMLS CUI [2,1])
C0035970 (UMLS CUI [2,2])
Rheumatoid Arthritis Moderate | Rheumatoid Arthritis Severe | Disease activity score DAS28 | C-reactive protein measurement | Tender 28 joint count | Swollen 28 joint count
Item
moderate to severe ra, confirmed by a disease activity score based on 28 joints and c-reactive protein (das28 (crp)) equal to or above 4.5 and a minimum of five tender and five swollen joints based on a 28 joint count (a joint can score as both tender and swollen)
boolean
C0003873 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0003873 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C4481729 (UMLS CUI [3])
C0201657 (UMLS CUI [4])
C2711398 (UMLS CUI [5])
C2711873 (UMLS CUI [6])
Methotrexate Dose unchanged U/week
Item
mtx (10-25 mg/week both inclusive) for at least 16 weeks, with an unchanged dose for at least 6 weeks prior to screening and until randomisation
boolean
C0025677 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0442739 (UMLS CUI [1,3])
C0560588 (UMLS CUI [1,4])
Gender Childbearing Potential Absent | Postmenopausal state | Follicle stimulating hormone measurement | Female Sterilization
Item
females who are not of child-bearing potential must have been post-menopausal for at least 1 year confirmed by follicle-stimulating hormone (fsh) equal to or above 26.7 u/l or be surgically sterile
boolean
C0079399 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0232970 (UMLS CUI [2])
C0202022 (UMLS CUI [3])
C0015787 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Inflammatory joint disease | Exception Rheumatoid Arthritis | Gout | Arthritis, Psoriatic | Juvenile arthritis | Arthritis, Reactive | Lyme Disease
Item
past or current inflammatory joint disease other than ra (e.g. gout [crystal proven], psoriatic arthritis, juvenile idiopathic arthritis, reactive arthritis or lyme disease
boolean
C0683381 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0003873 (UMLS CUI [2,2])
C0018099 (UMLS CUI [3])
C0003872 (UMLS CUI [4])
C3495559 (UMLS CUI [5])
C0085435 (UMLS CUI [6])
C0024198 (UMLS CUI [7])
Chronic infectious disease | Chronic osteomyelitis | Chronic pyelonephritis
Item
any active or ongoing chronic infectious disease (e.g. chronic osteomyelitis, chronic pyelonephritis) within 4 weeks prior to randomisation
boolean
C0151317 (UMLS CUI [1])
C0008707 (UMLS CUI [2])
C0085697 (UMLS CUI [3])
Heart Disease | Cardiovascular Disease
Item
clinically significant cardiac or cardiovascular disease
boolean
C0018799 (UMLS CUI [1])
C0007222 (UMLS CUI [2])
Malignant Neoplasms
Item
past or current malignancy
boolean
C0006826 (UMLS CUI [1])
Indication Latent Tuberculosis | Indication Tuberculosis
Item
evaluation of tuberculosis screening indicative of latent or active tuberculosis (tb)
boolean
C3146298 (UMLS CUI [1,1])
C1609538 (UMLS CUI [1,2])
C3146298 (UMLS CUI [2,1])
C0041296 (UMLS CUI [2,2])
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