ID

34348

Description

First Human Dose Trial of NNC0215-0384 in Subjects With Rheumatoid Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT01611688

Link

https://clinicaltrials.gov/show/NCT01611688

Keywords

  1. 1/16/19 1/16/19 -
Copyright Holder

see on clinicaltrials.gov

Uploaded on

January 16, 2019

DOI

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License

Creative Commons BY 4.0

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Eligibility Inflammation NCT01611688

Eligibility Inflammation NCT01611688

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
active ra, characterised by a das28 (crp)(disease activity score based on 28 joints and crp) above 3.2 and a minimum of two swollen joints based on a 68/66 joint count at screening
Description

ID.1

Data type

boolean

concomitant treatment with mtx (7.5 - 25 mg/week both inclusive) for at least 16 weeks, with a stable dose for at least 6 weeks prior to dosing
Description

ID.2

Data type

boolean

Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects with chronic inflammatory autoimmune disease other than ra
Description

ID.3

Data type

boolean

history of or current inflammatory joint disease other than ra such as gout (crystal proven), psoriatic arthritis, juvenile idiopathic arthritis, current reactive arthritis or lyme disease
Description

ID.4

Data type

boolean

any active or ongoing chronic infectious disease (e.g. chronic osteomyelitis, chronic pyelonephritis) requiring systemic anti-infectious treatment within 4 weeks prior to randomisation
Description

ID.5

Data type

boolean

clinically significant cardiac or cardiovascular disease
Description

ID.6

Data type

boolean

past or current malignancy
Description

ID.7

Data type

boolean

latent or active tuberculosis (tb) as documented by: a positive quantiferon® test (test can be performed up to 2 months prior to dosing). one retest is allowed in case of inconclusive results.- a history of active tb within the last 3 years even, if treated effectively. - a history of active tb more than 3 years ago, if there is no documentation that the prior anti-tb treatment was appropriate in duration and type
Description

ID.8

Data type

boolean

Similar models

Eligibility Inflammation NCT01611688

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
active ra, characterised by a das28 (crp)(disease activity score based on 28 joints and crp) above 3.2 and a minimum of two swollen joints based on a 68/66 joint count at screening
boolean
ID.2
Item
concomitant treatment with mtx (7.5 - 25 mg/week both inclusive) for at least 16 weeks, with a stable dose for at least 6 weeks prior to dosing
boolean
Item Group
C0680251 (UMLS CUI)
ID.3
Item
subjects with chronic inflammatory autoimmune disease other than ra
boolean
ID.4
Item
history of or current inflammatory joint disease other than ra such as gout (crystal proven), psoriatic arthritis, juvenile idiopathic arthritis, current reactive arthritis or lyme disease
boolean
ID.5
Item
any active or ongoing chronic infectious disease (e.g. chronic osteomyelitis, chronic pyelonephritis) requiring systemic anti-infectious treatment within 4 weeks prior to randomisation
boolean
ID.6
Item
clinically significant cardiac or cardiovascular disease
boolean
ID.7
Item
past or current malignancy
boolean
ID.8
Item
latent or active tuberculosis (tb) as documented by: a positive quantiferon® test (test can be performed up to 2 months prior to dosing). one retest is allowed in case of inconclusive results.- a history of active tb within the last 3 years even, if treated effectively. - a history of active tb more than 3 years ago, if there is no documentation that the prior anti-tb treatment was appropriate in duration and type
boolean

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