ID

40405

Beskrivning

Safety and Tolerability of Anti-IL-20 in Subjects With Rheumatoid Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT01038674

Länk

https://clinicaltrials.gov/show/NCT01038674

Nyckelord

Versioner (1)
  1. 2020-04-18 2020-04-18 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

18 april 2020

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Inflammation NCT01038674

Engelsk

Eligibility Inflammation NCT01038674

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
informed consent obtained before any trial-related activities
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
a diagnosis of rheumatoid arthritis made at least 3 months prior to screening
Beskrivning

Rheumatoid Arthritis Duration

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0449238
active rheumatoid arthritis, characterised by a das28 equal or above 3.2
Beskrivning

Rheumatoid Arthritis DAS28

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C4481729
methotrexate treatment (stable dose, equal or below 25 mg/week) for at least 4 weeks prior to study start (subjects receiving stable doses of oral corticosteroids, and/or non-steroidal anti-inflammatory drugs and/or acetaminophen and/or opioids according to prescribed recommended doses can be included)
Beskrivning

Methotrexate Dose Stable | Adrenal Cortex Hormones Oral Dose Stable | Non-Steroidal Anti-Inflammatory Agents Dose Recommended | Acetaminophen Dose Recommended | Opioids Dose Recommended

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0025677
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C0001617
UMLS CUI [2,2]
C1527415
UMLS CUI [2,3]
C0178602
UMLS CUI [2,4]
C0205360
UMLS CUI [3,1]
C0003211
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0034866
UMLS CUI [4,1]
C0000970
UMLS CUI [4,2]
C0178602
UMLS CUI [4,3]
C0034866
UMLS CUI [5,1]
C0242402
UMLS CUI [5,2]
C0178602
UMLS CUI [5,3]
C0034866
male subjects and female subjects of non-child bearing potential
Beskrivning

Male infertility | Childbearing Potential Absent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021364
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0332197
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
body mass index (bmi) less than 18.5 or above 35.0 kg/m2
Beskrivning

Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
subjects with chronic inflammatory autoimmune disease other than rheumatoid arthritis
Beskrivning

Autoimmune Diseases inflammatory chronic | Exception Rheumatoid Arthritis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004364
UMLS CUI [1,2]
C0333348
UMLS CUI [1,3]
C0205191
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0003873
history of or current inflammatory joint disease other than rheumatoid arthritis
Beskrivning

Inflammatory joint disease | Exception Rheumatoid Arthritis

Datatyp

boolean

Alias
UMLS CUI [1]
C0683381
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0003873
chronic or ongoing infectious disease requiring systemic anti-infectious treatment within 2 weeks prior to study start
Beskrivning

Chronic infectious disease | Communicable Diseases | Requirement Anti-infective therapy Systemic

Datatyp

boolean

Alias
UMLS CUI [1]
C0151317
UMLS CUI [2]
C0009450
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C1141958
UMLS CUI [3,3]
C0205373
past or current malignancy (as judged by the investigator)
Beskrivning

Malignant Neoplasms

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
clinically significant cardiac or cardiovascular disease
Beskrivning

Heart Diseases | Cardiovascular Diseases

Datatyp

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0007222
positive for human immunodeficiency virus (hiv), hepatitis or tuberculosis
Beskrivning

HIV Seropositivity | Hepatitis | Tuberculosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0019158
UMLS CUI [3]
C0041296
blood donation or blood loss of more than 0.45l within 2 months prior to study start, or longer if required by local regulations
Beskrivning

Blood Donation Amount Timespan | Blood Loss Amount Timespan

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005794
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0872291
UMLS CUI [2,1]
C3163616
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0872291
breast-feeding women
Beskrivning

Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0006147
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Similar models

Eligibility Inflammation NCT01038674

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
informed consent obtained before any trial-related activities
boolean
C0021430 (UMLS CUI [1])
Rheumatoid Arthritis Duration
Item
a diagnosis of rheumatoid arthritis made at least 3 months prior to screening
boolean
C0003873 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Rheumatoid Arthritis DAS28
Item
active rheumatoid arthritis, characterised by a das28 equal or above 3.2
boolean
C0003873 (UMLS CUI [1,1])
C4481729 (UMLS CUI [1,2])
Methotrexate Dose Stable | Adrenal Cortex Hormones Oral Dose Stable | Non-Steroidal Anti-Inflammatory Agents Dose Recommended | Acetaminophen Dose Recommended | Opioids Dose Recommended
Item
methotrexate treatment (stable dose, equal or below 25 mg/week) for at least 4 weeks prior to study start (subjects receiving stable doses of oral corticosteroids, and/or non-steroidal anti-inflammatory drugs and/or acetaminophen and/or opioids according to prescribed recommended doses can be included)
boolean
C0025677 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0001617 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
C0205360 (UMLS CUI [2,4])
C0003211 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0034866 (UMLS CUI [3,3])
C0000970 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0034866 (UMLS CUI [4,3])
C0242402 (UMLS CUI [5,1])
C0178602 (UMLS CUI [5,2])
C0034866 (UMLS CUI [5,3])
Male infertility | Childbearing Potential Absent
Item
male subjects and female subjects of non-child bearing potential
boolean
C0021364 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Body mass index
Item
body mass index (bmi) less than 18.5 or above 35.0 kg/m2
boolean
C1305855 (UMLS CUI [1])
Autoimmune Diseases inflammatory chronic | Exception Rheumatoid Arthritis
Item
subjects with chronic inflammatory autoimmune disease other than rheumatoid arthritis
boolean
C0004364 (UMLS CUI [1,1])
C0333348 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0003873 (UMLS CUI [2,2])
Inflammatory joint disease | Exception Rheumatoid Arthritis
Item
history of or current inflammatory joint disease other than rheumatoid arthritis
boolean
C0683381 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0003873 (UMLS CUI [2,2])
Chronic infectious disease | Communicable Diseases | Requirement Anti-infective therapy Systemic
Item
chronic or ongoing infectious disease requiring systemic anti-infectious treatment within 2 weeks prior to study start
boolean
C0151317 (UMLS CUI [1])
C0009450 (UMLS CUI [2])
C1514873 (UMLS CUI [3,1])
C1141958 (UMLS CUI [3,2])
C0205373 (UMLS CUI [3,3])
Malignant Neoplasms
Item
past or current malignancy (as judged by the investigator)
boolean
C0006826 (UMLS CUI [1])
Heart Diseases | Cardiovascular Diseases
Item
clinically significant cardiac or cardiovascular disease
boolean
C0018799 (UMLS CUI [1])
C0007222 (UMLS CUI [2])
HIV Seropositivity | Hepatitis | Tuberculosis
Item
positive for human immunodeficiency virus (hiv), hepatitis or tuberculosis
boolean
C0019699 (UMLS CUI [1])
C0019158 (UMLS CUI [2])
C0041296 (UMLS CUI [3])
Blood Donation Amount Timespan | Blood Loss Amount Timespan
Item
blood donation or blood loss of more than 0.45l within 2 months prior to study start, or longer if required by local regulations
boolean
C0005794 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0872291 (UMLS CUI [1,3])
C3163616 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0872291 (UMLS CUI [2,3])
Breast Feeding
Item
breast-feeding women
boolean
C0006147 (UMLS CUI [1])
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