ID

40403

Descripción

First-in-man Trial of NNC0142-0002 in Patients With Rheumatoid Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT00927927

Link

https://clinicaltrials.gov/show/NCT00927927

Palabras clave

Versiones (1)
  1. 18/4/20 18/4/20 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

18 de abril de 2020

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Inflammation NCT00927927

Inglés

Eligibility Inflammation NCT00927927

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
active rheumatoid arthritis, characterized by a disease activity score (das28) above 3.2, and a diagnosis of at least three months duration
Descripción

Rheumatoid Arthritis Duration Disease activity score das28

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0449238
UMLS CUI [1,3]
C4481729
aged between 18 and 75 years (both inclusive)
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
subjects on stable doses of methotrexate for at least 4 weeks prior to dosing
Descripción

Methotrexate Dose Stable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0025677
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
use of highly effective contraception during the trial (both males and females)
Descripción

Contraceptive methods

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0700589
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
a chronic inflammatory autoimmune or joint disease other than ra (rheumatoid arthritis)
Descripción

Autoimmune Diseases inflammatory chronic | Inflammatory joint disease chronic | Exception Rheumatoid Arthritis

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0004364
UMLS CUI [1,2]
C0333348
UMLS CUI [1,3]
C0205191
UMLS CUI [2,1]
C0683381
UMLS CUI [2,2]
C0205191
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0003873
an active or latent tuberculosis
Descripción

Tuberculosis | Latent Tuberculosis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0041296
UMLS CUI [2]
C1609538
any investigational or experimental therapy within 4 weeks or 5 half-lives (whichever is longer) prior to the screening visit
Descripción

Therapies, Investigational

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0949266
a known significant cardio-vascular disease
Descripción

Cardiovascular Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0007222
vaccination against live virus or bacteria within 4 weeks prior to randomization
Descripción

Vaccination Against Virus | Vaccination Against Bacteria

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0521124
UMLS CUI [1,3]
C0042776
UMLS CUI [2,1]
C0042196
UMLS CUI [2,2]
C0521124
UMLS CUI [2,3]
C0004611
the use of concomitant medications that are prohibited in the trial (e.g., certain dmards (antirheumatic therapies that are disease modifying), biologics (here: biotechnologically produced antibodies), intra-articular corticoid-injections, etc.)
Descripción

Pharmaceutical Preparations Illicit | DMARDs Some | Biological agents Some | Corticoid Intra-Articular Injections

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0332266
UMLS CUI [2,1]
C0242708
UMLS CUI [2,2]
C0205392
UMLS CUI [3,1]
C0005515
UMLS CUI [3,2]
C0205392
UMLS CUI [4,1]
C0001617
UMLS CUI [4,2]
C0021488
a positive test result for human immunodeficiency virus (hiv) infection, hepatitis b and/or hepatitis c, or tuberculosis skin test
Descripción

Positive Test Result HIV Infection | Hepatitis B positive | Hepatitis C positive | Tuberculosis skin test Positive

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1335447
UMLS CUI [1,2]
C0019693
UMLS CUI [2]
C0856706
UMLS CUI [3]
C1112419
UMLS CUI [4,1]
C0041290
UMLS CUI [4,2]
C1514241
donation of greater than or equal to 400 ml of blood within 8 weeks prior to trial entry
Descripción

Blood Donation Amount Timespan

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0005794
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0872291
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Similar models

Eligibility Inflammation NCT00927927

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Rheumatoid Arthritis Duration Disease activity score das28
Item
active rheumatoid arthritis, characterized by a disease activity score (das28) above 3.2, and a diagnosis of at least three months duration
boolean
C0003873 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C4481729 (UMLS CUI [1,3])
Age
Item
aged between 18 and 75 years (both inclusive)
boolean
C0001779 (UMLS CUI [1])
Methotrexate Dose Stable
Item
subjects on stable doses of methotrexate for at least 4 weeks prior to dosing
boolean
C0025677 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Contraceptive methods
Item
use of highly effective contraception during the trial (both males and females)
boolean
C0700589 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Autoimmune Diseases inflammatory chronic | Inflammatory joint disease chronic | Exception Rheumatoid Arthritis
Item
a chronic inflammatory autoimmune or joint disease other than ra (rheumatoid arthritis)
boolean
C0004364 (UMLS CUI [1,1])
C0333348 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
C0683381 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0003873 (UMLS CUI [3,2])
Tuberculosis | Latent Tuberculosis
Item
an active or latent tuberculosis
boolean
C0041296 (UMLS CUI [1])
C1609538 (UMLS CUI [2])
Therapies, Investigational
Item
any investigational or experimental therapy within 4 weeks or 5 half-lives (whichever is longer) prior to the screening visit
boolean
C0949266 (UMLS CUI [1])
Cardiovascular Disease
Item
a known significant cardio-vascular disease
boolean
C0007222 (UMLS CUI [1])
Vaccination Against Virus | Vaccination Against Bacteria
Item
vaccination against live virus or bacteria within 4 weeks prior to randomization
boolean
C0042196 (UMLS CUI [1,1])
C0521124 (UMLS CUI [1,2])
C0042776 (UMLS CUI [1,3])
C0042196 (UMLS CUI [2,1])
C0521124 (UMLS CUI [2,2])
C0004611 (UMLS CUI [2,3])
Pharmaceutical Preparations Illicit | DMARDs Some | Biological agents Some | Corticoid Intra-Articular Injections
Item
the use of concomitant medications that are prohibited in the trial (e.g., certain dmards (antirheumatic therapies that are disease modifying), biologics (here: biotechnologically produced antibodies), intra-articular corticoid-injections, etc.)
boolean
C0013227 (UMLS CUI [1,1])
C0332266 (UMLS CUI [1,2])
C0242708 (UMLS CUI [2,1])
C0205392 (UMLS CUI [2,2])
C0005515 (UMLS CUI [3,1])
C0205392 (UMLS CUI [3,2])
C0001617 (UMLS CUI [4,1])
C0021488 (UMLS CUI [4,2])
Positive Test Result HIV Infection | Hepatitis B positive | Hepatitis C positive | Tuberculosis skin test Positive
Item
a positive test result for human immunodeficiency virus (hiv) infection, hepatitis b and/or hepatitis c, or tuberculosis skin test
boolean
C1335447 (UMLS CUI [1,1])
C0019693 (UMLS CUI [1,2])
C0856706 (UMLS CUI [2])
C1112419 (UMLS CUI [3])
C0041290 (UMLS CUI [4,1])
C1514241 (UMLS CUI [4,2])
Blood Donation Amount Timespan
Item
donation of greater than or equal to 400 ml of blood within 8 weeks prior to trial entry
boolean
C0005794 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0872291 (UMLS CUI [1,3])
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