ID

31989

Beskrivning

A Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of Golimumab in Patients With Rheumatoid Arthritis (RA); ODM derived from: https://clinicaltrials.gov/show/NCT01362153

Länk

https://clinicaltrials.gov/show/NCT01362153

Nyckelord

Versioner (1)
  1. 2018-10-10 2018-10-10 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

10 oktober 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT01362153

Engelsk

Eligibility Rheumatoid Arthritis NCT01362153

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
have a diagnosis of ra for at least 3 months prior to screening
Beskrivning

Rheumatoid Arthritis Disease length

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0872146
have no history of latent or active tuberculosis (tb) and test negative for tb
Beskrivning

Latent Tuberculosis Absent | Tuberculosis Absent | Tuberculosis test negative

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1609538
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0041296
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C2242735
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
have inflammatory diseases other than ra
Beskrivning

Inflammatory disorder | Exception Rheumatoid Arthritis

Datatyp

boolean

Alias
UMLS CUI [1]
C1290884
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0003873
have been treated with disease-modifying anti-rheumatic drugs (dmards)/systemic immunosuppressives other than methotrexate (mtx), sulfasalazine, or hydroxychloroquine during the 4 weeks prior to the first administration of study agent
Beskrivning

Antirheumatic Drugs, Disease-Modifying | Immunosuppressive Agents Systemic | Exception Methotrexate | Exception Sulfasalazine | Exception Hydroxychloroquine

Datatyp

boolean

Alias
UMLS CUI [1]
C0242708
UMLS CUI [2,1]
C0021081
UMLS CUI [2,2]
C0205373
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0025677
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0036078
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0020336
have received intramuscular (im), iv, or intra-articular corticosteroids within 4 weeks of study agent administration
Beskrivning

Adrenal Cortex Hormones Intramuscular | Adrenal Cortex Hormones Intravenous | Intraarticular injection of corticosteroids

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C1556154
UMLS CUI [2,1]
C0001617
UMLS CUI [2,2]
C1522726
UMLS CUI [3]
C2064783
have a known hypersensitivity to human ig proteins
Beskrivning

Human immunoglobulin allergy

Datatyp

boolean

Alias
UMLS CUI [1]
C0571543
have received infliximab, golimumab, adalimumab or abatacept within 3 months, or etanercept or anakinra within 1 month prior to the first administration of study agent
Beskrivning

infliximab | golimumab | adalimumab | abatacept | Etanercept | anakinra

Datatyp

boolean

Alias
UMLS CUI [1]
C0666743
UMLS CUI [2]
C2353893
UMLS CUI [3]
C1122087
UMLS CUI [4]
C1619966
UMLS CUI [5]
C0717758
UMLS CUI [6]
C0245109
have received alefacept, efalizumab, natalizumab, rituximab, or any b-cell-depleting agent
Beskrivning

alefacept | efalizumab | natalizumab | rituximab | B-cell depletion therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0962603
UMLS CUI [2]
C1174995
UMLS CUI [3]
C1172734
UMLS CUI [4]
C0393022
UMLS CUI [5]
C1171324
have been treated with any other biologics or investigational drugs, within 5 half-lives of that drug prior to the first administration of study agent
Beskrivning

Biological agents | Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C0005515
UMLS CUI [2]
C0013230
have a history of latent or active granulomatous infection, including tuberculosis (tb), histoplasmosis, or coccidioidomycosis, prior to screening
Beskrivning

Granulomatous infection Latent | Granulomatous infection | Tuberculosis | Histoplasmosis | Coccidioidomycosis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1610637
UMLS CUI [1,2]
C0205275
UMLS CUI [2]
C1610637
UMLS CUI [3]
C0041296
UMLS CUI [4]
C0019655
UMLS CUI [5]
C0009186
have had a bacille calmette-guerin (bcg) vaccination within 12 months of screening
Beskrivning

Bacillus Calmette-Guerin vaccination

Datatyp

boolean

Alias
UMLS CUI [1]
C4305105
have had a serious infection (eg, hepatitis, pneumonia, pyelonephritis, or sepsis)
Beskrivning

Communicable Disease Serious | Hepatitis | Pneumonia | Pyelonephritis | Sepsis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C0019158
UMLS CUI [3]
C0032285
UMLS CUI [4]
C0034186
UMLS CUI [5]
C0243026
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Similar models

Eligibility Rheumatoid Arthritis NCT01362153

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Rheumatoid Arthritis Disease length
Item
have a diagnosis of ra for at least 3 months prior to screening
boolean
C0003873 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Latent Tuberculosis Absent | Tuberculosis Absent | Tuberculosis test negative
Item
have no history of latent or active tuberculosis (tb) and test negative for tb
boolean
C1609538 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0041296 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C2242735 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Inflammatory disorder | Exception Rheumatoid Arthritis
Item
have inflammatory diseases other than ra
boolean
C1290884 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0003873 (UMLS CUI [2,2])
Antirheumatic Drugs, Disease-Modifying | Immunosuppressive Agents Systemic | Exception Methotrexate | Exception Sulfasalazine | Exception Hydroxychloroquine
Item
have been treated with disease-modifying anti-rheumatic drugs (dmards)/systemic immunosuppressives other than methotrexate (mtx), sulfasalazine, or hydroxychloroquine during the 4 weeks prior to the first administration of study agent
boolean
C0242708 (UMLS CUI [1])
C0021081 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0025677 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0036078 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0020336 (UMLS CUI [5,2])
Adrenal Cortex Hormones Intramuscular | Adrenal Cortex Hormones Intravenous | Intraarticular injection of corticosteroids
Item
have received intramuscular (im), iv, or intra-articular corticosteroids within 4 weeks of study agent administration
boolean
C0001617 (UMLS CUI [1,1])
C1556154 (UMLS CUI [1,2])
C0001617 (UMLS CUI [2,1])
C1522726 (UMLS CUI [2,2])
C2064783 (UMLS CUI [3])
Human immunoglobulin allergy
Item
have a known hypersensitivity to human ig proteins
boolean
C0571543 (UMLS CUI [1])
infliximab | golimumab | adalimumab | abatacept | Etanercept | anakinra
Item
have received infliximab, golimumab, adalimumab or abatacept within 3 months, or etanercept or anakinra within 1 month prior to the first administration of study agent
boolean
C0666743 (UMLS CUI [1])
C2353893 (UMLS CUI [2])
C1122087 (UMLS CUI [3])
C1619966 (UMLS CUI [4])
C0717758 (UMLS CUI [5])
C0245109 (UMLS CUI [6])
alefacept | efalizumab | natalizumab | rituximab | B-cell depletion therapy
Item
have received alefacept, efalizumab, natalizumab, rituximab, or any b-cell-depleting agent
boolean
C0962603 (UMLS CUI [1])
C1174995 (UMLS CUI [2])
C1172734 (UMLS CUI [3])
C0393022 (UMLS CUI [4])
C1171324 (UMLS CUI [5])
Biological agents | Investigational New Drugs
Item
have been treated with any other biologics or investigational drugs, within 5 half-lives of that drug prior to the first administration of study agent
boolean
C0005515 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Granulomatous infection Latent | Granulomatous infection | Tuberculosis | Histoplasmosis | Coccidioidomycosis
Item
have a history of latent or active granulomatous infection, including tuberculosis (tb), histoplasmosis, or coccidioidomycosis, prior to screening
boolean
C1610637 (UMLS CUI [1,1])
C0205275 (UMLS CUI [1,2])
C1610637 (UMLS CUI [2])
C0041296 (UMLS CUI [3])
C0019655 (UMLS CUI [4])
C0009186 (UMLS CUI [5])
Bacillus Calmette-Guerin vaccination
Item
have had a bacille calmette-guerin (bcg) vaccination within 12 months of screening
boolean
C4305105 (UMLS CUI [1])
Communicable Disease Serious | Hepatitis | Pneumonia | Pyelonephritis | Sepsis
Item
have had a serious infection (eg, hepatitis, pneumonia, pyelonephritis, or sepsis)
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0019158 (UMLS CUI [2])
C0032285 (UMLS CUI [3])
C0034186 (UMLS CUI [4])
C0243026 (UMLS CUI [5])
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