ID

25281

Descrizione

Study of Atacicept in Anti-TNFα-naïve Patients With Moderate to Severely Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate; ODM derived from: https://clinicaltrials.gov/show/NCT00595413

collegamento

https://clinicaltrials.gov/show/NCT00595413

Keywords

versioni (1)
  1. 30/08/17 30/08/17 -
Caricato su

30 agosto 2017

DOI

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Licenza

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00595413

Inglese

Eligibility Rheumatoid Arthritis NCT00595413

1 moduli  
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
male and female subjects ≥ 18 years of age at the time of informed consent who have rheumatoid arthritis satisfying american college of rheumatology criteria and a disease history of at least 6 months.
Descrizione

Age | Informed Consent | Rheumatoid Arthritis disease length

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0021430
UMLS CUI [3,1]
C0003873
UMLS CUI [3,2]
C0872146
subjects must have active disease, defined by ≥ 8 swollen joints (out of 66), ≥ 8 tender joints (out of 68) and crp ≥ 10mg/l and/or esr ≥ 28 mm/hr, despite treatment with methotrexate (mtx) at a dose of ≥ 15 mg/week for > 3 months
Descrizione

Disease | Swollen joint count | Tender joint count | C-reactive protein measurement | Erythrocyte sedimentation rate measurement | Methotrexate Dose U/week

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0012634
UMLS CUI [2]
C0451521
UMLS CUI [3]
C0451530
UMLS CUI [4]
C0201657
UMLS CUI [5]
C1176468
UMLS CUI [6,1]
C0025677
UMLS CUI [6,2]
C0178602
UMLS CUI [6,3]
C0560588
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
inflammatory joint disease other than ra.
Descrizione

inflammatory joint disease | Exception Rheumatoid Arthritis

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0683381
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0003873
previous or concurrent treatment with any approved or investigational biological compound for ra,including but not restricted to any anti-tnfα agents, rituximab, abatacept, tocilizumab, interleukin-1 receptor antagonist (il-1ra) and belimumab.
Descrizione

Biological Factors Rheumatoid Arthritis | Biological Factors Investigational Rheumatoid Arthritis | Anti-tumor necrosis factor drug | rituximab | abatacept | tocilizumab | Interleukin-1 Receptor Antagonist | belimumab

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0005515
UMLS CUI [1,2]
C0003873
UMLS CUI [2,1]
C0005515
UMLS CUI [2,2]
C1517586
UMLS CUI [2,3]
C0003873
UMLS CUI [3]
C1562242
UMLS CUI [4]
C0393022
UMLS CUI [5]
C1619966
UMLS CUI [6]
C1609165
UMLS CUI [7]
C3536785
UMLS CUI [8]
C1723401
treatment with dmards other than mtx
Descrizione

Antirheumatic Drugs, Disease-Modifying | Exception Methotrexate

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0242708
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0025677
participation in any interventional clinical trial within 1 month before sd1
Descrizione

Study Subject Participation Status | Intervention

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0184661
methotrexate dose > 25 mg/week, prednisone dose >10 mg/day (or equivalent), or change in steroid or nsaid dosing regimen within 28 days before sd 1.
Descrizione

Methotrexate Dose U/week | Prednisone Dose U/day | Prednisone Equivalent | Steroids Dose Change | NSAID Dose Change

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0025677
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0560588
UMLS CUI [2,1]
C0032952
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0456683
UMLS CUI [3,1]
C0032952
UMLS CUI [3,2]
C0205163
UMLS CUI [4,1]
C0038317
UMLS CUI [4,2]
C0178602
UMLS CUI [4,3]
C0392747
UMLS CUI [5,1]
C0003211
UMLS CUI [5,2]
C0178602
UMLS CUI [5,3]
C0392747
live vaccine or ig treatment within 28 days before sd 1 or need for such treatment during the study (including follow-up).
Descrizione

Vaccines, Attenuated | Immunoglobulin

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0042211
UMLS CUI [2]
C0021027
any history or presence of active or latent tuberculosis, major infection requiring hospitalisation or intravenous anti-infectives within 28 days before sd 1.
Descrizione

Tuberculosis | Latent Tuberculosis | Communicable Disease Major Hospitalization Required | Communicable Disease Major | Anti-Infective Agents Intravenous Patient need for

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0041296
UMLS CUI [2]
C1609538
UMLS CUI [3,1]
C0009450
UMLS CUI [3,2]
C0205164
UMLS CUI [3,3]
C1708385
UMLS CUI [4,1]
C0009450
UMLS CUI [4,2]
C0205164
UMLS CUI [5,1]
C0003204
UMLS CUI [5,2]
C1522726
UMLS CUI [5,3]
C0686904
other major concurrent illness or organ dysfunction.
Descrizione

Comorbidity Major | Organ dysfunction

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205164
UMLS CUI [2]
C0349410
serum igg below 6 g/l.
Descrizione

serum IgG measurement

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2229761
known hypersensitivity to atacicept or to any of the components of the formulated atacicept.
Descrizione

Hypersensitivity Atacicept | Hypersensitivity Component Atacicept Formulation

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C2351058
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1705248
UMLS CUI [2,3]
C2351058
UMLS CUI [2,4]
C0524527
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Similar models

Eligibility Rheumatoid Arthritis NCT00595413

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
Age | Informed Consent | Rheumatoid Arthritis disease length
Item
male and female subjects ≥ 18 years of age at the time of informed consent who have rheumatoid arthritis satisfying american college of rheumatology criteria and a disease history of at least 6 months.
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
C0003873 (UMLS CUI [3,1])
C0872146 (UMLS CUI [3,2])
Disease | Swollen joint count | Tender joint count | C-reactive protein measurement | Erythrocyte sedimentation rate measurement | Methotrexate Dose U/week
Item
subjects must have active disease, defined by ≥ 8 swollen joints (out of 66), ≥ 8 tender joints (out of 68) and crp ≥ 10mg/l and/or esr ≥ 28 mm/hr, despite treatment with methotrexate (mtx) at a dose of ≥ 15 mg/week for > 3 months
boolean
C0012634 (UMLS CUI [1])
C0451521 (UMLS CUI [2])
C0451530 (UMLS CUI [3])
C0201657 (UMLS CUI [4])
C1176468 (UMLS CUI [5])
C0025677 (UMLS CUI [6,1])
C0178602 (UMLS CUI [6,2])
C0560588 (UMLS CUI [6,3])
Item Group
C0680251 (UMLS CUI)
inflammatory joint disease | Exception Rheumatoid Arthritis
Item
inflammatory joint disease other than ra.
boolean
C0683381 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0003873 (UMLS CUI [2,2])
Biological Factors Rheumatoid Arthritis | Biological Factors Investigational Rheumatoid Arthritis | Anti-tumor necrosis factor drug | rituximab | abatacept | tocilizumab | Interleukin-1 Receptor Antagonist | belimumab
Item
previous or concurrent treatment with any approved or investigational biological compound for ra,including but not restricted to any anti-tnfα agents, rituximab, abatacept, tocilizumab, interleukin-1 receptor antagonist (il-1ra) and belimumab.
boolean
C0005515 (UMLS CUI [1,1])
C0003873 (UMLS CUI [1,2])
C0005515 (UMLS CUI [2,1])
C1517586 (UMLS CUI [2,2])
C0003873 (UMLS CUI [2,3])
C1562242 (UMLS CUI [3])
C0393022 (UMLS CUI [4])
C1619966 (UMLS CUI [5])
C1609165 (UMLS CUI [6])
C3536785 (UMLS CUI [7])
C1723401 (UMLS CUI [8])
Antirheumatic Drugs, Disease-Modifying | Exception Methotrexate
Item
treatment with dmards other than mtx
boolean
C0242708 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0025677 (UMLS CUI [2,2])
Study Subject Participation Status | Intervention
Item
participation in any interventional clinical trial within 1 month before sd1
boolean
C2348568 (UMLS CUI [1])
C0184661 (UMLS CUI [2])
Methotrexate Dose U/week | Prednisone Dose U/day | Prednisone Equivalent | Steroids Dose Change | NSAID Dose Change
Item
methotrexate dose > 25 mg/week, prednisone dose >10 mg/day (or equivalent), or change in steroid or nsaid dosing regimen within 28 days before sd 1.
boolean
C0025677 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0560588 (UMLS CUI [1,3])
C0032952 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0456683 (UMLS CUI [2,3])
C0032952 (UMLS CUI [3,1])
C0205163 (UMLS CUI [3,2])
C0038317 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0392747 (UMLS CUI [4,3])
C0003211 (UMLS CUI [5,1])
C0178602 (UMLS CUI [5,2])
C0392747 (UMLS CUI [5,3])
Vaccines, Attenuated | Immunoglobulin
Item
live vaccine or ig treatment within 28 days before sd 1 or need for such treatment during the study (including follow-up).
boolean
C0042211 (UMLS CUI [1])
C0021027 (UMLS CUI [2])
Tuberculosis | Latent Tuberculosis | Communicable Disease Major Hospitalization Required | Communicable Disease Major | Anti-Infective Agents Intravenous Patient need for
Item
any history or presence of active or latent tuberculosis, major infection requiring hospitalisation or intravenous anti-infectives within 28 days before sd 1.
boolean
C0041296 (UMLS CUI [1])
C1609538 (UMLS CUI [2])
C0009450 (UMLS CUI [3,1])
C0205164 (UMLS CUI [3,2])
C1708385 (UMLS CUI [3,3])
C0009450 (UMLS CUI [4,1])
C0205164 (UMLS CUI [4,2])
C0003204 (UMLS CUI [5,1])
C1522726 (UMLS CUI [5,2])
C0686904 (UMLS CUI [5,3])
Comorbidity Major | Organ dysfunction
Item
other major concurrent illness or organ dysfunction.
boolean
C0009488 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0349410 (UMLS CUI [2])
serum IgG measurement
Item
serum igg below 6 g/l.
boolean
C2229761 (UMLS CUI [1])
Hypersensitivity Atacicept | Hypersensitivity Component Atacicept Formulation
Item
known hypersensitivity to atacicept or to any of the components of the formulated atacicept.
boolean
C0020517 (UMLS CUI [1,1])
C2351058 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1705248 (UMLS CUI [2,2])
C2351058 (UMLS CUI [2,3])
C0524527 (UMLS CUI [2,4])
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