ID

25281

Description

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

Link

https://clinicaltrials.gov/show/NCT00595413

Keywords

Versions (1)
  1. 8/30/17 8/30/17 -
Uploaded on

August 30, 2017

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Rheumatoid Arthritis NCT00595413

English

Eligibility Rheumatoid Arthritis NCT00595413

1 forms  
Inclusion Criteria
Description

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.
Description

Age | Informed Consent | Rheumatoid Arthritis disease length

Data type

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
Description

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

Data type

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
Description

Exclusion Criteria

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

inflammatory joint disease | Exception Rheumatoid Arthritis

Data type

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.
Description

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

Data type

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
Description

Antirheumatic Drugs, Disease-Modifying | Exception Methotrexate

Data type

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
Description

Study Subject Participation Status | Intervention

Data type

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.
Description

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

Data type

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).
Description

Vaccines, Attenuated | Immunoglobulin

Data type

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.
Description

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

Data type

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.
Description

Comorbidity Major | Organ dysfunction

Data type

boolean

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

serum IgG measurement

Data type

boolean

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

Hypersensitivity Atacicept | Hypersensitivity Component Atacicept Formulation

Data type

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
Back to the top of the page

Similar models

Eligibility Rheumatoid Arthritis NCT00595413

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial