ID

43909

Description

An Exploratory Study of Changes in Synovial Immune Responses Following BMS-188667 Therapy in Subjects With Active Rheumatoid Arthritis on Background DMARDs Who Have Failed Anti-TNF Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT00162201

Link

https://clinicaltrials.gov/show/NCT00162201

Keywords

Versions (2)
  1. 12/11/16 12/11/16 -
  2. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00162201

English

Eligibility Rheumatoid Arthritis NCT00162201

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
ra for at least 1 year
Description

Rheumatoid Arthritis disease length

Data type

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0872146
clear clinical signs of active ra in 1 knee joint
Description

Rheumatoid Arthritis Knee joint Clinical signs

Data type

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0022745
UMLS CUI [1,3]
C3540840
meet ara (1987) criteria for diagnosis of ra and acr (1991) criteria for ra functional classes i, ii, or iii
Description

Rheumatoid Arthritis Class Functional

Data type

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0456387
UMLS CUI [1,3]
C0205245
inadequate clinical response to a minimum of 3 months of therapy with anti-tnf-blocking agents
Description

Tumor necrosis factor alpha (TNF-) inhibitors Duration of therapy | Clinical Response Inadequate

Data type

boolean

Alias
UMLS CUI [1,1]
C3653350
UMLS CUI [1,2]
C0444921
UMLS CUI [2,1]
C4055223
UMLS CUI [2,2]
C0205412
taking background dmards for a minimum of 3 months and at stable doses for at least 28 days
Description

Disease-Modifying Antirheumatic Drugs Background | Duration of therapy Dose Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0242708
UMLS CUI [1,2]
C1706907
UMLS CUI [2,1]
C0444921
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
serious bacterial infection in last 3 months
Description

Bacterial Infection Serious

Data type

boolean

Alias
UMLS CUI [1,1]
C0004623
UMLS CUI [1,2]
C0205404
history of tb
Description

Tuberculosis

Data type

boolean

Alias
UMLS CUI [1]
C0041296
history of cancer within 5 years
Description

Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0006826
evidence of latent or active bacterial or viral infection
Description

Bacterial Infection Latent Evidence of | Bacterial Infection Evidence of | Virus Disease Latent Evidence of | Virus Disease Evidence of

Data type

boolean

Alias
UMLS CUI [1,1]
C0004623
UMLS CUI [1,2]
C0205275
UMLS CUI [1,3]
C0332120
UMLS CUI [2,1]
C0004623
UMLS CUI [2,2]
C0332120
UMLS CUI [3,1]
C0042769
UMLS CUI [3,2]
C0205275
UMLS CUI [3,3]
C0332120
UMLS CUI [4,1]
C0042769
UMLS CUI [4,2]
C0332120
intra-articular corticosteroids within 3 months
Description

intraarticular injection of corticosteroids

Data type

boolean

Alias
UMLS CUI [1]
C2064783
exposure to live vaccines
Description

Exposure to Attenuated Vaccines

Data type

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0042211
exposure to ctla4ig or bms-188667
Description

Exposure to abatacept | Exposure to BMS 188667

Data type

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C1619966
UMLS CUI [2,1]
C0332157
UMLS CUI [2,2]
C0378942
treatment with immunoadsorption column(s), mycophenolate mofetil, leflunomide, anakinra, cyclosporine, etanercept, adalimumab, infliximab, azathioprine, oral or parenteral gold, d-penacillamine, calcineurin inhibitors, cyclophosphamide or other alkylating agents
Description

Apheresis Immunoadsorption Columns | mycophenolate mofetil | leflunomide | anakinra | Cyclosporine | Etanercept | adalimumab | infliximab | Azathioprine | Oral form medicinal gold | Parenteral form medicinal gold | Penicillamine | Calcineurin inhibitor | Cyclophosphamide | Alkylating Agents

Data type

boolean

Alias
UMLS CUI [1]
C0179100
UMLS CUI [2]
C0209368
UMLS CUI [3]
C0063041
UMLS CUI [4]
C0245109
UMLS CUI [5]
C0010592
UMLS CUI [6]
C0717758
UMLS CUI [7]
C1122087
UMLS CUI [8]
C0666743
UMLS CUI [9]
C0004482
UMLS CUI [10]
C2585247
UMLS CUI [11]
C2585314
UMLS CUI [12]
C0030817
UMLS CUI [13]
C1562036
UMLS CUI [14]
C0010583
UMLS CUI [15]
C0002073
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Similar models

Eligibility Rheumatoid Arthritis NCT00162201

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Rheumatoid Arthritis disease length
Item
ra for at least 1 year
boolean
C0003873 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Rheumatoid Arthritis Knee joint Clinical signs
Item
clear clinical signs of active ra in 1 knee joint
boolean
C0003873 (UMLS CUI [1,1])
C0022745 (UMLS CUI [1,2])
C3540840 (UMLS CUI [1,3])
Rheumatoid Arthritis Class Functional
Item
meet ara (1987) criteria for diagnosis of ra and acr (1991) criteria for ra functional classes i, ii, or iii
boolean
C0003873 (UMLS CUI [1,1])
C0456387 (UMLS CUI [1,2])
C0205245 (UMLS CUI [1,3])
Tumor necrosis factor alpha (TNF-) inhibitors Duration of therapy | Clinical Response Inadequate
Item
inadequate clinical response to a minimum of 3 months of therapy with anti-tnf-blocking agents
boolean
C3653350 (UMLS CUI [1,1])
C0444921 (UMLS CUI [1,2])
C4055223 (UMLS CUI [2,1])
C0205412 (UMLS CUI [2,2])
Disease-Modifying Antirheumatic Drugs Background | Duration of therapy Dose Stable
Item
taking background dmards for a minimum of 3 months and at stable doses for at least 28 days
boolean
C0242708 (UMLS CUI [1,1])
C1706907 (UMLS CUI [1,2])
C0444921 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Bacterial Infection Serious
Item
serious bacterial infection in last 3 months
boolean
C0004623 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Tuberculosis
Item
history of tb
boolean
C0041296 (UMLS CUI [1])
Malignant Neoplasms
Item
history of cancer within 5 years
boolean
C0006826 (UMLS CUI [1])
Bacterial Infection Latent Evidence of | Bacterial Infection Evidence of | Virus Disease Latent Evidence of | Virus Disease Evidence of
Item
evidence of latent or active bacterial or viral infection
boolean
C0004623 (UMLS CUI [1,1])
C0205275 (UMLS CUI [1,2])
C0332120 (UMLS CUI [1,3])
C0004623 (UMLS CUI [2,1])
C0332120 (UMLS CUI [2,2])
C0042769 (UMLS CUI [3,1])
C0205275 (UMLS CUI [3,2])
C0332120 (UMLS CUI [3,3])
C0042769 (UMLS CUI [4,1])
C0332120 (UMLS CUI [4,2])
intraarticular injection of corticosteroids
Item
intra-articular corticosteroids within 3 months
boolean
C2064783 (UMLS CUI [1])
Exposure to Attenuated Vaccines
Item
exposure to live vaccines
boolean
C0332157 (UMLS CUI [1,1])
C0042211 (UMLS CUI [1,2])
Exposure to abatacept | Exposure to BMS 188667
Item
exposure to ctla4ig or bms-188667
boolean
C0332157 (UMLS CUI [1,1])
C1619966 (UMLS CUI [1,2])
C0332157 (UMLS CUI [2,1])
C0378942 (UMLS CUI [2,2])
Apheresis Immunoadsorption Columns | mycophenolate mofetil | leflunomide | anakinra | Cyclosporine | Etanercept | adalimumab | infliximab | Azathioprine | Oral form medicinal gold | Parenteral form medicinal gold | Penicillamine | Calcineurin inhibitor | Cyclophosphamide | Alkylating Agents
Item
treatment with immunoadsorption column(s), mycophenolate mofetil, leflunomide, anakinra, cyclosporine, etanercept, adalimumab, infliximab, azathioprine, oral or parenteral gold, d-penacillamine, calcineurin inhibitors, cyclophosphamide or other alkylating agents
boolean
C0179100 (UMLS CUI [1])
C0209368 (UMLS CUI [2])
C0063041 (UMLS CUI [3])
C0245109 (UMLS CUI [4])
C0010592 (UMLS CUI [5])
C0717758 (UMLS CUI [6])
C1122087 (UMLS CUI [7])
C0666743 (UMLS CUI [8])
C0004482 (UMLS CUI [9])
C2585247 (UMLS CUI [10])
C2585314 (UMLS CUI [11])
C0030817 (UMLS CUI [12])
C1562036 (UMLS CUI [13])
C0010583 (UMLS CUI [14])
C0002073 (UMLS CUI [15])
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