ID

31915

Description

A Multiple-dose Study of the Safety and Tolerability of REGN88(SAR153191) in Rheumatoid Arthritis Subjects; ODM derived from: https://clinicaltrials.gov/show/NCT01011959

Link

https://clinicaltrials.gov/show/NCT01011959

Keywords

  1. 10/8/18 10/8/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 8, 2018

DOI

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License

Creative Commons BY 4.0

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Eligibility Rheumatoid Arthritis NCT01011959

Eligibility Rheumatoid Arthritis NCT01011959

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with an established diagnosis of rheumatoid arthritis
Description

Rheumatoid Arthritis

Data type

boolean

Alias
UMLS CUI [1]
C0003873
patients currently treated with concomitant methotrexate for at least 12 weeks, with a stable dose for at least 6 weeks
Description

Methotrexate | Methotrexate Dose Stable

Data type

boolean

Alias
UMLS CUI [1]
C0025677
UMLS CUI [2,1]
C0025677
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
persistent chronic or current active infections
Description

Chronic infectious disease Persistent | Communicable Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0151317
UMLS CUI [1,2]
C0205322
UMLS CUI [2]
C0009450
patients who have taken anakinra within 2 weeks
Description

anakinra

Data type

boolean

Alias
UMLS CUI [1]
C0245109
patients who have taken etanercept, cyclosporine, mycophenolate, tacrolimus, gold, penicillamine, sulfasalazine or hydroxychloroquine within 4 weeks
Description

Etanercept | Cyclosporine | MYCOPHENOLATE | Tacrolimus | Gold | Penicillamine | Sulfasalazine | Hydroxychloroquine

Data type

boolean

Alias
UMLS CUI [1]
C0717758
UMLS CUI [2]
C0010592
UMLS CUI [3]
C0883242
UMLS CUI [4]
C0085149
UMLS CUI [5]
C0018026
UMLS CUI [6]
C0030817
UMLS CUI [7]
C0036078
UMLS CUI [8]
C0699177
patients who have taken adalimumab within 6 weeks
Description

adalimumab

Data type

boolean

Alias
UMLS CUI [1]
C1122087
patients who have taken abatacept, azathioprine, cyclophosphamide or infliximab within 12 weeks
Description

abatacept | Azathioprine | Cyclophosphamide | infliximab

Data type

boolean

Alias
UMLS CUI [1]
C1619966
UMLS CUI [2]
C0004482
UMLS CUI [3]
C0010583
UMLS CUI [4]
C0666743
patients who have taken leflunomide or rituximab within 6 months
Description

leflunomide | rituximab

Data type

boolean

Alias
UMLS CUI [1]
C0063041
UMLS CUI [2]
C0393022
patients who have had prior treatment with tocilizumab or any other anti-il-6 medication
Description

tocilizumab | Interleukin-6 Antagonists

Data type

boolean

Alias
UMLS CUI [1]
C1609165
UMLS CUI [2]
C3864925
significant arthritis or other medical condition that could interfere with study evaluations
Description

Arthritis Interferes with Evaluation | Other medical condition Interferes with Evaluation

Data type

boolean

Alias
UMLS CUI [1,1]
C0003864
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C1261322
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C1261322
participation in any clinical research study evaluating another investigational drug within 30 days
Description

Study Subject Participation Status | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230

Similar models

Eligibility Rheumatoid Arthritis NCT01011959

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Rheumatoid Arthritis
Item
patients with an established diagnosis of rheumatoid arthritis
boolean
C0003873 (UMLS CUI [1])
Methotrexate | Methotrexate Dose Stable
Item
patients currently treated with concomitant methotrexate for at least 12 weeks, with a stable dose for at least 6 weeks
boolean
C0025677 (UMLS CUI [1])
C0025677 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Chronic infectious disease Persistent | Communicable Disease
Item
persistent chronic or current active infections
boolean
C0151317 (UMLS CUI [1,1])
C0205322 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
anakinra
Item
patients who have taken anakinra within 2 weeks
boolean
C0245109 (UMLS CUI [1])
Etanercept | Cyclosporine | MYCOPHENOLATE | Tacrolimus | Gold | Penicillamine | Sulfasalazine | Hydroxychloroquine
Item
patients who have taken etanercept, cyclosporine, mycophenolate, tacrolimus, gold, penicillamine, sulfasalazine or hydroxychloroquine within 4 weeks
boolean
C0717758 (UMLS CUI [1])
C0010592 (UMLS CUI [2])
C0883242 (UMLS CUI [3])
C0085149 (UMLS CUI [4])
C0018026 (UMLS CUI [5])
C0030817 (UMLS CUI [6])
C0036078 (UMLS CUI [7])
C0699177 (UMLS CUI [8])
adalimumab
Item
patients who have taken adalimumab within 6 weeks
boolean
C1122087 (UMLS CUI [1])
abatacept | Azathioprine | Cyclophosphamide | infliximab
Item
patients who have taken abatacept, azathioprine, cyclophosphamide or infliximab within 12 weeks
boolean
C1619966 (UMLS CUI [1])
C0004482 (UMLS CUI [2])
C0010583 (UMLS CUI [3])
C0666743 (UMLS CUI [4])
leflunomide | rituximab
Item
patients who have taken leflunomide or rituximab within 6 months
boolean
C0063041 (UMLS CUI [1])
C0393022 (UMLS CUI [2])
tocilizumab | Interleukin-6 Antagonists
Item
patients who have had prior treatment with tocilizumab or any other anti-il-6 medication
boolean
C1609165 (UMLS CUI [1])
C3864925 (UMLS CUI [2])
Arthritis Interferes with Evaluation | Other medical condition Interferes with Evaluation
Item
significant arthritis or other medical condition that could interfere with study evaluations
boolean
C0003864 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C1261322 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C1261322 (UMLS CUI [2,3])
Study Subject Participation Status | Investigational New Drugs
Item
participation in any clinical research study evaluating another investigational drug within 30 days
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])

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