ID

31915

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT01011959

Nyckelord

  1. 2018-10-08 2018-10-08 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

8 oktober 2018

DOI

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Licens

Creative Commons BY 4.0

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Eligibility Rheumatoid Arthritis NCT01011959

Eligibility Rheumatoid Arthritis NCT01011959

Inclusion Criteria
Beskrivning

Inclusion Criteria

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

Rheumatoid Arthritis

Datatyp

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
Beskrivning

Methotrexate | Methotrexate Dose Stable

Datatyp

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
persistent chronic or current active infections
Beskrivning

Chronic infectious disease Persistent | Communicable Disease

Datatyp

boolean

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

anakinra

Datatyp

boolean

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

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

Datatyp

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
Beskrivning

adalimumab

Datatyp

boolean

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

abatacept | Azathioprine | Cyclophosphamide | infliximab

Datatyp

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
Beskrivning

leflunomide | rituximab

Datatyp

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
Beskrivning

tocilizumab | Interleukin-6 Antagonists

Datatyp

boolean

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

Arthritis Interferes with Evaluation | Other medical condition Interferes with Evaluation

Datatyp

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
Beskrivning

Study Subject Participation Status | Investigational New Drugs

Datatyp

boolean

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

Similar models

Eligibility Rheumatoid Arthritis NCT01011959

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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