ID

31915

Descripción

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

Palabras clave

Versiones (1)
  1. 8/10/18 8/10/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

8 de octubre de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT01011959

Inglés

Eligibility Rheumatoid Arthritis NCT01011959

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

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

Rheumatoid Arthritis

Tipo de datos

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
Descripción

Methotrexate | Methotrexate Dose Stable

Tipo de datos

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
persistent chronic or current active infections
Descripción

Chronic infectious disease Persistent | Communicable Disease

Tipo de datos

boolean

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

anakinra

Tipo de datos

boolean

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

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

Tipo de datos

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
Descripción

adalimumab

Tipo de datos

boolean

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

abatacept | Azathioprine | Cyclophosphamide | infliximab

Tipo de datos

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
Descripción

leflunomide | rituximab

Tipo de datos

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
Descripción

tocilizumab | Interleukin-6 Antagonists

Tipo de datos

boolean

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

Arthritis Interferes with Evaluation | Other medical condition Interferes with Evaluation

Tipo de datos

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
Descripción

Study Subject Participation Status | Investigational New Drugs

Tipo de datos

boolean

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

Eligibility Rheumatoid Arthritis NCT01011959

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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