ID

15958

Descrição

Efficacy and Safety of Sarilumab and Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (SARIL-RA-MONARCH); ODM derived from: https://clinicaltrials.gov/show/NCT02332590

Link

https://clinicaltrials.gov/show/NCT02332590

Palavras-chave

Versões (1)
  1. 21/06/2016 21/06/2016 -
Transferido a

21 de junho de 2016

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT02332590

Inglês

Eligibility Rheumatoid Arthritis NCT02332590

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of rheumatoid arthritis ≥3 months duration. american college of rheumatology (acr) class i-iii functional status.
Descrição

Rheumatoid Arthritis | disease length

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0003873
UMLS CUI [2]
C0872146
active ra defined as:
Descrição

Rheumatoid Arthritis Active

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0205177
at least 6 of 66 swollen joints and 8 of 68 tender joints,
Descrição

Joint swelling | Joint tenderness

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0152031
UMLS CUI [2]
C0240094
high sensitivity c-reactive protein (hs-crp) ≥8 mg/l or esr ≥28 mm/h, and
Descrição

C-reactive protein; high sensitivity (hsCRP) | Erythrocyte sedimentation rate measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0973334
UMLS CUI [2]
C1176468
das28esr >5.1. patients who per investigator judgment were either intolerant of, or considered inappropriate candidates for continued treatment with methotrexate (mtx), or after at least 12 weeks of continuous treatment with mtx, or inadequate responders treated with an adequate mtx dose for at least 12 weeks.
Descrição

Disease activity score 28 joint in rheumatoid arthritis Erythrocyte sedimentation rate measurement | Medical contraindication Therapeutic procedure Methotrexate | Methotrexate Disease Response Inadequate

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2732493
UMLS CUI [1,2]
C1176468
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0087111
UMLS CUI [2,3]
C0025677
UMLS CUI [3,1]
C0025677
UMLS CUI [3,2]
C1704632
UMLS CUI [3,3]
C0205412
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
age <18 years or the legal age of consent in the country of the study site, whichever is higher.
Descrição

Age | age subdivision of legal significance | Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0682055
UMLS CUI [3]
C0021430
current treatment with disease-modifying antirheumatic drug (dmards)/immunosuppressive agents including mtx, cyclosporine, mycophenolate, tacrolimus, gold, penicillamine, sulfasalazine or hydroxychloroquine within 2 weeks prior to the baseline (randomization visit) or azathioprine, cyclophosphamide within 12 weeks prior to baseline (randomization visit) or leflunomide within 8 weeks prior to the randomization visit, or 4 weeks after cholestyramine washout.
Descrição

Therapeutic procedure Antirheumatic Drugs, Disease-Modifying | Therapeutic procedure Immunosuppressive Agents | Methotrexate | Cyclosporine | MYCOPHENOLATE | Tacrolimus | Gold | Penicillamine | Sulfasalazine | Hydroxychloroquine | Azathioprine | Cyclophosphamide | leflunomide | Cholestyramine Washout

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0242708
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0021081
UMLS CUI [3]
C0025677
UMLS CUI [4]
C0010592
UMLS CUI [5]
C0883242
UMLS CUI [6]
C0085149
UMLS CUI [7]
C0018026
UMLS CUI [8]
C0030817
UMLS CUI [9]
C0036078
UMLS CUI [10]
C0020336
UMLS CUI [11]
C0004482
UMLS CUI [12]
C0010583
UMLS CUI [13]
C0063041
UMLS CUI [14,1]
C0008402
UMLS CUI [14,2]
C1710661
treatment with any prior biologic agent, including anti-interleukin 6 (il-6), il-6 receptor (il-6r) antagonists, and prior treatment with a janus kinase inhibitor.
Descrição

Biological Agents Previous | Interleukin-6 Antagonist | Interleukin-6 Receptor Antagonist | Prior Therapy Janus kinase inhibitor

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0005515
UMLS CUI [1,2]
C0205156
UMLS CUI [2]
C3864917
UMLS CUI [3]
C3819026
UMLS CUI [4,1]
C1514463
UMLS CUI [4,2]
C3854325
use of parenteral corticosteroids or intra-articular corticosteroids within 4 weeks prior to screening.
Descrição

Parenteral steroid treatment | intraarticular injection of corticosteroids

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3840673
UMLS CUI [2]
C2064783
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Descrição

Study Subject Participation Status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Rheumatoid Arthritis NCT02332590

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Rheumatoid Arthritis | disease length
Item
diagnosis of rheumatoid arthritis ≥3 months duration. american college of rheumatology (acr) class i-iii functional status.
boolean
C0003873 (UMLS CUI [1])
C0872146 (UMLS CUI [2])
Rheumatoid Arthritis Active
Item
active ra defined as:
boolean
C0003873 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
Joint swelling | Joint tenderness
Item
at least 6 of 66 swollen joints and 8 of 68 tender joints,
boolean
C0152031 (UMLS CUI [1])
C0240094 (UMLS CUI [2])
C-reactive protein; high sensitivity (hsCRP) | Erythrocyte sedimentation rate measurement
Item
high sensitivity c-reactive protein (hs-crp) ≥8 mg/l or esr ≥28 mm/h, and
boolean
C0973334 (UMLS CUI [1])
C1176468 (UMLS CUI [2])
Disease activity score 28 joint in rheumatoid arthritis Erythrocyte sedimentation rate measurement | Medical contraindication Therapeutic procedure Methotrexate | Methotrexate Disease Response Inadequate
Item
das28esr >5.1. patients who per investigator judgment were either intolerant of, or considered inappropriate candidates for continued treatment with methotrexate (mtx), or after at least 12 weeks of continuous treatment with mtx, or inadequate responders treated with an adequate mtx dose for at least 12 weeks.
boolean
C2732493 (UMLS CUI [1,1])
C1176468 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0025677 (UMLS CUI [2,3])
C0025677 (UMLS CUI [3,1])
C1704632 (UMLS CUI [3,2])
C0205412 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
Age | age subdivision of legal significance | Informed Consent
Item
age <18 years or the legal age of consent in the country of the study site, whichever is higher.
boolean
C0001779 (UMLS CUI [1])
C0682055 (UMLS CUI [2])
C0021430 (UMLS CUI [3])
Therapeutic procedure Antirheumatic Drugs, Disease-Modifying | Therapeutic procedure Immunosuppressive Agents | Methotrexate | Cyclosporine | MYCOPHENOLATE | Tacrolimus | Gold | Penicillamine | Sulfasalazine | Hydroxychloroquine | Azathioprine | Cyclophosphamide | leflunomide | Cholestyramine Washout
Item
current treatment with disease-modifying antirheumatic drug (dmards)/immunosuppressive agents including mtx, cyclosporine, mycophenolate, tacrolimus, gold, penicillamine, sulfasalazine or hydroxychloroquine within 2 weeks prior to the baseline (randomization visit) or azathioprine, cyclophosphamide within 12 weeks prior to baseline (randomization visit) or leflunomide within 8 weeks prior to the randomization visit, or 4 weeks after cholestyramine washout.
boolean
C0087111 (UMLS CUI [1,1])
C0242708 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0021081 (UMLS CUI [2,2])
C0025677 (UMLS CUI [3])
C0010592 (UMLS CUI [4])
C0883242 (UMLS CUI [5])
C0085149 (UMLS CUI [6])
C0018026 (UMLS CUI [7])
C0030817 (UMLS CUI [8])
C0036078 (UMLS CUI [9])
C0020336 (UMLS CUI [10])
C0004482 (UMLS CUI [11])
C0010583 (UMLS CUI [12])
C0063041 (UMLS CUI [13])
C0008402 (UMLS CUI [14,1])
C1710661 (UMLS CUI [14,2])
Biological Agents Previous | Interleukin-6 Antagonist | Interleukin-6 Receptor Antagonist | Prior Therapy Janus kinase inhibitor
Item
treatment with any prior biologic agent, including anti-interleukin 6 (il-6), il-6 receptor (il-6r) antagonists, and prior treatment with a janus kinase inhibitor.
boolean
C0005515 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C3864917 (UMLS CUI [2])
C3819026 (UMLS CUI [3])
C1514463 (UMLS CUI [4,1])
C3854325 (UMLS CUI [4,2])
Parenteral steroid treatment | intraarticular injection of corticosteroids
Item
use of parenteral corticosteroids or intra-articular corticosteroids within 4 weeks prior to screening.
boolean
C3840673 (UMLS CUI [1])
C2064783 (UMLS CUI [2])
Study Subject Participation Status
Item
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
boolean
C2348568 (UMLS CUI [1])
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