ID

31901

Description

TORPEDO Study: A Study on Rapid Effect of Tocilizumab in Patients With Rheumatoid Arthritis With an Inadequate Response to Disease-Modifying Antirheumatic Drugs (DMARDs) or Anti-TNF; ODM derived from: https://clinicaltrials.gov/show/NCT00977106

Lien

https://clinicaltrials.gov/show/NCT00977106

Mots-clés

Versions (1)
  1. 07/10/2018 07/10/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

7 octobre 2018

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00977106

Anglais

Eligibility Rheumatoid Arthritis NCT00977106

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult patients >/= 18 years of age
Description

Adult | Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
active moderate or severe rheumatoid arthritis of <10 years duration with inadequate response to methotrexate or anti-tnf
Description

Rheumatoid arthritis moderate Duration | Rheumatoid Arthritis Severe Duration | Methotrexate Response Inadequate | Anti-TNF drug Response Inadequate

Type de données

boolean

Alias
UMLS CUI [1,1]
C2368567
UMLS CUI [1,2]
C0449238
UMLS CUI [2,1]
C0003873
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C0449238
UMLS CUI [3,1]
C0025677
UMLS CUI [3,2]
C1704632
UMLS CUI [3,3]
C0205412
UMLS CUI [4,1]
C1562242
UMLS CUI [4,2]
C1704632
UMLS CUI [4,3]
C0205412
on methotrexate treatment for at least 10 weeks, at least 8 weeks on stable dose
Description

Methotrexate Dose Stable

Type de données

boolean

Alias
UMLS CUI [1,1]
C0025677
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
patients receiving oral corticosteroids and/or nsaids should be at stable dose for 4 weeks
Description

Adrenal Cortex Hormones Oral Dose Stable | NSAIDs Dose Stable

Type de données

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C1527415
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C0205360
UMLS CUI [2,1]
C0003211
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
rheumatic autoimmune disease other than ra, or significant systemic involvement secondary to ra
Description

Autoimmune Disease Rheumatic | Exception Rheumatoid Arthritis | Rheumatoid arthritis with systemic involvement

Type de données

boolean

Alias
UMLS CUI [1,1]
C0004364
UMLS CUI [1,2]
C0035435
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0003873
UMLS CUI [3]
C0494896
functional class iv by acr classification
Description

Rheumatoid Arthritis Functional Status Class

Type de données

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0598463
UMLS CUI [1,3]
C0456387
history of inflammatory joint disease other than ra
Description

Inflammatory joint disease | Exception Rheumatoid Arthritis

Type de données

boolean

Alias
UMLS CUI [1]
C0683381
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0003873
previous treatment with cell-depleting therapies, abatacept or rituximab
Description

B-cell depletion therapy | abatacept | rituximab

Type de données

boolean

Alias
UMLS CUI [1]
C1171324
UMLS CUI [2]
C1619966
UMLS CUI [3]
C0393022
active current or history of recurrent infection, or any major episode of infection requiring hospitalization or treatment with iv antibiotics <4 weeks or oral antibiotics <2 weeks prior to screening
Description

Communicable Disease | Recurrent infection | Episode Major Communicable Disease | Hospitalization Required | Requirement Antibiotics Intravenous | Requirement Antibiotics Oral

Type de données

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0239998
UMLS CUI [3,1]
C0332189
UMLS CUI [3,2]
C0205164
UMLS CUI [3,3]
C0009450
UMLS CUI [4]
C1708385
UMLS CUI [5,1]
C1514873
UMLS CUI [5,2]
C0003232
UMLS CUI [5,3]
C1522726
UMLS CUI [6,1]
C1514873
UMLS CUI [6,2]
C0003232
UMLS CUI [6,3]
C1527415
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Similar models

Eligibility Rheumatoid Arthritis NCT00977106

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age
Item
adult patients >/= 18 years of age
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Rheumatoid arthritis moderate Duration | Rheumatoid Arthritis Severe Duration | Methotrexate Response Inadequate | Anti-TNF drug Response Inadequate
Item
active moderate or severe rheumatoid arthritis of <10 years duration with inadequate response to methotrexate or anti-tnf
boolean
C2368567 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0003873 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0449238 (UMLS CUI [2,3])
C0025677 (UMLS CUI [3,1])
C1704632 (UMLS CUI [3,2])
C0205412 (UMLS CUI [3,3])
C1562242 (UMLS CUI [4,1])
C1704632 (UMLS CUI [4,2])
C0205412 (UMLS CUI [4,3])
Methotrexate Dose Stable
Item
on methotrexate treatment for at least 10 weeks, at least 8 weeks on stable dose
boolean
C0025677 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Adrenal Cortex Hormones Oral Dose Stable | NSAIDs Dose Stable
Item
patients receiving oral corticosteroids and/or nsaids should be at stable dose for 4 weeks
boolean
C0001617 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0205360 (UMLS CUI [1,4])
C0003211 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Autoimmune Disease Rheumatic | Exception Rheumatoid Arthritis | Rheumatoid arthritis with systemic involvement
Item
rheumatic autoimmune disease other than ra, or significant systemic involvement secondary to ra
boolean
C0004364 (UMLS CUI [1,1])
C0035435 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0003873 (UMLS CUI [2,2])
C0494896 (UMLS CUI [3])
Rheumatoid Arthritis Functional Status Class
Item
functional class iv by acr classification
boolean
C0003873 (UMLS CUI [1,1])
C0598463 (UMLS CUI [1,2])
C0456387 (UMLS CUI [1,3])
Inflammatory joint disease | Exception Rheumatoid Arthritis
Item
history of inflammatory joint disease other than ra
boolean
C0683381 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0003873 (UMLS CUI [2,2])
B-cell depletion therapy | abatacept | rituximab
Item
previous treatment with cell-depleting therapies, abatacept or rituximab
boolean
C1171324 (UMLS CUI [1])
C1619966 (UMLS CUI [2])
C0393022 (UMLS CUI [3])
Communicable Disease | Recurrent infection | Episode Major Communicable Disease | Hospitalization Required | Requirement Antibiotics Intravenous | Requirement Antibiotics Oral
Item
active current or history of recurrent infection, or any major episode of infection requiring hospitalization or treatment with iv antibiotics <4 weeks or oral antibiotics <2 weeks prior to screening
boolean
C0009450 (UMLS CUI [1])
C0239998 (UMLS CUI [2])
C0332189 (UMLS CUI [3,1])
C0205164 (UMLS CUI [3,2])
C0009450 (UMLS CUI [3,3])
C1708385 (UMLS CUI [4])
C1514873 (UMLS CUI [5,1])
C0003232 (UMLS CUI [5,2])
C1522726 (UMLS CUI [5,3])
C1514873 (UMLS CUI [6,1])
C0003232 (UMLS CUI [6,2])
C1527415 (UMLS CUI [6,3])
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