ID

12757

Description

A Study of CNTO 136 (Sirukumab), Administered Subcutaneously, in Patients With Active Rheumatoid Arthritis Despite Disease-Modifying Antirheumatic Drug (DMARD) Therapy (SIRROUND-D); ODM derived from: https://clinicaltrials.gov/show/NCT01604343

Lien

https://clinicaltrials.gov/show/NCT01604343

Mots-clés

Versions (1)
  1. 21/12/2015 21/12/2015 -
Téléchargé le

21 décembre 2015

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Arthritis, Rheumatoid NCT01604343

Anglais

Eligibility Arthritis, Rheumatoid NCT01604343

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
have a diagnosis of rheumatoid arthritis (ra) for at least 3 months before screening
Description

rheumatoid arthritis

Type de données

boolean

Alias
UMLS CUI [1]
C0003873
have moderately to severely active ra with at least 6 of 68 tender joints and 6 of 66 swollen joints, at screening and at baseline
Description

rheumatoid arthritis tender joints Joint swelling

Type de données

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0240094
UMLS CUI [1,3]
C0152031
have been unresponsive to single-agent or combination disease-modifying antirheumatic drugs (dmard) therapy that includes methotrexate (mtx) or sulfasalazine (ssz) due to lack of benefit after at least 12 weeks of dmard, as assessed by the treating physician
Description

disease-modifying antirheumatic drugs; methotrexate; sulfasalazine

Type de données

boolean

Alias
UMLS CUI [1]
C0242708
UMLS CUI [2]
C0025677
UMLS CUI [3]
C0036078
if using oral corticosteroids, must be on a stable dose equivalent to less than or equal to 10 mg/day of prednisone for at least 2 weeks prior to the first administration of study agent. if currently not using corticosteroids, must not have received oral corticosteroids for at least 2 weeks prior to the first administration of study agent
Description

oral corticosteroids

Type de données

boolean

Alias
UMLS CUI [1]
C3653473
if using non nonsteroidal anti-inflammatory drug (nsaids) or other analgesics for ra, must be on a stable dose for at least 2 weeks prior to the first administration of study agent
Description

nonsteroidal anti-inflammatory drug

Type de données

boolean

Alias
UMLS CUI [1]
C0003211
if using non-biologic dmard such as mtx, ssz, hydroxychloroquine, chloroquine, or bucillamine, must be on a stable dose for at least 4 weeks prior to the first administration of study agent and should have no serious toxic side effects attributable to the dmard
Description

Antirheumatic Drugs, Disease-Modifying Non-biological

Type de données

boolean

Alias
UMLS CUI [1,1]
C0242708
UMLS CUI [1,2]
C0445097
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
has a history of intolerance to at least 2 or inadequate response to at least 1 anti-tumor necrosis factor alpha agent after 3 months of therapy
Description

hypersensitivity Anti-tumor necrosis factor alpha drug

Type de données

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1562242
has received infliximab, golimumab, adalimumab, or certolizumab pegol within 3 months of the first study agent administration
Description

TNF-Blocker infliximab

Type de données

boolean

Alias
UMLS CUI [1,1]
C2266940
UMLS CUI [1,2]
C0666743
has received etanercept or yisaipu within 6 weeks of the first study agent administration
Description

etanercept

Type de données

boolean

Alias
UMLS CUI [1]
C0717758
has a history of intolerance to tocilizumab that precluded further treatment with it, or inadequate response to 3 months of tocilizumab (anti-il-6 receptor) therapy
Description

hypersensitivity tocilizumab

Type de données

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1609165
has used b-cell-depleting therapy (eg, rituximab) within 7 months of first study agent administration or have evidence during screening of abnormally low b cell level caused by previous b-cell depletion therapy
Description

rituximab

Type de données

boolean

Alias
UMLS CUI [1]
C0393022
has used anakinra within 4 weeks of first study agent administration
Description

anakinra

Type de données

boolean

Alias
UMLS CUI [1]
C0245109
has used any other biologic therapy for the treatment of ra within 3 months of the first study agent administration
Description

biologic therapy rheumatoid arthritis

Type de données

boolean

Alias
UMLS CUI [1,1]
C0005527
UMLS CUI [1,2]
C0003873
has received intra-articular (ia), intramuscular (im), or intravenous (iv) corticosteroids for ra, including adrenocorticotrophic hormone during the 4 weeks prior to first study agent administration-
Description

corticosteroids injection intra-articular intramuscular Intravenous

Type de données

boolean

Alias
UMLS CUI [1,1]
C2095490
UMLS CUI [1,2]
C0442108
UMLS CUI [1,3]
C0442117
UMLS CUI [1,4]
C0348016
has received leflunomide within 24 months before the first study agent administration and have not undergone a drug elimination procedure, unless the m1 metabolite is measured and is undetectable. if a drug elimination procedure is performed during screening, the m1 metabolite should be measured and found to be undetectable
Description

leflunomide; screening

Type de données

boolean

Alias
UMLS CUI [1]
C0063041
UMLS CUI [2]
C0220908
has a history of cyclophosphamide or cytotoxic agent use
Description

cytotoxic agent

Type de données

boolean

Alias
UMLS CUI [1]
C0304497
has received cyclosporine a, azathioprine, tacrolimus, mycophenolate mofetil, oral or parenteral gold, or d-penicillamine within 4 weeks of the first study agent administration
Description

cyclosporine; azathioprine

Type de données

boolean

Alias
UMLS CUI [1]
C0010592
UMLS CUI [2]
C0004482
has received an investigational drug (including investigational vaccines) or used an investigational medical device within 3 months or 5 half lives, whichever is longer, before the first study agent administration
Description

investigational drug status

Type de données

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0449438
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Similar models

Eligibility Arthritis, Rheumatoid NCT01604343

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
rheumatoid arthritis
Item
have a diagnosis of rheumatoid arthritis (ra) for at least 3 months before screening
boolean
C0003873 (UMLS CUI [1])
rheumatoid arthritis tender joints Joint swelling
Item
have moderately to severely active ra with at least 6 of 68 tender joints and 6 of 66 swollen joints, at screening and at baseline
boolean
C0003873 (UMLS CUI [1,1])
C0240094 (UMLS CUI [1,2])
C0152031 (UMLS CUI [1,3])
disease-modifying antirheumatic drugs; methotrexate; sulfasalazine
Item
have been unresponsive to single-agent or combination disease-modifying antirheumatic drugs (dmard) therapy that includes methotrexate (mtx) or sulfasalazine (ssz) due to lack of benefit after at least 12 weeks of dmard, as assessed by the treating physician
boolean
C0242708 (UMLS CUI [1])
C0025677 (UMLS CUI [2])
C0036078 (UMLS CUI [3])
oral corticosteroids
Item
if using oral corticosteroids, must be on a stable dose equivalent to less than or equal to 10 mg/day of prednisone for at least 2 weeks prior to the first administration of study agent. if currently not using corticosteroids, must not have received oral corticosteroids for at least 2 weeks prior to the first administration of study agent
boolean
C3653473 (UMLS CUI [1])
nonsteroidal anti-inflammatory drug
Item
if using non nonsteroidal anti-inflammatory drug (nsaids) or other analgesics for ra, must be on a stable dose for at least 2 weeks prior to the first administration of study agent
boolean
C0003211 (UMLS CUI [1])
Antirheumatic Drugs, Disease-Modifying Non-biological
Item
if using non-biologic dmard such as mtx, ssz, hydroxychloroquine, chloroquine, or bucillamine, must be on a stable dose for at least 4 weeks prior to the first administration of study agent and should have no serious toxic side effects attributable to the dmard
boolean
C0242708 (UMLS CUI [1,1])
C0445097 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
hypersensitivity Anti-tumor necrosis factor alpha drug
Item
has a history of intolerance to at least 2 or inadequate response to at least 1 anti-tumor necrosis factor alpha agent after 3 months of therapy
boolean
C0020517 (UMLS CUI [1,1])
C1562242 (UMLS CUI [1,2])
TNF-Blocker infliximab
Item
has received infliximab, golimumab, adalimumab, or certolizumab pegol within 3 months of the first study agent administration
boolean
C2266940 (UMLS CUI [1,1])
C0666743 (UMLS CUI [1,2])
etanercept
Item
has received etanercept or yisaipu within 6 weeks of the first study agent administration
boolean
C0717758 (UMLS CUI [1])
hypersensitivity tocilizumab
Item
has a history of intolerance to tocilizumab that precluded further treatment with it, or inadequate response to 3 months of tocilizumab (anti-il-6 receptor) therapy
boolean
C0020517 (UMLS CUI [1,1])
C1609165 (UMLS CUI [1,2])
rituximab
Item
has used b-cell-depleting therapy (eg, rituximab) within 7 months of first study agent administration or have evidence during screening of abnormally low b cell level caused by previous b-cell depletion therapy
boolean
C0393022 (UMLS CUI [1])
anakinra
Item
has used anakinra within 4 weeks of first study agent administration
boolean
C0245109 (UMLS CUI [1])
biologic therapy rheumatoid arthritis
Item
has used any other biologic therapy for the treatment of ra within 3 months of the first study agent administration
boolean
C0005527 (UMLS CUI [1,1])
C0003873 (UMLS CUI [1,2])
corticosteroids injection intra-articular intramuscular Intravenous
Item
has received intra-articular (ia), intramuscular (im), or intravenous (iv) corticosteroids for ra, including adrenocorticotrophic hormone during the 4 weeks prior to first study agent administration-
boolean
C2095490 (UMLS CUI [1,1])
C0442108 (UMLS CUI [1,2])
C0442117 (UMLS CUI [1,3])
C0348016 (UMLS CUI [1,4])
leflunomide; screening
Item
has received leflunomide within 24 months before the first study agent administration and have not undergone a drug elimination procedure, unless the m1 metabolite is measured and is undetectable. if a drug elimination procedure is performed during screening, the m1 metabolite should be measured and found to be undetectable
boolean
C0063041 (UMLS CUI [1])
C0220908 (UMLS CUI [2])
cytotoxic agent
Item
has a history of cyclophosphamide or cytotoxic agent use
boolean
C0304497 (UMLS CUI [1])
cyclosporine; azathioprine
Item
has received cyclosporine a, azathioprine, tacrolimus, mycophenolate mofetil, oral or parenteral gold, or d-penicillamine within 4 weeks of the first study agent administration
boolean
C0010592 (UMLS CUI [1])
C0004482 (UMLS CUI [2])
investigational drug status
Item
has received an investigational drug (including investigational vaccines) or used an investigational medical device within 3 months or 5 half lives, whichever is longer, before the first study agent administration
boolean
C0013230 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
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