ID

22933

Beskrivning

Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI) to Measure Response to Etanercept in Rheumatoid Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT00361634

Länk

https://clinicaltrials.gov/show/NCT00361634

Nyckelord

Versioner (1)
  1. 2017-06-17 2017-06-17 -
Uppladdad den

17 juni 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00361634

Engelsk

Eligibility Rheumatoid Arthritis NCT00361634

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
fulfillment of the 1987 american college of rheumatology (acr) criteria for ra with a disease duration > 6 months
Beskrivning

Rheumatoid Arthritis disease length

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0872146
presence of active disease (defined as both tender and swollen joints) in at least one wrist
Beskrivning

Rheumatoid arthritis of wrist Quantity | Joint tenderness | Joint swelling

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0409643
UMLS CUI [1,2]
C1265611
UMLS CUI [2]
C0240094
UMLS CUI [3]
C0152031
sub-optimal response to methotrexate (mtx) defined by the presence of the following criteria (based on 68/66 joint count): 8 or more swollen joints and 8 or more tender joints (with involvement of the wrist, fingers and at least one region outside the hands) at screening
Beskrivning

Methotrexate | Response Suboptimal | active joint count | Swollen joint count | Tender joint count | Involvement with Wrist | Involvement with Fingers | Involvement with Region Quantity outside Hand

Datatyp

boolean

Alias
UMLS CUI [1]
C0025677
UMLS CUI [2,1]
C1704632
UMLS CUI [2,2]
C2984009
UMLS CUI [3]
C4067216
UMLS CUI [4]
C0451521
UMLS CUI [5]
C0451530
UMLS CUI [6,1]
C1314939
UMLS CUI [6,2]
C0043262
UMLS CUI [7,1]
C1314939
UMLS CUI [7,2]
C0016129
UMLS CUI [8,1]
C1314939
UMLS CUI [8,2]
C0205147
UMLS CUI [8,3]
C1265611
UMLS CUI [8,4]
C0205101
UMLS CUI [8,5]
C0018563
must be receiving mtx at a stable dose > 15 mg/week at least 12 weeks prior to baseline
Beskrivning

Methotrexate Dose Stable U/week

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0025677
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [1,4]
C0560588
a lower dose is acceptable if otherwise not tolerated (toxicity documentation required).
Beskrivning

Dose Lowering Acceptable | Toxic effect Documentation Requirement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C2003888
UMLS CUI [1,3]
C1879533
UMLS CUI [2,1]
C0600688
UMLS CUI [2,2]
C0175636
UMLS CUI [2,3]
C1514873
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who are currently receiving disease modifying anti-rheumatic drug (dmard) therapy (other than mtx, hydroxychloroquine or sulfasalazine) including tumor necrosis factor (tnf) antagonists (etanercept, infliximab, and adalimumab), abatacept, rituximab, leflunomide, cyclosporine, and gold (oral and intramuscular injection) within 8 weeks or 5.5 half-lives, whichever is longer, of screening
Beskrivning

Antirheumatic Drugs, Disease-Modifying | Methotrexate | Hydroxychloroquine | Sulfasalazine | Tumor Necrosis Factor antagonists | Etanercept | infliximab | adalimumab | abatacept | rituximab | leflunomide | Cyclosporine | Oral gold | Intramuscular gold

Datatyp

boolean

Alias
UMLS CUI [1]
C0242708
UMLS CUI [2]
C0025677
UMLS CUI [3]
C0020336
UMLS CUI [4]
C0036078
UMLS CUI [5,1]
C0041368
UMLS CUI [5,2]
C0243076
UMLS CUI [6]
C0717758
UMLS CUI [7]
C0666743
UMLS CUI [8]
C1122087
UMLS CUI [9]
C1619966
UMLS CUI [10]
C0393022
UMLS CUI [11]
C0063041
UMLS CUI [12]
C0010592
UMLS CUI [13]
C2585247
UMLS CUI [14]
C0413372
co-existing condition requiring medications that alter vascular flow (e.g., nitrates, calcium channel blockers, ergot containing drugs) [potential effects of antihypertensive and migraine medications will be discussed with the sponsor]
Beskrivning

Comorbidity | Requirement Pharmaceutical Preparations Changing Blood flow | Nitrates | Calcium Channel Blockers | Ergot preparation | Antihypertensive Agents | Pharmaceutical Preparations Migraine

Datatyp

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C0392747
UMLS CUI [2,4]
C0232338
UMLS CUI [3]
C0028125
UMLS CUI [4]
C0006684
UMLS CUI [5]
C0304712
UMLS CUI [6]
C0003364
UMLS CUI [7,1]
C0013227
UMLS CUI [7,2]
C0149931
comorbid autoimmune disorders including systemic lupus erythematosus
Beskrivning

Autoimmune Diseases Comorbidity | Lupus Erythematosus, Systemic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004364
UMLS CUI [1,2]
C0009488
UMLS CUI [2]
C0024141
unable to undergo an mri examination (e.g., presence of a pacemaker, defibrillator, or other implanted device such as anterior interbody cages, aneurysm clip or pedicle screws
Beskrivning

Magnetic Resonance Imaging Receive Unable | Artificial cardiac pacemaker | Defibrillator | Implants | Insertion of interbody fusion cage | Aneurysm clip | Pedicle Screws

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0024485
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C1299582
UMLS CUI [2]
C0030163
UMLS CUI [3]
C0180307
UMLS CUI [4]
C0021102
UMLS CUI [5]
C1135559
UMLS CUI [6]
C0179977
UMLS CUI [7]
C1961768
allergic to contrast agent
Beskrivning

Contrast media allergy

Datatyp

boolean

Alias
UMLS CUI [1]
C0570562
tattoos [in area of examination if contains metallic pigment])
Beskrivning

Tattooing of skin Metallic Area MRI

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0191391
UMLS CUI [1,2]
C2986473
UMLS CUI [1,3]
C0205146
UMLS CUI [1,4]
C0024485
or will likely require sedation for the procedure
Beskrivning

Sedation Requirement Probably

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0344106
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0750492
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Similar models

Eligibility Rheumatoid Arthritis NCT00361634

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Rheumatoid Arthritis disease length
Item
fulfillment of the 1987 american college of rheumatology (acr) criteria for ra with a disease duration > 6 months
boolean
C0003873 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Rheumatoid arthritis of wrist Quantity | Joint tenderness | Joint swelling
Item
presence of active disease (defined as both tender and swollen joints) in at least one wrist
boolean
C0409643 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0240094 (UMLS CUI [2])
C0152031 (UMLS CUI [3])
Methotrexate | Response Suboptimal | active joint count | Swollen joint count | Tender joint count | Involvement with Wrist | Involvement with Fingers | Involvement with Region Quantity outside Hand
Item
sub-optimal response to methotrexate (mtx) defined by the presence of the following criteria (based on 68/66 joint count): 8 or more swollen joints and 8 or more tender joints (with involvement of the wrist, fingers and at least one region outside the hands) at screening
boolean
C0025677 (UMLS CUI [1])
C1704632 (UMLS CUI [2,1])
C2984009 (UMLS CUI [2,2])
C4067216 (UMLS CUI [3])
C0451521 (UMLS CUI [4])
C0451530 (UMLS CUI [5])
C1314939 (UMLS CUI [6,1])
C0043262 (UMLS CUI [6,2])
C1314939 (UMLS CUI [7,1])
C0016129 (UMLS CUI [7,2])
C1314939 (UMLS CUI [8,1])
C0205147 (UMLS CUI [8,2])
C1265611 (UMLS CUI [8,3])
C0205101 (UMLS CUI [8,4])
C0018563 (UMLS CUI [8,5])
Methotrexate Dose Stable U/week
Item
must be receiving mtx at a stable dose > 15 mg/week at least 12 weeks prior to baseline
boolean
C0025677 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0560588 (UMLS CUI [1,4])
Dose Lowering Acceptable | Toxic effect Documentation Requirement
Item
a lower dose is acceptable if otherwise not tolerated (toxicity documentation required).
boolean
C0178602 (UMLS CUI [1,1])
C2003888 (UMLS CUI [1,2])
C1879533 (UMLS CUI [1,3])
C0600688 (UMLS CUI [2,1])
C0175636 (UMLS CUI [2,2])
C1514873 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Antirheumatic Drugs, Disease-Modifying | Methotrexate | Hydroxychloroquine | Sulfasalazine | Tumor Necrosis Factor antagonists | Etanercept | infliximab | adalimumab | abatacept | rituximab | leflunomide | Cyclosporine | Oral gold | Intramuscular gold
Item
patients who are currently receiving disease modifying anti-rheumatic drug (dmard) therapy (other than mtx, hydroxychloroquine or sulfasalazine) including tumor necrosis factor (tnf) antagonists (etanercept, infliximab, and adalimumab), abatacept, rituximab, leflunomide, cyclosporine, and gold (oral and intramuscular injection) within 8 weeks or 5.5 half-lives, whichever is longer, of screening
boolean
C0242708 (UMLS CUI [1])
C0025677 (UMLS CUI [2])
C0020336 (UMLS CUI [3])
C0036078 (UMLS CUI [4])
C0041368 (UMLS CUI [5,1])
C0243076 (UMLS CUI [5,2])
C0717758 (UMLS CUI [6])
C0666743 (UMLS CUI [7])
C1122087 (UMLS CUI [8])
C1619966 (UMLS CUI [9])
C0393022 (UMLS CUI [10])
C0063041 (UMLS CUI [11])
C0010592 (UMLS CUI [12])
C2585247 (UMLS CUI [13])
C0413372 (UMLS CUI [14])
Comorbidity | Requirement Pharmaceutical Preparations Changing Blood flow | Nitrates | Calcium Channel Blockers | Ergot preparation | Antihypertensive Agents | Pharmaceutical Preparations Migraine
Item
co-existing condition requiring medications that alter vascular flow (e.g., nitrates, calcium channel blockers, ergot containing drugs) [potential effects of antihypertensive and migraine medications will be discussed with the sponsor]
boolean
C0009488 (UMLS CUI [1])
C1514873 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0392747 (UMLS CUI [2,3])
C0232338 (UMLS CUI [2,4])
C0028125 (UMLS CUI [3])
C0006684 (UMLS CUI [4])
C0304712 (UMLS CUI [5])
C0003364 (UMLS CUI [6])
C0013227 (UMLS CUI [7,1])
C0149931 (UMLS CUI [7,2])
Autoimmune Diseases Comorbidity | Lupus Erythematosus, Systemic
Item
comorbid autoimmune disorders including systemic lupus erythematosus
boolean
C0004364 (UMLS CUI [1,1])
C0009488 (UMLS CUI [1,2])
C0024141 (UMLS CUI [2])
Magnetic Resonance Imaging Receive Unable | Artificial cardiac pacemaker | Defibrillator | Implants | Insertion of interbody fusion cage | Aneurysm clip | Pedicle Screws
Item
unable to undergo an mri examination (e.g., presence of a pacemaker, defibrillator, or other implanted device such as anterior interbody cages, aneurysm clip or pedicle screws
boolean
C0024485 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0030163 (UMLS CUI [2])
C0180307 (UMLS CUI [3])
C0021102 (UMLS CUI [4])
C1135559 (UMLS CUI [5])
C0179977 (UMLS CUI [6])
C1961768 (UMLS CUI [7])
Contrast media allergy
Item
allergic to contrast agent
boolean
C0570562 (UMLS CUI [1])
Tattooing of skin Metallic Area MRI
Item
tattoos [in area of examination if contains metallic pigment])
boolean
C0191391 (UMLS CUI [1,1])
C2986473 (UMLS CUI [1,2])
C0205146 (UMLS CUI [1,3])
C0024485 (UMLS CUI [1,4])
Sedation Requirement Probably
Item
or will likely require sedation for the procedure
boolean
C0344106 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0750492 (UMLS CUI [1,3])
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