ID

44749

Beschrijving

Efficacy and Safety Study of CC-292 Versus Placebo as Co-therapy With Methotrexate in Active Rheumatoid Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT01975610

Link

https://clinicaltrials.gov/show/NCT01975610

Trefwoorden

Versies (1)
  1. 10-11-21 10-11-21 -
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Eligibility Rheumatoid Arthritis NCT01975610

Engels

Eligibility Rheumatoid Arthritis NCT01975610

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
female ≥18 years of age at the time of signing the informed consent.
Beschrijving

female ≥18 years of age at the time of signing the informed consent.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0086287
UMLS CUI [1,2]
C0001779
UMLS CUI [1,3]
C0021430
must meet the 2010 acr/eular classification criteria for ra (appendix a), have ra for at least 6 months and must continue to have active ra at the time of randomization despite at least 3 months of treatment with stable doses of mtx (7.5 to 25 mg/week oral or parenteral) for at least 4 weeks prior to randomization.
Beschrijving

must meet the 2010 acr/eular classification criteria for ra (appendix a), have ra for at least 6 months and must continue to have active ra at the time of randomization despite at least 3 months of treatment with stable doses of mtx (7.5 to 25 mg/week oral or parenteral) for at least 4 weeks prior to randomization

Datatype

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0008902
UMLS CUI [2]
C0872146
UMLS CUI [3,1]
C0003873
UMLS CUI [3,2]
C0205177
UMLS CUI [3,3]
C2348792
UMLS CUI [3,4]
C0034656
UMLS CUI [3,5]
C0444921
UMLS CUI [3,6]
C0025677
UMLS CUI [3,7]
C0178602
UMLS CUI [3,8]
C0205360
must have been treated with mtx for at least 3 months prior to randomization, and must be on a stable dose between 7.5 and 25 mg/week (po or parenteral, not both) for at least 4 weeks prior to randomization. subjects will be required to maintain their stable dose through day 28/week 4 of the study. oral folate supplementation is required with a minimum dose of 5 mg/week (ie, folic acid) while the subject is taking mtx. leucovorin may be used instead of folic acid and may be dosed up to 10 mg/week orally.
Beschrijving

must have been treated with mtx for at least 3 months prior to randomization, and must be on a stable dose between 7.5 and 25 mg/week (po or parenteral, not both) for at least 4 weeks prior to randomization. subjects will be required to maintain their stable dose through day 28/week 4 of the study. oral folate supplementation is required with a minimum dose of 5 mg/week (ie, folic acid) while the subject is taking mtx. leucovorin may be used instead of folic acid and may be dosed up to 10 mg/week orally.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0025677
UMLS CUI [1,2]
C0444921
UMLS CUI [2,1]
C0025677
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
UMLS CUI [2,4]
C0205156
UMLS CUI [3,1]
C0025677
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0205360
UMLS CUI [3,4]
C0347984
UMLS CUI [3,5]
C2347804
UMLS CUI [4,1]
C0556110
UMLS CUI [4,2]
C1527415
UMLS CUI [4,3]
C1514873
UMLS CUI [4,4]
C0178602
UMLS CUI [4,5]
C1524031
UMLS CUI [5,1]
C0023413
UMLS CUI [5,2]
C1523987
UMLS CUI [5,3]
C0016410
UMLS CUI [5,4]
C0178602
sulfasalazine is allowed as a concomitant medication, however, subject must be on a stable dose for at least 4 weeks prior to randomization and through day 28/week 4 of the study.
Beschrijving

sulfasalazine is allowed as a concomitant medication, however, subject must be on a stable dose for at least 4 weeks prior to randomization and through day 28/week 4 of the study.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0036078
UMLS CUI [1,2]
C0683607
UMLS CUI [1,3]
C2347852
UMLS CUI [1,4]
C0178602
UMLS CUI [1,5]
C0205360
UMLS CUI [1,6]
C0205156
UMLS CUI [1,7]
C0347984
UMLS CUI [1,8]
C2347804
hydroxychloroquine or chloroquine is allowed as concomitant medications, however, subject must be on a stable dose for at least 4 weeks prior to randomization and through day 28/week 4 of the study.
Beschrijving

hydroxychloroquine or chloroquine is allowed as concomitant medications, however, subject must be on a stable dose for at least 4 weeks prior to randomization and through day 28/week 4 of the study.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020336
UMLS CUI [1,2]
C0683607
UMLS CUI [1,3]
C2347852
UMLS CUI [1,4]
C0178602
UMLS CUI [1,5]
C0205360
UMLS CUI [1,6]
C0205156
UMLS CUI [1,7]
C0347984
UMLS CUI [1,8]
C2347804
UMLS CUI [2,1]
C0008269
UMLS CUI [2,2]
C0683607
UMLS CUI [2,3]
C2347852
UMLS CUI [2,4]
C0178602
UMLS CUI [2,5]
C0205360
UMLS CUI [2,6]
C0205156
UMLS CUI [2,7]
C0347984
UMLS CUI [2,8]
C2347804
modification of diet in renal disease formula (mdrd) estimated glomerular filtration rate (mdrd egfr) ≥ 60 ml/min/1.73m2+
Beschrijving

modification of diet in renal disease formula (mdrd) estimated glomerular filtration rate (mdrd egfr) ≥ 60 ml/min/1.73m2+

Datatype

boolean

Alias
UMLS CUI [1,1]
C3839656
UMLS CUI [1,2]
C3811844
UMLS CUI [1,3]
C1522609
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
currently using treatment with dmards (other than sulfasalazine, hydroxychloroquine or chloroquine and mtx), including biologics. previous use is only allowed after adequate washout (4 weeks or 5 half-lives, whichever is longer) prior to randomization.
Beschrijving

currently using treatment with dmards (other than sulfasalazine, hydroxychloroquine or chloroquine and mtx), including biologics. previous use is only allowed after adequate washout (4 weeks or 5 half-lives, whichever is longer) prior to randomization.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0242708
UMLS CUI [1,2]
C0332257
UMLS CUI [1,3]
C0005522
UMLS CUI [1,4]
C2827774
UMLS CUI [1,5]
C0332185
UMLS CUI [1,6]
C1705847
UMLS CUI [1,7]
C0036078
UMLS CUI [2,1]
C0242708
UMLS CUI [2,2]
C0332257
UMLS CUI [2,3]
C0005522
UMLS CUI [2,4]
C2827774
UMLS CUI [2,5]
C0332185
UMLS CUI [2,6]
C1705847
UMLS CUI [2,7]
C0020336
UMLS CUI [3,1]
C0242708
UMLS CUI [3,2]
C0332257
UMLS CUI [3,3]
C0005522
UMLS CUI [3,4]
C2827774
UMLS CUI [3,5]
C0332185
UMLS CUI [3,6]
C1705847
UMLS CUI [3,7]
C0025677
previous treatment with any cell depleting therapies, including investigational agents (eg, campath, anti-cd4, anti-cd5, anti-cd3, anti-cd19 and anti-cd20) within 6 months of screening.
Beschrijving

previous treatment with any cell depleting therapies, including investigational agents (eg, campath, anti-cd4, anti-cd5, anti-cd3, anti-cd19 and anti-cd20) within 6 months of screening.

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0332185
UMLS CUI [1,3]
C0677960
UMLS CUI [1,4]
C1171324
UMLS CUI [1,5]
C0332257
UMLS CUI [1,6]
C1875319
UMLS CUI [1,7]
C0939276
UMLS CUI [1,8]
C3831519
UMLS CUI [1,9]
C3831518
UMLS CUI [1,10]
C3891558
UMLS CUI [1,11]
C0796613
UMLS CUI [1,12]
C3891557
treatment with intravenous gamma globulin, plasmapheresis or prosorba® column within 2 weeks prior to randomization.
Beschrijving

treatment with intravenous gamma globulin, plasmapheresis or prosorba® column within 2 weeks prior to randomization.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0017007
UMLS CUI [1,2]
C0348016
UMLS CUI [1,3]
C0332185
UMLS CUI [2,1]
C0032134
UMLS CUI [2,2]
C0332185
UMLS CUI [3,1]
C0032105
UMLS CUI [3,2]
C1704449
UMLS CUI [3,3]
C0699733
UMLS CUI [3,4]
C0332185
intra-articular or parenteral corticosteroids are not allowed within 2 weeks prior to randomization.
Beschrijving

intra-articular or parenteral corticosteroids are not allowed within 2 weeks prior to randomization.

Datatype

boolean

Alias
UMLS CUI [1,1]
C2064783
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C0001617
UMLS CUI [2,2]
C1272936
UMLS CUI [2,3]
C0332185
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Similar models

Eligibility Rheumatoid Arthritis NCT01975610

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
female ≥18 years of age at the time of signing the informed consent.
Item
female ≥18 years of age at the time of signing the informed consent.
boolean
C0086287 (UMLS CUI [1,1])
C0001779 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
must meet the 2010 acr/eular classification criteria for ra (appendix a), have ra for at least 6 months and must continue to have active ra at the time of randomization despite at least 3 months of treatment with stable doses of mtx (7.5 to 25 mg/week oral or parenteral) for at least 4 weeks prior to randomization
Item
must meet the 2010 acr/eular classification criteria for ra (appendix a), have ra for at least 6 months and must continue to have active ra at the time of randomization despite at least 3 months of treatment with stable doses of mtx (7.5 to 25 mg/week oral or parenteral) for at least 4 weeks prior to randomization.
boolean
C0003873 (UMLS CUI [1,1])
C0008902 (UMLS CUI [1,2])
C0872146 (UMLS CUI [2])
C0003873 (UMLS CUI [3,1])
C0205177 (UMLS CUI [3,2])
C2348792 (UMLS CUI [3,3])
C0034656 (UMLS CUI [3,4])
C0444921 (UMLS CUI [3,5])
C0025677 (UMLS CUI [3,6])
C0178602 (UMLS CUI [3,7])
C0205360 (UMLS CUI [3,8])
must have been treated with mtx for at least 3 months prior to randomization, and must be on a stable dose between 7.5 and 25 mg/week (po or parenteral, not both) for at least 4 weeks prior to randomization. subjects will be required to maintain their stable dose through day 28/week 4 of the study. oral folate supplementation is required with a minimum dose of 5 mg/week (ie, folic acid) while the subject is taking mtx. leucovorin may be used instead of folic acid and may be dosed up to 10 mg/week orally.
Item
must have been treated with mtx for at least 3 months prior to randomization, and must be on a stable dose between 7.5 and 25 mg/week (po or parenteral, not both) for at least 4 weeks prior to randomization. subjects will be required to maintain their stable dose through day 28/week 4 of the study. oral folate supplementation is required with a minimum dose of 5 mg/week (ie, folic acid) while the subject is taking mtx. leucovorin may be used instead of folic acid and may be dosed up to 10 mg/week orally.
boolean
C0025677 (UMLS CUI [1,1])
C0444921 (UMLS CUI [1,2])
C0025677 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0205156 (UMLS CUI [2,4])
C0025677 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
C0347984 (UMLS CUI [3,4])
C2347804 (UMLS CUI [3,5])
C0556110 (UMLS CUI [4,1])
C1527415 (UMLS CUI [4,2])
C1514873 (UMLS CUI [4,3])
C0178602 (UMLS CUI [4,4])
C1524031 (UMLS CUI [4,5])
C0023413 (UMLS CUI [5,1])
C1523987 (UMLS CUI [5,2])
C0016410 (UMLS CUI [5,3])
C0178602 (UMLS CUI [5,4])
sulfasalazine is allowed as a concomitant medication, however, subject must be on a stable dose for at least 4 weeks prior to randomization and through day 28/week 4 of the study.
Item
sulfasalazine is allowed as a concomitant medication, however, subject must be on a stable dose for at least 4 weeks prior to randomization and through day 28/week 4 of the study.
boolean
C0036078 (UMLS CUI [1,1])
C0683607 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,4])
C0205360 (UMLS CUI [1,5])
C0205156 (UMLS CUI [1,6])
C0347984 (UMLS CUI [1,7])
C2347804 (UMLS CUI [1,8])
hydroxychloroquine or chloroquine is allowed as concomitant medications, however, subject must be on a stable dose for at least 4 weeks prior to randomization and through day 28/week 4 of the study.
Item
hydroxychloroquine or chloroquine is allowed as concomitant medications, however, subject must be on a stable dose for at least 4 weeks prior to randomization and through day 28/week 4 of the study.
boolean
C0020336 (UMLS CUI [1,1])
C0683607 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,4])
C0205360 (UMLS CUI [1,5])
C0205156 (UMLS CUI [1,6])
C0347984 (UMLS CUI [1,7])
C2347804 (UMLS CUI [1,8])
C0008269 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
C2347852 (UMLS CUI [2,3])
C0178602 (UMLS CUI [2,4])
C0205360 (UMLS CUI [2,5])
C0205156 (UMLS CUI [2,6])
C0347984 (UMLS CUI [2,7])
C2347804 (UMLS CUI [2,8])
modification of diet in renal disease formula (mdrd) estimated glomerular filtration rate (mdrd egfr) ≥ 60 ml/min/1.73m2+
Item
modification of diet in renal disease formula (mdrd) estimated glomerular filtration rate (mdrd egfr) ≥ 60 ml/min/1.73m2+
boolean
C3839656 (UMLS CUI [1,1])
C3811844 (UMLS CUI [1,2])
C1522609 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
currently using treatment with dmards (other than sulfasalazine, hydroxychloroquine or chloroquine and mtx), including biologics. previous use is only allowed after adequate washout (4 weeks or 5 half-lives, whichever is longer) prior to randomization.
Item
currently using treatment with dmards (other than sulfasalazine, hydroxychloroquine or chloroquine and mtx), including biologics. previous use is only allowed after adequate washout (4 weeks or 5 half-lives, whichever is longer) prior to randomization.
boolean
C0242708 (UMLS CUI [1,1])
C0332257 (UMLS CUI [1,2])
C0005522 (UMLS CUI [1,3])
C2827774 (UMLS CUI [1,4])
C0332185 (UMLS CUI [1,5])
C1705847 (UMLS CUI [1,6])
C0036078 (UMLS CUI [1,7])
C0242708 (UMLS CUI [2,1])
C0332257 (UMLS CUI [2,2])
C0005522 (UMLS CUI [2,3])
C2827774 (UMLS CUI [2,4])
C0332185 (UMLS CUI [2,5])
C1705847 (UMLS CUI [2,6])
C0020336 (UMLS CUI [2,7])
C0242708 (UMLS CUI [3,1])
C0332257 (UMLS CUI [3,2])
C0005522 (UMLS CUI [3,3])
C2827774 (UMLS CUI [3,4])
C0332185 (UMLS CUI [3,5])
C1705847 (UMLS CUI [3,6])
C0025677 (UMLS CUI [3,7])
previous treatment with any cell depleting therapies, including investigational agents (eg, campath, anti-cd4, anti-cd5, anti-cd3, anti-cd19 and anti-cd20) within 6 months of screening.
Item
previous treatment with any cell depleting therapies, including investigational agents (eg, campath, anti-cd4, anti-cd5, anti-cd3, anti-cd19 and anti-cd20) within 6 months of screening.
boolean
C1514463 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0677960 (UMLS CUI [1,3])
C1171324 (UMLS CUI [1,4])
C0332257 (UMLS CUI [1,5])
C1875319 (UMLS CUI [1,6])
C0939276 (UMLS CUI [1,7])
C3831519 (UMLS CUI [1,8])
C3831518 (UMLS CUI [1,9])
C3891558 (UMLS CUI [1,10])
C0796613 (UMLS CUI [1,11])
C3891557 (UMLS CUI [1,12])
treatment with intravenous gamma globulin, plasmapheresis or prosorba® column within 2 weeks prior to randomization.
Item
treatment with intravenous gamma globulin, plasmapheresis or prosorba® column within 2 weeks prior to randomization.
boolean
C0017007 (UMLS CUI [1,1])
C0348016 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
C0032134 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
C0032105 (UMLS CUI [3,1])
C1704449 (UMLS CUI [3,2])
C0699733 (UMLS CUI [3,3])
C0332185 (UMLS CUI [3,4])
intra-articular or parenteral corticosteroids are not allowed within 2 weeks prior to randomization.
Item
intra-articular or parenteral corticosteroids are not allowed within 2 weeks prior to randomization.
boolean
C2064783 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0001617 (UMLS CUI [2,1])
C1272936 (UMLS CUI [2,2])
C0332185 (UMLS CUI [2,3])
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