ID

44749

Descrizione

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

collegamento

https://clinicaltrials.gov/show/NCT01975610

Keywords

versioni (1)
  1. 10/11/21 10/11/21 -
Titolare del copyright

Celgene

Caricato su

10 novembre 2021

DOI

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Licenza

Creative Commons BY-NC 4.0
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Eligibility Rheumatoid Arthritis NCT01975610

Inglese

Eligibility Rheumatoid Arthritis NCT01975610

1 moduli  
Inclusion Criteria
Descrizione

Inclusion Criteria

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

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

Tipo di dati

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.
Descrizione

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

Tipo di dati

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.
Descrizione

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.

Tipo di dati

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.
Descrizione

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.

Tipo di dati

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.
Descrizione

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.

Tipo di dati

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+
Descrizione

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

Tipo di dati

boolean

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

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.
Descrizione

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.

Tipo di dati

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.
Descrizione

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.

Tipo di dati

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.
Descrizione

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

Tipo di dati

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.
Descrizione

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

Tipo di dati

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 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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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