ID

22713

Beschreibung

Safety and Efficacy Study of Adalimumab in Adult Chinese Rheumatoid Arthritis Subjects Treated With Methotrexate; ODM derived from: https://clinicaltrials.gov/show/NCT00538902

Link

https://clinicaltrials.gov/show/NCT00538902

Stichworte

Versionen (1)
  1. 10.06.17 10.06.17 -
Hochgeladen am

10. Juni 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00538902

Englisch

Eligibility Rheumatoid Arthritis NCT00538902

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
met acr criteria for diagnosis of active rheumatoid arthritis (ra) and have had at both the screening visit and week 0 visit at least four swollen joints (out of 66 assessed) and at least six tender joints(out of 68 assessed)
Beschreibung

rheumatoid arthritis, swollen joints, tender joints

Datentyp

boolean

Alias
UMLS CUI [1]
C0003873
UMLS CUI [2]
C0451521
UMLS CUI [3]
C0451530
subjects must have failed prior treatment with one or more disease-modifying antirheumatic drugs (dmards)
Beschreibung

failed prior treatment with one or more disease-modifying antirheumatic drugs

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0162643
UMLS CUI [1,2]
C0242708
dmards (other than methotrexate [mtx]) must have been discontinued for >= 28 days or at least 5 half-lives, whichever is greater, before the week 0 visit
Beschreibung

dmard discontinuation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0242708
UMLS CUI [1,2]
C4288399
traditional chinese medicines must have been discontinued for >= 28 days before the week 0 visit
Beschreibung

traditional chinese medicine

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0025124
UMLS CUI [1,2]
C0457454
subjects must have received at least three months of treatment with mtx (minimum 7.5 mg/week) and remained on a stable dose of mtx for >= 28 days prior to the screening visit
Beschreibung

methotrexat duration, stable dose

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0025677
UMLS CUI [1,2]
C0449238
UMLS CUI [2,1]
C0025677
UMLS CUI [2,2]
C0205360
UMLS CUI [2,3]
C0178602
glucocorticoids equivalent to <= 10 mg of prednisone and prednisone equivalent must have remained unchanged for at least 28 days prior to the week 0 visit
Beschreibung

steroid therapy, stable status

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0149783
UMLS CUI [1,2]
C0205360
must have been able and willing to give written informed consent and to comply with the requirements of this study protocol
Beschreibung

informed consent, protocol compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0525058
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
a history of, or current, acute inflammatory joint disease of different origin (e.g., mixed connective tissue disease, seronegative spondyloarthropathy, psoriatic arthritis, reiter's syndrome, systemic lupus erythematosus, fibromyalgia or any arthritide with onset prior to age 16 years
Beschreibung

inflammatory joint disease, mixed connective tissue disease, seronegative spondyloarthropathy, psoriatic arthritis, reiter's syndrome, systemic lupus erythematosus, fibromyalgia or any arthritide with onset prior to age 16 years

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0683381
UMLS CUI [1,2]
C0026272
UMLS CUI [1,3]
C0949691
UMLS CUI [1,4]
C0003872
UMLS CUI [1,5]
C0035012
UMLS CUI [1,6]
C0024141
UMLS CUI [1,7]
C0016053
UMLS CUI [1,8]
C1444845
wheelchair-bound or bedridden
Beschreibung

wheelchair bound or bedridden

Datentyp

boolean

Alias
UMLS CUI [1]
C0558195
UMLS CUI [2]
C0741453
joint surgery involving joints to be assessed within this study, within two months prior to the screening visit
Beschreibung

joint surgery

Datentyp

boolean

Alias
UMLS CUI [1]
C0185132
intra-articular, intramuscular or intravenous administration of corticosteroids within 28 days prior to the screening visit
Beschreibung

intra-articular, intramuscular or intravenous administration of corticosteroids

Datentyp

boolean

Alias
UMLS CUI [1]
C2064783
UMLS CUI [2]
C0585373
UMLS CUI [3]
C0563322
prior treatment with any tnf antagonist, including adalimumab
Beschreibung

prior therapy with any tnf antagonist

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C3653350
subject considered by the investigator, for any reason, to be an unsuitable candidate
Beschreibung

unsuitable for other reasons

Datentyp

boolean

Alias
UMLS CUI [1]
C3844399
female subject who is pregnant or breast-feeding or considering becoming pregnant
Beschreibung

pregnancy, breast feeding, childbearing potential

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C3831118
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Ähnliche Modelle

Eligibility Rheumatoid Arthritis NCT00538902

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
rheumatoid arthritis, swollen joints, tender joints
Item
met acr criteria for diagnosis of active rheumatoid arthritis (ra) and have had at both the screening visit and week 0 visit at least four swollen joints (out of 66 assessed) and at least six tender joints(out of 68 assessed)
boolean
C0003873 (UMLS CUI [1])
C0451521 (UMLS CUI [2])
C0451530 (UMLS CUI [3])
failed prior treatment with one or more disease-modifying antirheumatic drugs
Item
subjects must have failed prior treatment with one or more disease-modifying antirheumatic drugs (dmards)
boolean
C0162643 (UMLS CUI [1,1])
C0242708 (UMLS CUI [1,2])
dmard discontinuation
Item
dmards (other than methotrexate [mtx]) must have been discontinued for >= 28 days or at least 5 half-lives, whichever is greater, before the week 0 visit
boolean
C0242708 (UMLS CUI [1,1])
C4288399 (UMLS CUI [1,2])
traditional chinese medicine
Item
traditional chinese medicines must have been discontinued for >= 28 days before the week 0 visit
boolean
C0025124 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
methotrexat duration, stable dose
Item
subjects must have received at least three months of treatment with mtx (minimum 7.5 mg/week) and remained on a stable dose of mtx for >= 28 days prior to the screening visit
boolean
C0025677 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0025677 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
steroid therapy, stable status
Item
glucocorticoids equivalent to <= 10 mg of prednisone and prednisone equivalent must have remained unchanged for at least 28 days prior to the week 0 visit
boolean
C0149783 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
informed consent, protocol compliance
Item
must have been able and willing to give written informed consent and to comply with the requirements of this study protocol
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
inflammatory joint disease, mixed connective tissue disease, seronegative spondyloarthropathy, psoriatic arthritis, reiter's syndrome, systemic lupus erythematosus, fibromyalgia or any arthritide with onset prior to age 16 years
Item
a history of, or current, acute inflammatory joint disease of different origin (e.g., mixed connective tissue disease, seronegative spondyloarthropathy, psoriatic arthritis, reiter's syndrome, systemic lupus erythematosus, fibromyalgia or any arthritide with onset prior to age 16 years
boolean
C0683381 (UMLS CUI [1,1])
C0026272 (UMLS CUI [1,2])
C0949691 (UMLS CUI [1,3])
C0003872 (UMLS CUI [1,4])
C0035012 (UMLS CUI [1,5])
C0024141 (UMLS CUI [1,6])
C0016053 (UMLS CUI [1,7])
C1444845 (UMLS CUI [1,8])
wheelchair bound or bedridden
Item
wheelchair-bound or bedridden
boolean
C0558195 (UMLS CUI [1])
C0741453 (UMLS CUI [2])
joint surgery
Item
joint surgery involving joints to be assessed within this study, within two months prior to the screening visit
boolean
C0185132 (UMLS CUI [1])
intra-articular, intramuscular or intravenous administration of corticosteroids
Item
intra-articular, intramuscular or intravenous administration of corticosteroids within 28 days prior to the screening visit
boolean
C2064783 (UMLS CUI [1])
C0585373 (UMLS CUI [2])
C0563322 (UMLS CUI [3])
prior therapy with any tnf antagonist
Item
prior treatment with any tnf antagonist, including adalimumab
boolean
C1514463 (UMLS CUI [1,1])
C3653350 (UMLS CUI [1,2])
unsuitable for other reasons
Item
subject considered by the investigator, for any reason, to be an unsuitable candidate
boolean
C3844399 (UMLS CUI [1])
pregnancy, breast feeding, childbearing potential
Item
female subject who is pregnant or breast-feeding or considering becoming pregnant
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3])
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