Informações:
Falhas:
ID
14657
Descrição
Efficacy and Safety of Adalimumab in Patients With Active Rheumatoid Arthritis Treated Concomitantly With Methotrexate.; ODM derived from: https://clinicaltrials.gov/show/NCT00195702
Link
https://clinicaltrials.gov/show/NCT00195702
Palavras-chave
Versões (1)
- 25/04/2016 25/04/2016 -
Transferido a
25 de abril de 2016
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00195702
Eligibility Rheumatoid Arthritis NCT00195702
- StudyEvent: Eligibility
Similar models
Eligibility Rheumatoid Arthritis NCT00195702
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Age and health status
Item
age 18 or older and in good health (investigator discretion) with a recent stable medical history
boolean
C0001779 (UMLS CUI [1])
C0018759 (UMLS CUI [2])
C0018759 (UMLS CUI [2])
American college of rheumatology criteria for diagnosis of active rheumatoid arthritis
Item
met american college of rheumatology (acr) criteria for diagnosis of active rheumatoid arthritis (ra) and had at both screening and baseline visits >=6 swollen joints and >=9 tender joints, despite a minimum of 3-months treatment with methotrexate (mtx). (distal interphalangeal joints [dips] were not to be included in joint count for inclusion. the screening and baseline visits could be 3 to 28 days apart for patients not previously receiving disease-modifying anti-rheumatic drugs [dmards] other than mtx or 4 to 6 weeks for patients requiring a dmard washout period.)
boolean
C3273740 (UMLS CUI [1])
MTX therapy
Item
insufficient efficacy with mtx 12.5 to 25 mg per week (10 mg per week if mtx intolerant).
boolean
C0025677 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,2])
Second-line treatment
Item
if patient on a second-line treatment (dmard) other than mtx, he/she had to discontinue it for at least 28 days before the baseline visit (the washout period).
boolean
C1710038 (UMLS CUI [1])
Oral folic acid and leucovorin
Item
treatment with oral folic acid 1-3 mg/day or, if appropriate, up to 10 mg leucovorin per week.
boolean
C3216389 (UMLS CUI [1])
C0023413 (UMLS CUI [2])
C0023413 (UMLS CUI [2])
Rheumatoid factor, c-reactive protein and joint erosion on x-ray
Item
both rheumatoid factor positivity and a c-reactive protein value >=1 mg/dl, or at least one joint erosion on x-ray.
boolean
C0035448 (UMLS CUI [1])
C0006560 (UMLS CUI [2])
C0003885 (UMLS CUI [3])
C0006560 (UMLS CUI [2])
C0003885 (UMLS CUI [3])
Exclusion criteria
Item
subject considered by the investigator, for any reason, to be an unsuitable candidate for the study.
boolean
C0680251 (UMLS CUI [1])
Gynaecological status
Item
female subject who was pregnant or breast-feeding or considering becoming pregnant.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0006147 (UMLS CUI [2])
Adalimumab
Item
preceding treatment with any tumor necrosis factor (tnf) antagonist, including adalimumab.
boolean
C1122087 (UMLS CUI [1])
Alkylating agents
Item
prior exposure to alkylating agents, such as chlorambucil or cyclophosphamide.
boolean
C0002073 (UMLS CUI [1])
Corticosteroid therapy
Item
intra-articular, intramuscular, or intravenous administration of corticosteroids within 4 weeks prior to the screening visit.
boolean
C0149783 (UMLS CUI [1])
Wheelchair bound or bedridden
Item
subject was wheelchair bound or bedridden.
boolean
C0558195 (UMLS CUI [1])
C0741453 (UMLS CUI [2])
C0741453 (UMLS CUI [2])