Informações:
Falhas:
ID
17188
Descrição
A Study of the Safety and Efficacy of Golimumab in Subjects With Rheumatoid Arthritis That Are Methotrexate-naive; ODM derived from: https://clinicaltrials.gov/show/NCT00264537
Link
https://clinicaltrials.gov/show/NCT00264537
Palavras-chave
Versões (1)
- 30/08/2016 30/08/2016 -
Transferido a
30 de agosto de 2016
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00264537
Eligibility Rheumatoid Arthritis NCT00264537
- StudyEvent: Eligibility
Similar models
Eligibility Rheumatoid Arthritis NCT00264537
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Rheumatoid arthritis
Item
have a diagnosis of rheumatoid arthritis (ra) (according to the revised 1987 criteria of the acr) for at least 3 months prior to first administration of study agent
boolean
C0003873 (UMLS CUI [1])
methotrexate naïve
Item
are methotrexate (mtx)-naïve (ie, have not received more than 3 weekly doses of mtx for ra at any time)
boolean
C0025677 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
C0919936 (UMLS CUI [1,2])
swollen joint count, tender joint count; CRP, Westergren sedimentation rate; morning stiffness; bone erosion; anti-cyclic citrullinated peptide antibody-positive or rheumatoid factor positive
Item
have active ra as defined by persistent disease activity with at least 4 swollen and 4 tender joints, at the time of screening and baseline, and at least 2 of the following 4 criteria: a) c-reactive protein (crp) >=1.5 mg/dl at screening or erythrocyte sedimentation rate (esr) by westergren method of >= 28 mm in the first hour at screening or baseline, b)morning stiffness of >= 30 minutes at screening and baseline, c)bone erosion by x-ray and/or mri prior to first administration of study agent, d)anti-cyclic citrullinated peptide (anti-ccp) antibody-positive or rheumatoid factor (rf) positive at screening
boolean
C0451521 (UMLS CUI [1])
C0451530 (UMLS CUI [2])
C0201657 (UMLS CUI [3])
C0200705 (UMLS CUI [4])
C0457086 (UMLS CUI [5])
C0587240 (UMLS CUI [6])
C2210597 (UMLS CUI [7])
C0201660 (UMLS CUI [8])
C0451530 (UMLS CUI [2])
C0201657 (UMLS CUI [3])
C0200705 (UMLS CUI [4])
C0457086 (UMLS CUI [5])
C0587240 (UMLS CUI [6])
C2210597 (UMLS CUI [7])
C0201660 (UMLS CUI [8])
if using oral corticosteroids, must be on a stable dose
Item
if using oral corticosteroids, must be on a stable dose equivalent to <= 10 mg of prednisone/day for at least 2 weeks prior to first administration of study agent.
boolean
C0038317 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,2])
other inflammatory disease
Item
can not have inflammatory diseases other than ra that might confound the evaluation of the benefit of golimumab therapy
boolean
C1290884 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
disease-modifying anti-rheumatic drugs (dmards)/systemic immunosuppressives
Item
no treatment with disease-modifying anti-rheumatic drugs (dmards)/systemic immunosuppressives during the 4 weeks prior to the first administration of study agent
boolean
C0242708 (UMLS CUI [1])
C0021081 (UMLS CUI [2])
C0021081 (UMLS CUI [2])
treatment with biologic anti-tnf drugs
Item
no prior treatment with biologic anti-tnf drugs (infliximab, etanercept, adalimumab)
boolean
C0281481 (UMLS CUI [1])
Chronic or recurrent infectious disease
Item
no history of, or ongoing, chronic or recurrent infectious disease
boolean
C0151317 (UMLS CUI [1])
C0239998 (UMLS CUI [2])
C0239998 (UMLS CUI [2])
Infection
Item
no serious infection within 2 months prior to first administration of study agent.
boolean
C0009450 (UMLS CUI [1])