Informatie:
Fout:
ID
34563
Beschrijving
A Study Of PF-06410293 (Adalimumab-Pfizer) And Adalimumab (Humira) In Combination With Methotrexate In Subjects With Active Rheumatoid Arthritis (REFLECTIONS B538-02).; ODM derived from: https://clinicaltrials.gov/show/NCT02480153
Link
https://clinicaltrials.gov/show/NCT02480153
Trefwoorden
Versies (1)
- 19-01-19 19-01-19 -
Houder van rechten
see on clinicaltrials.gov
Geüploaded op
19 januari 2019
DOI
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Licentie
Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT02480153
Eligibility Rheumatoid Arthritis NCT02480153
- StudyEvent: Eligibility
Similar models
Eligibility Rheumatoid Arthritis NCT02480153
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
ID.1
Item
diagnosis of rheumatoid arthritis based on 2010 acr/eular criteria for at least 4 months.
boolean
ID.2
Item
at least 6 tender (of 68 assessed) and 6 swollen (of 66 assessed) joints at screening and baseline.
boolean
ID.3
Item
hs-crp equal or greater than 8 mg/l.
boolean
ID.4
Item
must have received methotrexate for at least 12 weeks and been on a stable dose for at least 4 weeks prior to the first study dose.
boolean
ID.5
Item
evidence of untreated or inadequately treated latent or active tb.
boolean
ID.6
Item
evidence of uncontrolled, clinically significant diseases, including moderate or severe heart failure (nyha class iii/iv) or malignancy in the previous 5 years.
boolean
ID.7
Item
history of infection requiring hospitalization or parenteral antimicrobial therapy within 6 months prior to first dose of study drug.
boolean
ID.8
Item
may have received no more than 2 doses of one biologic therapy (other than adalimumab or lymphocyte depleting therapy).
boolean
ID.9
Item
any second dmard must be washed out prior to the first study dose.
boolean