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ID
12560
Beschrijving
A Randomized, Double-blind, Placebo-controlled Clinical Study of the Oral IL-12/23 Inhibitor, STA-5326 Mesylate, Administered to Patients With Rheumatoid Arthritis to Determine Safety, Tolerability, Pharmacokinetic and Synovial Tissue Outcomes; ODM derived from: https://clinicaltrials.gov/show/NCT00642629
Link
https://clinicaltrials.gov/show/NCT00642629
Trefwoorden
Versies (1)
- 30-11-15 30-11-15 -
Geüploaded op
30 november 2015
DOI
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Licentie
Creative Commons BY 4.0
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Eligibility Active, Moderate to Severe Rheumatoid Arthritis NCT00642629
Eligibility Active, Moderate to Severe Rheumatoid Arthritis NCT00642629
- StudyEvent: Eligibility
Similar models
Eligibility Active, Moderate to Severe Rheumatoid Arthritis NCT00642629
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Patient sex and age
Item
male or female 18 years of age or older.
boolean
C0150831 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0001779 (UMLS CUI [2])
Diagnosis of Rheumatoid arthritis for at least 6 months
Item
has diagnosis of ra in conformance with the american college of rheumatology (acr) criteria for at least 6 months.
boolean
C0003873 (UMLS CUI [1])
active synovitis and is amenable to arthroscopic procedures
Item
has at least one knee, wrist, or ankle that has active synovitis and is amenable to arthroscopic procedures for the acquisition of synovial tissue via biopsy.
boolean
C0039103 (UMLS CUI [1])
C0750934 (UMLS CUI [2])
C0750934 (UMLS CUI [2])
must be taking methotrexate with a stable dose regimen
Item
must be taking methotrexate for a minimum of 4 months prior to day 1, with a stable dose regimen for at least 2 months, and
boolean
C0746573 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,2])
have plans to remain on the stable dose regimen of methotrexate for the duration of this study.
Item
have plans to remain on the stable dose regimen of methotrexate for the duration of this study.
boolean
C1321605 (UMLS CUI [1])
if female of childbearing potential, must be neither pregnant nor breast feeding
Item
if female of childbearing potential, must be neither pregnant nor breast feeding, and
boolean
C0549206 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
C0006147 (UMLS CUI [1,2])
negative pregnancy test must be willing to use
Item
must have a negative pregnancy test (serum β-hcg) within 1 week of day 1. must be willing to use "double-barrier" contraception methods for the duration of the study.
boolean
C0427780 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
C0700589 (UMLS CUI [2])
is taking any disease-modifying anti-rheumatic drug (dmard) other than mtx
Item
is taking any disease-modifying anti-rheumatic drug (dmard) other than mtx concomitantly or within 1 month prior to day 1.
boolean
C2347852 (UMLS CUI [1,1])
C0242708 (UMLS CUI [1,2])
C0242708 (UMLS CUI [1,2])
positive (≥10 mm) tuberculin (ppd) skin test
Item
a positive (≥10 mm) tuberculin (ppd) skin test, unless the patient has had prior bcg immunization or has received prior suppressive treatment such as 1 year of inh.
boolean
C3161220 (UMLS CUI [1])
has received any investigational drug or experimental procedure for the treatment of ra
Item
has received any investigational drug or experimental procedure for the treatment of ra within 3 months of day 1 for a biologic compound or within 1 month of day 1 for a non-biologic compound.
boolean
C2348568 (UMLS CUI [1])
has any clinically significant disease that would make the patient an unsuitable candidate for this trial.
Item
has any clinically significant disease that, in the opinion of the investigator, would make the patient an unsuitable candidate for this trial.
boolean
C0525058 (UMLS CUI [1])
C0439801 (UMLS CUI [2])
C0009488 (UMLS CUI [3])
C0439801 (UMLS CUI [2])
C0009488 (UMLS CUI [3])