ID

31861

Beschrijving

A Study for Patients With Active Rheumatoid Arthritis Despite Ongoing Methotrexate Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT00785928

Link

https://clinicaltrials.gov/show/NCT00785928

Trefwoorden

  1. 04-10-18 04-10-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

4 oktober 2018

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Rheumatoid Arthritis NCT00785928

Eligibility Rheumatoid Arthritis NCT00785928

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
have given written informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
women must not be at risk to become pregnant during study participation
Beschrijving

Gender | Risk Absent Pregnancy

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0035647
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0032961
diagnosis of rheumatoid arthritis
Beschrijving

Rheumatoid Arthritis

Datatype

boolean

Alias
UMLS CUI [1]
C0003873
current, regular use of methotrexate, at a stable dose
Beschrijving

Methotrexate Dose Stable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0025677
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
other criteria to be reviewed by study doctor
Beschrijving

Inclusion criteria Research Personnel

Datatype

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0035173
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
use of excluded medications(reviewed by study doctor)
Beschrijving

Pharmaceutical Preparations Excluded

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0332196
have not failed biologic tnfa inhibitor therapy
Beschrijving

TNF-alpha blockers Successful treatment

Datatype

boolean

Alias
UMLS CUI [1,1]
C2170827
UMLS CUI [1,2]
C0521982
have had recent or ongoing infection which, in the opinion of the study doctor put patient at an unacceptable risk for participation in the study
Beschrijving

Communicable Disease Study Subject Participation Status At risk

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1444641
evidence of tuberculosis
Beschrijving

Tuberculosis

Datatype

boolean

Alias
UMLS CUI [1]
C0041296
have systemic inflammatory condition other than ra, such as juvenile ra, crohn's disease, ulcerative colitis, psoriatic arthritis or seronegative spondyloarthropathy
Beschrijving

SYSTEMIC INFLAMMATORY PROCESS | Exception Rheumatoid Arthritis | Juvenile rheumatoid arthritis | Crohn Disease | Ulcerative Colitis | Arthritis, Psoriatic | Spondylarthropathy Seronegative

Datatype

boolean

Alias
UMLS CUI [1]
C0749224
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0003873
UMLS CUI [3]
C3714757
UMLS CUI [4]
C0010346
UMLS CUI [5]
C0009324
UMLS CUI [6]
C0003872
UMLS CUI [7,1]
C0949691
UMLS CUI [7,2]
C0521144
other criteria to be reviewed by study doctor
Beschrijving

Exclusion Criteria Research Personnel

Datatype

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0035173

Similar models

Eligibility Rheumatoid Arthritis NCT00785928

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
have given written informed consent
boolean
C0021430 (UMLS CUI [1])
Gender | Risk Absent Pregnancy
Item
women must not be at risk to become pregnant during study participation
boolean
C0079399 (UMLS CUI [1])
C0035647 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0032961 (UMLS CUI [2,3])
Rheumatoid Arthritis
Item
diagnosis of rheumatoid arthritis
boolean
C0003873 (UMLS CUI [1])
Methotrexate Dose Stable
Item
current, regular use of methotrexate, at a stable dose
boolean
C0025677 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Inclusion criteria Research Personnel
Item
other criteria to be reviewed by study doctor
boolean
C1512693 (UMLS CUI [1,1])
C0035173 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Pharmaceutical Preparations Excluded
Item
use of excluded medications(reviewed by study doctor)
boolean
C0013227 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
TNF-alpha blockers Successful treatment
Item
have not failed biologic tnfa inhibitor therapy
boolean
C2170827 (UMLS CUI [1,1])
C0521982 (UMLS CUI [1,2])
Communicable Disease Study Subject Participation Status At risk
Item
have had recent or ongoing infection which, in the opinion of the study doctor put patient at an unacceptable risk for participation in the study
boolean
C0009450 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
Tuberculosis
Item
evidence of tuberculosis
boolean
C0041296 (UMLS CUI [1])
SYSTEMIC INFLAMMATORY PROCESS | Exception Rheumatoid Arthritis | Juvenile rheumatoid arthritis | Crohn Disease | Ulcerative Colitis | Arthritis, Psoriatic | Spondylarthropathy Seronegative
Item
have systemic inflammatory condition other than ra, such as juvenile ra, crohn's disease, ulcerative colitis, psoriatic arthritis or seronegative spondyloarthropathy
boolean
C0749224 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0003873 (UMLS CUI [2,2])
C3714757 (UMLS CUI [3])
C0010346 (UMLS CUI [4])
C0009324 (UMLS CUI [5])
C0003872 (UMLS CUI [6])
C0949691 (UMLS CUI [7,1])
C0521144 (UMLS CUI [7,2])
Exclusion Criteria Research Personnel
Item
other criteria to be reviewed by study doctor
boolean
C0680251 (UMLS CUI [1,1])
C0035173 (UMLS CUI [1,2])

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