ID

31876

Beskrivning

Study of LX3305 and Methotrexate in Subjects With Stable Rheumatoid Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT00847886

Länk

https://clinicaltrials.gov/show/NCT00847886

Nyckelord

Versioner (1)
  1. 2018-10-06 2018-10-06 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

6 oktober 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00847886

Engelsk

Eligibility Rheumatoid Arthritis NCT00847886

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
males and females ≥ 18 years old
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
must be willing to practice 2 adequate methods of contraception for the duration of the study
Beskrivning

Contraceptive methods Quantity Willing

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0600109
rheumatoid arthritis present for at least 3 months; functional class i, ii, or iii as defined by acr criteria
Beskrivning

Rheumatoid Arthritis Functional Status Class Disease length

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0598463
UMLS CUI [1,3]
C0456387
UMLS CUI [1,4]
C0872146
treatment with methotrexate (7.5 to 25 mg per week) for at least the last 3 months, and currently receiving stable dose methotrexate for at least one month prior to the start of the study
Beskrivning

Methotrexate U/week | Methotrexate Dose Stable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0025677
UMLS CUI [1,2]
C0560588
UMLS CUI [2,1]
C0025677
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
ability to provide written informed consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
women who are pregnant or nursing
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
history of other current inflammatory arthritis
Beskrivning

Arthritis Other

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003864
UMLS CUI [1,2]
C0205394
history of opportunistic infection
Beskrivning

Opportunistic Infection

Datatyp

boolean

Alias
UMLS CUI [1]
C0029118
history of recurrent infections or current infection 2 weeks prior to start of study
Beskrivning

Recurrent infections | Communicable Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0239998
UMLS CUI [2]
C0009450
presence of significant, uncontrolled medical problems
Beskrivning

Medical Problem Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1254481
UMLS CUI [1,2]
C0205318
treatment with any disease-modifying anti-rheumatoid drugs other than methotrexate within 4 weeks prior to start of study
Beskrivning

Antirheumatic Drugs, Disease-Modifying | Exception Methotrexate

Datatyp

boolean

Alias
UMLS CUI [1]
C0242708
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0025677
use of chondroitin sulfate, glucosamine sulfate, minocycline, or matrix metalloproteinase inhibitors, h-2 blockers, proton pump inhibitors, or misoprostol within 4 weeks prior to study start
Beskrivning

Chondroitin Sulfates | Glucosamine Sulfate | Minocycline | Matrix Metalloproteinase Inhibitors | H2 blockers | Proton Pump Inhibitors | Misoprostol

Datatyp

boolean

Alias
UMLS CUI [1]
C0008466
UMLS CUI [2]
C0017720
UMLS CUI [3]
C0026187
UMLS CUI [4]
C1513016
UMLS CUI [5]
C0019593
UMLS CUI [6]
C0358591
UMLS CUI [7]
C0085174
receipt of live vaccine within 8 weeks prior to study start
Beskrivning

Live vaccine

Datatyp

boolean

Alias
UMLS CUI [1]
C0042211
rheumatoid arthritis, functional class iv as defined by acr criteria
Beskrivning

Rheumatoid Arthritis Functional Status Class

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0598463
UMLS CUI [1,3]
C0456387
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Similar models

Eligibility Rheumatoid Arthritis NCT00847886

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
males and females ≥ 18 years old
boolean
C0001779 (UMLS CUI [1])
Contraceptive methods Quantity Willing
Item
must be willing to practice 2 adequate methods of contraception for the duration of the study
boolean
C0700589 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
Rheumatoid Arthritis Functional Status Class Disease length
Item
rheumatoid arthritis present for at least 3 months; functional class i, ii, or iii as defined by acr criteria
boolean
C0003873 (UMLS CUI [1,1])
C0598463 (UMLS CUI [1,2])
C0456387 (UMLS CUI [1,3])
C0872146 (UMLS CUI [1,4])
Methotrexate U/week | Methotrexate Dose Stable
Item
treatment with methotrexate (7.5 to 25 mg per week) for at least the last 3 months, and currently receiving stable dose methotrexate for at least one month prior to the start of the study
boolean
C0025677 (UMLS CUI [1,1])
C0560588 (UMLS CUI [1,2])
C0025677 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
Informed Consent
Item
ability to provide written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
women who are pregnant or nursing
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Arthritis Other
Item
history of other current inflammatory arthritis
boolean
C0003864 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Opportunistic Infection
Item
history of opportunistic infection
boolean
C0029118 (UMLS CUI [1])
Recurrent infections | Communicable Disease
Item
history of recurrent infections or current infection 2 weeks prior to start of study
boolean
C0239998 (UMLS CUI [1])
C0009450 (UMLS CUI [2])
Medical Problem Uncontrolled
Item
presence of significant, uncontrolled medical problems
boolean
C1254481 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Antirheumatic Drugs, Disease-Modifying | Exception Methotrexate
Item
treatment with any disease-modifying anti-rheumatoid drugs other than methotrexate within 4 weeks prior to start of study
boolean
C0242708 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0025677 (UMLS CUI [2,2])
Chondroitin Sulfates | Glucosamine Sulfate | Minocycline | Matrix Metalloproteinase Inhibitors | H2 blockers | Proton Pump Inhibitors | Misoprostol
Item
use of chondroitin sulfate, glucosamine sulfate, minocycline, or matrix metalloproteinase inhibitors, h-2 blockers, proton pump inhibitors, or misoprostol within 4 weeks prior to study start
boolean
C0008466 (UMLS CUI [1])
C0017720 (UMLS CUI [2])
C0026187 (UMLS CUI [3])
C1513016 (UMLS CUI [4])
C0019593 (UMLS CUI [5])
C0358591 (UMLS CUI [6])
C0085174 (UMLS CUI [7])
Live vaccine
Item
receipt of live vaccine within 8 weeks prior to study start
boolean
C0042211 (UMLS CUI [1])
Rheumatoid Arthritis Functional Status Class
Item
rheumatoid arthritis, functional class iv as defined by acr criteria
boolean
C0003873 (UMLS CUI [1,1])
C0598463 (UMLS CUI [1,2])
C0456387 (UMLS CUI [1,3])
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