ID

31986

Beskrivning

A Study to Evaluate the Efficacy of Tacrolimus in Rheumatoid Arthritis Patients Shown Unsuccessful Response to Methotrexate; ODM derived from: https://clinicaltrials.gov/show/NCT01224418

Länk

https://clinicaltrials.gov/show/NCT01224418

Nyckelord

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

See clinicaltrials.gov

Uppladdad den

10 oktober 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT01224418

Engelsk

Eligibility Rheumatoid Arthritis NCT01224418

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with more than 6 months history of rheumatoid arthritis according to acr criteria
Beskrivning

Rheumatoid Arthritis Disease length

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0872146
patients who have been treated unsuccessfully to more than single dmards including methotrexate at the discretion of investigator
Beskrivning

DMARDs Quantity Treatment unsuccessful | Methotrexate Treatment unsuccessful

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0242708
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0438286
UMLS CUI [2,1]
C0025677
UMLS CUI [2,2]
C0438286
esr ≥ 30 mm/h or crp ≥ 1.0 mg/dl (esr: erythrocyte sedimentation rate, crp: c-reactive protein)
Beskrivning

Erythrocyte sedimentation rate measurement | C-reactive protein measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C1176468
UMLS CUI [2]
C0201657
patients are required to have at least 3 of 66 joints assessed as swollen
Beskrivning

Swollen joint count

Datatyp

boolean

Alias
UMLS CUI [1]
C0451521
patients are required to have at least 6 of 68 joints assessed as painful with pressure
Beskrivning

Painful joints With Pressure Count

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003862
UMLS CUI [1,2]
C0332287
UMLS CUI [1,3]
C1306345
UMLS CUI [1,4]
C0750480
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or breast-feeding patients. patients who plan to bear children or breast-feed during the study and within 6 month after completion of study
Beskrivning

Pregnancy | Breast Feeding | Pregnancy, Planned | Breast Feeding Planned

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
UMLS CUI [4,1]
C0006147
UMLS CUI [4,2]
C1301732
previous experience of tacrolimus (ointment excluded)
Beskrivning

Tacrolimus | Ointment Excluded

Datatyp

boolean

Alias
UMLS CUI [1]
C0085149
UMLS CUI [2,1]
C0028912
UMLS CUI [2,2]
C0332196
renal impairment or serum creatinine > 1.4 mg/dl
Beskrivning

Renal Insufficiency | Creatinine measurement, serum

Datatyp

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0201976
liver function failure as follows: viral hepatitis, non-viral hepatitis, cirrhosis, sgot/sgpt > 2x upper limit normal
Beskrivning

Liver Failure | Viral hepatitis | Non-viral hepatitis | Liver Cirrhosis | Aspartate aminotransferase increased | Alanine aminotransferase increased

Datatyp

boolean

Alias
UMLS CUI [1]
C0085605
UMLS CUI [2]
C0042721
UMLS CUI [3]
C4268643
UMLS CUI [4]
C0023890
UMLS CUI [5]
C0151904
UMLS CUI [6]
C0151905
patients with history of pancreatitis, glucose intolerance or complication or who indicates any of the following criteria:blood glucose level >110mg/dl before the meal and >200mg/dl after the meal hba1c > 6.4%
Beskrivning

Pancreatitis | Impaired glucose tolerance | Glucose Complication | Blood glucose measurement ante cibus | Blood glucose measurement Postprandial | Hemoglobin A1c measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0030305
UMLS CUI [2]
C0271650
UMLS CUI [3,1]
C0017725
UMLS CUI [3,2]
C0009566
UMLS CUI [4,1]
C0392201
UMLS CUI [4,2]
C1550738
UMLS CUI [5,1]
C0392201
UMLS CUI [5,2]
C0376674
UMLS CUI [6]
C0474680
cardiac disease(ischemic heart disease, treatment-requiring arrhythmia, heart failure)or complications
Beskrivning

Heart Disease | Myocardial Ischemia | Cardiac Arrhythmia Treatment required for | Heart failure | Cardiac complication

Datatyp

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0151744
UMLS CUI [3,1]
C0003811
UMLS CUI [3,2]
C0332121
UMLS CUI [4]
C0018801
UMLS CUI [5]
C0161816
other investigational drug within last 30 days
Beskrivning

Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
patients who have been treated with infliximab, adalimumab, or leflunomide within 8 weeks of start of the study
Beskrivning

infliximab | adalimumab | leflunomide

Datatyp

boolean

Alias
UMLS CUI [1]
C0666743
UMLS CUI [2]
C1122087
UMLS CUI [3]
C0063041
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Similar models

Eligibility Rheumatoid Arthritis NCT01224418

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Rheumatoid Arthritis Disease length
Item
patients with more than 6 months history of rheumatoid arthritis according to acr criteria
boolean
C0003873 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
DMARDs Quantity Treatment unsuccessful | Methotrexate Treatment unsuccessful
Item
patients who have been treated unsuccessfully to more than single dmards including methotrexate at the discretion of investigator
boolean
C0242708 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0438286 (UMLS CUI [1,3])
C0025677 (UMLS CUI [2,1])
C0438286 (UMLS CUI [2,2])
Erythrocyte sedimentation rate measurement | C-reactive protein measurement
Item
esr ≥ 30 mm/h or crp ≥ 1.0 mg/dl (esr: erythrocyte sedimentation rate, crp: c-reactive protein)
boolean
C1176468 (UMLS CUI [1])
C0201657 (UMLS CUI [2])
Swollen joint count
Item
patients are required to have at least 3 of 66 joints assessed as swollen
boolean
C0451521 (UMLS CUI [1])
Painful joints With Pressure Count
Item
patients are required to have at least 6 of 68 joints assessed as painful with pressure
boolean
C0003862 (UMLS CUI [1,1])
C0332287 (UMLS CUI [1,2])
C1306345 (UMLS CUI [1,3])
C0750480 (UMLS CUI [1,4])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding | Pregnancy, Planned | Breast Feeding Planned
Item
pregnant or breast-feeding patients. patients who plan to bear children or breast-feed during the study and within 6 month after completion of study
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C0006147 (UMLS CUI [4,1])
C1301732 (UMLS CUI [4,2])
Tacrolimus | Ointment Excluded
Item
previous experience of tacrolimus (ointment excluded)
boolean
C0085149 (UMLS CUI [1])
C0028912 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
Renal Insufficiency | Creatinine measurement, serum
Item
renal impairment or serum creatinine > 1.4 mg/dl
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Liver Failure | Viral hepatitis | Non-viral hepatitis | Liver Cirrhosis | Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
liver function failure as follows: viral hepatitis, non-viral hepatitis, cirrhosis, sgot/sgpt > 2x upper limit normal
boolean
C0085605 (UMLS CUI [1])
C0042721 (UMLS CUI [2])
C4268643 (UMLS CUI [3])
C0023890 (UMLS CUI [4])
C0151904 (UMLS CUI [5])
C0151905 (UMLS CUI [6])
Pancreatitis | Impaired glucose tolerance | Glucose Complication | Blood glucose measurement ante cibus | Blood glucose measurement Postprandial | Hemoglobin A1c measurement
Item
patients with history of pancreatitis, glucose intolerance or complication or who indicates any of the following criteria:blood glucose level >110mg/dl before the meal and >200mg/dl after the meal hba1c > 6.4%
boolean
C0030305 (UMLS CUI [1])
C0271650 (UMLS CUI [2])
C0017725 (UMLS CUI [3,1])
C0009566 (UMLS CUI [3,2])
C0392201 (UMLS CUI [4,1])
C1550738 (UMLS CUI [4,2])
C0392201 (UMLS CUI [5,1])
C0376674 (UMLS CUI [5,2])
C0474680 (UMLS CUI [6])
Heart Disease | Myocardial Ischemia | Cardiac Arrhythmia Treatment required for | Heart failure | Cardiac complication
Item
cardiac disease(ischemic heart disease, treatment-requiring arrhythmia, heart failure)or complications
boolean
C0018799 (UMLS CUI [1])
C0151744 (UMLS CUI [2])
C0003811 (UMLS CUI [3,1])
C0332121 (UMLS CUI [3,2])
C0018801 (UMLS CUI [4])
C0161816 (UMLS CUI [5])
Investigational New Drugs
Item
other investigational drug within last 30 days
boolean
C0013230 (UMLS CUI [1])
infliximab | adalimumab | leflunomide
Item
patients who have been treated with infliximab, adalimumab, or leflunomide within 8 weeks of start of the study
boolean
C0666743 (UMLS CUI [1])
C1122087 (UMLS CUI [2])
C0063041 (UMLS CUI [3])
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