ID

43783

Beskrivning

Co-Administration Of Methotrexate And CP-690,550; ODM derived from: https://clinicaltrials.gov/show/NCT01745055

Länk

https://clinicaltrials.gov/show/NCT01745055

Nyckelord

Versioner (2)
  1. 2017-06-20 2017-06-20 -
  2. 2021-09-20 2021-09-20 -
Uppladdad den

20 september 2021

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT01745055

Engelsk

Eligibility Rheumatoid Arthritis NCT01745055

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
adults diagnosed with moderate to severe ra (rheumatoid arthritis)
Beskrivning

Adult | Rheumatoid arthritis, moderate | Rheumatoid Arthritis Severe

Datatyp

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C2368567
UMLS CUI [3,1]
C0003873
UMLS CUI [3,2]
C0205082
diagnosis of ra based on the american college of rheumatology 1987 revised criteria.
Beskrivning

Rheumatoid Arthritis

Datatyp

boolean

Alias
UMLS CUI [1]
C0003873
treatment with an oral stable weekly dose of methotrexate (mtx) (15-25 mg/week, administered as a single dose [sd]) for a minimum of 4 doses (4 weeks)
Beskrivning

Methotrexate Oral Dose Stable U/week | Dose Single Quantity Minimum

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3216566
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [1,4]
C0560588
UMLS CUI [2,1]
C0178602
UMLS CUI [2,2]
C0205171
UMLS CUI [2,3]
C1265611
UMLS CUI [2,4]
C1524031
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
blood dyscrasias including confirmed: hemoglobin <9 g/dl or hematocrit <30%; white blood cell count <3.0 x 109/l; absolute neutrophil count <1.2 x 109/l; platelet count <100 x 109/l
Beskrivning

Hematological Disease | Hemoglobin measurement | Hematocrit level | White Blood Cell Count procedure | Absolute neutrophil count | Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0018939
UMLS CUI [2]
C0518015
UMLS CUI [3]
C0518014
UMLS CUI [4]
C0023508
UMLS CUI [5]
C0948762
UMLS CUI [6]
C0032181
evidence or history of clinically significant infections within the past 6 months (eg, those requiring hospitalization, requiring parenteral antimicrobial therapy, or those with recurrent oral or genital herpes, recurrent herpes zoster, or any infection otherwise judged by the investigator to have the potential for exacerbation by participation in the trial.
Beskrivning

Communicable Diseases | Hospitalization Required | Requirement Therapy Antimicrobial Parenteral | ORAL HERPES RECURRENT | Recurrent genital herpes | HERPES ZOSTER RECURRENT | Communicable Disease Worsening Due to Clinical Trial Participation

Datatyp

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C1708385
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C0087111
UMLS CUI [3,3]
C0443071
UMLS CUI [3,4]
C1518896
UMLS CUI [4]
C1274321
UMLS CUI [5]
C1274323
UMLS CUI [6]
C0744893
UMLS CUI [7,1]
C0009450
UMLS CUI [7,2]
C0332271
UMLS CUI [7,3]
C0678226
UMLS CUI [7,4]
C0008976
UMLS CUI [7,5]
C0679823
total bilirubin, ast (aspartate aminotransferase) or alt (alanine aminotransferase) more than 1.2 times the upper limit of normal at the screening visit, or a history of clinically significant elevated liver function tests (lfts) while on current mtx dose or chronic liver disease, recent or active hepatitis.
Beskrivning

Elevated total bilirubin | Aspartate aminotransferase increased | Alanine aminotransferase increased | Increased liver function tests During Methotrexate Dose | Chronic liver disease | Hepatitis

Datatyp

boolean

Alias
UMLS CUI [1]
C0741494
UMLS CUI [2]
C0151904
UMLS CUI [3]
C0151905
UMLS CUI [4,1]
C0877359
UMLS CUI [4,2]
C0347984
UMLS CUI [4,3]
C0025677
UMLS CUI [4,4]
C0178602
UMLS CUI [5]
C0341439
UMLS CUI [6]
C0019158
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Similar models

Eligibility Rheumatoid Arthritis NCT01745055

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Rheumatoid arthritis, moderate | Rheumatoid Arthritis Severe
Item
adults diagnosed with moderate to severe ra (rheumatoid arthritis)
boolean
C0001675 (UMLS CUI [1])
C2368567 (UMLS CUI [2])
C0003873 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
Rheumatoid Arthritis
Item
diagnosis of ra based on the american college of rheumatology 1987 revised criteria.
boolean
C0003873 (UMLS CUI [1])
Methotrexate Oral Dose Stable U/week | Dose Single Quantity Minimum
Item
treatment with an oral stable weekly dose of methotrexate (mtx) (15-25 mg/week, administered as a single dose [sd]) for a minimum of 4 doses (4 weeks)
boolean
C3216566 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0560588 (UMLS CUI [1,4])
C0178602 (UMLS CUI [2,1])
C0205171 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C1524031 (UMLS CUI [2,4])
Item Group
C0680251 (UMLS CUI)
Hematological Disease | Hemoglobin measurement | Hematocrit level | White Blood Cell Count procedure | Absolute neutrophil count | Platelet Count measurement
Item
blood dyscrasias including confirmed: hemoglobin <9 g/dl or hematocrit <30%; white blood cell count <3.0 x 109/l; absolute neutrophil count <1.2 x 109/l; platelet count <100 x 109/l
boolean
C0018939 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
C0518014 (UMLS CUI [3])
C0023508 (UMLS CUI [4])
C0948762 (UMLS CUI [5])
C0032181 (UMLS CUI [6])
Communicable Diseases | Hospitalization Required | Requirement Therapy Antimicrobial Parenteral | ORAL HERPES RECURRENT | Recurrent genital herpes | HERPES ZOSTER RECURRENT | Communicable Disease Worsening Due to Clinical Trial Participation
Item
evidence or history of clinically significant infections within the past 6 months (eg, those requiring hospitalization, requiring parenteral antimicrobial therapy, or those with recurrent oral or genital herpes, recurrent herpes zoster, or any infection otherwise judged by the investigator to have the potential for exacerbation by participation in the trial.
boolean
C0009450 (UMLS CUI [1])
C1708385 (UMLS CUI [2])
C1514873 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C0443071 (UMLS CUI [3,3])
C1518896 (UMLS CUI [3,4])
C1274321 (UMLS CUI [4])
C1274323 (UMLS CUI [5])
C0744893 (UMLS CUI [6])
C0009450 (UMLS CUI [7,1])
C0332271 (UMLS CUI [7,2])
C0678226 (UMLS CUI [7,3])
C0008976 (UMLS CUI [7,4])
C0679823 (UMLS CUI [7,5])
Elevated total bilirubin | Aspartate aminotransferase increased | Alanine aminotransferase increased | Increased liver function tests During Methotrexate Dose | Chronic liver disease | Hepatitis
Item
total bilirubin, ast (aspartate aminotransferase) or alt (alanine aminotransferase) more than 1.2 times the upper limit of normal at the screening visit, or a history of clinically significant elevated liver function tests (lfts) while on current mtx dose or chronic liver disease, recent or active hepatitis.
boolean
C0741494 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
C0877359 (UMLS CUI [4,1])
C0347984 (UMLS CUI [4,2])
C0025677 (UMLS CUI [4,3])
C0178602 (UMLS CUI [4,4])
C0341439 (UMLS CUI [5])
C0019158 (UMLS CUI [6])
Tillbaka till toppen 

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