ID

19229

Beskrivning

Phase 1 Dose Escalation Study of Intra-Articular Administration of tgAAC94; ODM derived from: https://clinicaltrials.gov/show/NCT00617032

Länk

https://clinicaltrials.gov/show/NCT00617032

Nyckelord

Versioner (1)
  1. 2016-12-13 2016-12-13 -
Uppladdad den

13 december 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00617032

Engelsk

Eligibility Rheumatoid Arthritis NCT00617032

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis, diagnosed according to published criteria
Beskrivning

Rheumatoid Arthritis | Arthritis, Psoriatic | Ankylosing spondylitis

Datatyp

boolean

Alias
UMLS CUI [1]
C0003873
UMLS CUI [2]
C0003872
UMLS CUI [3]
C0038013
persistent moderate (grade 2) or sever (grade 3) swelling due to inflammatory arthritis in at least one peripheral joint eligible for injection
Beskrivning

Swelling Moderate persistent | Swelling Severe persistent | Arthritis CTCAE Grades | Joints Peripheral Quantity | Indication Injection

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0205081
UMLS CUI [1,3]
C0205322
UMLS CUI [2,1]
C0038999
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C0205322
UMLS CUI [3,1]
C0003864
UMLS CUI [3,2]
C1516728
UMLS CUI [4,1]
C0022417
UMLS CUI [4,2]
C0205100
UMLS CUI [4,3]
C1265611
UMLS CUI [5,1]
C3146298
UMLS CUI [5,2]
C1533685
for subjects with rheumatoid arthritis, an adequate trial of at least one disease-modifying antirheumatic drug (dmard) prior to screening
Beskrivning

Disease-Modifying Antirheumatic Drugs Quantity Rheumatoid Arthritis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0242708
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0003873
for subjects currently on dmard(s), a stable regimen for inflammatory arthritis for the previous three months, with no changes in doses in the four weeks prior to screening
Beskrivning

Disease-Modifying Antirheumatic Drugs Dose unchanged | Regimen Stable Arthritis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0242708
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0442739
UMLS CUI [2,1]
C0040808
UMLS CUI [2,2]
C0205360
UMLS CUI [2,3]
C0003864
age greater than 18 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
be willing to practice effective birth control measures during the study, if of reproductive ability
Beskrivning

Fertility Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0015895
UMLS CUI [1,2]
C0700589
able to give written informed consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
current use of a tnf-alpha antagonist
Beskrivning

Tumor necrosis factor alpha (TNF-) inhibitors

Datatyp

boolean

Alias
UMLS CUI [1]
C3653350
disease severe enough to warrant use of a systemic tnf-alpha antagonist in the next three months
Beskrivning

Tumor necrosis factor alpha (TNF-) inhibitors Systemic | Disease Severe

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3653350
UMLS CUI [1,2]
C0205373
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0205082
discontinuation of tnf-alpha antagonists in the past because of safety concerns
Beskrivning

Tumor necrosis factor alpha (TNF-) inhibitors Discontinued | Safety Concern

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3653350
UMLS CUI [1,2]
C1444662
UMLS CUI [2,1]
C0036043
UMLS CUI [2,2]
C2699424
current use of anakinra
Beskrivning

anakinra

Datatyp

boolean

Alias
UMLS CUI [1]
C0245109
poor functional status, defined as being bed-bound or wheelchair-bound
Beskrivning

Functional Status Poor | Bed-ridden | Wheelchair bound

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0598463
UMLS CUI [1,2]
C0542537
UMLS CUI [2]
C0425251
UMLS CUI [3]
C0558195
corticosteriod therapy at doses higher than the equivalent of 10 mg prednisone per day
Beskrivning

Steroid therapy Dose | Prednisone U/day

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0149783
UMLS CUI [1,2]
C0178602
UMLS CUI [2,1]
C0032952
UMLS CUI [2,2]
C0456683
any of the following laboratory values: hemoglobin <8.5 gm/dl, white blood cell count <3500 per mm^3, platelet <100 k/microl, creatinine >2 mg/dl, bilirubin >2 mg/dl, ast or alt >2 times the upper limit of normal, or abnormal coagulation profiles
Beskrivning

Laboratory Results | Hemoglobin measurement | White Blood Cell Count procedure | Platelet Count measurement | Creatinine measurement, serum | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Abnormal coagulation profile

Datatyp

boolean

Alias
UMLS CUI [1]
C1254595
UMLS CUI [2]
C0518015
UMLS CUI [3]
C0023508
UMLS CUI [4]
C0032181
UMLS CUI [5]
C0201976
UMLS CUI [6]
C1278039
UMLS CUI [7]
C0201899
UMLS CUI [8]
C0201836
UMLS CUI [9]
C0375576
known hiv infection, known hepatitis c infection, or known positive serologic test for hepatitis b surface antigen
Beskrivning

HIV Infections | Hepatitis C | Hepatitis B surface antigen positive Serologic test

Datatyp

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0019196
UMLS CUI [3,1]
C0149709
UMLS CUI [3,2]
C0036743
positive ppd, unless previously treated with appropriate prophylaxis
Beskrivning

Mantoux: positive | Tuberculosis prophylaxis

Datatyp

boolean

Alias
UMLS CUI [1]
C0032739
UMLS CUI [2]
C0740413
pregnancy or lactation, either at the time of screening or planned in the next six months
Beskrivning

Pregnancy | Breast Feeding | Pregnancy, Planned

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
inflammatory bowel disease, such as crohn's disease or ulcerative colitis
Beskrivning

Inflammatory Bowel Diseases | Crohn Disease | Ulcerative Colitis

Datatyp

boolean

Alias
UMLS CUI [1]
C0021390
UMLS CUI [2]
C0010346
UMLS CUI [3]
C0009324
serious medical disease, such as sever liver or kidney disease, uncompensated congestive heart failure, myocardial infarction within six months, unstable angina, uncontrolled hypertension, severe pulmonary disease or active asthma, demyelinating neurological disease, history of cancer (other than cutaneous basal and squamous cell carcinoma) with less than five years documentation of a disease free state, insulin-dependent diabetes, recurrent opportunistic infections or other concurrent medical condition that, in the opinion of the investigator, would make the subject unsuitable for the study
Beskrivning

Disease Serious | Liver disease Severe | Kidney Disease Severe | Congestive heart failure Uncompensated | Myocardial Infarction | Angina, Unstable | Uncontrolled hypertension | Lung disease Severe | Asthma | Demyelinating disease of central nervous system | Malignant Neoplasms Disease Free of | Basal cell carcinoma | Squamous cell carcinoma of skin | Diabetes Mellitus, Insulin-Dependent | Recurrent opportunistic infections | Medical condition Study Subject Participation Status Limited

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0023895
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C0022658
UMLS CUI [3,2]
C0205082
UMLS CUI [4,1]
C0018802
UMLS CUI [4,2]
C0205433
UMLS CUI [5]
C0027051
UMLS CUI [6]
C0002965
UMLS CUI [7]
C1868885
UMLS CUI [8,1]
C0024115
UMLS CUI [8,2]
C0205082
UMLS CUI [9]
C0004096
UMLS CUI [10]
C0011302
UMLS CUI [11,1]
C0006826
UMLS CUI [11,2]
C0012634
UMLS CUI [11,3]
C0332296
UMLS CUI [12]
C0007117
UMLS CUI [13]
C0553723
UMLS CUI [14]
C0011854
UMLS CUI [15]
C1832324
UMLS CUI [16,1]
C3843040
UMLS CUI [16,2]
C2348568
UMLS CUI [16,3]
C0439801
unlikely to comply with the protocol
Beskrivning

Protocol Compliance Unlikely

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0750558
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Similar models

Eligibility Rheumatoid Arthritis NCT00617032

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Rheumatoid Arthritis | Arthritis, Psoriatic | Ankylosing spondylitis
Item
rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis, diagnosed according to published criteria
boolean
C0003873 (UMLS CUI [1])
C0003872 (UMLS CUI [2])
C0038013 (UMLS CUI [3])
Swelling Moderate persistent | Swelling Severe persistent | Arthritis CTCAE Grades | Joints Peripheral Quantity | Indication Injection
Item
persistent moderate (grade 2) or sever (grade 3) swelling due to inflammatory arthritis in at least one peripheral joint eligible for injection
boolean
C0038999 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0205322 (UMLS CUI [1,3])
C0038999 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0205322 (UMLS CUI [2,3])
C0003864 (UMLS CUI [3,1])
C1516728 (UMLS CUI [3,2])
C0022417 (UMLS CUI [4,1])
C0205100 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
C3146298 (UMLS CUI [5,1])
C1533685 (UMLS CUI [5,2])
Disease-Modifying Antirheumatic Drugs Quantity Rheumatoid Arthritis
Item
for subjects with rheumatoid arthritis, an adequate trial of at least one disease-modifying antirheumatic drug (dmard) prior to screening
boolean
C0242708 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0003873 (UMLS CUI [1,3])
Disease-Modifying Antirheumatic Drugs Dose unchanged | Regimen Stable Arthritis
Item
for subjects currently on dmard(s), a stable regimen for inflammatory arthritis for the previous three months, with no changes in doses in the four weeks prior to screening
boolean
C0242708 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0442739 (UMLS CUI [1,3])
C0040808 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
C0003864 (UMLS CUI [2,3])
Age
Item
age greater than 18 years
boolean
C0001779 (UMLS CUI [1])
Fertility Contraceptive methods
Item
be willing to practice effective birth control measures during the study, if of reproductive ability
boolean
C0015895 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Informed Consent
Item
able to give written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Tumor necrosis factor alpha (TNF-) inhibitors
Item
current use of a tnf-alpha antagonist
boolean
C3653350 (UMLS CUI [1])
Tumor necrosis factor alpha (TNF-) inhibitors Systemic | Disease Severe
Item
disease severe enough to warrant use of a systemic tnf-alpha antagonist in the next three months
boolean
C3653350 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Tumor necrosis factor alpha (TNF-) inhibitors Discontinued | Safety Concern
Item
discontinuation of tnf-alpha antagonists in the past because of safety concerns
boolean
C3653350 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0036043 (UMLS CUI [2,1])
C2699424 (UMLS CUI [2,2])
anakinra
Item
current use of anakinra
boolean
C0245109 (UMLS CUI [1])
Functional Status Poor | Bed-ridden | Wheelchair bound
Item
poor functional status, defined as being bed-bound or wheelchair-bound
boolean
C0598463 (UMLS CUI [1,1])
C0542537 (UMLS CUI [1,2])
C0425251 (UMLS CUI [2])
C0558195 (UMLS CUI [3])
Steroid therapy Dose | Prednisone U/day
Item
corticosteriod therapy at doses higher than the equivalent of 10 mg prednisone per day
boolean
C0149783 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0032952 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
Laboratory Results | Hemoglobin measurement | White Blood Cell Count procedure | Platelet Count measurement | Creatinine measurement, serum | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Abnormal coagulation profile
Item
any of the following laboratory values: hemoglobin <8.5 gm/dl, white blood cell count <3500 per mm^3, platelet <100 k/microl, creatinine >2 mg/dl, bilirubin >2 mg/dl, ast or alt >2 times the upper limit of normal, or abnormal coagulation profiles
boolean
C1254595 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
C0023508 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
C0201976 (UMLS CUI [5])
C1278039 (UMLS CUI [6])
C0201899 (UMLS CUI [7])
C0201836 (UMLS CUI [8])
C0375576 (UMLS CUI [9])
HIV Infections | Hepatitis C | Hepatitis B surface antigen positive Serologic test
Item
known hiv infection, known hepatitis c infection, or known positive serologic test for hepatitis b surface antigen
boolean
C0019693 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
C0149709 (UMLS CUI [3,1])
C0036743 (UMLS CUI [3,2])
Mantoux: positive | Tuberculosis prophylaxis
Item
positive ppd, unless previously treated with appropriate prophylaxis
boolean
C0032739 (UMLS CUI [1])
C0740413 (UMLS CUI [2])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
pregnancy or lactation, either at the time of screening or planned in the next six months
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Inflammatory Bowel Diseases | Crohn Disease | Ulcerative Colitis
Item
inflammatory bowel disease, such as crohn's disease or ulcerative colitis
boolean
C0021390 (UMLS CUI [1])
C0010346 (UMLS CUI [2])
C0009324 (UMLS CUI [3])
Disease Serious | Liver disease Severe | Kidney Disease Severe | Congestive heart failure Uncompensated | Myocardial Infarction | Angina, Unstable | Uncontrolled hypertension | Lung disease Severe | Asthma | Demyelinating disease of central nervous system | Malignant Neoplasms Disease Free of | Basal cell carcinoma | Squamous cell carcinoma of skin | Diabetes Mellitus, Insulin-Dependent | Recurrent opportunistic infections | Medical condition Study Subject Participation Status Limited
Item
serious medical disease, such as sever liver or kidney disease, uncompensated congestive heart failure, myocardial infarction within six months, unstable angina, uncontrolled hypertension, severe pulmonary disease or active asthma, demyelinating neurological disease, history of cancer (other than cutaneous basal and squamous cell carcinoma) with less than five years documentation of a disease free state, insulin-dependent diabetes, recurrent opportunistic infections or other concurrent medical condition that, in the opinion of the investigator, would make the subject unsuitable for the study
boolean
C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0023895 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0022658 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0018802 (UMLS CUI [4,1])
C0205433 (UMLS CUI [4,2])
C0027051 (UMLS CUI [5])
C0002965 (UMLS CUI [6])
C1868885 (UMLS CUI [7])
C0024115 (UMLS CUI [8,1])
C0205082 (UMLS CUI [8,2])
C0004096 (UMLS CUI [9])
C0011302 (UMLS CUI [10])
C0006826 (UMLS CUI [11,1])
C0012634 (UMLS CUI [11,2])
C0332296 (UMLS CUI [11,3])
C0007117 (UMLS CUI [12])
C0553723 (UMLS CUI [13])
C0011854 (UMLS CUI [14])
C1832324 (UMLS CUI [15])
C3843040 (UMLS CUI [16,1])
C2348568 (UMLS CUI [16,2])
C0439801 (UMLS CUI [16,3])
Protocol Compliance Unlikely
Item
unlikely to comply with the protocol
boolean
C0525058 (UMLS CUI [1,1])
C0750558 (UMLS CUI [1,2])
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