ID

37146

Description

99mTc-rhAnnexin V-128 a Phase I/IIa Study in Patients With Rheumatoid Arthritis (RA) or Ankylosing Spondylitis (AS); ODM derived from: https://clinicaltrials.gov/show/NCT02328027

Link

https://clinicaltrials.gov/show/NCT02328027

Keywords

Versions (1)
  1. 7/4/19 7/4/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 4, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT02328027

English

Eligibility Rheumatoid Arthritis NCT02328027

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients diagnosed with ra based on acr/eular 2010 criteria (score >=6), or patients diagnosed with as based on the asas criteria. patients with ra must have serology assessment performed and documented at the time of enrollment.
Description

Rheumatoid Arthritis Score | Serologic test

Data type

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0449820
UMLS CUI [2]
C0036743
patient with ra active disease (das > 2,6) and the introduction of a bi-dmard should be indicated. ra patients must have been treated with dmard (methotrexate, leflunomide and sulfasalazine) or combination of these treatments for at least 3 months. treatment will be pursued while on study.
Description

Rheumatoid Arthritis DAS28 | DMARD | Methotrexate | leflunomide | Sulfasalazine

Data type

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C4481729
UMLS CUI [2]
C0242708
UMLS CUI [3]
C0025677
UMLS CUI [4]
C0063041
UMLS CUI [5]
C0036078
or ra patients must have been previously treated with bi-dmard before initiation of the new bi-dmard treatment. the non-response of the previous bi-dmard treatment must be documented.
Description

DMARD Previous | Response Lacking

Data type

boolean

Alias
UMLS CUI [1,1]
C0242708
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C1704632
UMLS CUI [2,2]
C0332268
or patients with as with insufficiently controlled disease while under nsaid and indication for bi-dmard. these patients must be under nsaid for at least 3 months and under the same nsaid for at least 1 month prior to enrollment.
Description

Disease Poorly controlled | NSAID

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C3853134
UMLS CUI [2]
C0003211
≥ 18 years old
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
karnofsky ≥ 80%
Description

Karnofsky Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C0206065
negative pregnancy test for women with childbearing potential
Description

Childbearing Potential Pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
for women with childbearing potential, use of two reliable means of contraception (e.g., hormonal contraceptive, patch, vaginal ring, intrauterine device, associated with other barrier method of contraception such as the use of condoms) , throughout their participation in the study
Description

Childbearing Potential Contraceptive methods Quantity | Contraceptives, Oral, Hormonal | Contraceptive patch | Vaginal Ring | Intrauterine Devices | Contraception, Barrier | Female Condoms

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C1265611
UMLS CUI [2]
C0009907
UMLS CUI [3]
C2985284
UMLS CUI [4]
C0042260
UMLS CUI [5]
C0021900
UMLS CUI [6]
C0004764
UMLS CUI [7]
C0221829
absence of ecg anomaly
Description

ECG abnormal Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0522055
UMLS CUI [1,2]
C0332197
written icf signed
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnancy or lactation
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
liver impairment (alt, ast or bilirubin > 2 uln) at screening visit or baseline
Description

Liver Dysfunction | Alanine aminotransferase increased | Aspartate aminotransferase increased | Elevated total bilirubin

Data type

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C0151905
UMLS CUI [3]
C0151904
UMLS CUI [4]
C0741494
kidney impairment (serum creatinine > 1.5 mg/dl)
Description

Renal Insufficiency | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0201976
history of congestive heart failure (nyha iii & iv)
Description

Congestive heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
history of malignant disease within 5 years
Description

Malignant disease

Data type

boolean

Alias
UMLS CUI [1]
C0442867
history of any disease or relevant physical or psychiatric condition or abnormal physical finding which may interfere with the study objectives at the investigator judgment
Description

Disease Interferes with Study Protocol | Physical Condition Interferes with Study Protocol | Mental condition Interferes with Study Protocol | ABNORMAL PHYSICAL FINDING Interferes with Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348563
UMLS CUI [2,1]
C3714565
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C2348563
UMLS CUI [3,1]
C3840291
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C2348563
UMLS CUI [4,1]
C0149610
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C2348563
known hypersensitivity to the investigational drug or any of its components
Description

Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drug Component

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013230
UMLS CUI [2,3]
C1705248
participation to another clinical trial within 4 weeks before study inclusion except for patients who have participated or who are currently participating in an interventional study without any study drug administration.
Description

Study Subject Participation Status | Exception Interventional Study Without Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C3274035
UMLS CUI [2,3]
C0332288
UMLS CUI [2,4]
C0013230
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Similar models

Eligibility Rheumatoid Arthritis NCT02328027

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Rheumatoid Arthritis Score | Serologic test
Item
patients diagnosed with ra based on acr/eular 2010 criteria (score >=6), or patients diagnosed with as based on the asas criteria. patients with ra must have serology assessment performed and documented at the time of enrollment.
boolean
C0003873 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
C0036743 (UMLS CUI [2])
Rheumatoid Arthritis DAS28 | DMARD | Methotrexate | leflunomide | Sulfasalazine
Item
patient with ra active disease (das > 2,6) and the introduction of a bi-dmard should be indicated. ra patients must have been treated with dmard (methotrexate, leflunomide and sulfasalazine) or combination of these treatments for at least 3 months. treatment will be pursued while on study.
boolean
C0003873 (UMLS CUI [1,1])
C4481729 (UMLS CUI [1,2])
C0242708 (UMLS CUI [2])
C0025677 (UMLS CUI [3])
C0063041 (UMLS CUI [4])
C0036078 (UMLS CUI [5])
DMARD Previous | Response Lacking
Item
or ra patients must have been previously treated with bi-dmard before initiation of the new bi-dmard treatment. the non-response of the previous bi-dmard treatment must be documented.
boolean
C0242708 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C1704632 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
Disease Poorly controlled | NSAID
Item
or patients with as with insufficiently controlled disease while under nsaid and indication for bi-dmard. these patients must be under nsaid for at least 3 months and under the same nsaid for at least 1 month prior to enrollment.
boolean
C0012634 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
C0003211 (UMLS CUI [2])
Age
Item
≥ 18 years old
boolean
C0001779 (UMLS CUI [1])
Karnofsky Performance Status
Item
karnofsky ≥ 80%
boolean
C0206065 (UMLS CUI [1])
Childbearing Potential Pregnancy test negative
Item
negative pregnancy test for women with childbearing potential
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Childbearing Potential Contraceptive methods Quantity | Contraceptives, Oral, Hormonal | Contraceptive patch | Vaginal Ring | Intrauterine Devices | Contraception, Barrier | Female Condoms
Item
for women with childbearing potential, use of two reliable means of contraception (e.g., hormonal contraceptive, patch, vaginal ring, intrauterine device, associated with other barrier method of contraception such as the use of condoms) , throughout their participation in the study
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0009907 (UMLS CUI [2])
C2985284 (UMLS CUI [3])
C0042260 (UMLS CUI [4])
C0021900 (UMLS CUI [5])
C0004764 (UMLS CUI [6])
C0221829 (UMLS CUI [7])
ECG abnormal Absent
Item
absence of ecg anomaly
boolean
C0522055 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Informed Consent
Item
written icf signed
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnancy or lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Liver Dysfunction | Alanine aminotransferase increased | Aspartate aminotransferase increased | Elevated total bilirubin
Item
liver impairment (alt, ast or bilirubin > 2 uln) at screening visit or baseline
boolean
C0086565 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
C0741494 (UMLS CUI [4])
Renal Insufficiency | Creatinine measurement, serum
Item
kidney impairment (serum creatinine > 1.5 mg/dl)
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Congestive heart failure New York Heart Association Classification
Item
history of congestive heart failure (nyha iii & iv)
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Malignant disease
Item
history of malignant disease within 5 years
boolean
C0442867 (UMLS CUI [1])
Disease Interferes with Study Protocol | Physical Condition Interferes with Study Protocol | Mental condition Interferes with Study Protocol | ABNORMAL PHYSICAL FINDING Interferes with Study Protocol
Item
history of any disease or relevant physical or psychiatric condition or abnormal physical finding which may interfere with the study objectives at the investigator judgment
boolean
C0012634 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
C3714565 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2348563 (UMLS CUI [2,3])
C3840291 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C2348563 (UMLS CUI [3,3])
C0149610 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C2348563 (UMLS CUI [4,3])
Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drug Component
Item
known hypersensitivity to the investigational drug or any of its components
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C1705248 (UMLS CUI [2,3])
Study Subject Participation Status | Exception Interventional Study Without Investigational New Drugs
Item
participation to another clinical trial within 4 weeks before study inclusion except for patients who have participated or who are currently participating in an interventional study without any study drug administration.
boolean
C2348568 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C3274035 (UMLS CUI [2,2])
C0332288 (UMLS CUI [2,3])
C0013230 (UMLS CUI [2,4])
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