ID

37154

Beschreibung

Tolerance, Pharmacokinetics and Preliminary Efficacy of T0001 in RA (Rheumatoid Arthritis); ODM derived from: https://clinicaltrials.gov/show/NCT02481180

Link

https://clinicaltrials.gov/show/NCT02481180

Stichworte

Versionen (1)
  1. 04.07.19 04.07.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

4. Juli 2019

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT02481180

Englisch

Eligibility Rheumatoid Arthritis NCT02481180

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 18-45 years old;
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
diagnosed with active ra;
Beschreibung

Rheumatoid Arthritis

Datentyp

boolean

Alias
UMLS CUI [1]
C0003873
dmards therapy must not be used for at least 28 days prior to baseline;
Beschreibung

Antirheumatic Drugs, Disease-Modifying

Datentyp

boolean

Alias
UMLS CUI [1]
C0242708
if a patient has received nsaids，current nsaids therapy must have been at a stable dose for at least 28 days prior to baseline;
Beschreibung

NSAIDs Dose Stable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003211
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
patient or patient's legal representative able to give written informed consent for participation in the trial.
Beschreibung

Informed Consent | Informed Consent Patient Representative

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
acute or chronic infection, or history of active tuberculosis;
Beschreibung

Communicable Disease | Chronic infectious disease | Tuberculosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0151317
UMLS CUI [3]
C0041296
history of diseases of central nervous system, cardiovascular system, kidney, liver ( specified liver function index), digestive system, respiratory system , metabolism system;
Beschreibung

CNS disorder | Cardiovascular Diseases | Kidney Diseases | Liver diseases | Liver function Index Specified | Digestive System Disorders | Respiration Disorders | Metabolic Diseases

Datentyp

boolean

Alias
UMLS CUI [1]
C0007682
UMLS CUI [2]
C0007222
UMLS CUI [3]
C0022658
UMLS CUI [4]
C0023895
UMLS CUI [5,1]
C0232741
UMLS CUI [5,2]
C0918012
UMLS CUI [5,3]
C0205369
UMLS CUI [6]
C0012242
UMLS CUI [7]
C0035204
UMLS CUI [8]
C0025517
patients who have a high risk of infection (with a current infectious disease, a chronic infectious disease, a history of serious infectious disease);
Beschreibung

High risk of Communicable Disease | Communicable Disease | Chronic infectious disease | Communicable Disease Serious

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332167
UMLS CUI [1,2]
C0009450
UMLS CUI [2]
C0009450
UMLS CUI [3]
C0151317
UMLS CUI [4,1]
C0009450
UMLS CUI [4,2]
C0205404
patients who use 5 unit doses tuberculin skin test are positive( 48-72 hour scleroma reading≥5mm);
Beschreibung

Tuberculin unit Quantity | Tuberculin (skin test) positive | Scleroma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1532464
UMLS CUI [1,2]
C1265611
UMLS CUI [2]
C3161220
UMLS CUI [3]
C0035468
patients who currently have, or who have a history of, malignancy;
Beschreibung

Malignant Neoplasms

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
patients who lack of understanding ,communication or collaboration, and can't comply with the protocols;
Beschreibung

Comprehension Lacking | Communication Lacking | Compliance behavior Lacking | Protocol Compliance Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C0332268
UMLS CUI [2,1]
C0009452
UMLS CUI [2,2]
C0332268
UMLS CUI [3,1]
C1321605
UMLS CUI [3,2]
C0332268
UMLS CUI [4,1]
C0525058
UMLS CUI [4,2]
C1299582
female patients who are breastfeeding or pregnant, who are of childbearing potential.
Beschreibung

Breast Feeding | Pregnancy | Childbearing Potential

Datentyp

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0032961
UMLS CUI [3]
C3831118
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Ähnliche Modelle

Eligibility Rheumatoid Arthritis NCT02481180

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age 18-45 years old;
boolean
C0001779 (UMLS CUI [1])
Rheumatoid Arthritis
Item
diagnosed with active ra;
boolean
C0003873 (UMLS CUI [1])
Antirheumatic Drugs, Disease-Modifying
Item
dmards therapy must not be used for at least 28 days prior to baseline;
boolean
C0242708 (UMLS CUI [1])
NSAIDs Dose Stable
Item
if a patient has received nsaids，current nsaids therapy must have been at a stable dose for at least 28 days prior to baseline;
boolean
C0003211 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Informed Consent | Informed Consent Patient Representative
Item
patient or patient's legal representative able to give written informed consent for participation in the trial.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Communicable Disease | Chronic infectious disease | Tuberculosis
Item
acute or chronic infection, or history of active tuberculosis;
boolean
C0009450 (UMLS CUI [1])
C0151317 (UMLS CUI [2])
C0041296 (UMLS CUI [3])
CNS disorder | Cardiovascular Diseases | Kidney Diseases | Liver diseases | Liver function Index Specified | Digestive System Disorders | Respiration Disorders | Metabolic Diseases
Item
history of diseases of central nervous system, cardiovascular system, kidney, liver ( specified liver function index), digestive system, respiratory system , metabolism system;
boolean
C0007682 (UMLS CUI [1])
C0007222 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C0023895 (UMLS CUI [4])
C0232741 (UMLS CUI [5,1])
C0918012 (UMLS CUI [5,2])
C0205369 (UMLS CUI [5,3])
C0012242 (UMLS CUI [6])
C0035204 (UMLS CUI [7])
C0025517 (UMLS CUI [8])
High risk of Communicable Disease | Communicable Disease | Chronic infectious disease | Communicable Disease Serious
Item
patients who have a high risk of infection (with a current infectious disease, a chronic infectious disease, a history of serious infectious disease);
boolean
C0332167 (UMLS CUI [1,1])
C0009450 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0151317 (UMLS CUI [3])
C0009450 (UMLS CUI [4,1])
C0205404 (UMLS CUI [4,2])
Tuberculin unit Quantity | Tuberculin (skin test) positive | Scleroma
Item
patients who use 5 unit doses tuberculin skin test are positive( 48-72 hour scleroma reading≥5mm);
boolean
C1532464 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C3161220 (UMLS CUI [2])
C0035468 (UMLS CUI [3])
Malignant Neoplasms
Item
patients who currently have, or who have a history of, malignancy;
boolean
C0006826 (UMLS CUI [1])
Comprehension Lacking | Communication Lacking | Compliance behavior Lacking | Protocol Compliance Unable
Item
patients who lack of understanding ,communication or collaboration, and can't comply with the protocols;
boolean
C0162340 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
C0009452 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
C1321605 (UMLS CUI [3,1])
C0332268 (UMLS CUI [3,2])
C0525058 (UMLS CUI [4,1])
C1299582 (UMLS CUI [4,2])
Breast Feeding | Pregnancy | Childbearing Potential
Item
female patients who are breastfeeding or pregnant, who are of childbearing potential.
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C3831118 (UMLS CUI [3])
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