ID

37150

Description

Pragmatic Study Comparing the Clinical Evlauation Methods ( C) and / or Ultrasound Method ( B or D) in Rheumatoid Arthritis to Adapt Treatment; ODM derived from: https://clinicaltrials.gov/show/NCT02410304

Link

https://clinicaltrials.gov/show/NCT02410304

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 NCT02410304

English

Eligibility Rheumatoid Arthritis NCT02410304

1 forms  
Criteria
Description

Criteria

both gender patients aged 18 -to 80 years old
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patients will be eligible if they fulfill acr/eular 2010 rheumatoid arthritis
Description

Rheumatoid Arthritis Criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0243161
UMLS CUI [1,3]
C1550543
all the treatment recommended for rheumatoïd arthritis (anti-inflammatory drugs, steroids, hydroxychloroquine, salazopyrine, methotrexate, arava or biologics treatment: enbrel, humira, remicade, cimzia, tocilizumab, rituximab, abatacept, simponi) would be in stable posology since at least 12 weeks before inclusion
Description

Therapy Recommended Rheumatoid Arthritis | Anti-Inflammatory Agents | Steroids | Hydroxychloroquine | Salazopyrine | Methotrexate | Arava | Biological treatment | Enbrel | Humira | Remicade | Cimzia | tocilizumab | rituximab | abatacept | Simponi

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0034866
UMLS CUI [1,3]
C0003873
UMLS CUI [2]
C0003209
UMLS CUI [3]
C0038317
UMLS CUI [4]
C0020336
UMLS CUI [5]
C0073966
UMLS CUI [6]
C0025677
UMLS CUI [7]
C0718644
UMLS CUI [8]
C1531518
UMLS CUI [9]
C0720193
UMLS CUI [10]
C1171255
UMLS CUI [11]
C0723012
UMLS CUI [12]
C2343521
UMLS CUI [13]
C1609165
UMLS CUI [14]
C0393022
UMLS CUI [15]
C1619966
UMLS CUI [16]
C2684024
patients would be able to understand and be agree with the protocole
Description

Comprehension Study Protocol | Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
UMLS CUI [2]
C0525058
patients would be able to consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
exclusion criteria:
Description

Exclusion Criteria

Data type

boolean

Alias
UMLS CUI [1]
C0680251
patient unable to cooperate patient and who refuse to sign consent form
Description

Compliance behavior Unable | Informed Consent Refused

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1705116
patient unable to understand the study,under administrative supervision or legal guardianship
Description

Study Protocol Comprehension Unable | Patient supervision Administrative | Patient Guardianship

Data type

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0162340
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C0814286
UMLS CUI [2,2]
C3845829
UMLS CUI [3,1]
C0030705
UMLS CUI [3,2]
C0870627
signs and symptoms of uncontroled or severe progressive pathology at the level of renal, hepatic, hematological, endocrine, lung, cardiac, neurological or cerebral
Description

Signs and Symptoms Progressive Disease Uncontrolled | Signs and Symptoms Progressive Disease Severe | Kidney Diseases | Liver diseases | Hematological Disease | Endocrine System Diseases | Lung diseases | Heart Diseases | Nervous system disorder | Cerebral disorder

Data type

boolean

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C1335499
UMLS CUI [1,3]
C0205318
UMLS CUI [2,1]
C0037088
UMLS CUI [2,2]
C1335499
UMLS CUI [2,3]
C0205082
UMLS CUI [3]
C0022658
UMLS CUI [4]
C0023895
UMLS CUI [5]
C0018939
UMLS CUI [6]
C0014130
UMLS CUI [7]
C0024115
UMLS CUI [8]
C0018799
UMLS CUI [9]
C0027765
UMLS CUI [10]
C0234387
scheduled surgery procedure during the study on the estimated joint.
Description

Operation on joint Targeted Scheduled

Data type

boolean

Alias
UMLS CUI [1,1]
C0185132
UMLS CUI [1,2]
C1521840
UMLS CUI [1,3]
C0205539
patient non-affiliated to social security
Description

Social Security Affiliation Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0037435
UMLS CUI [1,2]
C1510825
UMLS CUI [1,3]
C0332197
pregnant and nursing mothers
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Rheumatoid Arthritis NCT02410304

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Age
Item
both gender patients aged 18 -to 80 years old
boolean
C0001779 (UMLS CUI [1])
Rheumatoid Arthritis Criteria Fulfill
Item
patients will be eligible if they fulfill acr/eular 2010 rheumatoid arthritis
boolean
C0003873 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Therapy Recommended Rheumatoid Arthritis | Anti-Inflammatory Agents | Steroids | Hydroxychloroquine | Salazopyrine | Methotrexate | Arava | Biological treatment | Enbrel | Humira | Remicade | Cimzia | tocilizumab | rituximab | abatacept | Simponi
Item
all the treatment recommended for rheumatoïd arthritis (anti-inflammatory drugs, steroids, hydroxychloroquine, salazopyrine, methotrexate, arava or biologics treatment: enbrel, humira, remicade, cimzia, tocilizumab, rituximab, abatacept, simponi) would be in stable posology since at least 12 weeks before inclusion
boolean
C0087111 (UMLS CUI [1,1])
C0034866 (UMLS CUI [1,2])
C0003873 (UMLS CUI [1,3])
C0003209 (UMLS CUI [2])
C0038317 (UMLS CUI [3])
C0020336 (UMLS CUI [4])
C0073966 (UMLS CUI [5])
C0025677 (UMLS CUI [6])
C0718644 (UMLS CUI [7])
C1531518 (UMLS CUI [8])
C0720193 (UMLS CUI [9])
C1171255 (UMLS CUI [10])
C0723012 (UMLS CUI [11])
C2343521 (UMLS CUI [12])
C1609165 (UMLS CUI [13])
C0393022 (UMLS CUI [14])
C1619966 (UMLS CUI [15])
C2684024 (UMLS CUI [16])
Comprehension Study Protocol | Protocol Compliance
Item
patients would be able to understand and be agree with the protocole
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2])
Informed Consent
Item
patients would be able to consent
boolean
C0021430 (UMLS CUI [1])
Exclusion Criteria
Item
exclusion criteria:
boolean
C0680251 (UMLS CUI [1])
Compliance behavior Unable | Informed Consent Refused
Item
patient unable to cooperate patient and who refuse to sign consent form
boolean
C1321605 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C1705116 (UMLS CUI [2,2])
Study Protocol Comprehension Unable | Patient supervision Administrative | Patient Guardianship
Item
patient unable to understand the study,under administrative supervision or legal guardianship
boolean
C2348563 (UMLS CUI [1,1])
C0162340 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0814286 (UMLS CUI [2,1])
C3845829 (UMLS CUI [2,2])
C0030705 (UMLS CUI [3,1])
C0870627 (UMLS CUI [3,2])
Signs and Symptoms Progressive Disease Uncontrolled | Signs and Symptoms Progressive Disease Severe | Kidney Diseases | Liver diseases | Hematological Disease | Endocrine System Diseases | Lung diseases | Heart Diseases | Nervous system disorder | Cerebral disorder
Item
signs and symptoms of uncontroled or severe progressive pathology at the level of renal, hepatic, hematological, endocrine, lung, cardiac, neurological or cerebral
boolean
C0037088 (UMLS CUI [1,1])
C1335499 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
C0037088 (UMLS CUI [2,1])
C1335499 (UMLS CUI [2,2])
C0205082 (UMLS CUI [2,3])
C0022658 (UMLS CUI [3])
C0023895 (UMLS CUI [4])
C0018939 (UMLS CUI [5])
C0014130 (UMLS CUI [6])
C0024115 (UMLS CUI [7])
C0018799 (UMLS CUI [8])
C0027765 (UMLS CUI [9])
C0234387 (UMLS CUI [10])
Operation on joint Targeted Scheduled
Item
scheduled surgery procedure during the study on the estimated joint.
boolean
C0185132 (UMLS CUI [1,1])
C1521840 (UMLS CUI [1,2])
C0205539 (UMLS CUI [1,3])
Social Security Affiliation Absent
Item
patient non-affiliated to social security
boolean
C0037435 (UMLS CUI [1,1])
C1510825 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Pregnancy | Breast Feeding
Item
pregnant and nursing mothers
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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