ID

31868

Descripción

Drug Outcome Survey for Biological Treatments in Rheumatoid Arthritis: an Observational Study (Dose); ODM derived from: https://clinicaltrials.gov/show/NCT00794118

Link

https://clinicaltrials.gov/show/NCT00794118

Palabras clave

Versiones (1)
  1. 5/10/18 5/10/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

5 de octubre de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00794118

Inglés

Eligibility Rheumatoid Arthritis NCT00794118

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. eighteen years of age or older
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
2. diagnosis of ra in accordance with ara 1987 classification has satisfied at least 4 of the following 7 criteria:
Descripción

Rheumatoid Arthritis Consistent with Classification Criteria | Criteria Quantity Fulfill

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0332290
UMLS CUI [1,3]
C0008902
UMLS CUI [1,4]
C0243161
UMLS CUI [2,1]
C0243161
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C1550543
1. morning stiffness in and around the joints lasting at least 1 hour;
Descripción

Morning stiffness - joint Duration

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0457086
UMLS CUI [1,2]
C0449238
2. arthritis of 3 or more joint areas;
Descripción

Arthritis Joint Area Quantity

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0003864
UMLS CUI [1,2]
C0022417
UMLS CUI [1,3]
C0205146
UMLS CUI [1,4]
C1265611
3. arthritis of hand joints;
Descripción

Arthritis Hand joints

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0003864
UMLS CUI [1,2]
C0459470
4. symmetric arthritis. simultaneous involvement of the same joint areas on both sides of the body;
Descripción

Arthritis Symmetric

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0003864
UMLS CUI [1,2]
C0332516
5. rheumatoid nodules;
Descripción

Rheumatoid Nodules

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0035450
6. serum rheumatoid factor (rf)
Descripción

RF | Rheumatoid factor presence in serum

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0035448
UMLS CUI [2]
C4481755
7. radiographic changes. criteria 1 through 4 must have been present for at least 6 weeks.
Descripción

Change Radiographic | Criteria Present Duration

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0392747
UMLS CUI [1,2]
C0444708
UMLS CUI [2,1]
C0243161
UMLS CUI [2,2]
C0150312
UMLS CUI [2,3]
C0449238
3. patients refractory or without complete response to dmards according to the italian guidelines for the clinical practice established by italian society of rheumatology
Descripción

DMARDs Unresponsive to Treatment | DMARDs Complete therapeutic response Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0242708
UMLS CUI [1,2]
C0205269
UMLS CUI [2,1]
C0242708
UMLS CUI [2,2]
C1275810
UMLS CUI [2,3]
C0332197
4. patients naive to anti-tnf drugs
Descripción

Anti-TNF drug naive

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1562242
UMLS CUI [1,2]
C0919936
5. outpatients
Descripción

Outpatients

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0029921
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients involved in controlled or interventional trials in the 12 previous months
Descripción

Study Subject Participation Status | Controlled study | Interventional Study

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0681867
UMLS CUI [3]
C3274035
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Similar models

Eligibility Rheumatoid Arthritis NCT00794118

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. eighteen years of age or older
boolean
C0001779 (UMLS CUI [1])
Rheumatoid Arthritis Consistent with Classification Criteria | Criteria Quantity Fulfill
Item
2. diagnosis of ra in accordance with ara 1987 classification has satisfied at least 4 of the following 7 criteria:
boolean
C0003873 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C0008902 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,4])
C0243161 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1550543 (UMLS CUI [2,3])
Morning stiffness - joint Duration
Item
1. morning stiffness in and around the joints lasting at least 1 hour;
boolean
C0457086 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Arthritis Joint Area Quantity
Item
2. arthritis of 3 or more joint areas;
boolean
C0003864 (UMLS CUI [1,1])
C0022417 (UMLS CUI [1,2])
C0205146 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
Arthritis Hand joints
Item
3. arthritis of hand joints;
boolean
C0003864 (UMLS CUI [1,1])
C0459470 (UMLS CUI [1,2])
Arthritis Symmetric
Item
4. symmetric arthritis. simultaneous involvement of the same joint areas on both sides of the body;
boolean
C0003864 (UMLS CUI [1,1])
C0332516 (UMLS CUI [1,2])
Rheumatoid Nodules
Item
5. rheumatoid nodules;
boolean
C0035450 (UMLS CUI [1])
RF | Rheumatoid factor presence in serum
Item
6. serum rheumatoid factor (rf)
boolean
C0035448 (UMLS CUI [1])
C4481755 (UMLS CUI [2])
Change Radiographic | Criteria Present Duration
Item
7. radiographic changes. criteria 1 through 4 must have been present for at least 6 weeks.
boolean
C0392747 (UMLS CUI [1,1])
C0444708 (UMLS CUI [1,2])
C0243161 (UMLS CUI [2,1])
C0150312 (UMLS CUI [2,2])
C0449238 (UMLS CUI [2,3])
DMARDs Unresponsive to Treatment | DMARDs Complete therapeutic response Absent
Item
3. patients refractory or without complete response to dmards according to the italian guidelines for the clinical practice established by italian society of rheumatology
boolean
C0242708 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
C0242708 (UMLS CUI [2,1])
C1275810 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Anti-TNF drug naive
Item
4. patients naive to anti-tnf drugs
boolean
C1562242 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
Outpatients
Item
5. outpatients
boolean
C0029921 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status | Controlled study | Interventional Study
Item
patients involved in controlled or interventional trials in the 12 previous months
boolean
C2348568 (UMLS CUI [1])
C0681867 (UMLS CUI [2])
C3274035 (UMLS CUI [3])
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