ID

31868

Beschreibung

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

Stichworte

  1. 05.10.18 05.10.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

5. Oktober 2018

DOI

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Lizenz

Creative Commons BY 4.0

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Eligibility Rheumatoid Arthritis NCT00794118

Eligibility Rheumatoid Arthritis NCT00794118

Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Age

Datentyp

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:
Beschreibung

Rheumatoid Arthritis Consistent with Classification Criteria | Criteria Quantity Fulfill

Datentyp

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;
Beschreibung

Morning stiffness - joint Duration

Datentyp

boolean

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

Arthritis Joint Area Quantity

Datentyp

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;
Beschreibung

Arthritis Hand joints

Datentyp

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;
Beschreibung

Arthritis Symmetric

Datentyp

boolean

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

Rheumatoid Nodules

Datentyp

boolean

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

RF | Rheumatoid factor presence in serum

Datentyp

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.
Beschreibung

Change Radiographic | Criteria Present Duration

Datentyp

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
Beschreibung

DMARDs Unresponsive to Treatment | DMARDs Complete therapeutic response Absent

Datentyp

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
Beschreibung

Anti-TNF drug naive

Datentyp

boolean

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

Outpatients

Datentyp

boolean

Alias
UMLS CUI [1]
C0029921
Exclusion Criteria
Beschreibung

Exclusion Criteria

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

Study Subject Participation Status | Controlled study | Interventional Study

Datentyp

boolean

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

Ähnliche Modelle

Eligibility Rheumatoid Arthritis NCT00794118

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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