ID

42668

Description

ODM derived from http://clinicaltrials.gov/show/NCT00754559

Link

http://clinicaltrials.gov/show/NCT00754559

Keywords

Versions (2)
  1. 12/6/13 12/6/13 - Martin Dugas
  2. 9/17/21 9/17/21 -
Uploaded on

September 17, 2021

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License

Creative Commons BY 4.0
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Eligibility NCT00754559 Rheumatoid Arthritis

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age at least 18 Years
Description

age at least 18 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Adult (person)
Description

adult patients, >=18 years of age

Data type

boolean

Alias
UMLS CUI 2011AA
C0001675
SNOMED CT 2011_0131
133936004
rheumatoid arthritis of >=6 months duration diagnosed according to the revised 1987 ACR criteria
Description

rheumatoid arthritis of >=6 months duration diagnosed according to the revised 1987 ACR criteria

Data type

boolean

Alias
UMLS CUI 2011AA
C0003873
SNOMED CT 2011_0131
69896004
MedDRA 14.1
10039073
ICD-10-CM Version 2010
M06.9
ICD-9-CM Version 2011
714.0
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0439091
SNOMED CT 2011_0131
276138003
HL7 V3 2006_05
GE
UMLS CUI 2011AA
C0205452
SNOMED CT 2011_0131
68244004
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C0439617
SNOMED CT 2011_0131
272129003
UMLS CUI 2011AA
C0596070
UMLS CUI 2011AA
C0557806
SNOMED CT 2011_0131
224864007
UMLS CUI 2011AA
C0035452
SNOMED CT 2011_0131
394810000
UMLS CUI 2011AA
CL414621
Disease activity score using 28 joint count
Description

DAS28 of >3.2

Data type

boolean

Alias
UMLS CUI 2011AA
C2711347
SNOMED CT 2011_0131
441870009
At screening either ESR >=28 mm/h or CRP >=1 mg/dL
Description

At screening either ESR >=28 mm/h or CRP >=1 mg/dL

Data type

boolean

Alias
UMLS CUI 2011AA
C1409616
UMLS CUI 2011AA
C1176468
SNOMED CT 2011_0131
416838001
MedDRA 14.1
10049184
LOINC Version 232
MTHU007980
UMLS CUI 2011AA
C0006560
SNOMED CT 2011_0131
61425002
LOINC Version 232
MTHU002335
Having received permitted DMARDs >= 1. Current DMARD therapy must have been at a stable dose for at least 8 weeks prior to baseline.
Description

Having received permitted DMARDs >= 1. Current DMARD therapy must have been at a stable dose for at least 8 weeks prior to baseline.

Data type

boolean

Alias
UMLS CUI 2011AA
C0521104
SNOMED CT 2011_0131
75554001
UMLS CUI 2011AA
C0242708
UMLS CUI 2011AA
C2827774
UMLS CUI 2011AA
C0205360
SNOMED CT 2011_0131
58158008
LOINC Version 232
MTHU015276
UMLS CUI 2011AA
C0178602
SNOMED CT 2011_0131
260911001
UMLS CUI 2011AA
C0205454
SNOMED CT 2011_0131
7319005
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1442488
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following screening
Description

major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following screening

Data type

boolean

Alias
UMLS CUI 2011AA
C0679637
UMLS CUI 2011AA
C0185132
SNOMED CT 2011_0131
112698002
MedDRA 14.1
10051056
UMLS CUI 2011AA
C0205454
SNOMED CT 2011_0131
7319005
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1409616
UMLS CUI 2011AA
C1301732
SNOMED CT 2011_0131
397943006
UMLS CUI 2011AA
C0679637
functional class IV as identified by the ACR classification of functional status in RA
Description

functional class IV as identified by the ACR classification of functional status in RA

Data type

boolean

Alias
UMLS CUI 2011AA
C0598463
LOINC Version 232
MTHU027728
UMLS CUI 2011AA
C0003873
SNOMED CT 2011_0131
69896004
MedDRA 14.1
10039073
ICD-10-CM Version 2010
M06.9
ICD-9-CM Version 2011
714.0
UMLS CUI 2011AA
C0441888
SNOMED CT 2011_0131
264750004
UMLS CUI 2011AA
C0596070
UMLS CUI 2011AA
C0557806
SNOMED CT 2011_0131
224864007
UMLS CUI 2011AA
C0035452
SNOMED CT 2011_0131
394810000
UMLS CUI 2011AA
C0008902
SNOMED CT 2011_0131
278201002
rheumatoid autoimmune disease other than RA
Description

rheumatoid autoimmune disease other than RA

Data type

boolean

Alias
UMLS CUI 2011AA
C1406307
UMLS CUI 2011AA
C0004364
SNOMED CT 2011_0131
85828009
MedDRA 14.1
10061664
ICD-10-CM Version 2010
M30-M36
CTCAE 1105E
E11258
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0003873
SNOMED CT 2011_0131
69896004
MedDRA 14.1
10039073
ICD-10-CM Version 2010
M06.9
ICD-9-CM Version 2011
714.0
prior history of or current inflammatory joint disease other than RA.
Description

prior history of or current inflammatory joint disease other than RA.

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0521116
SNOMED CT 2011_0131
15240007
UMLS CUI 2011AA
C0683381
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0003873
SNOMED CT 2011_0131
69896004
MedDRA 14.1
10039073
ICD-10-CM Version 2010
M06.9
ICD-9-CM Version 2011
714.0
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age at least 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
adult patients, >=18 years of age
Item
Adult (person)
boolean
C0001675 (UMLS CUI 2011AA)
133936004 (SNOMED CT 2011_0131)
rheumatoid arthritis of >=6 months duration diagnosed according to the revised 1987 ACR criteria
Item
rheumatoid arthritis of >=6 months duration diagnosed according to the revised 1987 ACR criteria
boolean
C0003873 (UMLS CUI 2011AA)
69896004 (SNOMED CT 2011_0131)
10039073 (MedDRA 14.1)
M06.9 (ICD-10-CM Version 2010)
714.0 (ICD-9-CM Version 2011)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0439091 (UMLS CUI 2011AA)
276138003 (SNOMED CT 2011_0131)
GE (HL7 V3 2006_05)
C0205452 (UMLS CUI 2011AA)
68244004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0439617 (UMLS CUI 2011AA)
272129003 (SNOMED CT 2011_0131)
C0596070 (UMLS CUI 2011AA)
C0557806 (UMLS CUI 2011AA)
224864007 (SNOMED CT 2011_0131)
C0035452 (UMLS CUI 2011AA)
394810000 (SNOMED CT 2011_0131)
CL414621 (UMLS CUI 2011AA)
DAS28 of >3.2
Item
Disease activity score using 28 joint count
boolean
C2711347 (UMLS CUI 2011AA)
441870009 (SNOMED CT 2011_0131)
At screening either ESR >=28 mm/h or CRP >=1 mg/dL
Item
At screening either ESR >=28 mm/h or CRP >=1 mg/dL
boolean
C1409616 (UMLS CUI 2011AA)
C1176468 (UMLS CUI 2011AA)
416838001 (SNOMED CT 2011_0131)
10049184 (MedDRA 14.1)
MTHU007980 (LOINC Version 232)
C0006560 (UMLS CUI 2011AA)
61425002 (SNOMED CT 2011_0131)
MTHU002335 (LOINC Version 232)
Having received permitted DMARDs >= 1. Current DMARD therapy must have been at a stable dose for at least 8 weeks prior to baseline.
Item
Having received permitted DMARDs >= 1. Current DMARD therapy must have been at a stable dose for at least 8 weeks prior to baseline.
boolean
C0521104 (UMLS CUI 2011AA)
75554001 (SNOMED CT 2011_0131)
C0242708 (UMLS CUI 2011AA)
C2827774 (UMLS CUI 2011AA)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0205454 (UMLS CUI 2011AA)
7319005 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1442488 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following screening
Item
major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following screening
boolean
C0679637 (UMLS CUI 2011AA)
C0185132 (UMLS CUI 2011AA)
112698002 (SNOMED CT 2011_0131)
10051056 (MedDRA 14.1)
C0205454 (UMLS CUI 2011AA)
7319005 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
C1301732 (UMLS CUI 2011AA)
397943006 (SNOMED CT 2011_0131)
C0679637 (UMLS CUI 2011AA)
functional class IV as identified by the ACR classification of functional status in RA
Item
functional class IV as identified by the ACR classification of functional status in RA
boolean
C0598463 (UMLS CUI 2011AA)
MTHU027728 (LOINC Version 232)
C0003873 (UMLS CUI 2011AA)
69896004 (SNOMED CT 2011_0131)
10039073 (MedDRA 14.1)
M06.9 (ICD-10-CM Version 2010)
714.0 (ICD-9-CM Version 2011)
C0441888 (UMLS CUI 2011AA)
264750004 (SNOMED CT 2011_0131)
C0596070 (UMLS CUI 2011AA)
C0557806 (UMLS CUI 2011AA)
224864007 (SNOMED CT 2011_0131)
C0035452 (UMLS CUI 2011AA)
394810000 (SNOMED CT 2011_0131)
C0008902 (UMLS CUI 2011AA)
278201002 (SNOMED CT 2011_0131)
rheumatoid autoimmune disease other than RA
Item
rheumatoid autoimmune disease other than RA
boolean
C1406307 (UMLS CUI 2011AA)
C0004364 (UMLS CUI 2011AA)
85828009 (SNOMED CT 2011_0131)
10061664 (MedDRA 14.1)
M30-M36 (ICD-10-CM Version 2010)
E11258 (CTCAE 1105E)
CL411789 (UMLS CUI 2011AA)
C0003873 (UMLS CUI 2011AA)
69896004 (SNOMED CT 2011_0131)
10039073 (MedDRA 14.1)
M06.9 (ICD-10-CM Version 2010)
714.0 (ICD-9-CM Version 2011)
prior history of or current inflammatory joint disease other than RA.
Item
prior history of or current inflammatory joint disease other than RA.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0521116 (UMLS CUI 2011AA)
15240007 (SNOMED CT 2011_0131)
C0683381 (UMLS CUI 2011AA)
CL411789 (UMLS CUI 2011AA)
C0003873 (UMLS CUI 2011AA)
69896004 (SNOMED CT 2011_0131)
10039073 (MedDRA 14.1)
M06.9 (ICD-10-CM Version 2010)
714.0 (ICD-9-CM Version 2011)
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