ID

4548

Description

ODM derived from http://clinicaltrials.gov/show/NCT00502840

Link

http://clinicaltrials.gov/show/NCT00502840

Keywords

Versions (2)
  1. 12/10/13 12/10/13 - Martin Dugas
  2. 9/17/21 9/17/21 -
Uploaded on

December 10, 2013

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT00502840 Rheumatoid Arthritis

German English

Eligibility

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

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age 18 Years to 75 Years
Description

age 18 Years to 75 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
adult patients with rheumatoid arthritis who participated in ML19070, and have completed the week 24 visit
Description

adult patients with rheumatoid arthritis who participated in ML19070, and have completed the week 24 visit

Data type

boolean

Alias
UMLS CUI 2011AA
C0700597
SNOMED CT 2011_0131
41847000
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
C0681850
UMLS CUI 2011AA
C0205197
SNOMED CT 2011_0131
255594003
UMLS CUI 2011AA
C0585339
SNOMED CT 2011_0131
396149002
UMLS CUI 2011AA
C1554196
HL7 V3 2006_05
ENC
eligible for re-treatment (DAS28 >2.6 after week 24, swollen joint count >=4, tender joint count >=4).
Description

eligible for re-treatment (DAS28 >2.6 after week 24, swollen joint count >=4, tender joint count >=4).

Data type

boolean

Alias
UMLS CUI 2011AA
C1302261
SNOMED CT 2011_0131
399223003
UMLS CUI 2011AA
C0376495
UMLS CUI 2011AA
C2711347
SNOMED CT 2011_0131
441870009
UMLS CUI 2011AA
C0231290
SNOMED CT 2011_0131
237679004
UMLS CUI 2011AA
C2825407
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
UMLS CUI 2011AA
C0451521
SNOMED CT 2011_0131
273856009
UMLS CUI 2011AA
C0451530
SNOMED CT 2011_0131
273865002
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
patients who have withdrawn from treatment in ML19070 pre-week 16
Description

patients who have withdrawn from treatment in ML19070 pre-week 16

Data type

boolean

Alias
UMLS CUI 2011AA
C0422727
SNOMED CT 2011_0131
185924006
UMLS CUI 2011AA
C2349954
UMLS CUI 2011AA
C0039798
patients with a previous response in DAS28 <0.6 to MabThera after week 16
Description

patients with a previous response in DAS28 <0.6 to MabThera after week 16

Data type

boolean

Alias
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
C0521982
SNOMED CT 2011_0131
182985004
UMLS CUI 2011AA
C2711347
SNOMED CT 2011_0131
441870009
UMLS CUI 2011AA
C0732355
SNOMED CT 2011_0131
386919002
UMLS CUI 2011AA
C0231290
SNOMED CT 2011_0131
237679004
concurrent treatment with any DMARD except for methotrexate, any TNF alpha inhibitor, or other biologic or investigational agent.
Description

concurrent treatment with any DMARD except for methotrexate, any TNF alpha inhibitor, or other biologic or investigational agent.

Data type

boolean

Alias
UMLS CUI 2011AA
C0009429
UMLS CUI 2011AA
C0242708
UMLS CUI 2011AA
C1456820
SNOMED CT 2011_0131
39525005
LOINC Version 232
MTHU004497
UMLS CUI 2011AA
C1554961
UMLS CUI 2011AA
C0025677
SNOMED CT 2011_0131
387381009
LOINC Version 232
MTHU005020
UMLS CUI 2011AA
C1562242
SNOMED CT 2011_0131
420693002
UMLS CUI 2011AA
C0005522
SNOMED CT 2011_0131
418980009
UMLS CUI 2011AA
C0013230
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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 18 Years to 75 Years
Item
age 18 Years to 75 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
adult patients with rheumatoid arthritis who participated in ML19070, and have completed the week 24 visit
Item
adult patients with rheumatoid arthritis who participated in ML19070, and have completed the week 24 visit
boolean
C0700597 (UMLS CUI 2011AA)
41847000 (SNOMED CT 2011_0131)
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)
C0681850 (UMLS CUI 2011AA)
C0205197 (UMLS CUI 2011AA)
255594003 (SNOMED CT 2011_0131)
C0585339 (UMLS CUI 2011AA)
396149002 (SNOMED CT 2011_0131)
C1554196 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
eligible for re-treatment (DAS28 >2.6 after week 24, swollen joint count >=4, tender joint count >=4).
Item
eligible for re-treatment (DAS28 >2.6 after week 24, swollen joint count >=4, tender joint count >=4).
boolean
C1302261 (UMLS CUI 2011AA)
399223003 (SNOMED CT 2011_0131)
C0376495 (UMLS CUI 2011AA)
C2711347 (UMLS CUI 2011AA)
441870009 (SNOMED CT 2011_0131)
C0231290 (UMLS CUI 2011AA)
237679004 (SNOMED CT 2011_0131)
C2825407 (UMLS CUI 2011AA)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C0451521 (UMLS CUI 2011AA)
273856009 (SNOMED CT 2011_0131)
C0451530 (UMLS CUI 2011AA)
273865002 (SNOMED CT 2011_0131)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
patients who have withdrawn from treatment in ML19070 pre-week 16
Item
patients who have withdrawn from treatment in ML19070 pre-week 16
boolean
C0422727 (UMLS CUI 2011AA)
185924006 (SNOMED CT 2011_0131)
C2349954 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
patients with a previous response in DAS28 <0.6 to MabThera after week 16
Item
patients with a previous response in DAS28 <0.6 to MabThera after week 16
boolean
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C0521982 (UMLS CUI 2011AA)
182985004 (SNOMED CT 2011_0131)
C2711347 (UMLS CUI 2011AA)
441870009 (SNOMED CT 2011_0131)
C0732355 (UMLS CUI 2011AA)
386919002 (SNOMED CT 2011_0131)
C0231290 (UMLS CUI 2011AA)
237679004 (SNOMED CT 2011_0131)
concurrent treatment with any DMARD except for methotrexate, any TNF alpha inhibitor, or other biologic or investigational agent.
Item
concurrent treatment with any DMARD except for methotrexate, any TNF alpha inhibitor, or other biologic or investigational agent.
boolean
C0009429 (UMLS CUI 2011AA)
C0242708 (UMLS CUI 2011AA)
C1456820 (UMLS CUI 2011AA)
39525005 (SNOMED CT 2011_0131)
MTHU004497 (LOINC Version 232)
C1554961 (UMLS CUI 2011AA)
C0025677 (UMLS CUI 2011AA)
387381009 (SNOMED CT 2011_0131)
MTHU005020 (LOINC Version 232)
C1562242 (UMLS CUI 2011AA)
420693002 (SNOMED CT 2011_0131)
C0005522 (UMLS CUI 2011AA)
418980009 (SNOMED CT 2011_0131)
C0013230 (UMLS CUI 2011AA)
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