ID
43276
Description
ODM derived from http://clinicaltrials.gov/show/NCT01261793
Link
http://clinicaltrials.gov/show/NCT01261793
Keywords
Versions (2)
- 2/22/13 2/22/13 - Martin Dugas
- 9/20/21 9/20/21 -
Uploaded on
September 20, 2021
DOI
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License
Creative Commons BY 4.0
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Eligibility NCT01261793 Systemic Lupus Erythematosus
Eligibility
- StudyEvent: Eligibility
Description
Exclusion Criteria
Description
Subjects who are breastfeeding, pregnant, or plan to become pregnant
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0030705
- SNOMED CT 2011_0131
- 116154003
- UMLS CUI 2011AA
- C0006147
- MedDRA 14.1
- 10006247
- UMLS CUI 2011AA
- C0549206
- MedDRA 14.1
- 10036586
- UMLS CUI 2011AA
- C0032992
- SNOMED CT 2011_0131
- 169565003
Description
Subjects with active, severe SLE disease activity which involves the renal system
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0205177
- SNOMED CT 2011_0131
- 55561003
- UMLS CUI 2011AA
- C0205082
- SNOMED CT 2011_0131
- 24484000
- UMLS CUI 2011AA
- C0024141
- SNOMED CT 2011_0131
- 55464009
- MedDRA 14.1
- 10042945
- ICD-10-CM Version 2010
- M32.9
- ICD-9-CM Version 2011
- 710.0
- UMLS CUI 2011AA
- C1314939
- SNOMED CT 2011_0131
- 248448006
- UMLS CUI 2011AA
- C0022646
- SNOMED CT 2011_0131
- 64033007
- LOINC Version 232
- MTHU002935
- UMLS CUI 2011AA
- C0449913
- SNOMED CT 2011_0131
- 246333005
- LOINC Version 232
- MTHU025766
Description
Subjects with active, severe, neuropsychiatric SLE, defined as any neuropsychiatric element scoring BILAG level A disease.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0205177
- SNOMED CT 2011_0131
- 55561003
- UMLS CUI 2011AA
- C0205082
- SNOMED CT 2011_0131
- 24484000
- UMLS CUI 2011AA
- C0752335
- MedDRA 14.1
- 10063663
- UMLS CUI 2011AA
- C1704788
- UMLS CUI 2011AA
- C0451046
- SNOMED CT 2011_0131
- 273339006
- UMLS CUI 2011AA
- C0456079
- SNOMED CT 2011_0131
- 276625007
- UMLS CUI 2011AA
- C1706281
- SNOMED CT 2011_0131
- 422097006
- UMLS CUI 2011AA
- C0012634
- SNOMED CT 2011_0131
- 64572001
Description
Subjects with the evidence of an immunosuppressive state
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0332120
- SNOMED CT 2011_0131
- 18669006
- UMLS CUI 2011AA
- C0021079
- SNOMED CT 2011_0131
- 86553008
- UMLS CUI 2011AA
- C1442792
Description
Subjects who, in the opinion of the investigator, are at a particularly high risk of significant infection
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0442824
- SNOMED CT 2011_0131
- 260358002
- UMLS CUI 2011AA
- C0332167
- SNOMED CT 2011_0131
- 15508007
- UMLS CUI 2011AA
- C0750502
- SNOMED CT 2011_0131
- 386134007
- UMLS CUI 2011AA
- C0009450
- SNOMED CT 2011_0131
- 257551009
- MedDRA 14.1
- 10021789
Description
History of malignant cancer, except the following treated cancers: cervical carcinoma in situ, basal cell carcinoma, or dermatological squamous cell carcinoma.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C2735088
- LOINC Version 232
- MTHU034770
- UMLS CUI 2011AA
- C1554961
- HL7 V3 2006_05
- E
- UMLS CUI 2011AA
- CL415147
- UMLS CUI 2011AA
- C0851140
- SNOMED CT 2011_0131
- 92564006
- MedDRA 14.1
- 10061809
- ICD-10-CM Version 2010
- D06.9
- ICD-9-CM Version 2011
- 233.1
- UMLS CUI 2011AA
- C0007117
- SNOMED CT 2011_0131
- 1338007, 254701007
- MedDRA 14.1
- 10004146
- UMLS CUI 2011AA
- C0553723
- SNOMED CT 2011_0131
- 254651007
- MedDRA 14.1
- 10041834
Description
Subjects receiving any live vaccination within the 8 weeks prior to screening (Visit 1).
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1514756
- UMLS CUI 2011AA
- C0042211
- 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
Description
Subjects with history of infections, including but not limited to concurrent acute or chronic viral hepatitis B or C
Data type
boolean
Alias
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C0009450
- SNOMED CT 2011_0131
- 257551009
- MedDRA 14.1
- 10021789
- UMLS CUI 2011AA
- C0332257
- SNOMED CT 2011_0131
- 55919000
- UMLS CUI 2011AA
- C0205178
- SNOMED CT 2011_0131
- 272118002
- UMLS CUI 2011AA
- C0019163
- SNOMED CT 2011_0131
- 66071002
- MedDRA 14.1
- 10019731
- UMLS CUI 2011AA
- C0019196
- SNOMED CT 2011_0131
- 50711007
- MedDRA 14.1
- 10019744
- ICD-10-CM Version 2010
- B19.20
- ICD-9-CM Version 2011
- 070.7
- UMLS CUI 2011AA
- C0524909
- SNOMED CT 2011_0131
- 61977001
- MedDRA 14.1
- 10008910
- ICD-10-CM Version 2010
- B18.1
- UMLS CUI 2011AA
- C0524910
- SNOMED CT 2011_0131
- 128302006
- MedDRA 14.1
- 10008912
- ICD-10-CM Version 2010
- B18.2
Description
Subjects with substance abuse or dependence or other relevant concurrent medical condition
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0740858
- SNOMED CT 2011_0131
- 66214007
- MedDRA 14.1
- 10066169
- LOINC Version 232
- MTHU019364
- UMLS CUI 2011AA
- C0038580
- SNOMED CT 2011_0131
- 2403008
- UMLS CUI 2011AA
- C0205394
- SNOMED CT 2011_0131
- 74964007
- UMLS CUI 2011AA
- C2347946
- UMLS CUI 2011AA
- C1699700
- HL7 V3 2006_05
- MEDCCAT
Description
Subjects with history of thromboembolic events within 1 year of screening Visit.
Data type
boolean
Alias
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C0040038
- MedDRA 14.1
- 10043565
Description
Subjects with significant hematologic abnormalities
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0750502
- SNOMED CT 2011_0131
- 386134007
- UMLS CUI 2011AA
- C0205488
- SNOMED CT 2011_0131
- 57407000
- UMLS CUI 2011AA
- C1704258
Description
Subject has received treatment with other anti-B cell antibodies within 12 months prior to screening (visit 1)
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1514756
- UMLS CUI 2011AA
- C0039798
- UMLS CUI 2011AA
- C0205394
- SNOMED CT 2011_0131
- 74964007
- UMLS CUI 2011AA
- C0003250
- SNOMED CT 2011_0131
- 49616005
- UMLS CUI 2011AA
- C0521124
- SNOMED CT 2011_0131
- 65897001
- UMLS CUI 2011AA
- C0004561
- SNOMED CT 2011_0131
- 112130006
- LOINC Version 232
- MTHU002435
Description
Subject use of oral anticoagulant (not including) nonsteroidal anti-inflammatory drugs (NSAIDs) within 12 weeks prior to screening (Visit 1)
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1524063
- SNOMED CT 2011_0131
- 260676000
- UMLS CUI 2011AA
- C1527415
- SNOMED CT 2011_0131
- 26643006
- HL7 V3 2006_05
- _OralRoute
- UMLS CUI 2011AA
- C0003280
- SNOMED CT 2011_0131
- 372862008
- UMLS CUI 2011AA
- CL411789
- UMLS CUI 2011AA
- C0003211
- SNOMED CT 2011_0131
- 16403005, 372665008
Description
Subject has previously participated in this study or has previously received epratuzumab treatment.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0205156
- SNOMED CT 2011_0131
- 9130008
- UMLS CUI 2011AA
- C0679823
- HL7 V3 2006_05
- PART
- UMLS CUI 2011AA
- C0150312
- SNOMED CT 2011_0131
- 52101004
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
- UMLS CUI 2011AA
- C1514756
- UMLS CUI 2011AA
- C1120776
- UMLS CUI 2011AA
- C0039798
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Eligibility
- StudyEvent: Eligibility
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710.0 (ICD-9-CM Version 2011)
C1314939 (UMLS CUI 2011AA)
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