ID
3739
Beskrivning
ODM derived from http://clinicaltrials.gov/show/NCT01294774
Länk
http://clinicaltrials.gov/show/NCT01294774
Nyckelord
Versioner (2)
- 2013-02-28 2013-02-28 - Martin Dugas
- 2021-09-20 2021-09-20 -
Uppladdad den
28 februari 2013
DOI
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Licens
Creative Commons BY 4.0
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Eligibility NCT01294774 Subacute Cutaneous Lupus Erythematosus
Eligibility
- StudyEvent: Eligibility
Beskrivning
Exclusion Criteria
Beskrivning
Patients with preexisting nephritis, central nervous or pulmonary involvement or any major internal organ damage, either related or unrelated to lupus, which are deemed by the Investigator to be clinically significant. Patients having signs or symptoms of other autoimmune diseases such as systemic lupus erythematosus or Sjogren`s syndrome are allowed to enter the study at the Investigator`s discretion.
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C2347662
- UMLS CUI 2011AA
- C0027697
- SNOMED CT 2011_0131
- 52845002
- MedDRA 14.1
- 10029117
- ICD-10-CM Version 2010
- N08
- UMLS CUI 2011AA
- C0449389
- SNOMED CT 2011_0131
- 260766009
- UMLS CUI 2011AA
- C2709248
- SNOMED CT 2011_0131
- 264164005
- LOINC Version 232
- MTHU031874
- UMLS CUI 2011AA
- C1314939
- SNOMED CT 2011_0131
- 248448006
- UMLS CUI 2011AA
- C0205164
- SNOMED CT 2011_0131
- 255603008
- UMLS CUI 2011AA
- C0332675
- SNOMED CT 2011_0131
- 105612003
- MedDRA 14.1
- 10061245
- UMLS CUI 2011AA
- C0699792
- SNOMED CT 2011_0131
- 263498003
- UMLS CUI 2011AA
- CL414700
- UMLS CUI 2011AA
- C0409974
- SNOMED CT 2011_0131
- 200936003
- MedDRA 14.1
- 10025134
- ICD-10-CM Version 2010
- L93
- ICD-9-CM Version 2011
- 695.4
Beskrivning
Patients who have been treated with:
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C0332293
- SNOMED CT 2011_0131
- 28995006
Beskrivning
immunoglobulins and/or monoclonal antibodies within 6 months prior to randomization.
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C0021027
- SNOMED CT 2011_0131
- 399771004
- HL7 V3 2006_05
- 14
- UMLS CUI 2011AA
- C0003250
- SNOMED CT 2011_0131
- 49616005
Beskrivning
rituximab, cyclophosphamide, or other immunosuppressive treatments with effects potentially lasting over 6 months, within 12 months prior to randomization.
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C0732355
- SNOMED CT 2011_0131
- 386919002
- UMLS CUI 2011AA
- C0010583
- SNOMED CT 2011_0131
- 387420009
- LOINC Version 232
- MTHU029970
- UMLS CUI 2011AA
- C0205394
- SNOMED CT 2011_0131
- 74964007
- UMLS CUI 2011AA
- C0021079
- SNOMED CT 2011_0131
- 86553008
Beskrivning
a medium or high dose (>= 1 mg prednisone or equivalent per body weight kg) corticosteroid therapy in the last 8 weeks prior to randomization.
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C0439536
- SNOMED CT 2011_0131
- 255508009
- UMLS CUI 2011AA
- C0178602
- SNOMED CT 2011_0131
- 260911001
- UMLS CUI 2011AA
- C0444956
- SNOMED CT 2011_0131
- 261829003
- UMLS CUI 2011AA
- C0032952
- SNOMED CT 2011_0131
- 116602009
- LOINC Version 232
- MTHU003245
- UMLS CUI 2011AA
- CL415123
- UMLS CUI 2011AA
- C0149783
- SNOMED CT 2011_0131
- 297279009
- MedDRA 14.1
- 10062117
Beskrivning
antimalarial agents (hydroxychloroquine, chloroquine or quinacrine) in the last 6 weeks prior to randomization.
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C0003374
- SNOMED CT 2011_0131
- 80229008
- UMLS CUI 2011AA
- C0020336
- SNOMED CT 2011_0131
- 373540008
- LOINC Version 232
- MTHU016851
- UMLS CUI 2011AA
- C0008269
- SNOMED CT 2011_0131
- 373468005
- LOINC Version 232
- MTHU014870
- UMLS CUI 2011AA
- C0034403
- SNOMED CT 2011_0131
- 350225009
- LOINC Version 232
- MTHU007608
Beskrivning
biologic therapies, such as etanercept, within the last 4 weeks prior to randomization.
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C0005527
- UMLS CUI 2011AA
- C0717758
- SNOMED CT 2011_0131
- 387045004
Beskrivning
any other immunosuppressive or immunomodulatory therapy such as methotrexate, azathioprine, cyclosporin A or mycophenolate, thalidomide, retinoids or dapsone in the last 4 weeks prior to randomization.
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C1963758
- SNOMED CT 2011_0131
- 86553008
- MedDRA 14.1
- 10067473
- UMLS CUI 2011AA
- C0025677
- SNOMED CT 2011_0131
- 387381009
- LOINC Version 232
- MTHU005020
- UMLS CUI 2011AA
- C0004482
- SNOMED CT 2011_0131
- 372574004
- LOINC Version 232
- MTHU006794
- UMLS CUI 2011AA
- C0010592
- SNOMED CT 2011_0131
- 387467008
- LOINC Version 232
- MTHU005140
- UMLS CUI 2011AA
- C0883242
- LOINC Version 232
- MTHU011568
- UMLS CUI 2011AA
- C0039736
- SNOMED CT 2011_0131
- 78702007
- UMLS CUI 2011AA
- C2267033
- UMLS CUI 2011AA
- C0010980
- SNOMED CT 2011_0131
- 17308007
- LOINC Version 232
- MTHU024811
Beskrivning
total lymphoid irradiation or bone marrow transplantation.
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C1519560
- UMLS CUI 2011AA
- C0005961
- SNOMED CT 2011_0131
- 23719005
- MedDRA 14.1
- 10061730
- ICD-9-CM Version 2011
- 41.00
Beskrivning
Pregnant, planning to get pregnant, and/or lactating females or males planning to father a child within time period of the study or subsequent exclusionary period.
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C0549206
- MedDRA 14.1
- 10036586
- UMLS CUI 2011AA
- C0032992
- SNOMED CT 2011_0131
- 169565003
- UMLS CUI 2011AA
- C2828358
- UMLS CUI 2011AA
- C0015780
- SNOMED CT 2011_0131
- 248152002
- HL7 V3 2006_05
- F
- UMLS CUI 2011AA
- C0024554
- SNOMED CT 2011_0131
- 248153007
- HL7 V3 2006_05
- M
- UMLS CUI 2011AA
- C1301732
- SNOMED CT 2011_0131
- 397943006
- UMLS CUI 2011AA
- C0015671
- SNOMED CT 2011_0131
- 66839005
- LOINC Version 232
- MTHU035601
- HL7 V3 2006_05
- FTH
- UMLS CUI 2011AA
- C0008059
- SNOMED CT 2011_0131
- 67822003
- HL7 V3 2006_05
- CHILD
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Eligibility
- StudyEvent: Eligibility
397669002 (SNOMED CT 2011_0131)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
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248152002 (SNOMED CT 2011_0131)
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49616005 (SNOMED CT 2011_0131)
386919002 (SNOMED CT 2011_0131)
C0010583 (UMLS CUI 2011AA)
387420009 (SNOMED CT 2011_0131)
MTHU029970 (LOINC Version 232)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0021079 (UMLS CUI 2011AA)
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255508009 (SNOMED CT 2011_0131)
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260911001 (SNOMED CT 2011_0131)
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C0149783 (UMLS CUI 2011AA)
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10062117 (MedDRA 14.1)
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23719005 (SNOMED CT 2011_0131)
10061730 (MedDRA 14.1)
41.00 (ICD-9-CM Version 2011)
10036586 (MedDRA 14.1)
C0032992 (UMLS CUI 2011AA)
169565003 (SNOMED CT 2011_0131)
C2828358 (UMLS CUI 2011AA)
C0015780 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
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