ID
43290
Description
ODM derived from http://clinicaltrials.gov/show/NCT01294774
Link
http://clinicaltrials.gov/show/NCT01294774
Keywords
Versions (2)
- 2/28/13 2/28/13 - 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 NCT01294774 Subacute Cutaneous Lupus Erythematosus
Eligibility
- StudyEvent: Eligibility
Description
Exclusion Criteria
Description
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.
Data type
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
Description
Patients who have been treated with:
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0332293
- SNOMED CT 2011_0131
- 28995006
Description
immunoglobulins and/or monoclonal antibodies within 6 months prior to randomization.
Data type
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
Description
rituximab, cyclophosphamide, or other immunosuppressive treatments with effects potentially lasting over 6 months, within 12 months prior to randomization.
Data type
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
Description
a medium or high dose (>= 1 mg prednisone or equivalent per body weight kg) corticosteroid therapy in the last 8 weeks prior to randomization.
Data type
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
Description
antimalarial agents (hydroxychloroquine, chloroquine or quinacrine) in the last 6 weeks prior to randomization.
Data type
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
Description
biologic therapies, such as etanercept, within the last 4 weeks prior to randomization.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0005527
- UMLS CUI 2011AA
- C0717758
- SNOMED CT 2011_0131
- 387045004
Description
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.
Data type
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
Description
total lymphoid irradiation or bone marrow transplantation.
Data type
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
Description
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.
Data type
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
- C0086287
- SNOMED CT 2011_0131
- 248152002
- HL7 V3 2006_05
- F
- UMLS CUI 2011AA
- C0086582
- 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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