ID

4415

Beschreibung

ODM derived from http://clinicaltrials.gov/show/NCT00823173

Link

http://clinicaltrials.gov/show/NCT00823173

Stichworte

Versionen (3)
  1. 09.12.13 09.12.13 - Martin Dugas
  2. 16.04.14 16.04.14 - Julian Varghese
  3. 20.09.21 20.09.21 -
Hochgeladen am

9. Dezember 2013

DOI

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Lizenz

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Eligibility NCT00823173 Anterior Uveitis

Deutsch Englisch

Eligibility

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

age at least 18 Years

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Signed and dated informed consent.
Beschreibung

Signed and dated informed consent.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C1519316
UMLS CUI 2011AA
C0011008
SNOMED CT 2011_0131
410671006
LOINC Version 232
MTHU021546
UMLS CUI 2011AA
C0021430
Patients with the typical presentation of HLA-B27 positive AAU (unilateral, painful anterior uveitis of sudden onset).
Beschreibung

Patients with the typical presentation of HLA-B27 positive AAU (unilateral, painful anterior uveitis of sudden onset).

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0019740
SNOMED CT 2011_0131
34453005
LOINC Version 232
MTHU012533
UMLS CUI 2011AA
CL415097
UMLS CUI 2011AA
C0701807
SNOMED CT 2011_0131
4927003
ICD-10-CM Version 2010
H20.0
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0205092
SNOMED CT 2011_0131
66459002
UMLS CUI 2011AA
CL414713
UMLS CUI 2011AA
C0042165
SNOMED CT 2011_0131
410692006
MedDRA 14.1
10046852
UMLS CUI 2011AA
C1272517
SNOMED CT 2011_0131
385315009
2+ anterior chamber cells according to the SUN Working Group criteria, as assessed by slit lamp biomicroscopy.
Beschreibung

2+ anterior chamber cells according to the SUN Working Group criteria, as assessed by slit lamp biomicroscopy.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C2827735
UMLS CUI 2011AA
C0423282
SNOMED CT 2011_0131
246993000
MedDRA 14.1
10053781
UMLS CUI 2011AA
C0332290
SNOMED CT 2011_0131
385433004
UMLS CUI 2011AA
C0038136
UMLS CUI 2011AA
C0042164
SNOMED CT 2011_0131
128473001
MedDRA 14.1
10046851
ICD-10-CM Version 2010
H20.9
CTCAE 1105E
E10442
UMLS CUI 2011AA
C0600281
UMLS CUI 2011AA
CL414621
UMLS CUI 2011AA
C0582103
SNOMED CT 2011_0131
225886003
UMLS CUI 2011AA
C0183355
SNOMED CT 2011_0131
397247004
Start of the typical first symptoms of the current attack, defined as the point in time when the patient felt the first sensation of the attack, within the last 72 hours before initiation of treatment with the study medication.
Beschreibung

Start of the typical first symptoms of the current attack, defined as the point in time when the patient felt the first sensation of the attack, within the last 72 hours before initiation of treatment with the study medication.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0205435
SNOMED CT 2011_0131
255216001
UMLS CUI 2011AA
C1457887
LOINC Version 232
MTHU021540
ICD-9-CM Version 2011
780-789.99
UMLS CUI 2011AA
C1304680
SNOMED CT 2011_0131
216299002
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C2348558
UMLS CUI 2011AA
C0013227
Negative pregnancy test for females of childbearing potential (pre menopausal, <2 years post-menopausal, not surgically sterile).
Beschreibung

Negative pregnancy test for females of childbearing potential (pre menopausal, <2 years post-menopausal, not surgically sterile).

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0427780
SNOMED CT 2011_0131
250425007
MedDRA 14.1
10036574
UMLS CUI 2011AA
C0015780
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0279752
UMLS CUI 2011AA
C0232970
SNOMED CT 2011_0131
76498008
Patients with a negative QuantiFERON TB Gold test result.
Beschreibung

Patients with a negative QuantiFERON TB Gold test result.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C1875713
UMLS CUI 2011AA
C1334932
Patients who currently have no clinically apparent symptoms of an HLA B27 associated acute extraocular disorder requiring systemic immunosuppressive therapy.
Beschreibung

Patients who currently have no clinically apparent symptoms of an HLA B27 associated acute extraocular disorder requiring systemic immunosuppressive therapy.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0019740
SNOMED CT 2011_0131
34453005
LOINC Version 232
MTHU012533
UMLS CUI 2011AA
C0332281
SNOMED CT 2011_0131
47429007
UMLS CUI 2011AA
C0241886
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C0205373
SNOMED CT 2011_0131
31099001
UMLS CUI 2011AA
C0021079
SNOMED CT 2011_0131
86553008
Patients who are willing and able to cooperate with study requirements.
Beschreibung

Patients who are willing and able to cooperate with study requirements.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0600109
SNOMED CT 2011_0131
225466006
UMLS CUI 2011AA
C0085732
SNOMED CT 2011_0131
371150009
UMLS CUI 2011AA
C0392337
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C1514873
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
IOP elevation requiring therapy.
Beschreibung

IOP elevation requiring therapy.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0234708
SNOMED CT 2011_0131
112222000
MedDRA 14.1
10022806
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C0039798
Uncontrolled diabetes mellitus and diabetic retinopathy.
Beschreibung

Uncontrolled diabetes mellitus and diabetic retinopathy.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0205318
SNOMED CT 2011_0131
19032002
UMLS CUI 2011AA
C0011849
SNOMED CT 2011_0131
191044006
UMLS CUI 2011AA
C0011884
SNOMED CT 2011_0131
4855003
MedDRA 14.1
10012689
LOINC Version 232
MTHU020818
ICD-9-CM Version 2011
362.0
Patients with a single eye or a pinhole Snellen visual acuity 20/200 or worse in the non study eye.
Beschreibung

Patients with a single eye or a pinhole Snellen visual acuity 20/200 or worse in the non study eye.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0205171
SNOMED CT 2011_0131
50607009
UMLS CUI 2011AA
C0015392
SNOMED CT 2011_0131
81745001
LOINC Version 232
MTHU000064
UMLS CUI 2011AA
C0450042
SNOMED CT 2011_0131
257492003
UMLS CUI 2011AA
C1827708
SNOMED CT 2011_0131
422673001
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0015392
SNOMED CT 2011_0131
81745001
LOINC Version 232
MTHU000064
<= 1+ Anterior chamber cells (finding)
Beschreibung

Patients with <= 1+ anterior chamber cells.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0423282
SNOMED CT 2011_0131
246993000
MedDRA 14.1
10053781
Patients with 3+ or 4+ anterior chamber cells or hypopyon.
Beschreibung

Patients with 3+ or 4+ anterior chamber cells or hypopyon.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C2827736
UMLS CUI 2011AA
C2827737
UMLS CUI 2011AA
C0423282
SNOMED CT 2011_0131
246993000
MedDRA 14.1
10053781
UMLS CUI 2011AA
C0020641
SNOMED CT 2011_0131
87807004
MedDRA 14.1
10021086
ICD-10-CM Version 2010
H20.05
ICD-9-CM Version 2011
364.05
Patients in whom the time of the beginning of the current attack can not be determined.
Beschreibung

Patients in whom the time of the beginning of the current attack can not be determined.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0439547
SNOMED CT 2011_0131
272105005
UMLS CUI 2011AA
C0439659
SNOMED CT 2011_0131
246062003
LOINC Version 232
MTHU026300
UMLS CUI 2011AA
C0521116
SNOMED CT 2011_0131
15240007
UMLS CUI 2011AA
C1304680
SNOMED CT 2011_0131
216299002
UMLS CUI 2011AA
C0439673
SNOMED CT 2011_0131
261665006
Patients exhibiting corneal ulceration or a history of recurrent herpetic keratitis or clinical evidence of herpetic dermatitis.
Beschreibung

Patients exhibiting corneal ulceration or a history of recurrent herpetic keratitis or clinical evidence of herpetic dermatitis.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0010043
SNOMED CT 2011_0131
91514001
MedDRA 14.1
10011060
ICD-10-CM Version 2010
H16.0
ICD-9-CM Version 2011
370.0
CTCAE 1105E
E10359
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C1274320
SNOMED CT 2011_0131
402891002
UMLS CUI 2011AA
C0332120
SNOMED CT 2011_0131
18669006
UMLS CUI 2011AA
C1262170
MedDRA 14.1
10062639
Patients currently treated with topical corticosteroids.
Beschreibung

Patients currently treated with topical corticosteroids.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C2827774
UMLS CUI 2011AA
C0304604
SNOMED CT 2011_0131
331645009
Patients treated with systemic immunosuppressive therapy within the last 2 months.
Beschreibung

Patients treated with systemic immunosuppressive therapy within the last 2 months.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0205373
SNOMED CT 2011_0131
31099001
UMLS CUI 2011AA
C0021079
SNOMED CT 2011_0131
86553008
Patients treated with a systemically administered TNF-alpha inhibitor within the last 2 months.
Beschreibung

Patients treated with a systemically administered TNF-alpha inhibitor within the last 2 months.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0205373
SNOMED CT 2011_0131
31099001
UMLS CUI 2011AA
C1521801
UMLS CUI 2011AA
C1562242
SNOMED CT 2011_0131
416897008
Pregnant or breast-feeding women or women of childbearing potential, who with their partners refuse to use 2 reliable methods of contraception (including 1 barrier method) during the study.
Beschreibung

Pregnant or breast-feeding women or women of childbearing potential, who with their partners refuse to use 2 reliable methods of contraception (including 1 barrier method) during the study.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
UMLS CUI 2011AA
C0032961
SNOMED CT 2011_0131
289908002
MedDRA 14.1
10036556
LOINC Version 232
MTHU035048
UMLS CUI 2011AA
C0006147
MedDRA 14.1
10006247
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0682323
SNOMED CT 2011_0131
262043009
HL7 V3 2006_05
SIGOTHR
UMLS CUI 2011AA
C2733540
SNOMED CT 2011_0131
443390004
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
UMLS CUI 2011AA
C0004764
SNOMED CT 2011_0131
225370004
Male patients with a female partner who could become pregnant and who refuse, with their partner, to use 2 reliable methods of contraception (including 1 barrier method) during the study.
Beschreibung

Male patients with a female partner who could become pregnant and who refuse, with their partner, to use 2 reliable methods of contraception (including 1 barrier method) during the study.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0024554
SNOMED CT 2011_0131
248153007
HL7 V3 2006_05
M
UMLS CUI 2011AA
C0015780
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C0682323
SNOMED CT 2011_0131
262043009
HL7 V3 2006_05
SIGOTHR
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C2733540
SNOMED CT 2011_0131
443390004
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
UMLS CUI 2011AA
C0004764
SNOMED CT 2011_0131
225370004
Patients whose clinical presentation is suggestive for an active bacterial, viral or fungal infection anywhere in the body.
Beschreibung

Patients whose clinical presentation is suggestive for an active bacterial, viral or fungal infection anywhere in the body.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0750491
SNOMED CT 2011_0131
415684004
UMLS CUI 2011AA
C0004623
SNOMED CT 2011_0131
87628006
MedDRA 14.1
10060945
ICD-10-CM Version 2010
A49.9
UMLS CUI 2011AA
C0042769
SNOMED CT 2011_0131
34014006
MedDRA 14.1
10047461
ICD-10-CM Version 2010
B34.9
UMLS CUI 2011AA
C0026946
SNOMED CT 2011_0131
3218000
MedDRA 14.1
10017533
ICD-10-CM Version 2010
B35-B49
ICD-9-CM Version 2011
110-118.99
Patients with history of recurrent infections, or a clinical presentation suggestive of a chronic infection requiring antimicrobial therapy (e.g. syphilis) including active episodes of serious viral infections by, e.g. herpes simplex, herpes zoster, cytomegalic or hepatitis viruses or clinical signs of fungal infections, such as histoplasmosis, aspergillosis or coccidiomycosis.
Beschreibung

Patients with history of recurrent infections, or a clinical presentation suggestive of a chronic infection requiring antimicrobial therapy (e.g. syphilis) including active episodes of serious viral infections by, e.g. herpes simplex, herpes zoster, cytomegalic or hepatitis viruses or clinical signs of fungal infections, such as histoplasmosis, aspergillosis or coccidiomycosis.

Datentyp

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0239998
MedDRA 14.1
10067860
UMLS CUI 2011AA
C0750491
SNOMED CT 2011_0131
415684004
UMLS CUI 2011AA
C0151317
SNOMED CT 2011_0131
177010002
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C1136254
SNOMED CT 2011_0131
250428009
LOINC Version 232
MTHU014499
UMLS CUI 2011AA
C0039128
SNOMED CT 2011_0131
76272004
MedDRA 14.1
10062120
ICD-10-CM Version 2010
A53.9
ICD-9-CM Version 2011
097.9
UMLS CUI 2011AA
C0019348
SNOMED CT 2011_0131
88594005
MedDRA 14.1
10019948
ICD-10-CM Version 2010
B00
ICD-9-CM Version 2011
054
UMLS CUI 2011AA
C0019360
SNOMED CT 2011_0131
4740000
MedDRA 14.1
10019974
ICD-10-CM Version 2010
B02
ICD-9-CM Version 2011
53
UMLS CUI 2011AA
C0010825
SNOMED CT 2011_0131
407444007
MedDRA 14.1
10009701
LOINC Version 232
MTHU033986
UMLS CUI 2011AA
C0019186
UMLS CUI 2011AA
C0019655
SNOMED CT 2011_0131
12962009
MedDRA 14.1
10020141
ICD-10-CM Version 2010
B39.9
ICD-9-CM Version 2011
115.90
UMLS CUI 2011AA
C0004030
SNOMED CT 2011_0131
65553006
MedDRA 14.1
10003488
ICD-10-CM Version 2010
B44
ICD-9-CM Version 2011
117.3
UMLS CUI 2011AA
C0262426
Patients presenting with higher intraocular pressure in the uveitic eye than in the contralateral eye.
Beschreibung

Patients presenting with higher intraocular pressure in the uveitic eye than in the contralateral eye.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0578862
SNOMED CT 2011_0131
302157000
UMLS CUI 2011AA
C0042164
SNOMED CT 2011_0131
128473001
MedDRA 14.1
10046851
ICD-10-CM Version 2010
H20.9
CTCAE 1105E
E10442
UMLS CUI 2011AA
C0015392
SNOMED CT 2011_0131
81745001
LOINC Version 232
MTHU000064
UMLS CUI 2011AA
C0439093
SNOMED CT 2011_0131
276140008
HL7 V3 2006_05
GT
UMLS CUI 2011AA
C0441988
SNOMED CT 2011_0131
255209002
UMLS CUI 2011AA
C0015392
SNOMED CT 2011_0131
81745001
LOINC Version 232
MTHU000064
Patients with known carrier status of human immunodeficiency virus, hepatitis B or hepatitis C.
Beschreibung

Patients with known carrier status of human immunodeficiency virus, hepatitis B or hepatitis C.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0449439
SNOMED CT 2011_0131
246098006
UMLS CUI 2011AA
C0019682
SNOMED CT 2011_0131
19030005
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
Patients with a history of demyelinating disease (multiple sclerosis) or optic neuritis.
Beschreibung

Patients with a history of demyelinating disease (multiple sclerosis) or optic neuritis.

Datentyp

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0011304
SNOMED CT 2011_0131
32693004
MedDRA 14.1
10012305
UMLS CUI 2011AA
C0026769
SNOMED CT 2011_0131
24700007
MedDRA 14.1
10028245
LOINC Version 232
MTHU020805
ICD-10-CM Version 2010
G35
ICD-9-CM Version 2011
340
UMLS CUI 2011AA
C0029134
SNOMED CT 2011_0131
66760008
MedDRA 14.1
10030942
ICD-10-CM Version 2010
H46.9
ICD-9-CM Version 2011
377.30
Patients with positive or unclear QuantiFERON TB Gold test result or history of high risk exposure to Mycobacterium tuberculosis.
Beschreibung

Patients with positive or unclear QuantiFERON TB Gold test result or history of high risk exposure to Mycobacterium tuberculosis.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C1875713
UMLS CUI 2011AA
C1335447
UMLS CUI 2011AA
CL427836
UMLS CUI 2011AA
C0587081
SNOMED CT 2011_0131
118246004
UMLS CUI 2011AA
C0332167
SNOMED CT 2011_0131
15508007
UMLS CUI 2011AA
C2732789
SNOMED CT 2011_0131
444507004
Patients with known coexisting malignancy.
Beschreibung

Patients with known coexisting malignancy.

Datentyp

boolean

Alias
UMLS CUI 2011AA
CL415222
UMLS CUI 2011AA
C0006826
SNOMED CT 2011_0131
363346000
MedDRA 14.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
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Ähnliche Modelle

Eligibility

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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)
Signed and dated informed consent.
Item
Signed and dated informed consent.
boolean
C1519316 (UMLS CUI 2011AA)
C0011008 (UMLS CUI 2011AA)
410671006 (SNOMED CT 2011_0131)
MTHU021546 (LOINC Version 232)
C0021430 (UMLS CUI 2011AA)
Patients with the typical presentation of HLA-B27 positive AAU (unilateral, painful anterior uveitis of sudden onset).
Item
Patients with the typical presentation of HLA-B27 positive AAU (unilateral, painful anterior uveitis of sudden onset).
boolean
C0019740 (UMLS CUI 2011AA)
34453005 (SNOMED CT 2011_0131)
MTHU012533 (LOINC Version 232)
CL415097 (UMLS CUI 2011AA)
C0701807 (UMLS CUI 2011AA)
4927003 (SNOMED CT 2011_0131)
H20.0 (ICD-10-CM Version 2010)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0205092 (UMLS CUI 2011AA)
66459002 (SNOMED CT 2011_0131)
CL414713 (UMLS CUI 2011AA)
C0042165 (UMLS CUI 2011AA)
410692006 (SNOMED CT 2011_0131)
10046852 (MedDRA 14.1)
C1272517 (UMLS CUI 2011AA)
385315009 (SNOMED CT 2011_0131)
2+ anterior chamber cells according to the SUN Working Group criteria, as assessed by slit lamp biomicroscopy.
Item
2+ anterior chamber cells according to the SUN Working Group criteria, as assessed by slit lamp biomicroscopy.
boolean
C2827735 (UMLS CUI 2011AA)
C0423282 (UMLS CUI 2011AA)
246993000 (SNOMED CT 2011_0131)
10053781 (MedDRA 14.1)
C0332290 (UMLS CUI 2011AA)
385433004 (SNOMED CT 2011_0131)
C0038136 (UMLS CUI 2011AA)
C0042164 (UMLS CUI 2011AA)
128473001 (SNOMED CT 2011_0131)
10046851 (MedDRA 14.1)
H20.9 (ICD-10-CM Version 2010)
E10442 (CTCAE 1105E)
C0600281 (UMLS CUI 2011AA)
CL414621 (UMLS CUI 2011AA)
C0582103 (UMLS CUI 2011AA)
225886003 (SNOMED CT 2011_0131)
C0183355 (UMLS CUI 2011AA)
397247004 (SNOMED CT 2011_0131)
Start of the typical first symptoms of the current attack, defined as the point in time when the patient felt the first sensation of the attack, within the last 72 hours before initiation of treatment with the study medication.
Item
Start of the typical first symptoms of the current attack, defined as the point in time when the patient felt the first sensation of the attack, within the last 72 hours before initiation of treatment with the study medication.
boolean
C0205435 (UMLS CUI 2011AA)
255216001 (SNOMED CT 2011_0131)
C1457887 (UMLS CUI 2011AA)
MTHU021540 (LOINC Version 232)
780-789.99 (ICD-9-CM Version 2011)
C1304680 (UMLS CUI 2011AA)
216299002 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C2348558 (UMLS CUI 2011AA)
C0013227 (UMLS CUI 2011AA)
Negative pregnancy test for females of childbearing potential (pre menopausal, <2 years post-menopausal, not surgically sterile).
Item
Negative pregnancy test for females of childbearing potential (pre menopausal, <2 years post-menopausal, not surgically sterile).
boolean
C0427780 (UMLS CUI 2011AA)
250425007 (SNOMED CT 2011_0131)
10036574 (MedDRA 14.1)
C0015780 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0279752 (UMLS CUI 2011AA)
C0232970 (UMLS CUI 2011AA)
76498008 (SNOMED CT 2011_0131)
Patients with a negative QuantiFERON TB Gold test result.
Item
Patients with a negative QuantiFERON TB Gold test result.
boolean
C1875713 (UMLS CUI 2011AA)
C1334932 (UMLS CUI 2011AA)
Patients who currently have no clinically apparent symptoms of an HLA B27 associated acute extraocular disorder requiring systemic immunosuppressive therapy.
Item
Patients who currently have no clinically apparent symptoms of an HLA B27 associated acute extraocular disorder requiring systemic immunosuppressive therapy.
boolean
C1518422 (UMLS CUI 2011AA)
C0019740 (UMLS CUI 2011AA)
34453005 (SNOMED CT 2011_0131)
MTHU012533 (LOINC Version 232)
C0332281 (UMLS CUI 2011AA)
47429007 (SNOMED CT 2011_0131)
C0241886 (UMLS CUI 2011AA)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C1514873 (UMLS CUI 2011AA)
C0205373 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
C0021079 (UMLS CUI 2011AA)
86553008 (SNOMED CT 2011_0131)
Patients who are willing and able to cooperate with study requirements.
Item
Patients who are willing and able to cooperate with study requirements.
boolean
C0600109 (UMLS CUI 2011AA)
225466006 (SNOMED CT 2011_0131)
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C0392337 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1514873 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
IOP elevation requiring therapy.
Item
IOP elevation requiring therapy.
boolean
C0234708 (UMLS CUI 2011AA)
112222000 (SNOMED CT 2011_0131)
10022806 (MedDRA 14.1)
C1514873 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
Uncontrolled diabetes mellitus and diabetic retinopathy.
Item
Uncontrolled diabetes mellitus and diabetic retinopathy.
boolean
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C0011849 (UMLS CUI 2011AA)
191044006 (SNOMED CT 2011_0131)
C0011884 (UMLS CUI 2011AA)
4855003 (SNOMED CT 2011_0131)
10012689 (MedDRA 14.1)
MTHU020818 (LOINC Version 232)
362.0 (ICD-9-CM Version 2011)
Patients with a single eye or a pinhole Snellen visual acuity 20/200 or worse in the non study eye.
Item
Patients with a single eye or a pinhole Snellen visual acuity 20/200 or worse in the non study eye.
boolean
C0205171 (UMLS CUI 2011AA)
50607009 (SNOMED CT 2011_0131)
C0015392 (UMLS CUI 2011AA)
81745001 (SNOMED CT 2011_0131)
MTHU000064 (LOINC Version 232)
C0450042 (UMLS CUI 2011AA)
257492003 (SNOMED CT 2011_0131)
C1827708 (UMLS CUI 2011AA)
422673001 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0015392 (UMLS CUI 2011AA)
81745001 (SNOMED CT 2011_0131)
MTHU000064 (LOINC Version 232)
Patients with <= 1+ anterior chamber cells.
Item
<= 1+ Anterior chamber cells (finding)
boolean
C0423282 (UMLS CUI 2011AA)
246993000 (SNOMED CT 2011_0131)
10053781 (MedDRA 14.1)
Patients with 3+ or 4+ anterior chamber cells or hypopyon.
Item
Patients with 3+ or 4+ anterior chamber cells or hypopyon.
boolean
C2827736 (UMLS CUI 2011AA)
C2827737 (UMLS CUI 2011AA)
C0423282 (UMLS CUI 2011AA)
246993000 (SNOMED CT 2011_0131)
10053781 (MedDRA 14.1)
C0020641 (UMLS CUI 2011AA)
87807004 (SNOMED CT 2011_0131)
10021086 (MedDRA 14.1)
H20.05 (ICD-10-CM Version 2010)
364.05 (ICD-9-CM Version 2011)
Patients in whom the time of the beginning of the current attack can not be determined.
Item
Patients in whom the time of the beginning of the current attack can not be determined.
boolean
C0439547 (UMLS CUI 2011AA)
272105005 (SNOMED CT 2011_0131)
C0439659 (UMLS CUI 2011AA)
246062003 (SNOMED CT 2011_0131)
MTHU026300 (LOINC Version 232)
C0521116 (UMLS CUI 2011AA)
15240007 (SNOMED CT 2011_0131)
C1304680 (UMLS CUI 2011AA)
216299002 (SNOMED CT 2011_0131)
C0439673 (UMLS CUI 2011AA)
261665006 (SNOMED CT 2011_0131)
Patients exhibiting corneal ulceration or a history of recurrent herpetic keratitis or clinical evidence of herpetic dermatitis.
Item
Patients exhibiting corneal ulceration or a history of recurrent herpetic keratitis or clinical evidence of herpetic dermatitis.
boolean
C0010043 (UMLS CUI 2011AA)
91514001 (SNOMED CT 2011_0131)
10011060 (MedDRA 14.1)
H16.0 (ICD-10-CM Version 2010)
370.0 (ICD-9-CM Version 2011)
E10359 (CTCAE 1105E)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C1274320 (UMLS CUI 2011AA)
402891002 (SNOMED CT 2011_0131)
C0332120 (UMLS CUI 2011AA)
18669006 (SNOMED CT 2011_0131)
C1262170 (UMLS CUI 2011AA)
10062639 (MedDRA 14.1)
Patients currently treated with topical corticosteroids.
Item
Patients currently treated with topical corticosteroids.
boolean
C2827774 (UMLS CUI 2011AA)
C0304604 (UMLS CUI 2011AA)
331645009 (SNOMED CT 2011_0131)
Patients treated with systemic immunosuppressive therapy within the last 2 months.
Item
Patients treated with systemic immunosuppressive therapy within the last 2 months.
boolean
C0205373 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
C0021079 (UMLS CUI 2011AA)
86553008 (SNOMED CT 2011_0131)
Patients treated with a systemically administered TNF-alpha inhibitor within the last 2 months.
Item
Patients treated with a systemically administered TNF-alpha inhibitor within the last 2 months.
boolean
C0205373 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
C1521801 (UMLS CUI 2011AA)
C1562242 (UMLS CUI 2011AA)
416897008 (SNOMED CT 2011_0131)
Pregnant or breast-feeding women or women of childbearing potential, who with their partners refuse to use 2 reliable methods of contraception (including 1 barrier method) during the study.
Item
Pregnant or breast-feeding women or women of childbearing potential, who with their partners refuse to use 2 reliable methods of contraception (including 1 barrier method) during the study.
boolean
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C0032961 (UMLS CUI 2011AA)
289908002 (SNOMED CT 2011_0131)
10036556 (MedDRA 14.1)
MTHU035048 (LOINC Version 232)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0682323 (UMLS CUI 2011AA)
262043009 (SNOMED CT 2011_0131)
SIGOTHR (HL7 V3 2006_05)
C2733540 (UMLS CUI 2011AA)
443390004 (SNOMED CT 2011_0131)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
C0004764 (UMLS CUI 2011AA)
225370004 (SNOMED CT 2011_0131)
Male patients with a female partner who could become pregnant and who refuse, with their partner, to use 2 reliable methods of contraception (including 1 barrier method) during the study.
Item
Male patients with a female partner who could become pregnant and who refuse, with their partner, to use 2 reliable methods of contraception (including 1 barrier method) during the study.
boolean
C0024554 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C0015780 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0682323 (UMLS CUI 2011AA)
262043009 (SNOMED CT 2011_0131)
SIGOTHR (HL7 V3 2006_05)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C2733540 (UMLS CUI 2011AA)
443390004 (SNOMED CT 2011_0131)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
C0004764 (UMLS CUI 2011AA)
225370004 (SNOMED CT 2011_0131)
Patients whose clinical presentation is suggestive for an active bacterial, viral or fungal infection anywhere in the body.
Item
Patients whose clinical presentation is suggestive for an active bacterial, viral or fungal infection anywhere in the body.
boolean
C0750491 (UMLS CUI 2011AA)
415684004 (SNOMED CT 2011_0131)
C0004623 (UMLS CUI 2011AA)
87628006 (SNOMED CT 2011_0131)
10060945 (MedDRA 14.1)
A49.9 (ICD-10-CM Version 2010)
C0042769 (UMLS CUI 2011AA)
34014006 (SNOMED CT 2011_0131)
10047461 (MedDRA 14.1)
B34.9 (ICD-10-CM Version 2010)
C0026946 (UMLS CUI 2011AA)
3218000 (SNOMED CT 2011_0131)
10017533 (MedDRA 14.1)
B35-B49 (ICD-10-CM Version 2010)
110-118.99 (ICD-9-CM Version 2011)
Patients with history of recurrent infections, or a clinical presentation suggestive of a chronic infection requiring antimicrobial therapy (e.g. syphilis) including active episodes of serious viral infections by, e.g. herpes simplex, herpes zoster, cytomegalic or hepatitis viruses or clinical signs of fungal infections, such as histoplasmosis, aspergillosis or coccidiomycosis.
Item
Patients with history of recurrent infections, or a clinical presentation suggestive of a chronic infection requiring antimicrobial therapy (e.g. syphilis) including active episodes of serious viral infections by, e.g. herpes simplex, herpes zoster, cytomegalic or hepatitis viruses or clinical signs of fungal infections, such as histoplasmosis, aspergillosis or coccidiomycosis.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0239998 (UMLS CUI 2011AA)
10067860 (MedDRA 14.1)
C0750491 (UMLS CUI 2011AA)
415684004 (SNOMED CT 2011_0131)
C0151317 (UMLS CUI 2011AA)
177010002 (SNOMED CT 2011_0131)
C1514873 (UMLS CUI 2011AA)
C1136254 (UMLS CUI 2011AA)
250428009 (SNOMED CT 2011_0131)
MTHU014499 (LOINC Version 232)
C0039128 (UMLS CUI 2011AA)
76272004 (SNOMED CT 2011_0131)
10062120 (MedDRA 14.1)
A53.9 (ICD-10-CM Version 2010)
097.9 (ICD-9-CM Version 2011)
C0019348 (UMLS CUI 2011AA)
88594005 (SNOMED CT 2011_0131)
10019948 (MedDRA 14.1)
B00 (ICD-10-CM Version 2010)
054 (ICD-9-CM Version 2011)
C0019360 (UMLS CUI 2011AA)
4740000 (SNOMED CT 2011_0131)
10019974 (MedDRA 14.1)
B02 (ICD-10-CM Version 2010)
53 (ICD-9-CM Version 2011)
C0010825 (UMLS CUI 2011AA)
407444007 (SNOMED CT 2011_0131)
10009701 (MedDRA 14.1)
MTHU033986 (LOINC Version 232)
C0019186 (UMLS CUI 2011AA)
C0019655 (UMLS CUI 2011AA)
12962009 (SNOMED CT 2011_0131)
10020141 (MedDRA 14.1)
B39.9 (ICD-10-CM Version 2010)
115.90 (ICD-9-CM Version 2011)
C0004030 (UMLS CUI 2011AA)
65553006 (SNOMED CT 2011_0131)
10003488 (MedDRA 14.1)
B44 (ICD-10-CM Version 2010)
117.3 (ICD-9-CM Version 2011)
C0262426 (UMLS CUI 2011AA)
Patients presenting with higher intraocular pressure in the uveitic eye than in the contralateral eye.
Item
Patients presenting with higher intraocular pressure in the uveitic eye than in the contralateral eye.
boolean
C0578862 (UMLS CUI 2011AA)
302157000 (SNOMED CT 2011_0131)
C0042164 (UMLS CUI 2011AA)
128473001 (SNOMED CT 2011_0131)
10046851 (MedDRA 14.1)
H20.9 (ICD-10-CM Version 2010)
E10442 (CTCAE 1105E)
C0015392 (UMLS CUI 2011AA)
81745001 (SNOMED CT 2011_0131)
MTHU000064 (LOINC Version 232)
C0439093 (UMLS CUI 2011AA)
276140008 (SNOMED CT 2011_0131)
GT (HL7 V3 2006_05)
C0441988 (UMLS CUI 2011AA)
255209002 (SNOMED CT 2011_0131)
C0015392 (UMLS CUI 2011AA)
81745001 (SNOMED CT 2011_0131)
MTHU000064 (LOINC Version 232)
Patients with known carrier status of human immunodeficiency virus, hepatitis B or hepatitis C.
Item
Patients with known carrier status of human immunodeficiency virus, hepatitis B or hepatitis C.
boolean
C0449439 (UMLS CUI 2011AA)
246098006 (SNOMED CT 2011_0131)
C0019682 (UMLS CUI 2011AA)
19030005 (SNOMED CT 2011_0131)
C0019163 (UMLS CUI 2011AA)
66071002 (SNOMED CT 2011_0131)
10019731 (MedDRA 14.1)
C0019196 (UMLS CUI 2011AA)
50711007 (SNOMED CT 2011_0131)
10019744 (MedDRA 14.1)
B19.20 (ICD-10-CM Version 2010)
070.7 (ICD-9-CM Version 2011)
Patients with a history of demyelinating disease (multiple sclerosis) or optic neuritis.
Item
Patients with a history of demyelinating disease (multiple sclerosis) or optic neuritis.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0011304 (UMLS CUI 2011AA)
32693004 (SNOMED CT 2011_0131)
10012305 (MedDRA 14.1)
C0026769 (UMLS CUI 2011AA)
24700007 (SNOMED CT 2011_0131)
10028245 (MedDRA 14.1)
MTHU020805 (LOINC Version 232)
G35 (ICD-10-CM Version 2010)
340 (ICD-9-CM Version 2011)
C0029134 (UMLS CUI 2011AA)
66760008 (SNOMED CT 2011_0131)
10030942 (MedDRA 14.1)
H46.9 (ICD-10-CM Version 2010)
377.30 (ICD-9-CM Version 2011)
Patients with positive or unclear QuantiFERON TB Gold test result or history of high risk exposure to Mycobacterium tuberculosis.
Item
Patients with positive or unclear QuantiFERON TB Gold test result or history of high risk exposure to Mycobacterium tuberculosis.
boolean
C1875713 (UMLS CUI 2011AA)
C1335447 (UMLS CUI 2011AA)
CL427836 (UMLS CUI 2011AA)
C0587081 (UMLS CUI 2011AA)
118246004 (SNOMED CT 2011_0131)
C0332167 (UMLS CUI 2011AA)
15508007 (SNOMED CT 2011_0131)
C2732789 (UMLS CUI 2011AA)
444507004 (SNOMED CT 2011_0131)
Patients with known coexisting malignancy.
Item
Patients with known coexisting malignancy.
boolean
CL415222 (UMLS CUI 2011AA)
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
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