ID

16556

Descrizione

MIPSO Vergleichende Untersuchung der bakteriellen Mikrobiota in der Haut sowie dem Darm von Psoriasis-Patienten vor und nach systemischer Behandlung mit Adalimumab bzw. Ustekinumab oder Ciclosporin (EudraCT 2014-003022-40) Principal Investigator: Prof. Dr. Dr. h.c. Thomas A. Luger

Keywords

versioni (4)
  1. 17/11/15 17/11/15 -
  2. 08/12/15 08/12/15 -
  3. 08/12/15 08/12/15 -
  4. 23/07/16 23/07/16 -
Caricato su

23 luglio 2016

DOI

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Licenza

Creative Commons BY-NC 3.0
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Eligibility Determination Psoriasis MIPSO EudraCT 2014-003022-40 DRKS00007147

Tedesco Inglese

Eligibility Determination Psoriasis MIPSO EudraCT 2014-003022-40

1 moduli  
Patient identification
Descrizione

Patient identification

Alias
UMLS CUI-1
C1269815
Patient number?
Descrizione

Patient Number

Tipo di dati

text

Alias
UMLS CUI [1]
C1830427
Date of consent
Descrizione

Date of consent

Tipo di dati

date

Unità di misura
  • dd/mm/yyyy
dd/mm/yyyy
Date of screening
Descrizione

Date of screening

Tipo di dati

date

Unità di misura
  • dd/mm/yyyy
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1710477
dd/mm/yyyy
Inclusion criteria
Descrizione

Inclusion criteria

Alias
UMLS CUI-1
C1512693
Patients with at least moderate psoriasis vulgaris (PASI ≥ 10) plaque-type.
Descrizione

Patients with at least moderate psoriasis vulgaris (PASI ≥ 10) plaque-type.

Tipo di dati

boolean

Alias
UMLS CUI [1]
C4027888
≥18 years (male and female)
Descrizione

≥18 years (male and female)

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0001779
Indications for treatment with adalimumab, ustekinumab or cyclosporine in accordance with the guidelines for psoriasis and the individual prescribing information.
Descrizione

Indications for treatment with adalimumab, ustekinumab or cyclosporine in accordance with the guidelines for psoriasis and the individual prescribing information.

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1122087
UMLS CUI [2]
C1608841
UMLS CUI [3]
C0010592
Patients with moderate to severe chronic plaque psoriasis who have not responded to other systemic therapy including cyclosporine, methotrexate or PUVA or who have a contraindication or intolerance to such therapy exists.
Descrizione

Patients with moderate to severe chronic plaque psoriasis who have not responded to other systemic therapy including cyclosporine, methotrexate or PUVA or who have a contraindication or intolerance to such therapy exists.

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C1524062
UMLS CUI [1,2]
C1512693
UMLS CUI [1,3]
C1122087
UMLS CUI [2,1]
C1524062
UMLS CUI [2,2]
C1512693
UMLS CUI [2,3]
C1608841
Patients with at least moderate psoriasis vulgaris (PASI ≥ 10) plaque-type, which are not sufficiently treated with conventional systemic therapy.
Descrizione

Patients with at least moderate psoriasis vulgaris (PASI ≥ 10) plaque-type, which are not sufficiently treated with conventional systemic therapy.

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C1524062
UMLS CUI [1,2]
C1512693
UMLS CUI [1,3]
C0010592
Exclusion criteria
Descrizione

Exclusion criteria

Alias
UMLS CUI-1
C0680251
Therapy with systemic immunosuppressants (such as cyclosporine or methotrexate), adalimumab, etanercept, infliximab, or ustekinumab in a period of 5 half-lives of the respective medication before taking the initial swab specimens / biopsies.
Descrizione

Therapy with systemic immunosuppressants (such as cyclosporine or methotrexate), adalimumab, etanercept, infliximab, or ustekinumab in a period of 5 half-lives of the respective medication before taking the initial swab specimens / biopsies.

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0021079
UMLS CUI [1,2]
C0205373
Concurrent therapy with systemic immunosuppressants.
Descrizione

Concurrent therapy with systemic immunosuppressants.

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0009429
UMLS CUI [1,2]
C0021079
UMLS CUI [1,3]
C0205373
Antibiotic therapy over a period of at least 4 weeks before taking the initial swab specimens / biopsies or antibiotic therapy during the study.
Descrizione

Antibiotic therapy over a period of at least 4 weeks before taking the initial swab specimens / biopsies or antibiotic therapy during the study.

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0338237
Psoriasis patients who currently receive or have received phototherapy for a period of 2 weeks before the withdrawal of the initial swab specimens / biopsies.
Descrizione

Psoriasis patients who currently receive or have received phototherapy for a period of 2 weeks before the withdrawal of the initial swab specimens / biopsies.

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0031765
Patients who can not interrupt the local, topical therapy with calcineurin inhibitors or vitamin D3 analogues in the conditions laid down for the smear preparations / biopsies skin areas. The topical treatment with calcineurin inhibitors or vitamin D3 analogs can be continued in lesional skin areas that are not intended for smear preparations / biopsies. In the conditions laid down for the smear preparations / biopsies skin areas must be done 7 days prior to taking the samples no topical therapy.
Descrizione

Patients who can not interrupt the local, topical therapy with calcineurin inhibitors or vitamin D3 analogues in the conditions laid down for the smear preparations / biopsies skin areas. The topical treatment with calcineurin inhibitors or vitamin D3 analogs can be continued in lesional skin areas that are not intended for smear preparations / biopsies. In the conditions laid down for the smear preparations / biopsies skin areas must be done 7 days prior to taking the samples no topical therapy.

Tipo di dati

boolean

Alias
UMLS CUI [1]
C3888969
Clinically significant active infection (eg active tuberculosis or other severe infections such as sepsis and opportunistic infections). Latent tuberculosis. A history of latent or active tuberculosis that has not been adequately treated safely.
Descrizione

Clinically significant active infection (eg active tuberculosis or other severe infections such as sepsis and opportunistic infections). Latent tuberculosis. A history of latent or active tuberculosis that has not been adequately treated safely.

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0009450
Chronic carriers of the hepatitis B virus (HBsAg positive).
Descrizione

Chronic carriers of the hepatitis B virus (HBsAg positive).

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0149709
HIV-positive patients
Descrizione

HIV-positive patients.

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0019699
Maligne Erkrankungen aktuell oder in der Vorgeschichte.
Descrizione

Malignancies current or history.

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0006826
Immunodeficient patients (primary disease or as a result of therapy)
Descrizione

Immunodeficient patients (primary disease or as a result of therapy).

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021051
Patients receiving chemotherapy or radiation therapy or currently one who received chemotherapy / radiotherapy within the last 12 months before the withdrawal of the initial swab specimens / biopsies.
Descrizione

Patients receiving chemotherapy or radiation therapy or currently one who received chemotherapy / radiotherapy within the last 12 months before the withdrawal of the initial swab specimens / biopsies.

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
Patients are not stable with uncontrolled chronic diseases that require continuous treatment (such as diabetes, hepatitis, organ transplantation), and from the perspective of the investigator.
Descrizione

Patients are not stable with uncontrolled chronic diseases that require continuous treatment (such as diabetes, hepatitis, organ transplantation), and from the perspective of the investigator.

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0008679
UMLS CUI [1,2]
C0205318
Patients with other chronic skin diseases such as atopic dermatitis or lupus erythematosus that may affect the cutaneous microbiota.
Descrizione

Patients with other chronic skin diseases such as atopic dermatitis or lupus erythematosus that may affect the cutaneous microbiota.

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1290009
Patients with psychiatric comorbidity, which cause a lack or lack of capacity to consent.
Descrizione

Patients with psychiatric comorbidity, which cause a lack or lack of capacity to consent.

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0009488
Participation in another interventional examination before study completion in a period of 4 weeks and 5 half-lives of the former investigational, whichever is longer.
Descrizione

Participation in another interventional examination before study completion in a period of 4 weeks and 5 half-lives of the former investigational, whichever is longer.

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2348568
For childbearing women or men with female partners of childbearing unwillingness reliable forms of contraception (Pearl index <1) apply. With Stelara® patients treated these contraceptive methods have to at least 15 weeks after the end of treatment with Humira® patients treated for at least 5 months after the end of treatment continue.
Descrizione

For childbearing women or men with female partners of childbearing unwillingness reliable forms of contraception (Pearl index <1) apply. With Stelara® patients treated these contraceptive methods have to at least 15 weeks after the end of treatment with Humira® patients treated for at least 5 months after the end of treatment continue.

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
Patients who were positive for MRSA in the history over a period of 6 months prior to withdrawal of the first swab specimens / biopsies.
Descrizione

Patients who were positive for MRSA in the history over a period of 6 months prior to withdrawal of the first swab specimens / biopsies.

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0343401
Patients with psoriasis vulgaris exclusively in the head area.
Descrizione

Patients with psoriasis vulgaris exclusively in the head area.

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0263361
UMLS CUI [1,2]
C0018670
Additional exclusion criteria Adalimumab
Descrizione

Additional exclusion criteria Adalimumab

Alias
UMLS CUI-1
C0680251
UMLS CUI-2
C1122087
Hypersensitivity to the active substance or to any of the excipients of Humira®.
Descrizione

Hypersensitivity to the active substance or to any of the excipients of Humira®.

Tipo di dati

integer

Alias
UMLS CUI [1]
C0020517
Moderate to severe heart failure (NYHA class III / IV).
Descrizione

Moderate to severe heart failure (NYHA class III / IV).

Tipo di dati

integer

Alias
UMLS CUI [1]
C1275491
Pre-existing or incipient demyelinating diseases of the CNS or peripheral nervous system.
Descrizione

Pre-existing or incipient demyelinating diseases of the CNS or peripheral nervous system.

Tipo di dati

integer

Alias
UMLS CUI [1]
C0751873
Concurrent therapy with anakinra or abatacept.
Descrizione

Concurrent therapy with anakinra or abatacept.

Tipo di dati

integer

Alias
UMLS CUI [1]
C0245109
UMLS CUI [2]
C1619966
Concomitant vaccination with live vaccines. This applies for a period up to 5 months after end of therapy.
Descrizione

Concomitant vaccination with live vaccines. This applies for a period up to 5 months after end of therapy.

Tipo di dati

integer

Alias
UMLS CUI [1]
C0042196
Additional exclusion criteria Ustekinumab
Descrizione

Additional exclusion criteria Ustekinumab

Alias
UMLS CUI-1
C0680251
UMLS CUI-2
C1608841
Hypersensitivity to the active substance or to any of the excipients of Stelara®, allergy to latex.
Descrizione

Hypersensitivity to the active substance or to any of the excipients of Stelara®, allergy to latex.

Tipo di dati

integer

Alias
UMLS CUI [1]
C0020517
Simultaneous vaccination with live viruses or live bacteria. This applies for a period of 2 weeks prior to initiation of therapy with Stelara® until at least 15 weeks after end of therapy.
Descrizione

Simultaneous vaccination with live viruses or live bacteria. This applies for a period of 2 weeks prior to initiation of therapy with Stelara® until at least 15 weeks after end of therapy.

Tipo di dati

integer

Alias
UMLS CUI [1]
C0042196
Additional exclusion criteria Cyclosporine
Descrizione

Additional exclusion criteria Cyclosporine

Alias
UMLS CUI-1
C0680251
UMLS CUI-2
C0010592
Known hypersensitivity to ciclosporin and / or against any of the excipients of the ciclosporin preparation.
Descrizione

Known hypersensitivity to ciclosporin and / or against any of the excipients of the ciclosporin preparation.

Tipo di dati

integer

Alias
UMLS CUI [1]
C0020517
Uncontrolled arterial hypertension.
Descrizione

Uncontrolled arterial hypertension.

Tipo di dati

integer

Alias
UMLS CUI [1]
C1868885
Uncontrolled infectious diseases.
Descrizione

Uncontrolled infectious diseases.

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
Not healed infection with varicella, incl. Herpes zoster infection, herpes simplex infections, and other viral infections (eg, mollusks, condyloma, multiple warts)
Descrizione

Not healed infection with varicella, incl. Herpes zoster infection, herpes simplex infections, and other viral infections (eg, mollusks, condyloma, multiple warts)

Tipo di dati

integer

Alias
UMLS CUI [1]
C0586989
Relevant renal impairment
Descrizione

Relevant renal impairment

Tipo di dati

integer

Alias
UMLS CUI [1]
C1565489
Severe liver disease, GOT> 2 x ULN, GPT> 2x ULN, yGT> 2 x ULN, bilirubin> 2 x ULN
Descrizione

Severe liver disease, GOT> 2 x ULN, GPT> 2x ULN, yGT> 2 x ULN, bilirubin> 2 x ULN

Tipo di dati

integer

Alias
UMLS CUI [1]
C3829821
Hyperuricemia
Descrizione

Hyperuricemia

Tipo di dati

integer

Alias
UMLS CUI [1]
C0740394
Hyperkalemia
Descrizione

Hyperkalemia

Tipo di dati

integer

Alias
UMLS CUI [1]
C0020461
State after prior PUVA therapy with cumulative dose> 1000 J / cm²
Descrizione

State after prior PUVA therapy with cumulative dose> 1000 J / cm²

Tipo di dati

integer

Alias
UMLS CUI [1]
C0853073
State after many years of methotrexate therapy
Descrizione

State after many years of methotrexate therapy

Tipo di dati

integer

Alias
UMLS CUI [1]
C0025677
Therapy with Etretinate within 4 weeks prior to initiating therapy with cyclosporine
Descrizione

Therapy with Etretinate within 4 weeks prior to initiating therapy with cyclosporine

Tipo di dati

integer

Alias
UMLS CUI [1]
C0015137
Concurrent therapy with retinoids
Descrizione

Concurrent therapy with retinoids

Tipo di dati

integer

Alias
UMLS CUI [1]
C3653550
Concurrent therapy with coal tar
Descrizione

Concurrent therapy with coal tar

Tipo di dati

integer

Alias
UMLS CUI [1]
C0009137
Concurrent therapy with simvastatin
Descrizione

Concurrent therapy with simvastatin

Tipo di dati

integer

Alias
UMLS CUI [1]
C0074554
Concurrent therapy with tacrolimus
Descrizione

Concurrent therapy with tacrolimus

Tipo di dati

integer

Alias
UMLS CUI [1]
C0085149
Concomitant use of St. John's wort (Hypericum perforatum)
Descrizione

Concomitant use of St. John's wort (Hypericum perforatum)

Tipo di dati

integer

Alias
UMLS CUI [1]
C0936242
Concomitant therapy with drugs that are substrates of multidrug efflux transporters P-glycoprotein or Organic Anion Transporting Polypeptides and are joined for the increased plasma concentrations with serious and / or life-threatening events, such as Bosentan, Dabigatran-Etexilate and Aliskiren.
Descrizione

Concomitant therapy with drugs that are substrates of multidrug efflux transporters P-glycoprotein or Organic Anion Transporting Polypeptides and are joined for the increased plasma concentrations with serious and / or life-threatening events, such as Bosentan, Dabigatran-Etexilate and Aliskiren.

Tipo di dati

integer

Alias
UMLS CUI [1]
C0069906
UMLS CUI [2]
C0949791
Concomitant vaccination with live vaccines
Descrizione

Concomitant vaccination with live vaccines

Tipo di dati

integer

Alias
UMLS CUI [1]
C0042196
Alcohol disease, contraindication to the use of alcohol (eg. epilepsy)
Descrizione

Alcohol disease, contraindication to the use of alcohol (eg. epilepsy)

Tipo di dati

integer

Alias
UMLS CUI [1]
C0038586
Erythrodermic or pustular psoriasis
Descrizione

Erythrodermic or pustular psoriasis

Tipo di dati

integer

Alias
UMLS CUI [1]
C0748052
UMLS CUI [2]
C0152081
Psoriatic forms that may be caused or exacerbated by drugs.
Descrizione

Psoriatic forms that may be caused or exacerbated by drugs.

Tipo di dati

integer

Alias
UMLS CUI [1]
C1304130
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Similar models

Eligibility Determination Psoriasis MIPSO EudraCT 2014-003022-40

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Patient identification
C1269815 (UMLS CUI-1)
Patient number
Item
Patient number?
text
C1830427 (UMLS CUI [1])
Date of consent
Item
Date of consent
date
Date of screening
Item
Date of screening
date
C0011008 (UMLS CUI [1,1])
C1710477 (UMLS CUI [1,2])
Item Group
Inclusion criteria
C1512693 (UMLS CUI-1)
PASI
Item
Patients with at least moderate psoriasis vulgaris (PASI ≥ 10) plaque-type.
boolean
C4027888 (UMLS CUI [1])
Age
Item
≥18 years (male and female)
boolean
C0001779 (UMLS CUI [1])
Adalimumab, ustekinumab or cyclosporine
Item
Indications for treatment with adalimumab, ustekinumab or cyclosporine in accordance with the guidelines for psoriasis and the individual prescribing information.
boolean
C1122087 (UMLS CUI [1])
C1608841 (UMLS CUI [2])
C0010592 (UMLS CUI [3])
Item
Patients with moderate to severe chronic plaque psoriasis who have not responded to other systemic therapy including cyclosporine, methotrexate or PUVA or who have a contraindication or intolerance to such therapy exists.
integer
C1524062 (UMLS CUI [1,1])
C1512693 (UMLS CUI [1,2])
C1122087 (UMLS CUI [1,3])
C1524062 (UMLS CUI [2,1])
C1512693 (UMLS CUI [2,2])
C1608841 (UMLS CUI [2,3])
Additional inclusion criterion for patients who should receive adalimumab or ustekinumab
Code List
Patients with moderate to severe chronic plaque psoriasis who have not responded to other systemic therapy including cyclosporine, methotrexate or PUVA or who have a contraindication or intolerance to such therapy exists.
CL Item
yes (1)
CL Item
no (2)
CL Item
NA (3)
Item
Patients with at least moderate psoriasis vulgaris (PASI ≥ 10) plaque-type, which are not sufficiently treated with conventional systemic therapy.
integer
C1524062 (UMLS CUI [1,1])
C1512693 (UMLS CUI [1,2])
C0010592 (UMLS CUI [1,3])
Additional inclusion criterion for patients who should receive adalimumab or ustekinumab
Code List
Patients with at least moderate psoriasis vulgaris (PASI ≥ 10) plaque-type, which are not sufficiently treated with conventional systemic therapy.
CL Item
yes (1)
CL Item
no (2)
CL Item
NA (3)
Item Group
Exclusion criteria
C0680251 (UMLS CUI-1)
Systemic immunosuppressants
Item
Therapy with systemic immunosuppressants (such as cyclosporine or methotrexate), adalimumab, etanercept, infliximab, or ustekinumab in a period of 5 half-lives of the respective medication before taking the initial swab specimens / biopsies.
boolean
C0021079 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
Concurrent therapy with systemic immunosuppressants
Item
Concurrent therapy with systemic immunosuppressants.
boolean
C0009429 (UMLS CUI [1,1])
C0021079 (UMLS CUI [1,2])
C0205373 (UMLS CUI [1,3])
Antibiotic therapy
Item
Antibiotic therapy over a period of at least 4 weeks before taking the initial swab specimens / biopsies or antibiotic therapy during the study.
boolean
C0338237 (UMLS CUI [1])
Phototherapy
Item
Psoriasis patients who currently receive or have received phototherapy for a period of 2 weeks before the withdrawal of the initial swab specimens / biopsies.
boolean
C0031765 (UMLS CUI [1])
Temporary interruption of therapy
Item
Patients who can not interrupt the local, topical therapy with calcineurin inhibitors or vitamin D3 analogues in the conditions laid down for the smear preparations / biopsies skin areas. The topical treatment with calcineurin inhibitors or vitamin D3 analogs can be continued in lesional skin areas that are not intended for smear preparations / biopsies. In the conditions laid down for the smear preparations / biopsies skin areas must be done 7 days prior to taking the samples no topical therapy.
boolean
C3888969 (UMLS CUI [1])
Infection
Item
Clinically significant active infection (eg active tuberculosis or other severe infections such as sepsis and opportunistic infections). Latent tuberculosis. A history of latent or active tuberculosis that has not been adequately treated safely.
boolean
C0009450 (UMLS CUI [1])
HBsAg positive
Item
Chronic carriers of the hepatitis B virus (HBsAg positive).
boolean
C0149709 (UMLS CUI [1])
HIV-positive
Item
HIV-positive patients
boolean
C0019699 (UMLS CUI [1])
Malignancies
Item
Maligne Erkrankungen aktuell oder in der Vorgeschichte.
boolean
C0006826 (UMLS CUI [1])
Immunodeficient patients
Item
Immunodeficient patients (primary disease or as a result of therapy)
boolean
C0021051 (UMLS CUI [1])
Chemotherapy or radiation therapy
Item
Patients receiving chemotherapy or radiation therapy or currently one who received chemotherapy / radiotherapy within the last 12 months before the withdrawal of the initial swab specimens / biopsies.
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
Uncontrolled chronic diseases
Item
Patients are not stable with uncontrolled chronic diseases that require continuous treatment (such as diabetes, hepatitis, organ transplantation), and from the perspective of the investigator.
boolean
C0008679 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Chronic skin diseases
Item
Patients with other chronic skin diseases such as atopic dermatitis or lupus erythematosus that may affect the cutaneous microbiota.
boolean
C1290009 (UMLS CUI [1])
Psychiatric comorbidity
Item
Patients with psychiatric comorbidity, which cause a lack or lack of capacity to consent.
boolean
C0004936 (UMLS CUI [1,1])
C0009488 (UMLS CUI [1,2])
Study participation status
Item
Participation in another interventional examination before study completion in a period of 4 weeks and 5 half-lives of the former investigational, whichever is longer.
boolean
C2348568 (UMLS CUI [1])
Pregnancy or lactation
Item
For childbearing women or men with female partners of childbearing unwillingness reliable forms of contraception (Pearl index <1) apply. With Stelara® patients treated these contraceptive methods have to at least 15 weeks after the end of treatment with Humira® patients treated for at least 5 months after the end of treatment continue.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
MRSA
Item
Patients who were positive for MRSA in the history over a period of 6 months prior to withdrawal of the first swab specimens / biopsies.
boolean
C0343401 (UMLS CUI [1])
Psoriasis vulgaris: head area
Item
Patients with psoriasis vulgaris exclusively in the head area.
boolean
C0263361 (UMLS CUI [1,1])
C0018670 (UMLS CUI [1,2])
Item Group
Additional exclusion criteria Adalimumab
C0680251 (UMLS CUI-1)
C1122087 (UMLS CUI-2)
Item
Hypersensitivity to the active substance or to any of the excipients of Humira®.
integer
C0020517 (UMLS CUI [1])
Additional inclusion criterion for patients who should receive adalimumab or ustekinumab
Code List
Hypersensitivity to the active substance or to any of the excipients of Humira®.
CL Item
yes (1)
CL Item
no (2)
CL Item
NA (3)
Item
Moderate to severe heart failure (NYHA class III / IV).
integer
C1275491 (UMLS CUI [1])
Additional inclusion criterion for patients who should receive adalimumab or ustekinumab
Code List
Moderate to severe heart failure (NYHA class III / IV).
CL Item
yes (1)
CL Item
no (2)
CL Item
NA (3)
Item
Pre-existing or incipient demyelinating diseases of the CNS or peripheral nervous system.
integer
C0751873 (UMLS CUI [1])
Additional inclusion criterion for patients who should receive adalimumab or ustekinumab
Code List
Pre-existing or incipient demyelinating diseases of the CNS or peripheral nervous system.
CL Item
yes (1)
CL Item
no (2)
CL Item
NA (3)
Item
Concurrent therapy with anakinra or abatacept.
integer
C0245109 (UMLS CUI [1])
C1619966 (UMLS CUI [2])
Additional inclusion criterion for patients who should receive adalimumab or ustekinumab
Code List
Concurrent therapy with anakinra or abatacept.
CL Item
yes (1)
CL Item
no (2)
CL Item
NA (3)
Item
Concomitant vaccination with live vaccines. This applies for a period up to 5 months after end of therapy.
integer
C0042196 (UMLS CUI [1])
Additional inclusion criterion for patients who should receive adalimumab or ustekinumab
Code List
Concomitant vaccination with live vaccines. This applies for a period up to 5 months after end of therapy.
CL Item
yes (1)
CL Item
no (2)
CL Item
NA (3)
Item Group
Additional exclusion criteria Ustekinumab
C0680251 (UMLS CUI-1)
C1608841 (UMLS CUI-2)
Item
Hypersensitivity to the active substance or to any of the excipients of Stelara®, allergy to latex.
integer
C0020517 (UMLS CUI [1])
Additional inclusion criterion for patients who should receive adalimumab or ustekinumab
Code List
Hypersensitivity to the active substance or to any of the excipients of Stelara®, allergy to latex.
CL Item
yes (1)
CL Item
no (2)
CL Item
NA (3)
Item
Simultaneous vaccination with live viruses or live bacteria. This applies for a period of 2 weeks prior to initiation of therapy with Stelara® until at least 15 weeks after end of therapy.
integer
C0042196 (UMLS CUI [1])
Additional inclusion criterion for patients who should receive adalimumab or ustekinumab
Code List
Simultaneous vaccination with live viruses or live bacteria. This applies for a period of 2 weeks prior to initiation of therapy with Stelara® until at least 15 weeks after end of therapy.
CL Item
yes (1)
CL Item
no (2)
CL Item
NA (3)
Item Group
Additional exclusion criteria Cyclosporine
C0680251 (UMLS CUI-1)
C0010592 (UMLS CUI-2)
Item
Known hypersensitivity to ciclosporin and / or against any of the excipients of the ciclosporin preparation.
integer
C0020517 (UMLS CUI [1])
Additional inclusion criterion for patients who should receive adalimumab or ustekinumab
Code List
Known hypersensitivity to ciclosporin and / or against any of the excipients of the ciclosporin preparation.
CL Item
yes (1)
CL Item
no (2)
CL Item
NA (3)
Item
Uncontrolled arterial hypertension.
integer
C1868885 (UMLS CUI [1])
Additional inclusion criterion for patients who should receive adalimumab or ustekinumab
Code List
Uncontrolled arterial hypertension.
CL Item
yes (1)
CL Item
no (2)
CL Item
NA (3)
Item
Uncontrolled infectious diseases.
integer
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Additional inclusion criterion for patients who should receive adalimumab or ustekinumab
Code List
Uncontrolled infectious diseases.
CL Item
yes (1)
CL Item
no (2)
CL Item
NA (3)
Item
Not healed infection with varicella, incl. Herpes zoster infection, herpes simplex infections, and other viral infections (eg, mollusks, condyloma, multiple warts)
integer
C0586989 (UMLS CUI [1])
Additional inclusion criterion for patients who should receive adalimumab or ustekinumab
Code List
Not healed infection with varicella, incl. Herpes zoster infection, herpes simplex infections, and other viral infections (eg, mollusks, condyloma, multiple warts)
CL Item
yes (1)
CL Item
no (2)
CL Item
NA (3)
Item
Relevant renal impairment
integer
C1565489 (UMLS CUI [1])
Additional inclusion criterion for patients who should receive adalimumab or ustekinumab
Code List
Relevant renal impairment
CL Item
yes (1)
CL Item
no (2)
CL Item
NA (3)
Item
Severe liver disease, GOT> 2 x ULN, GPT> 2x ULN, yGT> 2 x ULN, bilirubin> 2 x ULN
integer
C3829821 (UMLS CUI [1])
Additional inclusion criterion for patients who should receive adalimumab or ustekinumab
Code List
Severe liver disease, GOT> 2 x ULN, GPT> 2x ULN, yGT> 2 x ULN, bilirubin> 2 x ULN
CL Item
yes (1)
CL Item
no (2)
CL Item
NA (3)
Item
Hyperuricemia
integer
C0740394 (UMLS CUI [1])
Additional inclusion criterion for patients who should receive adalimumab or ustekinumab
Code List
Hyperuricemia
CL Item
yes (1)
CL Item
no (2)
CL Item
NA (3)
Item
Hyperkalemia
integer
C0020461 (UMLS CUI [1])
Additional inclusion criterion for patients who should receive adalimumab or ustekinumab
Code List
Hyperkalemia
CL Item
yes (1)
CL Item
no (2)
CL Item
NA (3)
Item
State after prior PUVA therapy with cumulative dose> 1000 J / cm²
integer
C0853073 (UMLS CUI [1])
Additional inclusion criterion for patients who should receive adalimumab or ustekinumab
Code List
State after prior PUVA therapy with cumulative dose> 1000 J / cm²
CL Item
yes (1)
CL Item
no (2)
CL Item
NA (3)
Item
State after many years of methotrexate therapy
integer
C0025677 (UMLS CUI [1])
Additional inclusion criterion for patients who should receive adalimumab or ustekinumab
Code List
State after many years of methotrexate therapy
CL Item
yes (1)
CL Item
no (2)
CL Item
NA (3)
Item
Therapy with Etretinate within 4 weeks prior to initiating therapy with cyclosporine
integer
C0015137 (UMLS CUI [1])
Additional inclusion criterion for patients who should receive adalimumab or ustekinumab
Code List
Therapy with Etretinate within 4 weeks prior to initiating therapy with cyclosporine
CL Item
yes (1)
CL Item
no (2)
CL Item
NA (3)
Item
Concurrent therapy with retinoids
integer
C3653550 (UMLS CUI [1])
Additional inclusion criterion for patients who should receive adalimumab or ustekinumab
Code List
Concurrent therapy with retinoids
CL Item
yes (1)
CL Item
no (2)
CL Item
NA (3)
Item
Concurrent therapy with coal tar
integer
C0009137 (UMLS CUI [1])
Additional inclusion criterion for patients who should receive adalimumab or ustekinumab
Code List
Concurrent therapy with coal tar
CL Item
yes (1)
CL Item
no (2)
CL Item
NA (3)
Item
Concurrent therapy with simvastatin
integer
C0074554 (UMLS CUI [1])
Additional inclusion criterion for patients who should receive adalimumab or ustekinumab
Code List
Concurrent therapy with simvastatin
CL Item
yes (1)
CL Item
no (2)
CL Item
NA (3)
Item
Concurrent therapy with tacrolimus
integer
C0085149 (UMLS CUI [1])
Additional inclusion criterion for patients who should receive adalimumab or ustekinumab
Code List
Concurrent therapy with tacrolimus
CL Item
yes (1)
CL Item
no (2)
CL Item
NA (3)
Item
Concomitant use of St. John's wort (Hypericum perforatum)
integer
C0936242 (UMLS CUI [1])
Additional inclusion criterion for patients who should receive adalimumab or ustekinumab
Code List
Concomitant use of St. John's wort (Hypericum perforatum)
CL Item
yes (1)
CL Item
no (2)
CL Item
NA (3)
Item
Concomitant therapy with drugs that are substrates of multidrug efflux transporters P-glycoprotein or Organic Anion Transporting Polypeptides and are joined for the increased plasma concentrations with serious and / or life-threatening events, such as Bosentan, Dabigatran-Etexilate and Aliskiren.
integer
C0069906 (UMLS CUI [1])
C0949791 (UMLS CUI [2])
Additional inclusion criterion for patients who should receive adalimumab or ustekinumab
Code List
Concomitant therapy with drugs that are substrates of multidrug efflux transporters P-glycoprotein or Organic Anion Transporting Polypeptides and are joined for the increased plasma concentrations with serious and / or life-threatening events, such as Bosentan, Dabigatran-Etexilate and Aliskiren.
CL Item
yes (1)
CL Item
no (2)
CL Item
NA (3)
Item
Concomitant vaccination with live vaccines
integer
C0042196 (UMLS CUI [1])
Additional inclusion criterion for patients who should receive adalimumab or ustekinumab
Code List
Concomitant vaccination with live vaccines
CL Item
yes (1)
CL Item
no (2)
CL Item
NA (3)
Item
Alcohol disease, contraindication to the use of alcohol (eg. epilepsy)
integer
C0038586 (UMLS CUI [1])
Additional inclusion criterion for patients who should receive adalimumab or ustekinumab
Code List
Alcohol disease, contraindication to the use of alcohol (eg. epilepsy)
CL Item
yes (1)
CL Item
no (2)
CL Item
NA (3)
Item
Erythrodermic or pustular psoriasis
integer
C0748052 (UMLS CUI [1])
C0152081 (UMLS CUI [2])
Additional inclusion criterion for patients who should receive adalimumab or ustekinumab
Code List
Erythrodermic or pustular psoriasis
CL Item
yes (1)
CL Item
no (2)
CL Item
NA (3)
Item
Psoriatic forms that may be caused or exacerbated by drugs.
integer
C1304130 (UMLS CUI [1])
Additional inclusion criterion for patients who should receive adalimumab or ustekinumab
Code List
Psoriatic forms that may be caused or exacerbated by drugs.
CL Item
yes (1)
CL Item
no (2)
CL Item
NA (3)
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