ID

12655

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

8 dicembre 2015

DOI

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Licenza

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

Tedesco Inglese

Eligibility Determination Psoriasis MIPSO EudraCT 2014-003022-40

1 moduli  
Patient identification
Descrizione

Patient identification

Patient number
Descrizione

Patient Number

Tipo di dati

text

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
dd/mm/yyyy
Inclusion criteria
Descrizione

Inclusion criteria

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

≥18 years (male and female)
Descrizione

≥18 years (male and female)

Tipo di dati

boolean

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

Additional inclusion criterion for patients who should receive adalimumab or ustekinumab
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

Additional inclusion criterion for patients who should receive ciclosporin
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

Exclusion criteria
Descrizione

Exclusion criteria

Therapy with systemic immunosuppressants
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

Concurrent therapy with systemic immunosuppressants
Descrizione

Concurrent therapy with systemic immunosuppressants.

Tipo di dati

boolean

Antibiotic therapy over a period of at least 4 weeks or 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

Psoriasis patients who currently receive or have received phototherapy
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

Patients who can not interrupt the local, topical therapy with calcineurin inhibitors or vitamin D3 analogues in the skin areas
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

Clinically significant active infection
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

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

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

Tipo di dati

boolean

HIV-positive patients
Descrizione

HIV-positive patients.

Tipo di dati

boolean

Malignancies current or history
Descrizione

Malignancies current or history.

Tipo di dati

boolean

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

Patients receiving chemotherapy or radiation therapy
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

Patients are not stable with uncontrolled chronic diseases
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

Patients with other chronic skin diseases
Descrizione

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

Tipo di dati

boolean

Patients with psychiatric comorbidity
Descrizione

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

Tipo di dati

boolean

Participation in another interventional examination
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

Pregnancy or lactation
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

Patients who were positive for MRSA
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

Patients with psoriasis vulgaris exclusively in the head area
Descrizione

Patients with psoriasis vulgaris exclusively in the head area.

Tipo di dati

boolean

Additional exclusion criteria Adalimumab
Descrizione

Additional exclusion criteria Adalimumab

Hypersensitivity
Descrizione

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

Tipo di dati

integer

Moderate to severe heart failure
Descrizione

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

Tipo di dati

integer

Demyelinating diseases of the CNS
Descrizione

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

Tipo di dati

integer

Concurrent therapy with Anakinra or Abatacept
Descrizione

Concurrent therapy with anakinra or abatacept.

Tipo di dati

integer

Concomitant vaccination with live vaccines
Descrizione

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

Tipo di dati

integer

Additional exclusion criteria Ustekinumab
Descrizione

Additional exclusion criteria Ustekinumab

Hypersensitivity
Descrizione

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

Tipo di dati

integer

Simultaneous vaccination with live viruses or live bacteria
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

Additional exclusion criteria Ciclosporin
Descrizione

Additional exclusion criteria Ciclosporin

Hypersensitivity
Descrizione

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

Tipo di dati

integer

Uncontrolled arterial hypertension
Descrizione

Uncontrolled arterial hypertension.

Tipo di dati

integer

Uncontrolled infectious diseases
Descrizione

Uncontrolled infectious diseases.

Tipo di dati

integer

Not healed infection with varicella
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

Relevant renal impairment
Descrizione

Relevant renal impairment

Tipo di dati

integer

Severe liver disease
Descrizione

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

Tipo di dati

integer

Hyperuricemia
Descrizione

Hyperuricemia

Tipo di dati

integer

Hyperkalemia
Descrizione

Hyperkalemia

Tipo di dati

integer

State after prior PUVA therapy
Descrizione

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

Tipo di dati

integer

State after many years of methotrexate therapy
Descrizione

State after many years of methotrexate therapy

Tipo di dati

integer

Therapy with Etretinate
Descrizione

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

Tipo di dati

integer

Concurrent therapy with retinoids
Descrizione

Concurrent therapy with retinoids

Tipo di dati

integer

Concurrent therapy with coal tar
Descrizione

Concurrent therapy with coal tar

Tipo di dati

integer

Concurrent therapy with simvastatin
Descrizione

Concurrent therapy with simvastatin

Tipo di dati

integer

Concurrent therapy with tacrolimus
Descrizione

Concurrent therapy with tacrolimus

Tipo di dati

integer

Concomitant use of Hypericum perforatum
Descrizione

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

Tipo di dati

integer

Concomitant therapy with P-glycoprotein or OATP subtrates
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

Concomitant vaccination with live vaccines
Descrizione

Concomitant vaccination with live vaccines

Tipo di dati

integer

Alcohol disease
Descrizione

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

Tipo di dati

integer

Erythrodermic or pustular psoriasis
Descrizione

Erythrodermic or pustular psoriasis

Tipo di dati

integer

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

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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
Patient number
Item
text
Date of consent
Item
Date of consent
date
Date of screening
Item
Date of screening
date
Item Group
Inclusion criteria
Patients with at least moderate psoriasis vulgaris (PASI ≥ 10) plaque-type
Item
boolean
≥18 years (male and female)
Item
boolean
Indications for treatment with adalimumab, ustekinumab or cyclosporine in accordance with the guidelines for psoriasis and the individual prescribing information
Item
boolean
Additional inclusion criterion for patients who should receive adalimumab or ustekinumab
Code List
Additional inclusion criterion for patients who should receive adalimumab or ustekinumab
CL Item
yes (1)
CL Item
no (2)
CL Item
NA (3)
Additional inclusion criterion for patients who should receive adalimumab or ustekinumab
Code List
Additional inclusion criterion for patients who should receive ciclosporin
CL Item
yes (1)
CL Item
no (2)
CL Item
NA (3)
Item Group
Exclusion criteria
Therapy with systemic immunosuppressants
Item
boolean
Concurrent therapy with systemic immunosuppressants
Item
boolean
Antibiotic therapy over a period of at least 4 weeks or during the study
Item
boolean
Psoriasis patients who currently receive or have received phototherapy
Item
boolean
Patients who can not interrupt the local, topical therapy with calcineurin inhibitors or vitamin D3 analogues in the skin areas
Item
boolean
Clinically significant active infection
Item
boolean
Chronic carriers of the hepatitis B virus
Item
Chronic carriers of the hepatitis B virus (HBsAg positive)
boolean
HIV-positive
Item
HIV-positive patients
boolean
Malignancies current or history
Item
boolean
Immunodeficient patients
Item
Immunodeficient patients (primary disease or as a result of therapy)
boolean
Patients receiving chemotherapy or radiation therapy
Item
boolean
Patients are not stable with uncontrolled chronic diseases
Item
boolean
Patients with other chronic skin diseases
Item
boolean
Patients with psychiatric comorbidity
Item
boolean
Participation in another interventional examination
Item
boolean
Pregnancy or lactation
Item
boolean
Patients who were positive for MRSA
Item
boolean
Patients with psoriasis vulgaris exclusively in the head area
Item
boolean
Item Group
Additional exclusion criteria Adalimumab
Item
integer
Additional inclusion criterion for patients who should receive adalimumab or ustekinumab
Code List
Hypersensitivity
CL Item
yes (1)
CL Item
no (2)
CL Item
NA (3)
Additional inclusion criterion for patients who should receive adalimumab or ustekinumab
Code List
Moderate to severe heart failure
CL Item
yes (1)
CL Item
no (2)
CL Item
NA (3)
Additional inclusion criterion for patients who should receive adalimumab or ustekinumab
Code List
Demyelinating diseases of the CNS
CL Item
yes (1)
CL Item
no (2)
CL Item
NA (3)
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)
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 Group
Additional exclusion criteria Ustekinumab
Item
integer
Additional inclusion criterion for patients who should receive adalimumab or ustekinumab
Code List
Hypersensitivity
CL Item
yes (1)
CL Item
no (2)
CL Item
NA (3)
Additional inclusion criterion for patients who should receive adalimumab or ustekinumab
Code List
Simultaneous vaccination with live viruses or live bacteria
CL Item
yes (1)
CL Item
no (2)
CL Item
NA (3)
Item Group
Additional exclusion criteria Ciclosporin
Item
integer
Additional inclusion criterion for patients who should receive adalimumab or ustekinumab
Code List
Hypersensitivity
CL Item
yes (1)
CL Item
no (2)
CL Item
NA (3)
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)
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)
Additional inclusion criterion for patients who should receive adalimumab or ustekinumab
Code List
Not healed infection with varicella
CL Item
yes (1)
CL Item
no (2)
CL Item
NA (3)
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)
Additional inclusion criterion for patients who should receive adalimumab or ustekinumab
Code List
Severe liver disease
CL Item
yes (1)
CL Item
no (2)
CL Item
NA (3)
Item
Hyperuricemia
integer
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
integer
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)
Additional inclusion criterion for patients who should receive adalimumab or ustekinumab
Code List
State after prior PUVA therapy
CL Item
yes (1)
CL Item
no (2)
CL Item
NA (3)
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)
Additional inclusion criterion for patients who should receive adalimumab or ustekinumab
Code List
Therapy with Etretinate
CL Item
yes (1)
CL Item
no (2)
CL Item
NA (3)
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)
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)
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)
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)
Additional inclusion criterion for patients who should receive adalimumab or ustekinumab
Code List
Concomitant use of Hypericum perforatum
CL Item
yes (1)
CL Item
no (2)
CL Item
NA (3)
Additional inclusion criterion for patients who should receive adalimumab or ustekinumab
Code List
Concomitant therapy with P-glycoprotein or OATP subtrates
CL Item
yes (1)
CL Item
no (2)
CL Item
NA (3)
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
integer
Additional inclusion criterion for patients who should receive adalimumab or ustekinumab
Code List
Alcohol disease
CL Item
yes (1)
CL Item
no (2)
CL Item
NA (3)
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)
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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