ID

12425

Description

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

Versions (4)
  1. 11/17/15 11/17/15 -
  2. 12/8/15 12/8/15 -
  3. 12/8/15 12/8/15 -
  4. 7/23/16 7/23/16 -
Uploaded on

November 17, 2015

DOI

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

German English

Eligibility Determination Psoriasis MIPSO EudraCT 2014-003022-40

1 forms  
Patient identification
Description

Patient identification

Patient number
Description

Patient Number

Data type

text

Date of consent
Description

Date of consent

Data type

date

Measurement units
  • dd/mm/yyyy
dd/mm/yyyy
Date of screening
Description

Date of screening

Data type

date

Measurement units
  • dd/mm/yyyy
dd/mm/yyyy
Inclusion criteria
Description

Inclusion criteria

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

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

Data type

boolean

≥18 years (male and female)
Description

≥18 years (male and female)

Data type

boolean

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

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

Data type

boolean

Additional inclusion criterion for patients who should receive adalimumab or ustekinumab
Description

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.

Data type

integer

Additional inclusion criterion for patients who should receive ciclosporin
Description

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

Data type

integer

Exclusion criteria
Description

Exclusion criteria

Therapy with systemic immunosuppressants
Description

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.

Data type

boolean

Concurrent therapy with systemic immunosuppressants
Description

Concurrent therapy with systemic immunosuppressants.

Data type

boolean

Antibiotic therapy over a period of at least 4 weeks or during the study
Description

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

Data type

boolean

Psoriasis patients who currently receive or have received phototherapy
Description

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

Data type

boolean

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

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.

Data type

boolean

Clinically significant active infection
Description

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.

Data type

boolean

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

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

Data type

boolean

HIV-positive patients
Description

HIV-positive patients.

Data type

boolean

Malignancies current or history
Description

Malignancies current or history.

Data type

boolean

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

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

Data type

boolean

Patients receiving chemotherapy or radiation therapy
Description

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.

Data type

boolean

Patients are not stable with uncontrolled chronic diseases
Description

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.

Data type

boolean

Patients with other chronic skin diseases
Description

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

Data type

boolean

Patients with psychiatric comorbidity
Description

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

Data type

boolean

Participation in another interventional examination
Description

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.

Data type

boolean

Pregnancy or lactation
Description

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.

Data type

boolean

Patients who were positive for MRSA
Description

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

Data type

boolean

Patients with psoriasis vulgaris exclusively in the head area
Description

Patients with psoriasis vulgaris exclusively in the head area.

Data type

boolean

Additional exclusion criteria Adalimumab
Description

Additional exclusion criteria Adalimumab

Hypersensitivity
Description

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

Data type

integer

Moderate to severe heart failure
Description

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

Data type

integer

Demyelinating diseases of the CNS
Description

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

Data type

integer

Concurrent therapy with Anakinra or Abatacept
Description

Concurrent therapy with anakinra or abatacept.

Data type

integer

Concomitant vaccination with live vaccines
Description

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

Data type

integer

Additional exclusion criteria Ustekinumab
Description

Additional exclusion criteria Ustekinumab

Hypersensitivity
Description

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

Data type

integer

Simultaneous vaccination with live viruses or live bacteria
Description

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.

Data type

integer

Additional exclusion criteria Ciclosporin
Description

Additional exclusion criteria Ciclosporin

Hypersensitivity
Description

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

Data type

integer

Uncontrolled arterial hypertension
Description

Uncontrolled arterial hypertension.

Data type

integer

Uncontrolled infectious diseases
Description

Uncontrolled infectious diseases.

Data type

integer

Not healed infection with varicella
Description

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

Data type

integer

Relevant renal impairment
Description

Relevant renal impairment

Data type

integer

Severe liver disease
Description

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

Data type

integer

Hyperuricemia
Description

Hyperuricemia

Data type

integer

Hyperkalemia
Description

Hyperkalemia

Data type

integer

State after prior PUVA therapy
Description

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

Data type

integer

State after many years of methotrexate therapy
Description

State after many years of methotrexate therapy

Data type

integer

Therapy with Etretinate
Description

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

Data type

integer

Concurrent therapy with retinoids
Description

Concurrent therapy with retinoids

Data type

integer

Concurrent therapy with coal tar
Description

Concurrent therapy with coal tar

Data type

integer

Concurrent therapy with simvastatin
Description

Concurrent therapy with simvastatin

Data type

integer

Concurrent therapy with tacrolimus
Description

Concurrent therapy with tacrolimus

Data type

integer

Concomitant use of Hypericum perforatum
Description

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

Data type

integer

Concomitant therapy with P-glycoprotein or OATP subtrates
Description

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.

Data type

integer

Concomitant vaccination with live vaccines
Description

Concomitant vaccination with live vaccines

Data type

integer

Alcohol disease
Description

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

Data type

integer

Erythrodermic or pustular psoriasis
Description

Erythrodermic or pustular psoriasis

Data type

integer

Psoriatic forms that may be caused or exacerbated by drugs
Description

Psoriatic forms that may be caused or exacerbated by drugs.

Data type

integer

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Similar models

Eligibility Determination Psoriasis MIPSO EudraCT 2014-003022-40

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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