Eligibility Determination Psoriasis MIPSO EudraCT 2014-003022-40

Beschreibung

Patient Number

Datentyp

text

Beschreibung

Date of consent

Datentyp

date

Maßeinheiten

• dd/mm/yyyy

Beschreibung

Date of screening

Datentyp

date

Maßeinheiten

• dd/mm/yyyy

Beschreibung

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

Datentyp

boolean

Beschreibung

≥18 years (male and female)

Datentyp

boolean

Beschreibung

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

Datentyp

boolean

Beschreibung

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.

Datentyp

integer

Beschreibung

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

Datentyp

integer

Beschreibung

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.

Datentyp

boolean

Beschreibung

Concurrent therapy with systemic immunosuppressants.

Datentyp

boolean

Beschreibung

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

Datentyp

boolean

Beschreibung

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

Datentyp

boolean

Beschreibung

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.

Datentyp

boolean

Beschreibung

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.

Datentyp

boolean

Beschreibung

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

Datentyp

boolean

Beschreibung

HIV-positive patients.

Datentyp

boolean

Beschreibung

Malignancies current or history.

Datentyp

boolean

Beschreibung

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

Datentyp

boolean

Beschreibung

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.

Datentyp

boolean

Beschreibung

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.

Datentyp

boolean

Beschreibung

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

Datentyp

boolean

Beschreibung

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

Datentyp

boolean

Beschreibung

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.

Datentyp

boolean

Beschreibung

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.

Datentyp

boolean

Beschreibung

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

Datentyp

boolean

Beschreibung

Patients with psoriasis vulgaris exclusively in the head area.

Datentyp

boolean

Beschreibung

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

Datentyp

integer

Beschreibung

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

Datentyp

integer

Beschreibung

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

Datentyp

integer

Beschreibung

Concurrent therapy with anakinra or abatacept.

Datentyp

integer

Beschreibung

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

Datentyp

integer

Beschreibung

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

Datentyp

integer

Beschreibung

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.

Datentyp

integer

Beschreibung

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

Datentyp

integer

Beschreibung

Uncontrolled arterial hypertension.

Datentyp

integer

Beschreibung

Uncontrolled infectious diseases.

Datentyp

integer

Beschreibung

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

Datentyp

integer

Beschreibung

Relevant renal impairment

Datentyp

integer

Beschreibung

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

Datentyp

integer

Beschreibung

Hyperuricemia

Datentyp

integer

Beschreibung

Hyperkalemia

Datentyp

integer

Beschreibung

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

Datentyp

integer

Beschreibung

State after many years of methotrexate therapy

Datentyp

integer

Beschreibung

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

Datentyp

integer

Beschreibung

Concurrent therapy with retinoids

Datentyp

integer

Beschreibung

Concurrent therapy with coal tar

Datentyp

integer

Beschreibung

Concurrent therapy with simvastatin

Datentyp

integer

Beschreibung

Concurrent therapy with tacrolimus

Datentyp

integer

Beschreibung

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

Datentyp

integer

Beschreibung

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.

Datentyp

integer

Beschreibung

Concomitant vaccination with live vaccines

Datentyp

integer

Beschreibung

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

Datentyp

integer

Beschreibung

Erythrodermic or pustular psoriasis

Datentyp

integer

Beschreibung

Psoriatic forms that may be caused or exacerbated by drugs.

Datentyp

integer