Eligibility Determination Psoriasis MIPSO EudraCT 2014-003022-40

Descripción

Patient Number

Tipo de datos

text

Descripción

Date of consent

Tipo de datos

date

Unidades de medida

• dd/mm/yyyy

Descripción

Date of screening

Tipo de datos

date

Unidades de medida

• dd/mm/yyyy

Descripción

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

Tipo de datos

boolean

Descripción

≥18 years (male and female)

Tipo de datos

boolean

Descripción

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

Tipo de datos

boolean

Descripción

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 de datos

integer

Descripción

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

Tipo de datos

integer

Descripción

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 de datos

boolean

Descripción

Concurrent therapy with systemic immunosuppressants.

Tipo de datos

boolean

Descripción

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

Tipo de datos

boolean

Descripción

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 de datos

boolean

Descripción

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 de datos

boolean

Descripción

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 de datos

boolean

Descripción

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

Tipo de datos

boolean

Descripción

HIV-positive patients.

Tipo de datos

boolean

Descripción

Malignancies current or history.

Tipo de datos

boolean

Descripción

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

Tipo de datos

boolean

Descripción

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 de datos

boolean

Descripción

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 de datos

boolean

Descripción

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

Tipo de datos

boolean

Descripción

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

Tipo de datos

boolean

Descripción

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 de datos

boolean

Descripción

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 de datos

boolean

Descripción

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 de datos

boolean

Descripción

Patients with psoriasis vulgaris exclusively in the head area.

Tipo de datos

boolean

Descripción

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

Tipo de datos

integer

Descripción

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

Tipo de datos

integer

Descripción

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

Tipo de datos

integer

Descripción

Concurrent therapy with anakinra or abatacept.

Tipo de datos

integer

Descripción

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

Tipo de datos

integer

Descripción

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

Tipo de datos

integer

Descripción

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 de datos

integer

Descripción

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

Tipo de datos

integer

Descripción

Uncontrolled arterial hypertension.

Tipo de datos

integer

Descripción

Uncontrolled infectious diseases.

Tipo de datos

integer

Descripción

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

Tipo de datos

integer

Descripción

Relevant renal impairment

Tipo de datos

integer

Descripción

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

Tipo de datos

integer

Descripción

Hyperuricemia

Tipo de datos

integer

Descripción

Hyperkalemia

Tipo de datos

integer

Descripción

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

Tipo de datos

integer

Descripción

State after many years of methotrexate therapy

Tipo de datos

integer

Descripción

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

Tipo de datos

integer

Descripción

Concurrent therapy with retinoids

Tipo de datos

integer

Descripción

Concurrent therapy with coal tar

Tipo de datos

integer

Descripción

Concurrent therapy with simvastatin

Tipo de datos

integer

Descripción

Concurrent therapy with tacrolimus

Tipo de datos

integer

Descripción

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

Tipo de datos

integer

Descripción

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 de datos

integer

Descripción

Concomitant vaccination with live vaccines

Tipo de datos

integer

Descripción

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

Tipo de datos

integer

Descripción

Erythrodermic or pustular psoriasis

Tipo de datos

integer

Descripción

Psoriatic forms that may be caused or exacerbated by drugs.

Tipo de datos

integer