ID
12655
Descrição
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
Palavras-chave
Versões (4)
- 17/11/2015 17/11/2015 -
- 08/12/2015 08/12/2015 -
- 08/12/2015 08/12/2015 -
- 23/07/2016 23/07/2016 -
Transferido a
8 de dezembro de 2015
DOI
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Licença
Creative Commons BY-NC 3.0 Legacy
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Eligibility Determination Psoriasis MIPSO EudraCT 2014-003022-40
Eligibility Determination Psoriasis MIPSO EudraCT 2014-003022-40
- StudyEvent: ODM
Descrição
Inclusion criteria
Descrição
Patients with at least moderate psoriasis vulgaris (PASI ≥ 10) plaque-type.
Tipo de dados
boolean
Descrição
≥18 years (male and female)
Tipo de dados
boolean
Descrição
Indications for treatment with adalimumab, ustekinumab or cyclosporine in accordance with the guidelines for psoriasis and the individual prescribing information.
Tipo de dados
boolean
Descrição
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 dados
integer
Descrição
Patients with at least moderate psoriasis vulgaris (PASI ≥ 10) plaque-type, which are not sufficiently treated with conventional systemic therapy.
Tipo de dados
integer
Descrição
Exclusion criteria
Descrição
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 dados
boolean
Descrição
Concurrent therapy with systemic immunosuppressants.
Tipo de dados
boolean
Descrição
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 dados
boolean
Descrição
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 dados
boolean
Descrição
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 dados
boolean
Descrição
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 dados
boolean
Descrição
Chronic carriers of the hepatitis B virus (HBsAg positive).
Tipo de dados
boolean
Descrição
HIV-positive patients.
Tipo de dados
boolean
Descrição
Malignancies current or history.
Tipo de dados
boolean
Descrição
Immunodeficient patients (primary disease or as a result of therapy).
Tipo de dados
boolean
Descrição
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 dados
boolean
Descrição
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 dados
boolean
Descrição
Patients with other chronic skin diseases such as atopic dermatitis or lupus erythematosus that may affect the cutaneous microbiota.
Tipo de dados
boolean
Descrição
Patients with psychiatric comorbidity, which cause a lack or lack of capacity to consent.
Tipo de dados
boolean
Descrição
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 dados
boolean
Descrição
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 dados
boolean
Descrição
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 dados
boolean
Descrição
Patients with psoriasis vulgaris exclusively in the head area.
Tipo de dados
boolean
Descrição
Additional exclusion criteria Adalimumab
Descrição
Hypersensitivity to the active substance or to any of the excipients of Humira®.
Tipo de dados
integer
Descrição
Moderate to severe heart failure (NYHA class III / IV).
Tipo de dados
integer
Descrição
Pre-existing or incipient demyelinating diseases of the CNS or peripheral nervous system.
Tipo de dados
integer
Descrição
Concurrent therapy with anakinra or abatacept.
Tipo de dados
integer
Descrição
Concomitant vaccination with live vaccines. This applies for a period up to 5 months after end of therapy.
Tipo de dados
integer
Descrição
Additional exclusion criteria Ustekinumab
Descrição
Hypersensitivity to the active substance or to any of the excipients of Stelara®, allergy to latex.
Tipo de dados
integer
Descrição
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 dados
integer
Descrição
Additional exclusion criteria Ciclosporin
Descrição
Known hypersensitivity to ciclosporin and / or against any of the excipients of the ciclosporin preparation.
Tipo de dados
integer
Descrição
Uncontrolled arterial hypertension.
Tipo de dados
integer
Descrição
Uncontrolled infectious diseases.
Tipo de dados
integer
Descrição
Not healed infection with varicella, incl. Herpes zoster infection, herpes simplex infections, and other viral infections (eg, mollusks, condyloma, multiple warts)
Tipo de dados
integer
Descrição
Relevant renal impairment
Tipo de dados
integer
Descrição
Severe liver disease, GOT> 2 x ULN, GPT> 2x ULN, yGT> 2 x ULN, bilirubin> 2 x ULN
Tipo de dados
integer
Descrição
Hyperuricemia
Tipo de dados
integer
Descrição
Hyperkalemia
Tipo de dados
integer
Descrição
State after prior PUVA therapy with cumulative dose> 1000 J / cm²
Tipo de dados
integer
Descrição
State after many years of methotrexate therapy
Tipo de dados
integer
Descrição
Therapy with Etretinate within 4 weeks prior to initiating therapy with cyclosporine
Tipo de dados
integer
Descrição
Concurrent therapy with retinoids
Tipo de dados
integer
Descrição
Concurrent therapy with coal tar
Tipo de dados
integer
Descrição
Concurrent therapy with simvastatin
Tipo de dados
integer
Descrição
Concurrent therapy with tacrolimus
Tipo de dados
integer
Descrição
Concomitant use of St. John's wort (Hypericum perforatum)
Tipo de dados
integer
Descrição
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 dados
integer
Descrição
Concomitant vaccination with live vaccines
Tipo de dados
integer
Descrição
Alcohol disease, contraindication to the use of alcohol (eg. epilepsy)
Tipo de dados
integer
Descrição
Erythrodermic or pustular psoriasis
Tipo de dados
integer
Descrição
Psoriatic forms that may be caused or exacerbated by drugs.
Tipo de dados
integer
Similar models
Eligibility Determination Psoriasis MIPSO EudraCT 2014-003022-40
- StudyEvent: ODM