ID
12657
Beskrivning
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
Nyckelord
Versioner (4)
- 2015-11-17 2015-11-17 -
- 2015-12-08 2015-12-08 -
- 2015-12-08 2015-12-08 -
- 2016-07-23 2016-07-23 -
Uppladdad den
8 december 2015
DOI
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Licens
Creative Commons BY-NC 3.0
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Eligibility Determination Psoriasis MIPSO EudraCT 2014-003022-40
Eligibility Determination Psoriasis MIPSO EudraCT 2014-003022-40
- StudyEvent: ODM
Beskrivning
Inclusion criteria
Beskrivning
Patients with at least moderate psoriasis vulgaris (PASI ≥ 10) plaque-type.
Datatyp
boolean
Beskrivning
≥18 years (male and female)
Datatyp
boolean
Beskrivning
Indications for treatment with adalimumab, ustekinumab or cyclosporine in accordance with the guidelines for psoriasis and the individual prescribing information.
Datatyp
boolean
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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.
Datatyp
integer
Beskrivning
Patients with at least moderate psoriasis vulgaris (PASI ≥ 10) plaque-type, which are not sufficiently treated with conventional systemic therapy.
Datatyp
integer
Beskrivning
Exclusion criteria
Beskrivning
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.
Datatyp
boolean
Beskrivning
Concurrent therapy with systemic immunosuppressants.
Datatyp
boolean
Beskrivning
Antibiotic therapy over a period of at least 4 weeks before taking the initial swab specimens / biopsies or antibiotic therapy during the study.
Datatyp
boolean
Beskrivning
Psoriasis patients who currently receive or have received phototherapy for a period of 2 weeks before the withdrawal of the initial swab specimens / biopsies.
Datatyp
boolean
Beskrivning
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.
Datatyp
boolean
Beskrivning
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.
Datatyp
boolean
Beskrivning
Chronic carriers of the hepatitis B virus (HBsAg positive).
Datatyp
boolean
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HIV-positive patients.
Datatyp
boolean
Beskrivning
Malignancies current or history.
Datatyp
boolean
Beskrivning
Immunodeficient patients (primary disease or as a result of therapy).
Datatyp
boolean
Beskrivning
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.
Datatyp
boolean
Beskrivning
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.
Datatyp
boolean
Beskrivning
Patients with other chronic skin diseases such as atopic dermatitis or lupus erythematosus that may affect the cutaneous microbiota.
Datatyp
boolean
Beskrivning
Patients with psychiatric comorbidity, which cause a lack or lack of capacity to consent.
Datatyp
boolean
Beskrivning
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.
Datatyp
boolean
Beskrivning
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.
Datatyp
boolean
Beskrivning
Patients who were positive for MRSA in the history over a period of 6 months prior to withdrawal of the first swab specimens / biopsies.
Datatyp
boolean
Beskrivning
Patients with psoriasis vulgaris exclusively in the head area.
Datatyp
boolean
Beskrivning
Additional exclusion criteria Adalimumab
Beskrivning
Hypersensitivity to the active substance or to any of the excipients of Humira®.
Datatyp
integer
Beskrivning
Moderate to severe heart failure (NYHA class III / IV).
Datatyp
integer
Beskrivning
Pre-existing or incipient demyelinating diseases of the CNS or peripheral nervous system.
Datatyp
integer
Beskrivning
Concurrent therapy with anakinra or abatacept.
Datatyp
integer
Beskrivning
Concomitant vaccination with live vaccines. This applies for a period up to 5 months after end of therapy.
Datatyp
integer
Beskrivning
Additional exclusion criteria Ustekinumab
Beskrivning
Hypersensitivity to the active substance or to any of the excipients of Stelara®, allergy to latex.
Datatyp
integer
Beskrivning
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.
Datatyp
integer
Beskrivning
Additional exclusion criteria Ciclosporin
Beskrivning
Known hypersensitivity to ciclosporin and / or against any of the excipients of the ciclosporin preparation.
Datatyp
integer
Beskrivning
Uncontrolled arterial hypertension.
Datatyp
integer
Beskrivning
Uncontrolled infectious diseases.
Datatyp
integer
Beskrivning
Not healed infection with varicella, incl. Herpes zoster infection, herpes simplex infections, and other viral infections (eg, mollusks, condyloma, multiple warts)
Datatyp
integer
Beskrivning
Relevant renal impairment
Datatyp
integer
Beskrivning
Severe liver disease, GOT> 2 x ULN, GPT> 2x ULN, yGT> 2 x ULN, bilirubin> 2 x ULN
Datatyp
integer
Beskrivning
Hyperuricemia
Datatyp
integer
Beskrivning
Hyperkalemia
Datatyp
integer
Beskrivning
State after prior PUVA therapy with cumulative dose> 1000 J / cm²
Datatyp
integer
Beskrivning
State after many years of methotrexate therapy
Datatyp
integer
Beskrivning
Therapy with Etretinate within 4 weeks prior to initiating therapy with cyclosporine
Datatyp
integer
Beskrivning
Concurrent therapy with retinoids
Datatyp
integer
Beskrivning
Concurrent therapy with coal tar
Datatyp
integer
Beskrivning
Concurrent therapy with simvastatin
Datatyp
integer
Beskrivning
Concurrent therapy with tacrolimus
Datatyp
integer
Beskrivning
Concomitant use of St. John's wort (Hypericum perforatum)
Datatyp
integer
Beskrivning
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.
Datatyp
integer
Beskrivning
Concomitant vaccination with live vaccines
Datatyp
integer
Beskrivning
Alcohol disease, contraindication to the use of alcohol (eg. epilepsy)
Datatyp
integer
Beskrivning
Erythrodermic or pustular psoriasis
Datatyp
integer
Beskrivning
Psoriatic forms that may be caused or exacerbated by drugs.
Datatyp
integer
Similar models
Eligibility Determination Psoriasis MIPSO EudraCT 2014-003022-40
- StudyEvent: ODM