ID
12425
Beschrijving
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
Trefwoorden
Versies (4)
- 17-11-15 17-11-15 -
- 08-12-15 08-12-15 -
- 08-12-15 08-12-15 -
- 23-07-16 23-07-16 -
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17 november 2015
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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
Beschrijving
Inclusion criteria
Beschrijving
Patients with at least moderate psoriasis vulgaris (PASI ≥ 10) plaque-type.
Datatype
boolean
Beschrijving
≥18 years (male and female)
Datatype
boolean
Beschrijving
Indications for treatment with adalimumab, ustekinumab or cyclosporine in accordance with the guidelines for psoriasis and the individual prescribing information.
Datatype
boolean
Beschrijving
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.
Datatype
integer
Beschrijving
Patients with at least moderate psoriasis vulgaris (PASI ≥ 10) plaque-type, which are not sufficiently treated with conventional systemic therapy.
Datatype
integer
Beschrijving
Exclusion criteria
Beschrijving
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.
Datatype
boolean
Beschrijving
Concurrent therapy with systemic immunosuppressants.
Datatype
boolean
Beschrijving
Antibiotic therapy over a period of at least 4 weeks before taking the initial swab specimens / biopsies or antibiotic therapy during the study.
Datatype
boolean
Beschrijving
Psoriasis patients who currently receive or have received phototherapy for a period of 2 weeks before the withdrawal of the initial swab specimens / biopsies.
Datatype
boolean
Beschrijving
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.
Datatype
boolean
Beschrijving
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.
Datatype
boolean
Beschrijving
Chronic carriers of the hepatitis B virus (HBsAg positive).
Datatype
boolean
Beschrijving
HIV-positive patients.
Datatype
boolean
Beschrijving
Malignancies current or history.
Datatype
boolean
Beschrijving
Immunodeficient patients (primary disease or as a result of therapy).
Datatype
boolean
Beschrijving
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.
Datatype
boolean
Beschrijving
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.
Datatype
boolean
Beschrijving
Patients with other chronic skin diseases such as atopic dermatitis or lupus erythematosus that may affect the cutaneous microbiota.
Datatype
boolean
Beschrijving
Patients with psychiatric comorbidity, which cause a lack or lack of capacity to consent.
Datatype
boolean
Beschrijving
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.
Datatype
boolean
Beschrijving
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.
Datatype
boolean
Beschrijving
Patients who were positive for MRSA in the history over a period of 6 months prior to withdrawal of the first swab specimens / biopsies.
Datatype
boolean
Beschrijving
Patients with psoriasis vulgaris exclusively in the head area.
Datatype
boolean
Beschrijving
Additional exclusion criteria Adalimumab
Beschrijving
Hypersensitivity to the active substance or to any of the excipients of Humira®.
Datatype
integer
Beschrijving
Moderate to severe heart failure (NYHA class III / IV).
Datatype
integer
Beschrijving
Pre-existing or incipient demyelinating diseases of the CNS or peripheral nervous system.
Datatype
integer
Beschrijving
Concurrent therapy with anakinra or abatacept.
Datatype
integer
Beschrijving
Concomitant vaccination with live vaccines. This applies for a period up to 5 months after end of therapy.
Datatype
integer
Beschrijving
Additional exclusion criteria Ustekinumab
Beschrijving
Hypersensitivity to the active substance or to any of the excipients of Stelara®, allergy to latex.
Datatype
integer
Beschrijving
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.
Datatype
integer
Beschrijving
Additional exclusion criteria Ciclosporin
Beschrijving
Known hypersensitivity to ciclosporin and / or against any of the excipients of the ciclosporin preparation.
Datatype
integer
Beschrijving
Uncontrolled arterial hypertension.
Datatype
integer
Beschrijving
Uncontrolled infectious diseases.
Datatype
integer
Beschrijving
Not healed infection with varicella, incl. Herpes zoster infection, herpes simplex infections, and other viral infections (eg, mollusks, condyloma, multiple warts)
Datatype
integer
Beschrijving
Relevant renal impairment
Datatype
integer
Beschrijving
Severe liver disease, GOT> 2 x ULN, GPT> 2x ULN, yGT> 2 x ULN, bilirubin> 2 x ULN
Datatype
integer
Beschrijving
Hyperuricemia
Datatype
integer
Beschrijving
Hyperkalemia
Datatype
integer
Beschrijving
State after prior PUVA therapy with cumulative dose> 1000 J / cm²
Datatype
integer
Beschrijving
State after many years of methotrexate therapy
Datatype
integer
Beschrijving
Therapy with Etretinate within 4 weeks prior to initiating therapy with cyclosporine
Datatype
integer
Beschrijving
Concurrent therapy with retinoids
Datatype
integer
Beschrijving
Concurrent therapy with coal tar
Datatype
integer
Beschrijving
Concurrent therapy with simvastatin
Datatype
integer
Beschrijving
Concurrent therapy with tacrolimus
Datatype
integer
Beschrijving
Concomitant use of St. John's wort (Hypericum perforatum)
Datatype
integer
Beschrijving
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.
Datatype
integer
Beschrijving
Concomitant vaccination with live vaccines
Datatype
integer
Beschrijving
Alcohol disease, contraindication to the use of alcohol (eg. epilepsy)
Datatype
integer
Beschrijving
Erythrodermic or pustular psoriasis
Datatype
integer
Beschrijving
Psoriatic forms that may be caused or exacerbated by drugs.
Datatype
integer
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Eligibility Determination Psoriasis MIPSO EudraCT 2014-003022-40
- StudyEvent: ODM