ID
12655
Description
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
Mots-clés
Versions (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 -
Téléchargé le
8 décembre 2015
DOI
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Licence
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
Description
Inclusion criteria
Description
Patients with at least moderate psoriasis vulgaris (PASI ≥ 10) plaque-type.
Type de données
boolean
Description
≥18 years (male and female)
Type de données
boolean
Description
Indications for treatment with adalimumab, ustekinumab or cyclosporine in accordance with the guidelines for psoriasis and the individual prescribing information.
Type de données
boolean
Description
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.
Type de données
integer
Description
Patients with at least moderate psoriasis vulgaris (PASI ≥ 10) plaque-type, which are not sufficiently treated with conventional systemic therapy.
Type de données
integer
Description
Exclusion criteria
Description
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.
Type de données
boolean
Description
Concurrent therapy with systemic immunosuppressants.
Type de données
boolean
Description
Antibiotic therapy over a period of at least 4 weeks before taking the initial swab specimens / biopsies or antibiotic therapy during the study.
Type de données
boolean
Description
Psoriasis patients who currently receive or have received phototherapy for a period of 2 weeks before the withdrawal of the initial swab specimens / biopsies.
Type de données
boolean
Description
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.
Type de données
boolean
Description
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.
Type de données
boolean
Description
Chronic carriers of the hepatitis B virus (HBsAg positive).
Type de données
boolean
Description
HIV-positive patients.
Type de données
boolean
Description
Malignancies current or history.
Type de données
boolean
Description
Immunodeficient patients (primary disease or as a result of therapy).
Type de données
boolean
Description
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.
Type de données
boolean
Description
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.
Type de données
boolean
Description
Patients with other chronic skin diseases such as atopic dermatitis or lupus erythematosus that may affect the cutaneous microbiota.
Type de données
boolean
Description
Patients with psychiatric comorbidity, which cause a lack or lack of capacity to consent.
Type de données
boolean
Description
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.
Type de données
boolean
Description
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.
Type de données
boolean
Description
Patients who were positive for MRSA in the history over a period of 6 months prior to withdrawal of the first swab specimens / biopsies.
Type de données
boolean
Description
Patients with psoriasis vulgaris exclusively in the head area.
Type de données
boolean
Description
Additional exclusion criteria Adalimumab
Description
Hypersensitivity to the active substance or to any of the excipients of Humira®.
Type de données
integer
Description
Moderate to severe heart failure (NYHA class III / IV).
Type de données
integer
Description
Pre-existing or incipient demyelinating diseases of the CNS or peripheral nervous system.
Type de données
integer
Description
Concurrent therapy with anakinra or abatacept.
Type de données
integer
Description
Concomitant vaccination with live vaccines. This applies for a period up to 5 months after end of therapy.
Type de données
integer
Description
Additional exclusion criteria Ustekinumab
Description
Hypersensitivity to the active substance or to any of the excipients of Stelara®, allergy to latex.
Type de données
integer
Description
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.
Type de données
integer
Description
Additional exclusion criteria Ciclosporin
Description
Known hypersensitivity to ciclosporin and / or against any of the excipients of the ciclosporin preparation.
Type de données
integer
Description
Uncontrolled arterial hypertension.
Type de données
integer
Description
Uncontrolled infectious diseases.
Type de données
integer
Description
Not healed infection with varicella, incl. Herpes zoster infection, herpes simplex infections, and other viral infections (eg, mollusks, condyloma, multiple warts)
Type de données
integer
Description
Relevant renal impairment
Type de données
integer
Description
Severe liver disease, GOT> 2 x ULN, GPT> 2x ULN, yGT> 2 x ULN, bilirubin> 2 x ULN
Type de données
integer
Description
Hyperuricemia
Type de données
integer
Description
Hyperkalemia
Type de données
integer
Description
State after prior PUVA therapy with cumulative dose> 1000 J / cm²
Type de données
integer
Description
State after many years of methotrexate therapy
Type de données
integer
Description
Therapy with Etretinate within 4 weeks prior to initiating therapy with cyclosporine
Type de données
integer
Description
Concurrent therapy with retinoids
Type de données
integer
Description
Concurrent therapy with coal tar
Type de données
integer
Description
Concurrent therapy with simvastatin
Type de données
integer
Description
Concurrent therapy with tacrolimus
Type de données
integer
Description
Concomitant use of St. John's wort (Hypericum perforatum)
Type de données
integer
Description
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.
Type de données
integer
Description
Concomitant vaccination with live vaccines
Type de données
integer
Description
Alcohol disease, contraindication to the use of alcohol (eg. epilepsy)
Type de données
integer
Description
Erythrodermic or pustular psoriasis
Type de données
integer
Description
Psoriatic forms that may be caused or exacerbated by drugs.
Type de données
integer
Similar models
Eligibility Determination Psoriasis MIPSO EudraCT 2014-003022-40
- StudyEvent: ODM