ID
16556
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 -
Geüploaded op
23 juli 2016
DOI
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Licentie
Creative Commons BY-NC 3.0
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Eligibility Determination Psoriasis MIPSO EudraCT 2014-003022-40 DRKS00007147
Eligibility Determination Psoriasis MIPSO EudraCT 2014-003022-40
- StudyEvent: ODM
Beschrijving
Inclusion criteria
Alias
- UMLS CUI-1
- C1512693
Beschrijving
Patients with at least moderate psoriasis vulgaris (PASI ≥ 10) plaque-type.
Datatype
boolean
Alias
- UMLS CUI [1]
- C4027888
Beschrijving
≥18 years (male and female)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0001779
Beschrijving
Indications for treatment with adalimumab, ustekinumab or cyclosporine in accordance with the guidelines for psoriasis and the individual prescribing information.
Datatype
boolean
Alias
- UMLS CUI [1]
- C1122087
- UMLS CUI [2]
- C1608841
- UMLS CUI [3]
- C0010592
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
Alias
- UMLS CUI [1,1]
- C1524062
- UMLS CUI [1,2]
- C1512693
- UMLS CUI [1,3]
- C1122087
- UMLS CUI [2,1]
- C1524062
- UMLS CUI [2,2]
- C1512693
- UMLS CUI [2,3]
- C1608841
Beschrijving
Patients with at least moderate psoriasis vulgaris (PASI ≥ 10) plaque-type, which are not sufficiently treated with conventional systemic therapy.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1524062
- UMLS CUI [1,2]
- C1512693
- UMLS CUI [1,3]
- C0010592
Beschrijving
Exclusion criteria
Alias
- UMLS CUI-1
- C0680251
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
Alias
- UMLS CUI [1,1]
- C0021079
- UMLS CUI [1,2]
- C0205373
Beschrijving
Concurrent therapy with systemic immunosuppressants.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0009429
- UMLS CUI [1,2]
- C0021079
- UMLS CUI [1,3]
- C0205373
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
Alias
- UMLS CUI [1]
- C0338237
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
Alias
- UMLS CUI [1]
- C0031765
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
Alias
- UMLS CUI [1]
- C3888969
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
Alias
- UMLS CUI [1]
- C0009450
Beschrijving
Chronic carriers of the hepatitis B virus (HBsAg positive).
Datatype
boolean
Alias
- UMLS CUI [1]
- C0149709
Beschrijving
HIV-positive patients.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0019699
Beschrijving
Malignancies current or history.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0006826
Beschrijving
Immunodeficient patients (primary disease or as a result of therapy).
Datatype
boolean
Alias
- UMLS CUI [1]
- C0021051
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
Alias
- UMLS CUI [1]
- C0392920
- UMLS CUI [2]
- C1522449
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
Alias
- UMLS CUI [1,1]
- C0008679
- UMLS CUI [1,2]
- C0205318
Beschrijving
Patients with other chronic skin diseases such as atopic dermatitis or lupus erythematosus that may affect the cutaneous microbiota.
Datatype
boolean
Alias
- UMLS CUI [1]
- C1290009
Beschrijving
Patients with psychiatric comorbidity, which cause a lack or lack of capacity to consent.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0004936
- UMLS CUI [1,2]
- C0009488
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
Alias
- UMLS CUI [1]
- C2348568
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
Alias
- UMLS CUI [1]
- C0032961
- UMLS CUI [2]
- C0006147
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
Alias
- UMLS CUI [1]
- C0343401
Beschrijving
Patients with psoriasis vulgaris exclusively in the head area.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0263361
- UMLS CUI [1,2]
- C0018670
Beschrijving
Additional exclusion criteria Adalimumab
Alias
- UMLS CUI-1
- C0680251
- UMLS CUI-2
- C1122087
Beschrijving
Hypersensitivity to the active substance or to any of the excipients of Humira®.
Datatype
integer
Alias
- UMLS CUI [1]
- C0020517
Beschrijving
Moderate to severe heart failure (NYHA class III / IV).
Datatype
integer
Alias
- UMLS CUI [1]
- C1275491
Beschrijving
Pre-existing or incipient demyelinating diseases of the CNS or peripheral nervous system.
Datatype
integer
Alias
- UMLS CUI [1]
- C0751873
Beschrijving
Concurrent therapy with anakinra or abatacept.
Datatype
integer
Alias
- UMLS CUI [1]
- C0245109
- UMLS CUI [2]
- C1619966
Beschrijving
Concomitant vaccination with live vaccines. This applies for a period up to 5 months after end of therapy.
Datatype
integer
Alias
- UMLS CUI [1]
- C0042196
Beschrijving
Additional exclusion criteria Ustekinumab
Alias
- UMLS CUI-1
- C0680251
- UMLS CUI-2
- C1608841
Beschrijving
Hypersensitivity to the active substance or to any of the excipients of Stelara®, allergy to latex.
Datatype
integer
Alias
- UMLS CUI [1]
- C0020517
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
Alias
- UMLS CUI [1]
- C0042196
Beschrijving
Additional exclusion criteria Cyclosporine
Alias
- UMLS CUI-1
- C0680251
- UMLS CUI-2
- C0010592
Beschrijving
Known hypersensitivity to ciclosporin and / or against any of the excipients of the ciclosporin preparation.
Datatype
integer
Alias
- UMLS CUI [1]
- C0020517
Beschrijving
Uncontrolled arterial hypertension.
Datatype
integer
Alias
- UMLS CUI [1]
- C1868885
Beschrijving
Uncontrolled infectious diseases.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0009450
- UMLS CUI [1,2]
- C0205318
Beschrijving
Not healed infection with varicella, incl. Herpes zoster infection, herpes simplex infections, and other viral infections (eg, mollusks, condyloma, multiple warts)
Datatype
integer
Alias
- UMLS CUI [1]
- C0586989
Beschrijving
Relevant renal impairment
Datatype
integer
Alias
- UMLS CUI [1]
- C1565489
Beschrijving
Severe liver disease, GOT> 2 x ULN, GPT> 2x ULN, yGT> 2 x ULN, bilirubin> 2 x ULN
Datatype
integer
Alias
- UMLS CUI [1]
- C3829821
Beschrijving
Hyperuricemia
Datatype
integer
Alias
- UMLS CUI [1]
- C0740394
Beschrijving
Hyperkalemia
Datatype
integer
Alias
- UMLS CUI [1]
- C0020461
Beschrijving
State after prior PUVA therapy with cumulative dose> 1000 J / cm²
Datatype
integer
Alias
- UMLS CUI [1]
- C0853073
Beschrijving
State after many years of methotrexate therapy
Datatype
integer
Alias
- UMLS CUI [1]
- C0025677
Beschrijving
Therapy with Etretinate within 4 weeks prior to initiating therapy with cyclosporine
Datatype
integer
Alias
- UMLS CUI [1]
- C0015137
Beschrijving
Concurrent therapy with retinoids
Datatype
integer
Alias
- UMLS CUI [1]
- C3653550
Beschrijving
Concurrent therapy with coal tar
Datatype
integer
Alias
- UMLS CUI [1]
- C0009137
Beschrijving
Concurrent therapy with simvastatin
Datatype
integer
Alias
- UMLS CUI [1]
- C0074554
Beschrijving
Concurrent therapy with tacrolimus
Datatype
integer
Alias
- UMLS CUI [1]
- C0085149
Beschrijving
Concomitant use of St. John's wort (Hypericum perforatum)
Datatype
integer
Alias
- UMLS CUI [1]
- C0936242
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
Alias
- UMLS CUI [1]
- C0069906
- UMLS CUI [2]
- C0949791
Beschrijving
Concomitant vaccination with live vaccines
Datatype
integer
Alias
- UMLS CUI [1]
- C0042196
Beschrijving
Alcohol disease, contraindication to the use of alcohol (eg. epilepsy)
Datatype
integer
Alias
- UMLS CUI [1]
- C0038586
Beschrijving
Erythrodermic or pustular psoriasis
Datatype
integer
Alias
- UMLS CUI [1]
- C0748052
- UMLS CUI [2]
- C0152081
Beschrijving
Psoriatic forms that may be caused or exacerbated by drugs.
Datatype
integer
Alias
- UMLS CUI [1]
- C1304130
Similar models
Eligibility Determination Psoriasis MIPSO EudraCT 2014-003022-40
- StudyEvent: ODM
C1710477 (UMLS CUI [1,2])
C1608841 (UMLS CUI [2])
C0010592 (UMLS CUI [3])
C1512693 (UMLS CUI [1,2])
C1122087 (UMLS CUI [1,3])
C1524062 (UMLS CUI [2,1])
C1512693 (UMLS CUI [2,2])
C1608841 (UMLS CUI [2,3])
C1512693 (UMLS CUI [1,2])
C0010592 (UMLS CUI [1,3])
C0205373 (UMLS CUI [1,2])
C0021079 (UMLS CUI [1,2])
C0205373 (UMLS CUI [1,3])
C1522449 (UMLS CUI [2])
C0205318 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2])
C0018670 (UMLS CUI [1,2])
C1122087 (UMLS CUI-2)
C1619966 (UMLS CUI [2])
C1608841 (UMLS CUI-2)
C0010592 (UMLS CUI-2)
C0205318 (UMLS CUI [1,2])
C0949791 (UMLS CUI [2])
C0152081 (UMLS CUI [2])