Psoriasis MedDRA version: 18.1 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris System Organ Class: 100000004858
Conditions
Interventions
Trade Name: Stelara ® 45 mg Injektionslösung in einer Fertigspritze
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Ustekinumab
CAS Number: 815610-63-0
Other des
Sponsors
Universitätsklinikum Münster
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria for all patients: 1. Patients with at least moderate psoriasis vulgaris (plaque psoriasis) (PASI = 10). 2. > 18 years (male and female). 3. Treatment according to the guidelines and standard therapies for psoriasis with adalimumab, ustekinumab or cyclosporine. Additional inclusion criteria for patients who will receive adalimumab or ustekinumab: 1.Patients with moderate or severe chronic plaque psoriasis who did not respond to other systemic therapy such as ciclosporine, methotrexate, or PUVA or patients with contraindications or intolerance to such a therapy. Additional inclusion criteria for patients who will receive ciclosporine: 1.Patients with at least moderate psoriasis vulgaris (plaque psoriasis) (PASI = 10) who are not adequately treatable with conventional systemic therapy. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 29 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 7
Exclusion criteria
Exclusion criteria: Exclusion criteria for all patients: 1.Patients treated with systemic immunosuppressives, adalimumab, etanercept, ustekinumab or infliximab within a period of 5 half-life periods of the respective drug before taking the initial skin swabs /biopsies. 2.Simultaneous therapy with systemic immunosuppressives. 3.Patients treated with antibiotics within at least 4 weeks before taking the initial skin swabs/biopsies or patients treated with antibiotics in the course of the trial with the exception of tuberculosis prophylaxis with Isoniazid. 4.Psoriasis patients who currently receive phototherapy or have received phototherapy within a period of 2 weeks before taking the initial skin swabs/biopsies. 5.Patients who can not interrupt the local, topical therapy with calcineurin inhibitors or vitamin D3 analogues in skin areas chosen for the skin swabs/biopsies. In skin areas chosen for the swabs/biopsies topical therapy is not allowed within 7 days before sampling. 6.Patients with relevant active infections (e.g. active tuberculosis or other severe infections such as sepsis and opportunistic infections). 7.HbsAG-positive patients. HCV-PCR-positive patients. 8.HIV-positive patients. 9.Current malignancies or history of malignancies. 10.Immunodeficient patients. 11.Patients who currently receive chemotherapy or radiotherapy or received chemotherapy or radiotherapy within the last 12 months prior to sampling of the initial skin swabs/biopsies. 12.Patients with uncontrolled chronic diseases which require continuous therapy, and which are not stable in the opinion of the investigator. 13.Patients with other chronic skin diseases such as atopic dermatitis or lupus erythematosus, which could affect the cutaneous microbiota. 14.Patients with psychiatric comorbidity, which causes deficient or missing ability for consent. 15.Participation in an another interventional trial during this trial or within 4 weeks of study entry or within 5 half-life periods of the prior investigational drug according to which period is longer. 16.Pregnancy or lactation. Women of childbearing potential or men with female partners of childbearing potential: Unwilling to agree to use reliable contraceptive methods (Pearl index < 1) during the trial and in addition to it at least 15 weeks after termination of therapy with Stelara® and at least 5 months after termination of therapy with Humira®. 17.Evidence of MRSA within 6 months before taking the initial skin swabs/biopsies. 18.Patients with psoriasis vulgaris exlusively located in the area of the head. Additional exclusion criteria for patients who will receive adalimumab: 1.Allergy to adalimumab or the other excipients of Humira®. 2.Heart failure NYHA III° or IV°. 3.Preexisting or incipient demyelinating diseases of the CNS or the PNS. 4.Simultaneous therapy with anakinra or abatacept. 5.Simultaneous vaccination with life vaccines. Vaccination with life vaccines within 5 months after the end of therapy with adalimumab. 6. Contraindications against tuberculosis prophylaxis with Isoniazid in the respective patients. Additional exclusion criteria for patients who will receive ustekinumab: 1.Allergy to ustekinumab or the other excipients of Stelara®. Allergy to latex. 2.Simultaneous vaccination with life vaccines or vaccination with life vaccines within 2 weeks of starting therapy with ustekinimab and within at least 15 weeks after the end of therapy with ustekinumab. 3. Contraindications against tub
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Change in the composition of the cutaneous microbiota in lesional skin of psoriasis patients after systemic treatment with adalimumab, ustekinumab or cyclosporine (baseline versus 4 weeks after start of treatment).;Secondary Objective: -Descriptive analysis of phylogenetic changes in the cutaneous microbiota in lesional skin of psoriasis patients after systemic treatment with adalimumab, ustekinumab or cyclosporine throughout the entire treatment and observation period of 24 weeks. - Comparison of the phylogenetic change in the cutaneous microbiota with clinical parameters or therapy success respectively (PASI, BSA). - Proof of phylogenetic changes in the intestinal microbiota in faecal specimens of patients with psoriasis after systemic treatment with adalimumab, ustekinumab or cyclosporine. - Descriptive analysis of phenotypic changes in the cutaneous and intestinal microbiota following systemic treatment with adalimumab, ustekinumab or cyclosporine in patients whose phylogenetic modifications of the microbiota could be correlated with clinical parameters.;Primary end point(s): Comparison of the differences in the relative frequencies of microorganisms in lesional skin of psoriasis patients before treatment with adalimumab, ustekinumab or cyclosporine versus 4 weeks after start of treatment. ;Timepoint(s) of evaluation of this end point: Baseline versus Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Comparison of the differences in the relative frequencies of the microorganisms in lesional skin of psoriasis patients treated with adalimumab, ustekinumab or cyclosporine, over the entire study period. - Comparison of the differences in the relative frequencies of intestinal microorganisms in psoriasis patients treated with adalimumab, ustekinumab or cyclosporine, over the entire study period. - Correlation of the differences in the relative frequencies of the microorganisms in lesional skin of psoriasis patients treated with adalimumab, ustekinumab or cyclosporine, with PASI and BSA ??over the entire study period. - Correlation of the differences in the relative frequencies of the intestinal microorganisms of psoriasis patients treated with adalimumab, ustekinumab or cyclosporine, with PASI and BSA ??over the entire study period. - Comparison of the differences in the phenotypic modifications of microorganisms in lesional skin of psoriasis patients treated with adalimumab, ustekinumab or cyclosporine, over the entire study period, after a correlation of phylogenetic modifications and clinical parameters (PASI, BSA) could be detected. - Comparison of the differences in the phenotypic modifications of intestinal microorganisms in psoriasis patients treated with adalimumab, ustekinumab or cyclosporine, over the entire study period, after a correlation of phylogenetic modifications and clinical parameters (PASI, BSA) could be detected.;Timepoint(s) of evaluation of this end point: Day 0, 28, 56, 84, 112,140, 168 | — |
Countries
Germany
Contacts
Public ContactHautklinik
Universitätsklinikum Münster
Outcome results
None listed