Comparison of the bacterial microbiota in the skin and gut of psoriasis patients before and after sytemic treatment with adalimumab and ustekinumab or cyclosporin
Organizational Data
- DRKS-ID:
- DRKS00007147
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2015-03-31
- Last update in DRKS:
- 2023-01-04
- Registration type:
- Prospective
Acronym/abbreviation of the study
MIPSO
URL of the study
No Entry
Brief summary in lay language
The aim of this study is to investigate the treatment effects of different drugs (adalimumab, ustekinumab and cyclosporine) on the presence of microorganisms (e.g.bacteria) in skin and in stool in adult patients with psoriasis vulgaris. During the study period, which extends over a total of about 24 weeks, swabs from skin, biopsies from skin and stool samples will be taken repeatedly.
Brief summary in scientific language
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).
Health condition or problem studied
- Free text:
- MedDRA - Psoriasis vulgaris (10050576)
- ICD10:
- L40.0 - Psoriasis vulgaris
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Stelara® (ustekinumab) 45 mg resp. 90 mg s.c. Day 0, 28 and 112
- Arm 2:
- Humira® (Adalimumab) 80 mg s.c. Day 0, 40 mg s.c. Day 8 and then every 2 weeks
- Arm 3:
- Cyclosporine capsules oral, dosage according to the AWMF-Guidelines for Psoriasis vulgaris
Endpoints
- Primary outcome:
- 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 by use of DNA sequence analysis.
- Secondary outcome:
- - 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.
Study Design
- Purpose:
- Diagnostic
- Allocation:
- Non-randomized controlled study
- Control:
-
- Active control (effective treatment of control group)
- Phase:
- IV
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Klinik für Hautkrankheiten Münster
Recruitment period and number of participants
- Planned study start date:
- 2015-04-16
- Actual study start date:
- 2015-06-19
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2017-09-11
- Target Sample Size:
- 36
- Final Sample Size:
- 37
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional 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 cyclosporine, methotrexate, or PUVA or patients with contraindications or intolerance to such a therapy. Additional inclusion criteria for patients who will receive cyclosporine: 1.Patients with at least moderate psoriasis vulgaris (plaque psoriasis) (PASI ≥ 10) who are not adequately treatable with conventional systemic therapy.
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. Topical treatment with calcineurin inhibitors or vitamin D3 analogues may be continued in lesional skin areas that are not intended for 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 tuberculosis prophylaxis with Isoniazid in the respective patients. Additional exclusion criteria for patients who will receive ciclosporine: 1.Allergy to cyclosporine medication. 2.Uncontrolled arterial hypertension. 3.Uncontrolled infections. 4.Active infections with varicella including herpes zoster infections, herpes simplex infections and other viral infections (e.g. molluscs, condylomata, multiple warts). 5.Relevant renal impairment. 6.Severe hepatic disease, GOT > 2 x ULN, GPT > 2 x ULN, yGT > 2 x ULN, Bilrubin > 2 x ULN. 7.Hyperuricaemia. 8.Hyperkaliaemia. 9.History of PUVA therapie with a cumulative dose of > 1000 J/cm² 10.Therapy with etretinat within 4 weeks of starting therapy with ciclosporine. 11.Simultaneous therapy with retinoids. 12.Simultaneous therapy with coal tar. 13.Simultaneous therapy with rosuvastatin. 14.Simultaneous therapy with tacrolimus. 15.Simultaneous therapy with amber. 16.Simultaneous therapy with drugs which are substrates of the multidrug efflux transporter P-glycoprotein or of organic anion transporting polypeptides and in which increased plasma concentrations are associated with life-threatening events (e.g. bosentan, dabigatran etexilate and aliskiren). 17.Simultaneous vaccination with life vaccines. 18.Alcoholism. Contraindications to ingestion of alcohol (e.g. epilepsy). 19.Erythrodermic or pustular psoriasis. 20.Types of psoriasis which might be caused or exacerbated by drugs.
Addresses
Primary Sponsor
- Address:
- Universitätsklinikum MünsterAlbert-Schweitzer-Campus 1, Geb. D548149 MünsterGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.klinikum.uni-muenster.de
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Universitätsklinikum Münster, Klinik für HautkrankheitenProf. Dr. Karin LoserVon-Esmarch-Str. 5848149 MünsterGermany
- Telephone:
- 0251 / 83-52953
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Universitätsklinikum Münster, Klinik für Hautkrankheiten, Zentrale Studienkoordination für innovative Dermatologie (ZID)Dr. med. Athanasios TsianakasVon-Esmarch-Str. 5848149 MünsterGermany
- Telephone:
- 0251 / 83-57291 oder -56558
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Universitätsklinikum Münster, Klinik für HautkrankheitenProf. Dr. Karin LoserVon-Esmarch-Str. 5848149 MünsterGermany
- Telephone:
- 0251 / 83-52953
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Commercial (pharmaceutical industry, medical engineering industry, etc.)
- Address:
- Janssen Cilag GmbHJohnson & Johnson-Platz 141470 NeussGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Ärztekammer Westfalen-Lippe und der Westfälischen Wilhelms-Universität MünsterGartenstraße 210-21448147 MünsterGermany
- Telephone:
- +49-251-9292460
- Fax:
- +49-251-9292478
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2014-10-27
- Ethics committee number:
- 2014-577-f-A
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2015-03-19
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- 2014-003022-40
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- Studienergebnisse finden sich im EU Clinical Trail Register
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry