Disease under investigation: Adult patients of both genders with moderate to severe chronic plaque psoriasis who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or PUVA. This is the exact label indication of Humira. Conditions: In this clinical trial Humira treatment will be performed completely "in-label" over 16 weeks (and facultatively over an additional 4 weeks during follow-up).
Conditions
Interventions
Trade Name: Humira 40 mg injection solution in pre-filled syringe
Pharmaceutical Form: Injection*
Sponsors
Faculty of Medicine, Otto-von-Guericke-University Magdeburg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: According to approved label status of Humira: Adult patients with moderate to severe plaque psoriasis, who have failed to respond to, or who have a contraindication to, or are intolerant of other systemic therapies including cyclosporine, methotrexate or PUVA. No pre-treatment with Humira in the history. The patient is able to understand the study and capable to give informed consent. Written informed consent. Age of more than 18 years. Psorias area and severity index (PASI) of more than 10 or involvement of body surface by psoriasis for more than 10% or dermatologic life quality index (DLQI, according to Finlay and Kahn) or more than 10. Exclusion of an active or latent tuberculosis by negative tuberculosis-skin-test and chest x-ray. Consideration of the following wash-out-intervals before the start of study medication: i) 2 weeks for antipsoriatic topical drugs (vitamin D and analogues, dithranol, corticosteroids, tar, tazarotene), ii) 4 weeks for conventional antipsoriatic systemic drugs (cyclosporine, methotrexate, fumarates, acitretin), iii) 4 weeks for uv-treatment, iv) 3 months for infliximab, golimumab, etanercept, and efalizumab, v) 6 months for ustekinumab, and vi) 6 months for any investigational compound / drug. In case of treatment with a beta-blocker, ACE-inhibitor, anti-malaria drug (resochin), interferon or lithium: stable medication with these agents for at least 4 weeks before the start of the study medication. No foreseeable necessity for vaccination with a live-vaccine during 4 weeks before the start of the study medication, during 16 weeks of study medication and during 8 weeks afterwards. Willingness to keep natural sun light exposure adequately constant and to avoid the use of artificial uv exposition (solarium). Use of anticonception in female study participants under study medication and up to at least 5 months after the last Humira injection. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: According to approved label status of Humira: - Hypersensitivity against the active compound (i.e. adalimumab) or any other compound of Humira. - Active tuberculosis or other severe infections, alike sepsis and opportunistic infections. - Moderate to severe heart insufficiency (NYHA class III/IV). - HIV infection. - History of hepatitis B or hepatitis C. - Intake of immunosuppressive agents / drugs. - Indication for a demyelinating disease (e.g. multiple sclerosis) in the patient`s history or in the history of a family member. - Malignancies of recent relevance (incl. solid tumors, malignant hematopoetic diseases, lymphoproliferative diseases, melanocytic skin cancer). - Intolerance to biologics. - Precedent or current medication with azathioprine or 6-mercaptopurine. - History of a Felty syndrome or of a splenomegaly in combination with leukocytopenia. - Pregnancy. - Breast feeding. - Serious other reason out of the investigator´s judgement. Absolute criteria for premature discontinuation are: - Occurence of preganancy. - Clinically significant worsening of disease, defined as an increase of PASI of > 50% as compared to the beginning of study medication. - Grade 3 systemic toxicity. - Grade 4 adverse event or a serious adverse event thought to be related to study medication. - Serious infection (grade 3) incl. sepsis syndrome with hypotension. - Withdrawal of consent. - Need for vaccination with live-vaccine. The treatment may be discontinued under the following conditions: - Lack of subject compliance. - Significant protocol deviation. - Upon decision of the investigator due to serious other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Analysis of the topoproteome of skin tissue under standard treatment of psoriasis with Humira in an optimum of 12 patients by taking skin biopsies in local anesthesia before the beginning of the treatment (from involved and uninvolved psoriatic skin) and at weeks 1, 4 and 16 after the beginning of the treatment (from originally involved skin, representative areas). The skin tissue will be analyzed by multi epitope ligand cartography (=MELC). ;Secondary Objective: - Determination of anti-psoriatic treatment efficacy of Humira as well as detection of reponders and non-responders by determination of the following established standard parameters in the course of the above mentioned treatment: 1) psoriasis area and severity index (PASI), 2) physician´s global assessment (PGA), 3) pruritus score and 4) dermatology life quality index (DLQI). - Determination of treatment safety by the detection of possibly occuring adverse events.;Primary end point(s): - The primary endpoint is the antipsoriatic treatment of the study participants with a standard "in-label" Humira treatment for 16 weeks. At that time point the individual PASI-response and the PASI-50-response- as well as PASI-75-response-rates will be recorded. - The primary study parameter is the analysis of the inflammatory topoproteome in skin tissue as detected by multi epitope ligand cartography (= MELC). | — |
Countries
Germany
Outcome results
None listed