This pilot lab-based study will assess skin biopsies from psoriatic patients treated with infliximab and aim to compare the proteomic profiles of samples obtained under the following conditions: 1- psoriatic non-lesional skin
Conditions
Interventions
Trade Name: Remicade
Product Name: Remicade
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: Infliximab
Sponsors
Associação para Desenvolvimento da Dermatologia do Hospital de Santa Maria
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1- Moderate to severe chronic plaque-psoriasis, assessed by PASI score > 10 2- Clinical indicaition to infliximab therapy 3- > 18 years old 4- Written infromed consent prior to any study related procedure 5- 60 days washout of prior systemic therapy 6- No primary vaccinations =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1- Guttate, erythrodermic or pustular psoriasis as sole or predominant form of psoriasis 2- History of severe allergic or anaphylactic reactions to monoclonal antibodies 3- Ongoing uncontrolled bacterial, fungal or atypical mycobacterial infection 4- Opportunistic infection 5- Seropositivity for HIV, HBV or HBC virus 6- Pregnancy or breastfeeding 7- Hematological abnormalities 8- History of active tuberculosis or treatment for TB in the previous year 9- Lupus or elevation of ANA / anti dsDNA titers 10- Any malignancy in the previous 5 years, including lymphoproliferative disorders. Patients with fully resolved basel cell or squamous cell skin cancer may be enrolled. 11- Hospital admission for cardiac disease, stroke, pulmonary disease < 1year. 12- Any medical condition that, in the judgement of the investigator, would jeopardize the patient safety.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the proteomic profiles of skin samples obtained from psoriatic patients before starting and under infliximab treatment from: 1- Psoriatic non-lesional skin 2- psoriatic lesional skin ;Secondary Objective: 1-Identify disease and therapeutic biomarkers 2- Correlate the disease-modifying effects at molecualr level with clinical outcomes;Primary end point(s): Patients reaching greater or equal PASI 75 response at week 12 will be eligible for sample collection for this research study that will compare the proteome of non-lesional and lesional skin samples before and under 12 weeks of infliximab treatment. | — |
Countries
Portugal
Outcome results
None listed