Psoriasis
Conditions
Interventions
Trade Name: REMICADE
Product Name: INFLIXIMAB
Pharmaceutical Form: Powder for injection*
INN or Proposed INN: INFLIXIMAB
CAS Number: 170
Sponsors
The Newcastle upon Tyne Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Prospective experimental clinical study Study population: inpatients and outpatients attending the dermatology department in Newcastle-Upon-Tyne with chronic psoriasis, aged 18 years or over, giving written informed consent, who will be receiving active treatment for thier psoriasis, as [part of routine clinical care. The following information will be required from participants: Age and sex Age of onset of psoriasis Large/ small plaque disease Involvement of scalp/ nails/ joints Previous psoriatic treatments Any other medications Past medical history Patients recruited into the study will be questioned about their psoriasis and any previous treatments that they have tried, they will also be examined to assess the extent of their psoriasis. This will be recorded by coding data so that patient confidentiality is maintained. Patients were recruited who are about to commence anti-psoriatic treatment and who meet the inclusion/exclusion criteria outlined above. Prior to treatment two skin biopsies will be performed, one from involved (plaque) skin and one from uninvolved skin. Up to 2 further skin biopsies will be taken from involved skin at specific time points during therapy. The severity of psoriasis will be graded and the induction of apoptosis correlated with clinical and histological improvement in psoriatic plaques. A maximum of 4 skin biopsies will be taken from each patient. This will involve anaesthetising a small area of skin with 1-2 mls of 1% lignocaine. A 4mm punch biopsy sample will be taken, and 1 to 2 stitches inserted to aid wound healing. These will need to be removed 1 week later. Skin samples from patients will be examined prior to commencing treatment, before clinical improvement and during clearance (range 1 day to 3 months). A control sample of healthy skin, taken from the same patients will be compared to the psoriatic skin. This will allow us show that differences in skin are due to the psoriasis rather that individual variation. 20mls of venous blood will also be taken for DNA analysis. 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: Use of other immune modifying drug for 3 months prior to inclusion in the trial (including oral steroids) Use of topical treatments (except emulsifying creams/ ointments) for 1 week prior to inclusion in the trial Immune modifying disease Pregnancy Disseminated cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: We aim to study apoptosis in psoriatic skin biopsies during the clinical resolution of psoriatic plaques in response to a variety of treatments and correlate this with clinical improvement.;Secondary Objective: To define the molecular mechanism of action of various routine treatments used in the management of psoriasis; Primary end point(s): Not applicable This is a prospective, obeservational study monitoring the response to anti-psoriatic therapy. This will be assessed through clinical response, histological response and changes in a number of immunophenotypic markers specifically investigating changes in cell proliferation, differentiation, death (including apoptosis), inflammation and angiogenesis. | — |
Countries
United Kingdom
Outcome results
None listed