PLAN-psoriasis feasibility trial
Research type
Research Study
Full title
Patient-Led ‘As Needed’ treatment vs therapeutic drug monitoring guided treatment vs continuous treatment for psoriasis: a UK multicentre assessor-blind, parallel group, open-label randomised controlled feasibility trial
IRAS ID
335278
Contact name
Satveer Mahil
Contact email
Sponsor organisation
Guy's and St Thomas' Foundation NHS Trust
ISRCTN Number
ISRCTN17922845
Duration of Study in the UK
2 years, 7 months, 1 days
Research summary
Psoriasis is a condition that causes scaly patches of skin that are dry and red, and can cause itchiness and soreness. It affects 2-3% of the UK population.
More severe psoriasis is often treated with injection medicines called 'biologics'. Biologics target specific parts of the immune system and are very effective at clearing psoriasis. People who have clear or nearly clear psoriasis currently take their biologic treatment continuously and indefinitely, but this may not be necessary for everyone. Continuous use is burdensome (for example, regular injections, hospital follow-up, risk of drug side effects including infections) and expensive. It may not be the best way of using these medications long-term.
Personalised treatment plans may allow each person to take the lowest amount of their biologic that is needed to keep their psoriasis well-controlled. This would benefit both patients and the NHS by reducing the risks and burden of treatment.
The PLAN-psoriasis feasibility trial is a feasibility randomised controlled trial (RCT) that will investigate whether it is practical and acceptable (to patients and healthcare professionals) to use two different types of personalised treatment strategies for biologic use, compared to standard care (continuous treatment).
The two personalised treatment plans we will investigate at in this feasibility study are:
1. Patient-led 'as needed' treatment: participants stop their biologic treatment, and they re-start it at the first sign of psoriasis appearing.
2. Therapeutic Drug Monitoring (TDM) guided treatment: the dose of the participant's biologic treatment is calculated based on the concentration of drug in their blood (measured using a blood test).
The above will be compared to standard care: participants continue their biologic treatment at the standard dose.
We will recruit 90 participants, (30 participants in each arm) and they will be asked to follow their allocated treatment plan for biologic use for 12 months.
REC name
London - City & East Research Ethics Committee
REC reference
24/LO/0089
Date of REC Opinion
12 Feb 2024
REC opinion
Further Information Favourable Opinion