As part of the 14th Substantial Amendment for the study, there have been some changes to the eligibility criteria for patients on conventional treatments. The implementation date for Substantial Amendment 14 is 08/05/2025; these changes will affect any patients consented from that date onwards.
The main change is that the only eligible conventional therapy is Methotrexate. We can no longer accept patient registrations starting on Acitretin, Ciclosporin, Fumaric Acid Esters, Hydroxycarbamide, and Systemic Oral PUVA.
There are two exceptions to the above:
Patients with Generalised Pustular Psoriasis (GPP): GPP patients can also be recruited if they are starting on either Acitretin or Ciclosporin. They also do not need to meet the minimum PASI or DLQI criteria, but we will still need both a PASI and a DLQI recorded at baseline.
Paediatric patients: Any patient who is under the age of 16 when they are consented can be recruited if they start on any of our historical conventional treatments. These are Methotrexate, Acitretin, Ciclosporin, Fumaric Acid Esters, Hydroxycarbamide, and Systemic Oral PUVA. Paediatric patients do not need to meet the minimum DLQI criteria, but we will still need a DLQI recorded at baseline.
We will update the eligibility poster on the website and the eligibility checker built into the database in the near future.
If you are ever unsure if a patient is eligible for the study, please contact us and we can confirm for you.