SEquential Treatment of PSoriasis With Biologics

ConditionPsoriasis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRoyal United Hospitals Bath NHS Foundation Trust

About this trial

Psoriasis is a common skin condition that leads to patches of scaled skin which can be inflamed, sore and itchy. It can affect any area of skin on the body, as well as nails, and can be widespread and severe. Over the past 20 years, many new treatments have been developed and approved for severe psoriasis. Most of these newer treatments are given by injection and, as a group, are known as biologics. Many people respond well to biologics and have a meaningful improvement in their condition. There is a smaller proportion of people who do not respond well, or develop side effects, and so must switch drugs to try and improve their condition. In some cases, people need multiple lines of biologic treatment. Currently very little is understood about how well people respond when they are treated with three or more biologics in a row, as very few trials have been done in these cases.

This study aims to use data from people who have already been treated with biologics by their Dermatology teams in the NHS and use the information obtained during their normal clinic appointments to investigate this question. The investigators will assess how well people respond to each line of biologic drug (1st to 10th). They will look at whether people respond as well or less well over time, the more biologics they have. People can be included in the research if they are 18 or over and have been treated with a biologic for psoriasis in participating hospitals in the NHS in England. In this study the investigators are assessing data from events that have previously happened, and so no extra visits are required

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of chronic plaque psoriasis by a Dermatology consultant

Prior treatment with biologic or targeted synthetic treatment (1 to 10 lines) for psoriasis in the United Kingdom

Disqualifiers

Diagnosis of other forms of psoriasis for example generalised pustular psoriasis

Trial population

Participants taken from population who have been treated with biologics and targeted synthetic treatments in Dermatology departments at participating NHS sites.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

366 Participants
are grouped into 2 trial groups
Group A: 2nd Line Biologic
Group B: 3rd+ Line Biologic

Trial outcomes

Primary outcomes

1

PASI75

75% improvement in Psoriasis Area and Severity Index (PASI)

Time frame
12-16 weeks and 6 months

Secondary outcomes

1

PASI90

90% improvement in PASI score

Time frame
12-16 weeks and 6 months
2

PASI100

100% improvement to PASI score

Time frame
12-16 weeks and 6 months
3

PASI<2

Achievement of a PASI score \<2

Time frame
12-16 weeks and 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Royal United Hospitals Bath NHS Foundation Trust

Lead sponsor

University of Bath

Collaborator

University of Leeds

Collaborator