METHorMAB Trial
Research type
Research Study
Full title
An observer blind randomised controlled trial to compare the clinical and health economic benefits of prescribing adalimumab instead of methotrexate in patients with moderate psoriasis with psoriasis area and severity index (PASI) scores of ≥5 and <10
IRAS ID
1013551
Contact name
Philip Hampton
Contact email
Sponsor organisation
The Newcastle upon Tyne Hospitals NHS Foundation Trust
ISRCTN Number
ISRCTN18260393
Research summary
Psoriasis is a long term skin condition that causes red, scaly, and sometimes painful patches on the skin. It affects about 3% of people in the UK and can have a major impact on daily life and wellbeing. For many years, one of the main treatments has been methotrexate (MTX), taken as tablets or injections. Although MTX can help, it requires regular blood tests because it can sometimes affect the liver or bone marrow.
In the last 15 years, newer treatments called biologics have become available. These are injections that block the signals in the immune system that cause psoriasis. The most commonly used biologic is adalimumab (ADA). At the moment, ADA is only offered to people with severe psoriasis because there is not enough research showing whether it works better than MTX for people with moderate psoriasis. ADA also tends to cause fewer side effects and usually requires far fewer clinic visits.
This study aims to compare ADA and MTX to see which treatment helps more people achieve a major improvement in their skin. A 75% improvement in psoriasis severity is the internationally recognised standard for a meaningful response, as patients who reach this level usually notice a significant benefit in their daily lives.
If ADA is shown to work better than MTX for moderate psoriasis, the results could influence future NICE guidance and potentially improve treatment options for many patients.
The study will also look at the cost of each treatment and how they affect quality of life.
310 patients will be recruited from 15–20 dermatology clinics. Participants will be randomly assigned to receive either weekly MTX injections or ADA injections every two weeks. After 16 weeks, their skin improvement will be assessed and the two treatments compared.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
26/SC/0155
Date of REC Opinion
17 Jun 2026
REC opinion
Further Information Favourable Opinion