Methotrexate Study

We aim to include 1200 patients with rheumatoid arthritis or psoriasis, recruited at centres in the UK. 

We are inviting people who have been diagnosed with having psoriasis or rheumatoid arthritis for more than 2 years to take part. We want to include people who have been on methotrexate therapy for the past 6 months or more and people who have never taken methotrexate.  

Participation involves one appointment with our Research Team.  

Our Researcher will arrange to meet you at the research centre at the Queens Medical Centre or in the mobile research unit or alternatively arrange to attend your routine hospital clinic appointment and conduct your study visit there.  

If you decide to take part, you will be asked to sign a consent form at your appointment. Consent can also be taken verbally (over the telephone) or electronically in conjunction with a phone call, in advance of your appointment which will reduce the amount of time needed for your appointment.​ 

The research team will: ​ 

• Try to answer any questions you have,​ 

• Ask about your health and medical history (including medications), ​ 

• Ask if we can access your Digital health records to collect further details of your health conditions and treatments, 

• Measure your height, weight and waist. 

• Ask you to have a Fibroscan if you have not had a one recently (this is optional- you can indicate this on the consent form). ​The researcher will upload the results of your Fibroscan to your hospital records and/or Digital Health Record (DHR) which may be accessed by your care team or GP.

• Ask if you are willing to donate any surplus samples left over from your diagnostic tests (such as biopsy tissue), for research​ (this is optional- you can indicate this on the consent form). ​ 

  • Ask if you are willing to allow other researchers to utilise any samples left over after this study finishes by sharing them in a tissue bank (this is optional- you can indicate this on the consent form).

  • Ask if we can keep your contact details in our database to contact you about study findings and future projects ​(this is optional- you can indicate this on the consent form).​

We will measure various substances and constituents of your blood (e.g. proteins, DNA, and fats) in the samples collected for research.   

As part of this project or future projects, we may send samples to research teams at other institutions (within or outside the UK) for collaborative health research, or to commercial service providers for specialist analysis. All samples will be labelled with a code so you cannot be identified. All sample shipments and any data sharing for research will require contract agreements with the lead investigator and the research sponsor. 

We will assess your blood samples for common genetic (DNA) patterns and variations which relate to drug transport and processing, inflammation, liver injury and scarring of the liver. ​We will not carry out genetic testing of your samples to detect known inherited disorders. The results of the analysis will not be available to you since this information does not meet quality-control levels required for clinical diagnostics (so may be inaccurate) and the implications of any findings are not currently clear. You can indicate on the consent form if a DNA sample can be collected.​  

The samples will be securely transported and stored at the study sites/centres. We would like to store any un-used samples left over when the research project has ended for future research studies by us or by researchers (in partnership with us) at other trusted institutions. You will need to indicate on your consent form if you would like your samples to be stored or not. 

Only the designated investigator will retain the link between the study code and identifiable information at the study centre. Samples shared outside the institution once the study ends will be fully anonymized. Datasets will be anonymized when shared. 

Samples will be destroyed when the study ends if you have not consented for future use and when they are unsuitable for storage. Samples used by other researchers will be returned or destroyed.