An Exploratory Phase II, Randomized, Open-Label, Proof-of-Concept Trial Evaluating Add-on Polyunsaturated Fatty Acid Ethyl Esters on Pain and Minimal Disease Activity in Psoriatic Arthritis Patients Starting TNF-alpha Inhibitors
Psoriatic arthritis causes painful, swollen joints alongside red, scaly skin patches. Doctors often treat this condition with powerful targeted drugs called TNF inhibitors. While these medicines work well to calm inflammation, many people still experience troublesome everyday pain and tiredness. This trial investigates whether adding medical-grade polyunsaturated fatty acids (special healthy fats similar to fish oils) can help patients feel even better. Researchers want to find out if this add-on supplement can reduce pain scores and help patients achieve 'minimal disease activity'—a state where symptoms cause very little trouble. Adults aged 18 and older who are about to start a TNF inhibitor can take part. Over six months, participants will attend regular check-ups, answer questionnaires about pain and quality of life, and give routine blood samples. The goal is to discover a safe, simple way to boost arthritis relief.
At a glance
What is this study about?
Psoriatic arthritis is a long-term condition where the body's immune system mistakenly attacks both the skin and the joints. This causes joint swelling, stiffness, and severe discomfort. One common and effective way doctors treat psoriatic arthritis is with biologic medicines known as TNF inhibitors. These drugs block a specific protein in the body that triggers inflammation. However, even when these medicines work, many people still live with lingering joint pain, fatigue, and poor sleep.
This study looks at whether adding a daily supplement of purified polyunsaturated fatty acids can help. These are healthy fats, much like the omega-3 oils found in oily fish, which are well known for having natural anti-inflammatory qualities. Scientists want to know whether pairing these healthy fats with standard biologic injections gives a better boost to pain relief than taking the biologic medicine alone.
Over the course of six months, researchers will measure whether participants experience lower pain levels and reach what rheumatologists call 'minimal disease activity.' This means having few or no tender joints, clear or nearly clear skin, and being able to carry on with daily life with minimal discomfort.
If successful, this trial could provide a simple, low-risk way to enhance standard arthritis care. It may help people manage their symptoms better, reduce the need for extra painkiller medications, and improve day-to-day quality of life.
Key takeaways
- Tests whether omega-3-style fatty acids help ease psoriatic arthritis pain.
- Designed for adults aged 18 and over who are starting a TNF inhibitor biologic.
- Lasts for six months with clinic visits at the start, month 3, and month 6.
- Monitors joint swelling, skin symptoms, pain scores, and general quality of life.
- Participation is entirely voluntary and will not impact your normal NHS rights.
Who may be eligible?
This study is open to adults aged 18 and over who have been diagnosed with psoriatic arthritis. To take part, you must be due to start a standard biologic medicine called a TNF-alpha inhibitor. Common examples of these medicines include adalimumab, etanercept, infliximab, certolizumab pegol, or golimumab.
You may not be able to join if you have certain other serious health conditions, known allergies to the study supplements, or if you are already taking high doses of fish oil or omega-3 supplements that cannot be paused. Your rheumatology team will check your full medical history to confirm if the trial is safe and suitable for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am aged 18 or older.
- I have been diagnosed with psoriatic arthritis.
- My doctor is planning to start me on a TNF inhibitor biologic (such as adalimumab or etanercept).
- I am willing to attend clinic visits and complete surveys over a six-month period.
- I am happy to discuss my current supplements and diet with the study team.
What does participation involve?
Taking part lasts for about six months. If you join, you will start your prescribed TNF inhibitor as planned and either take the fatty acid capsules alongside it or continue with your standard care. You will visit the clinic at the start of the study, at three months, and at six months. During these visits, doctors will examine your joints and skin, take small blood samples to check inflammation levels, and ask you to fill in questionnaires about your pain, sleep, tiredness, and daily activities. You may also be asked to keep a brief diary of what you eat.
Potential risks and benefits
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Common questions
What are polyunsaturated fatty acids?
They are healthy fats, similar to the omega-3 oils found in foods like salmon and walnuts, which help lower inflammation in the body.
Will I have to stop my normal arthritis medicine?
No. The study is designed to test the supplement as an 'add-on' to your prescribed TNF inhibitor, not as a replacement for it.
What does 'open-label' mean?
It means that both you and your trial doctors will know exactly which treatment you are receiving during the study.
Do I have to pay to take part?
No. Study-related supplements, tests, and specialist appointments are provided free of charge.
Can I leave the study early if I want to?
Yes. You can withdraw from the study at any time, for any reason, without it affecting your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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