All studies
CompletedPhase IIInterventional

Identifying the best combinations of drugs for treating inflammatory diseases

Rheumatoid arthritis and psoriatic arthritis cause painful, swollen joints that can lead to permanent damage over time. Many people take biological medicines called TNF inhibitors to manage their symptoms. While these drugs help, they often do not clear inflammation completely. This UK study, led by Cardiff University, tests whether adding a second approved arthritis medicine called tocilizumab can put arthritis into full remission. Tocilizumab targets a different part of the immune system to calm inflammation. Adults with active arthritis who are already taking a TNF inhibitor can take part. Participants will take tocilizumab alongside their regular treatment for 24 weeks. The study starts with a half dose to check safety before moving to a full dose. Doctors will closely track your health to see if this drug combination is safe and helps your joints feel better.

At a glance

Status
Completed
Phase
Phase II
Sponsor
Cardiff University
Enrolment target
40
Start
15 Apr 2025
Estimated completion
13 Feb 2026

What is this study about?

Rheumatoid arthritis and psoriatic arthritis are long-term conditions that cause the immune system to mistakenly attack the joints. This causes pain, stiffness, and swelling. The main goal of modern treatment is to achieve remission, which means stopping the inflammation entirely so that joints are protected from lasting damage.

Many patients take targeted biological drugs called tumour necrosis factor (TNF) inhibitors, such as adalimumab or etanercept. While these medicines help a great deal, many people still experience lingering swelling and discomfort. Blood tests show that another inflammatory signal, called interleukin-6 (IL-6), might keep the disease active even when TNF is blocked.

This trial is testing whether combining two biological medicines can completely shut down this stubborn inflammation. Tocilizumab is an established medicine that blocks IL-6. By adding tocilizumab to an existing TNF inhibitor, researchers hope to give people a much better chance of reaching complete remission and keeping their joints healthy in the long term.

Key takeaways

  • Tests adding a second medicine (tocilizumab) to existing arthritis treatments.
  • Aimed at adults with active rheumatoid or psoriatic arthritis who still have swollen joints.
  • Treatment lasts for 24 weeks, starting at a half dose for safety.
  • Doctors will check whether the combination can safely bring about full remission.
  • Participation is entirely voluntary and will not affect your standard NHS treatment options.

Who may be eligible?

You may be able to join this study if you are 18 or older and have a confirmed diagnosis of either rheumatoid arthritis or psoriatic arthritis. You must currently be taking an approved TNF inhibitor medicine (such as etanercept, adalimumab, golimumab, certolizumab, or infliximab) but still have active joint swelling and pain.

You will not be able to participate if you have taken IL-6 medicines like tocilizumab or sarilumab in the past. People with active infections, serious heart conditions, a history of recent joint infections, or cancer in the past ten years cannot take part.

This trial is also not suitable for women who are pregnant or breastfeeding. Both men and women taking part must agree to use effective contraception during the study and for at least three months after stopping the study medicine.

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.

  1. I am aged 18 or older.
  2. I have been diagnosed with rheumatoid arthritis or psoriatic arthritis.
  3. I currently take a TNF inhibitor (such as adalimumab, etanercept, or infliximab).
  4. I still have noticeable swelling, pain, or inflammation in my joints.
  5. I have never taken tocilizumab or sarilumab before.
  6. I do not have an active infection, severe heart failure, or a recent history of cancer.
Answer every question to see your result.

What does participation involve?

If you take part, you will receive the study medicine, tocilizumab, to take alongside your usual TNF inhibitor. For the first eight weeks, you will receive half the standard dose to see how your body tolerates it. If you have no troublesome side effects, your doctor will increase this to the full dose. The total treatment period lasts 24 weeks. During this time, you will attend regular hospital appointments so doctors can examine your joints, run routine blood tests, and check for any side effects. You will need to tell the study team about all other medicines, vitamins, or herbal remedies you take.

Potential risks and benefits

The main hope of this study is that combining these treatments will lower inflammation, ease your joint pain, and slow down joint damage. However, there is no guarantee that your symptoms will improve, and your condition could stay the same or worsen. Because tocilizumab affects the immune system, it carries risks such as an increased chance of infections or other side effects. Your study doctor will monitor you closely at every visit to manage any issues. Taking part is completely voluntary, and you can leave the study at any time without it affecting your standard NHS care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Not provided at time of registration
    Unverified
    NO COUNTRY SPECIFIED, assuming England, England

Common questions

What is tocilizumab?

Tocilizumab is an approved prescription medicine used for rheumatoid arthritis. It works by blocking interleukin-6, a protein in the body that triggers joint inflammation.

Will I have to stop my current arthritis medication?

No. The purpose of this study is to see what happens when tocilizumab is added directly to your existing TNF inhibitor treatment.

What happens if I experience side effects?

Your study doctor can prescribe treatments to help manage side effects. If necessary, they can lower your dose or stop the study medicine temporarily or permanently.

Do I have to pay to take part in this study?

No, you do not have to pay for the study medicine or the extra clinical assessments involved in the trial.

Can I leave the study early if I change my mind?

Yes. You are free to withdraw from the trial at any point, and your normal healthcare will continue as usual.

How to find out more

Ian Thomas

Always speak to your GP or specialist before deciding to take part in a study.

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