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RecruitingPhase IVInterventional

The 3TR-PARTNER-RA study: Are RNA signatures (biomarkers) in the tissue which surrounds the joints (synovial tissue) from patients with early Rheumatoid Arthritis (symptoms <12 months) predictive of response to biologic drug treatments?

Rheumatoid arthritis causes painful, swollen joints. While effective treatments exist, around 40% of people do not get enough relief from standard advanced medicines. At present, finding the right drug often involves trial and error. This trial, led by Queen Mary University of London, tests whether analyzing joint tissue can predict the right treatment straight away. It is open to adults who have had rheumatoid arthritis symptoms for less than a year and have not yet taken disease-modifying arthritis medicines. Participants will have a quick, ultrasound-guided sample taken from a swollen joint under local anaesthetic. Everyone will take standard arthritis medication (methotrexate), plus either abatacept (a targeted biologic medicine) or an inactive dummy treatment (placebo). Visits take place every four weeks for about four months, followed by a final safety check. The goal is to make future arthritis treatments faster, safer, and tailored to each person.

At a glance

Status
Recruiting
Phase
Phase IV
Sponsor
Queen Mary University of London
Enrolment target
200
Start
23 Jun 2025
Estimated completion
01 Dec 2027

What is this study about?

Rheumatoid arthritis is a condition where the body's immune system mistakenly attacks the joints, leading to swelling, stiffness, and pain. Starting effective treatment early is vital to protect joints from permanent damage. Today, doctors have several modern medications to choose from, including powerful targeted treatments known as biologic drugs. However, not every drug works for every person, and nearly four in ten people do not see enough improvement with their first biologic medicine.

Finding the right treatment can currently take months of trying different options. The 3TR-PARTNER-RA study aims to replace this guessing game with precision medicine. Researchers want to find out whether examining tiny genetic patterns (called RNA markers) in the lining of an inflamed joint can predict whether a person will respond well to a biologic medicine called abatacept (Orencia).

By taking a small sample of joint tissue before treatment begins, scientists hope to match patients to the medicine most likely to help them. If successful, this research could lead to more personalised care on the NHS, helping people get their symptoms under control much sooner while avoiding medicines that are unlikely to work for them.

Key takeaways

  • Tests whether joint tissue samples can predict which early rheumatoid arthritis patients will benefit from the medicine abatacept.
  • Aims to reduce trial-and-error prescribing and bring personalised treatment to the NHS.
  • Open to adults with early rheumatoid arthritis (symptoms under 12 months) who have not yet taken DMARDs.
  • All participants receive active arthritis medication (methotrexate) alongside either abatacept or a placebo.
  • Involves a numbed joint biopsy, monthly clinic visits for 16 weeks, and a safety check-up 30 days later.

Who may be eligible?

This study is designed for adults aged 18 and over who have been diagnosed with rheumatoid arthritis fairly recently, having had symptoms for less than 12 months. Your arthritis needs to be moderately or severely active, and you must have at least one swollen joint (such as a knee, wrist, or ankle) that is suitable for taking a small tissue sample.

To take part, you must not have previously taken disease-modifying anti-rheumatic drugs (known as DMARDs) or biologic medicines. You also need to be able to attend regular hospital appointments and undergo simple blood tests.

You may not be eligible if you take certain blood-thinning medications like warfarin, have other primary autoimmune joint diseases, or have known allergies to the study medications. A doctor will carefully review your general health and medical history to confirm whether joining 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.

  1. I am aged 18 or over.
  2. I have had symptoms of rheumatoid arthritis for less than 12 months.
  3. I have at least one joint that is currently swollen and inflamed.
  4. I have never taken DMARDs or biologic drugs for my arthritis.
  5. I am comfortable having a small joint sample taken using local anaesthetic.
  6. I can attend hospital visits every 4 weeks for about four months.
Answer every question to see your result.

What does participation involve?

If you take part, your involvement will last around five months in total. At the start, a trained doctor will perform a joint biopsy. They will use ultrasound imaging and a local anaesthetic injection to numb the joint before taking a tiny tissue sample. You will then be randomly chosen by a computer to receive either abatacept injections or dummy injections (a placebo). All participants will also receive methotrexate, a standard medicine commonly prescribed for rheumatoid arthritis. You will visit the clinic every 4 weeks for 16 weeks to check your joints, complete health questionnaires, and have routine blood tests. Around 30 days after your week-16 visit, you will have one final safety check-up.

Potential risks and benefits

Taking part may improve your arthritis symptoms because everyone receives active treatment with methotrexate, and some will receive abatacept. However, individual improvement cannot be guaranteed. The knowledge gained will help doctors choose better treatments for future patients. The main risks include short-term tenderness or bruising where the joint sample was taken, mild injection reactions, or a slightly increased chance of common infections. Your safety is monitored closely throughout the study. Taking part is completely voluntary, and you have the right to withdraw at any time without it affecting your standard NHS care.

Locations (10)

  • Barts Health
    Approximate
    London, England
  • The Kellgran Centre for Rheumatology, Manchester Royal Infirmary
    City only
    Manchester, England
  • AOU Maggiore della Carità di Novara
    City only
    Novara, Italy
  • Azienda Ospedaliero Universitaria di Cagliari
    City only
    Cagliari, Italy
  • Istituto Clinico Humanitas - Humanitas Mirasole S.p.A
    City only
    Milan, Italy
  • Cliniques Universitaires St LUC
    Unverified
    Brussels, Belgium
  • Hospital Clínic De Barcelona
    Unverified
    Barcelona, Spain
  • Hospital Universitario Reina Sofía
    Unverified
    Córdoba, Spain
  • Instituto De Medicina Molecular João Lobo Antunes
    Unverified
    Lisboa, Portugal
  • University Hospital Paduae
    Unverified
    Padova PD, Italy

Common questions

Will the joint biopsy be painful?

The doctor numbs the skin and joint using a local anaesthetic before taking the sample. You may feel some pressure, but it should not be painful. You might experience mild aching or bruising for a few days afterwards.

What is a placebo and will I definitely receive active treatment?

A placebo looks identical to the study drug but contains no active medicine. In this trial, you have a chance of receiving either abatacept or a placebo. However, every participant also receives methotrexate, which is an active and proven arthritis treatment.

How long will I be involved in the study?

You will be in the study for around five months. This includes 16 weeks of treatment with monthly hospital visits, followed by one final safety visit about a month later.

Can I keep taking my usual painkillers?

In most cases, standard pain relief can be continued. However, you should discuss all medicines and supplements you take with the study team so they can ensure they are safe to use together.

What happens if I decide to leave the trial early?

You are free to stop participating at any point, for any reason. Deciding to leave will not affect your standard NHS medical care or your relationship with your doctors.

How to find out more

Experimental Medicine & Rheumatology Clinical Trials

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

Interested in taking part?

Register your interest

Share your details and the research team for "The 3TR-PARTNER-RA study: Are RNA signatures (biomarkers) in…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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