Phase IIa Proof-of-Concept Study, with Dose-Titration Based on Treat-to-Target Strategy, to Investigate the Efficacy, Safety, and Tolerability of Subcutaneous Injection of Folate-based Liposomes Encapsulating Methotrexate (FBL-MTX) in Disease-modifying Antirheumatic Drugs (DMARD)-naïve Patients with Moderate-to-Severe Active Rheumatoid Arthritis and in Patients with an Inadequate Response or Intolerance to Oral MTX.
Rheumatoid arthritis causes painful, swollen, and stiff joints. Methotrexate is a common medicine used to treat it, but standard tablets can cause unpleasant side effects or may not work well enough for everyone. This Phase II clinical trial tests a new version of the medicine called FBL-MTX. It packages methotrexate into microscopic, fat-like bubbles designed to travel directly to inflamed areas. The medicine is given as an injection under the skin. The study is open to adults aged 18 and over who have active rheumatoid arthritis. This includes people who have never taken standard arthritis drugs, as well as those who could not tolerate oral methotrexate. Over 14 weeks, doctors will monitor whether this treatment calms inflammation, eases joint pain, and improves daily life, while keeping a close eye on patient safety and well-being.
At a glance
What is this study about?
Rheumatoid arthritis is a long-term condition where the immune system mistakenly attacks the lining of the joints. This causes ongoing inflammation, pain, swelling, and morning stiffness. A medicine called methotrexate is usually the first choice of treatment. While it works well for many, taking it as a weekly tablet can sometimes trigger stomach upsets, nausea, or may simply not give enough relief.
This clinical study explores a new way to deliver the medicine. Researchers have created 'FBL-MTX', which wraps methotrexate inside tiny, natural fat bubbles known as liposomes. These bubbles are designed to carry the medicine directly to the inflamed joint tissues. The hope is that this targeted approach will allow the medicine to work effectively where it is needed most, potentially with fewer whole-body side effects.
The trial follows a 'treat-to-target' strategy. This means doctors carefully check your symptoms and adjust your dose to try and achieve the lowest possible disease activity, or even complete remission. Over 14 weeks, researchers will measure changes in joint tenderness and swelling, check blood inflammation levels, and see how everyday physical ability improves. The findings will help determine if this injection is safe and effective enough for wider use in future care.
Key takeaways
- Tests a new, targeted injection form of methotrexate for rheumatoid arthritis.
- Open to adults with moderate-to-severe symptoms, including those who struggled with standard tablets.
- Aims to reduce joint swelling and pain by guiding the drug straight to inflamed tissues.
- Involves regular health checks, joint exams, and blood tests over 14 weeks.
- Participation is entirely voluntary and you can withdraw at any stage.
Who may be eligible?
This study is looking for adults aged 18 and older who have moderate-to-severe active rheumatoid arthritis. It is open both to people who have never tried disease-modifying antirheumatic drugs (DMARDs) and to those who have previously taken oral methotrexate tablets but found they caused intolerable side effects or did not relieve symptoms.
To keep you safe, certain medical conditions may mean you cannot join. People with severe active infections, significant liver or kidney problems, or certain blood disorders will not be able to participate. Because methotrexate can harm an unborn baby, this study is also not suitable for women who are pregnant, planning a pregnancy, or breastfeeding.
A doctor at the study site will go through your full health history, carry out a thorough joint examination, and perform routine blood and heart tests to confirm whether this trial is safe and appropriate 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 over.
- I have been diagnosed with moderate-to-severe active rheumatoid arthritis.
- I have not yet taken DMARDs, OR oral methotrexate tablets did not work well or caused side effects.
- I am able and willing to attend clinic visits over a 14-week period.
- I am not pregnant, planning a pregnancy, or breastfeeding.
What does participation involve?
Taking part in this study lasts around 14 weeks. You will receive the study medicine as an injection just under the skin. Your dose may be gently adjusted over time based on how your joints respond. You will need to attend regular clinic appointments, usually every four weeks (such as at weeks 4, 8, 12, and 14). During these visits, doctors will examine your joints, check your blood pressure and heart rate, take routine blood and urine samples, and carry out heart traces (ECGs). You will also be asked to complete simple surveys about your joint stiffness, pain levels, and how easily you can carry out everyday tasks.
Potential risks and benefits
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Common questions
What is FBL-MTX?
It is a new form of methotrexate packaged inside microscopic fat bubbles (liposomes). It is designed to target inflamed joints more directly when injected under the skin.
How long will I be involved in the study?
The main treatment and assessment period lasts for 14 weeks, with check-ups at the hospital clinic roughly once a month.
Do I have to pay to take part?
No. The study treatment, appointments, and medical tests are provided free of charge. Travel expenses to and from the clinic are usually covered.
Will I receive a dummy treatment (placebo)?
This study focuses on testing the new active medicine and adjusting the dose to control arthritis symptoms, so participants receive the active study treatment.
Can I leave the study early if I change my mind?
Yes. Taking part is completely voluntary. You can withdraw at any time, and doing so will never affect your relationship with your healthcare team or your future care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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