New injectable methotrexate aims to tame rheumatoid arthritis with fewer side effects

NCT ID NCT06565273

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tests an injectable form of methotrexate called FBL-MTX for people with moderate-to-severe rheumatoid arthritis. The drug is designed to deliver methotrexate directly into the body using tiny fat bubbles, which may improve how well it works and reduce side effects compared to the standard pill form. The study includes two groups: those who have never taken disease-modifying drugs and those who did not respond well to or could not tolerate oral methotrexate. Researchers will adjust the dose based on each person's response over 14 weeks to find the best balance of benefit and safety.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance

FBL-MTX (folate-based liposomes encapsulating methotrexate)

What this could lead to

If successful, this could offer a more effective and better-tolerated treatment option for people with rheumatoid arthritis who cannot take oral methotrexate.

What could go wrong

This is an early phase 2 study with only 40 participants, so results may not apply to everyone. The drug may still cause side effects or fail to show clear benefit.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Conditions

The condition(s) this trial relates to.

rheumatoid arthritis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Unidade Local de Saúde da Guarda, EPE

    Guarda, 6300-858, Portugal

  • Unidade Local de Saúde da Região de Aveiro, EPE

    Aveiro, 3814-501, Portugal

  • Unidade Local de Saúde da Região de Leiria, EPE

    Leiria, 2410-197, Portugal

  • Unidade Local de Saúde de Braga, EPE, Centro Clínico Académico de Braga (2CA-Braga)

    Braga, 4710-243, Portugal

  • Unidade Local de Saúde de Gaia e Espinho, EPE

    Vila Nova de Gaia, 4434-502, Portugal

  • Unidade Local de Saúde de São João, EPE

    Porto, 4200-319, Portugal

  • Unidade Local de Saúde do Alto Ave, EPE

    Guimarães, 4835-044, Portugal

  • Unidade Local de Saúde do Alto Minho, EPE

    Ponte de Lima, 4990-041, Portugal