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

NCT ID NCT06565273

Ongoing Disease control Sponsor: SOLFARCOS - Pharmaceutical and Cosmetic Solutions Ltd Source: ClinicalTrials.gov ↗

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for RHEUMATOID ARTHRITIS are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

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.

RHEUMATOID ARTHRITIS

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.