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

NCT ID NCT06565273

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male or non-pregnant female subjects with moderate-to-severe active RA, age ≥ 18 years, Body Mass Index \> 35 kg/m2. * Diagnosis of RA according to the 2010 classification criteria of the American College of Rheumatology/ European Alliance of Associations for Rheumatology, formerly known as European League Against Rheumatism, (ACR/EULAR), with a Total Score ≥ 6/10. * At least moderately active disease, as defined by DAS28-CRP \>3.2 at Screening and Baseline, including: * Tender joint count (TJC) ≥ 4 * Swollen joint count (SJC) ≥ 4 * C Reactive protein (CRP) ≥ 5 mg/L * Documented history of positive RA factor and/or cyclic citrullinated peptide antibody test. * Chest X-ray performed in the previous 3 months not suggestive of tuberculosis. * If under nonsteroidal anti-inflammatory drugs (NSAIDs), must be able to be on a stable regimen from at least 2 weeks before baseline up to end-of-study. * If under an oral corticosteroid (≤ 10 mg per day of prednisone or equivalent), must be able to be on a stable regimen from at least 4 weeks before baseline up to EoS. * Eligible to start treatment with an immunomodulator. * No evidence of clinically significant active infection. Exclusion Criteria: * Positive Interferon-Gamma Release Assay (IGRA) test result. * Creatinine clearance \< 60 mL/min.

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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.

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

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