Evaluating FBL-MTX for treating rheumatoid arthritis

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.

This study is testing a new way to give methotrexate to see if it helps people with moderate-to-severe rheumatoid arthritis feel better while being easier to take.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: SOLFARCOS - Pharmaceutical and Cosmetic Solutions Ltd (other)
• Drugs / interventions: prednisone, methotrexate
• Locations: 8 sites (Aveiro and 7 other locations)
• Trial ID: NCT06565273 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the efficacy, safety, and tolerability of FBL-MTX, a folate-based liposome formulation of methotrexate, administered subcutaneously to patients with moderate-to-severe active rheumatoid arthritis (RA). Participants will undergo an initial screening to confirm eligibility, followed by a treatment period consisting of eight visits over 12 weeks, where doses will be adjusted based on clinical response. The study will include both DMARD-naïve patients and those with inadequate response or intolerance to oral methotrexate. The goal is to provide a more patient-friendly administration method while maintaining efficacy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with moderate-to-severe active rheumatoid arthritis and a body mass index greater than 35 kg/m2.

Not a fit: Patients with mild RA or those who have not been diagnosed with rheumatoid arthritis will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a more effective and convenient option for managing rheumatoid arthritis.

How similar studies have performed: Other studies have explored similar approaches with methotrexate, but the specific formulation and administration method of FBL-MTX is novel.

Eligibility criteria

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.

Where this trial is running

Aveiro and 7 other locations

• Unidade Local de Saúde da Região de Aveiro, EPE — Aveiro, Portugal (RECRUITING)
• Unidade Local de Saúde de Braga, EPE, Centro Clínico Académico de Braga (2CA-Braga) — Braga, Portugal (RECRUITING)
• Unidade Local de Saúde da Guarda, EPE — Guarda, Portugal (RECRUITING)
• Unidade Local de Saúde do Alto Ave, EPE — Guimarães, Portugal (RECRUITING)
• Unidade Local de Saúde da Região de Leiria, EPE — Leiria, Portugal (RECRUITING)
• Unidade Local de Saúde do Alto Minho, EPE — Ponte de Lima, Portugal (RECRUITING)
• Unidade Local de Saúde de São João, EPE — Porto, Portugal (RECRUITING)
• Unidade Local de Saúde de Gaia e Espinho, EPE — Vila Nova de Gaia, Portugal (RECRUITING)

Study contacts

• Principal investigator: José Costa, MD — Unidade Local de Saúde do Alto Minho, EPE
• Study coordinator: José Costa, MD

Conditions: Rheumatoid Arthritis