NCT06565273CompletedPhase 2
Study to Investigate the Efficacy, Safety, and Tolerability of FBL-MTX in Patients With 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.
Source: ClinicalTrials.gov · Last updated 25 Sept 2026
Brief summary (registry, in English)
The goal of this clinical trial is to evaluate the efficacy of FBL-MTX administered by subcutaneous route in Rheumatoid Arthritis patients. Participants will be screened within 28 days prior to treatment period, to confirm that they meet the selection criteria for the study. Treatment period: The treatment period will consist of eight sequential study visits, separated by a 2-week interval. * DMARD-naïve Patients: Patients will be administered an initial dose of FBL-MTX of 1 mg, by SC route. Subsequent doses will be titrated according to clinical response at intervals of 4 weeks, for 12 weeks. Maximum dosage will be 2.5 mg, every 2 weeks. * Patients with an Inadequate Response or Intolerance to Oral MTX: Patients will be administered an initial dose of FBL-MTX 2.5 mg, by SC route. Subsequent doses will be titrated according to clinical response at intervals of 4 weeks, for 12 weeks. Maximum dosage will be 2.5 mg, every two weeks.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (actual)
- First submitted
- 8 Aug 2024
- Start date
- 24 Jul 2024
- Primary completion date
- 20 Jul 2026
- Lead sponsor
- SOLFARCOS - Pharmaceutical and Cosmetic Solutions Ltd
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT06565273
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 40
- From 24 Jul 2024 to the primary completion date, 20 Jul 2026
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- Creatinine clearance \< 60 mL/min.
Other
- Positive Interferon-Gamma Release Assay (IGRA) test result.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Unidade Local de Saúde da Região de Aveiro, EPE Coordinator of this site? Confirm its status | Aveiro | Portugal | Unknown status |
| Unidade Local de Saúde de Braga, EPE, Centro Clínico Académico de Braga (2CA-Braga) Coordinator of this site? Confirm its status | Braga | Portugal | Unknown status |
| Unidade Local de Saúde da Guarda, EPE Coordinator of this site? Confirm its status | Guarda | Portugal | Unknown status |
| Unidade Local de Saude do Alto Ave, EPE Coordinator of this site? Confirm its status | Guimarães | Portugal | Unknown status |
| Unidade Local de Saúde da Região de Leiria, EPE Coordinator of this site? Confirm its status | Leiria | Portugal | Unknown status |
| Unidade Local de Saúde do Alto Minho, EPE Coordinator of this site? Confirm its status | Ponte de Lima | Portugal | Unknown status |
| Unidade Local de Saúde de São João, EPE Coordinator of this site? Confirm its status | Porto | Portugal | Unknown status |
| Unidade Local de Saúde de Gaia e Espinho, EPE Coordinator of this site? Confirm its status | Vila Nova de Gaia | Portugal | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.