RecruitingPhase 2NCT06565273

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.

Sponsor

SOLFARCOS - Pharmaceutical and Cosmetic Solutions Ltd

Enrollment

40 participants

Start Date

Jul 24, 2024

Study Type

INTERVENTIONAL

Conditions

Rheumatoid Arthritis

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new treatment for moderate-to-severe rheumatoid arthritis (RA) — a condition where the immune system attacks the joints, causing pain, swelling, and stiffness — in patients who are overweight or obese (BMI above 35). **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of rheumatoid arthritis - Your BMI is above 35 kg/m² - Your RA is currently moderately to severely active (based on tender and swollen joint counts and inflammation markers) - You have tested positive for rheumatoid factor and/or anti-CCP antibodies - You do not have tuberculosis (TB) — confirmed by a recent chest X-ray and blood test **You may NOT be eligible if...** - You have tested positive on a tuberculosis blood test (IGRA test) - You have significantly reduced kidney function (creatinine clearance below 60 mL/min) - You have active, uncontrolled infection - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFBL-MTX

Patients will be administered an initial dose of FBL-MTX by subcutaneous route. Subsequent doses will be titrated according to clinical response. Maximum dosage will be 2.5 mg, every 2 weeks.