Phase IIa Study to Investigate the Efficacy, Safety, and Tolerability of Subcutaneous FBL-MTX in Moderate-to-Severe Active Rheumatoid Arthritis Patients

What this Trial Is About

Researchers are evaluating the efficacy, safety, and tolerability of folate-based liposomes encapsulating methotrexate FBL-MTX administered by subcutaneous injection in patients with moderate-to-severe active rheumatoid arthritis RA. This Phase IIa proof-of-concept study focuses on patients who are either new to disease-modifying antirheumatic drugs DMARD-nave or have had an inadequate response or intolerance to oral methotrexate. The study aims to explore whether the subcutaneous route offers a patient-friendly treatment with comparable efficacy. The study treatment involves administering FBL-MTX by subcutaneous injection with dosing adjusted based on clinical response. DMARD-nave patients start with a 1 mg dose, which can be increased every four weeks over 12 weeks up to a maximum of 2.5 mg every two weeks. Patients with an inadequate response or intolerance to oral methotrexate start at 2.5 mg, with similar dose titration. The treatment period includes eight visits spaced two weeks apart. Participants will be screened within 28 days before treatment to confirm eligibility. During the study, assessments will include disease activity scores such as DAS28-CRP, clinical response criteria ACR20, ACR50, ACR70, and quality-of-life questionnaires over 14 weeks. Safety monitoring includes tracking adverse events and laboratory tests. The total study duration for each participant spans from screening up to week 14 of treatment evaluation.

Study to Investigate the Efficacy, Safety, and Tolerability of FBL-MTX in Patients With Rheumatoid Arthritis