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

StatusCompleted
PhasePhase 2
Started

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Record History

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  1. Primary endpoints: details revised at 2 of 11 entries
    • Trial completed
    • Primary and study completion dates changed from estimate of Jun 30, 2026 to Jul 20, 2026
    • Eligibility criteria expanded, about 14 words
  2. Primary and study completion dates: Jul 31, 2025 to Jun 30, 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 8 of 8 sites
    v2
  3. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
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.
Trial Details
NCT Number NCT06565273
Lead Sponsor SOLFARCOS - Pharmaceutical and Cosmetic Solutions Ltd
Conditions
(from sponsor)		 Rheumatoid Arthritis
Related terms Arthritis, Rheumatoid
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov