Status:
RECRUITING
Study to Investigate the Efficacy, Safety, and Tolerability of FBL-MTX in Patients With Rheumatoid Arthritis
Lead Sponsor:
SOLFARCOS - Pharmaceutical and Cosmetic Solutions Ltd
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 treat...
Detailed Description
The Sponsor is developing folate-based liposomes encapsulating methotrexate (FBL-MTX) as a putative therapy for RA, by intravenous (IV) or subcutaneous (SC) administration. Considering the presented ...
Eligibility Criteria
Inclusion
- 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
- Positive Interferon-Gamma Release Assay (IGRA) test result.
- Creatinine clearance \< 60 mL/min.
Key Trial Info
Start Date :
July 24 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06565273
Start Date
July 24 2024
End Date
July 31 2025
Last Update
August 21 2024
Active Locations (8)
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1
Unidade Local de Saúde da Região de Aveiro, EPE
Aveiro, Portugal, 3814-501
2
Unidade Local de Saúde de Braga, EPE, Centro Clínico Académico de Braga (2CA-Braga)
Braga, Portugal, 4710-243
3
Unidade Local de Saúde da Guarda, EPE
Guarda, Portugal, 6300-858
4
Unidade Local de Saúde do Alto Ave, EPE
Guimarães, Portugal, 4835-044