Study to Investigate the Efficacy, Safety, and Tolerability of FBL-MTX in Patients With Rheumatoid Arthritis
NCT Number: NCT06565273
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Rheumatoid Arthritis
Interventions: DRUG: FBL-MTX
Sponsor: SOLFARCOS - Pharmaceutical and Cosmetic Solutions Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-07-24
Completion Date: 2025-07-31
Locations: Unidade Local de Saúde da Região de Aveiro, EPE, Aveiro, 3814-501, Portugal|Unidade Local de Saúde de Braga, EPE, Centro Clínico Académico de Braga (2CA-Braga), Braga, 4710-243, Portugal|Unidade Local de Saúde da Guarda, EPE, Guarda, 6300-858, Portugal|Unidade Local de Saúde do Alto Ave, EPE, Guimarães, 4835-044, Portugal|Unidade Local de Saúde da Região de Leiria, EPE, Leiria, 2410-197, Portugal|Unidade Local de Saúde do Alto Minho, EPE, Ponte De Lima, 4990-041, Portugal|Unidade Local de Saúde de São João, EPE, Porto, 4200-319, Portugal|Unidade Local de Saúde de Gaia e Espinho, EPE, Vila Nova De Gaia, 4434-502, Portugal

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.

Primary Outcome Measures: Change from baseline in Disease Activity Score (DAS) for 28-joint count using C-reactive protein (DAS28-CRP) at Week 14, The DAS28-CRP is a combined index for measuring disease activity in Rheumatoid Arthritis. The components of the DAS28-CRP assessment include: 28 tender and swollen joint counts, CRP, and Patient's Global Assessment of Disease Activity, using a visual analogue scale (VAS): DAS28-CRP = 0.56\*sqrt(28\*Tender Joint Count) + 0.28\*sqrt(28\*Swollen joint count) + 0.36\*ln(C-Reactive protein+1) + 0.014\* global visual analogue scale + 0.96; Note: The 28 joints examined and assessed as tender or not tender for TJC and as swollen or not swollen for SJC include 14 joints on each side of the participant's body: 2 shoulders, 2 elbows, 2 wrists, 10 metacarpophalangeal joints, 2 interphalangeal joints of the thumb, 8 proximal interphalangeal joints, and 2 knees. Higher scores mean a worse outcome., From screening up to week 14.|Change from baseline in DAS28-CRP at Weeks 4, 8, and 12., The DAS28-CRP is a combined index for measuring disease activity in Rheumatoid Arthritis. The components of the DAS28-CRP assessment include: 28 tender and swollen joint counts, CRP, and Patient's Global Assessment of Disease Activity, using a visual analogue scale (VAS): DAS28-CRP = 0.56\*sqrt(28\*Tender Joint Count) + 0.28\*sqrt(28\*Swollen joint count) + 0.36\*ln(C-Reactive protein+1) + 0.014\* global visual analogue scale + 0.96; Note: The 28 joints examined and assessed as tender or not tender for TJC and as swollen or not swollen for SJC include 14 joints on each side of the participant's body: 2 shoulders, 2 elbows, 2 wrists, 10 metacarpophalangeal joints, 2 interphalangeal joints of the thumb, 8 proximal interphalangeal joints, and 2 knees. Higher scores mean a worse outcome., From screening up to weeks 4, 8 and 12.|Number of subjects who achieve remission (DAS28-CRP <2.6) at Weeks 4, 8, 12, and 14., The DAS28-CRP is a combined index for measuring disease activity in Rheumatoid Arthritis. The components of the DAS28-CRP assessment include: 28 tender and swollen joint counts, CRP, and Patient's Global Assessment of Disease Activity, using a visual analogue scale (VAS): DAS28-CRP = 0.56\*sqrt(28\*Tender Joint Count) + 0.28\*sqrt(28\*Swollen joint count) + 0.36\*ln(C-Reactive protein+1) + 0.014\* global visual analogue scale + 0.96; Note: The 28 joints examined and assessed as tender or not tender for TJC and as swollen or not swollen for SJC include 14 joints on each side of the participant's body: 2 shoulders, 2 elbows, 2 wrists, 10 metacarpophalangeal joints, 2 interphalangeal joints of the thumb, 8 proximal interphalangeal joints, and 2 knees. Higher scores mean a worse outcome., From screening up to weeks 4, 8, 12 and 14.|Number of subjects who achieve low disease activity (DAS28-CRP <3.2) at Weeks 4, 8, 12, and 14., From screening up to weeks 4, 8, 12 and 14.|Number of subjects who achieve American College of Rheumatology (ACR) 20% (ACR20) response at Weeks 4, 8, 12, and 14., From screening up to weeks 4, 8, 12 and 14.|Number of subjects who achieve ACR50 response at Weeks 4, 8, 12, and 14., From screening up to weeks 4, 8, 12 and 14.|Number of subjects who achieve ACR70 response at Weeks 4, 8, 12, and 14., From screening up to weeks 4, 8, 12 and 14.|Change from baseline in Clinical Disease Activity Index (CDAI) at Weeks 4, 8, 12, and 14., From screening up to weeks 4, 8, 12 and 14.|Change from baseline in Simplified Disease Activity Index (SDAI) at Weeks 4, 8, 12, and 14., From screening up to weeks 4, 8, 12 and 14.|Change from baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) score at Weeks 4, 8, 12, and 14., From screening up to weeks 4, 8, 12 and 14.|Change from baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) at Week 14., From screening up to Week 14.
Secondary Outcome Measures: Incidence of TEAEs and SAEs. Clinically relevant abnormalities in vital signs, 12-lead ECG, and laboratory parameters will be reported as AEs., From date of screening until the date of the last post-study follow-up visit.