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

NCT06565273 | Active Not Recruiting Phase 2

• 1 other identifier: FBL-MTX-201
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 8

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 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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (1)

• 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.

Study Arms (1)

FBL-MTX

EXPERIMENTAL

* 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.

Drug: FBL-MTX

Interventions

FBL-MTX DRUG

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.

FBL-MTX

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Positive Interferon-Gamma Release Assay (IGRA) test result.
• Creatinine clearance \< 60 mL/min.

Sponsors & Collaborators

• SOLFARCOS - Pharmaceutical and Cosmetic Solutions Ltd: lead

Study Sites (8)

Unidade Local de Saúde da Região de Aveiro, EPE

Aveiro, 3814-501, Portugal

Location

Unidade Local de Saúde de Braga, EPE, Centro Clínico Académico de Braga (2CA-Braga)

Braga, 4710-243, Portugal

Location

Unidade Local de Saúde da Guarda, EPE

Guarda, 6300-858, Portugal

Location

Unidade Local de Saúde do Alto Ave, EPE

Guimarães, 4835-044, Portugal

Location

Unidade Local de Saúde da Região de Leiria, EPE

Leiria, 2410-197, Portugal

Location

Unidade Local de Saúde do Alto Minho, EPE

Ponte de Lima, 4990-041, Portugal

Location

Unidade Local de Saúde de São João, EPE

Porto, 4200-319, Portugal

Location

Unidade Local de Saúde de Gaia e Espinho, EPE

Vila Nova de Gaia, 4434-502, Portugal

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• José Costa, MD

  Unidade Local de Saúde do Alto Minho, EPE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: August 21, 2024
• Study Start: July 24, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

PT (8)