Actively Recruiting
Study to Investigate the Efficacy, Safety, and Tolerability of FBL-MTX in Patients With Rheumatoid Arthritis
Led by SOLFARCOS - Pharmaceutical and Cosmetic Solutions Ltd · Updated on 2024-08-21
40
Participants Needed
8
Research Sites
53 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Study to Investigate the Efficacy, Safety, and Tolerability of FBL-MTX in Patients With Rheumatoid Arthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or non-pregnant female subjects with moderate-to-severe active Rheumatoid Arthritis, aged 18 years or older, with Body Mass Index above 35 kg/m2
- Diagnosis of Rheumatoid Arthritis based on 2010 ACR/EULAR classification criteria with a total score of 6 or higher
- At least moderately active disease defined by DAS28-CRP above 3.2 at screening and baseline
- Tender joint count of 4 or more
- Swollen joint count of 4 or more
- C Reactive protein level of 5 mg/L or higher
- Documented history of positive Rheumatoid Arthritis factor and/or cyclic citrullinated peptide antibody test
- Chest X-ray within the last 3 months not suggestive of tuberculosis
- Stable regimen of NSAIDs for at least 2 weeks before baseline through end of study if applicable
- Stable regimen of oral corticosteroids (10 mg or less prednisone or equivalent) for at least 4 weeks before baseline through end of study if applicable
- Eligible to start treatment with an immunomodulator
- No evidence of clinically significant active infection
You will not qualify if you...
- Positive Interferon-Gamma Release Assay (IGRA) test result
- Creatinine clearance less than 60 mL/min
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Unidade Local de Saúde da Região de Aveiro, EPE
Aveiro, Portugal, 3814-501
Actively Recruiting
2
Unidade Local de Saúde de Braga, EPE, Centro Clínico Académico de Braga (2CA-Braga)
Braga, Portugal, 4710-243
Actively Recruiting
3
Unidade Local de Saúde da Guarda, EPE
Guarda, Portugal, 6300-858
Actively Recruiting
4
Unidade Local de Saúde do Alto Ave, EPE
Guimarães, Portugal, 4835-044
Actively Recruiting
5
Unidade Local de Saúde da Região de Leiria, EPE
Leiria, Portugal, 2410-197
Actively Recruiting
6
Unidade Local de Saúde do Alto Minho, EPE
Ponte de Lima, Portugal, 4990-041
Actively Recruiting
7
Unidade Local de Saúde de São João, EPE
Porto, Portugal, 4200-319
Actively Recruiting
8
Unidade Local de Saúde de Gaia e Espinho, EPE
Vila Nova de Gaia, Portugal, 4434-502
Actively Recruiting
Research Team
J
José Costa, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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