Study to Investigate the Efficacy, Safety, and Tolerability of FBL-MTX in Patients With Rheumatoid Arthritis
NCT ID: NCT06565273
Last Updated: 2024-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
40 participants
INTERVENTIONAL
2024-07-24
2025-07-31
Brief Summary
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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.
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Detailed Description
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Considering the presented non-clinical and clinical data for FBL-MTX and that SC administration is the most adequate route for patient self-administration, the Sponsor intends to proceed the clinical development of FBL-MTX with the objective of providing a more patient-friendly product with at least the same efficacy.
This proof-of-concept study intends to demonstrate the plausibility of FBL-MTX SC administration in patients through the exploratory evaluation of SC FBL-MTX efficacy in patients with moderate-to-severe active RA, and collection data on its safety and tolerability.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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FBL-MTX
* 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.
FBL-MTX
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.
Interventions
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FBL-MTX
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.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* Creatinine clearance \< 60 mL/min.
18 Years
ALL
No
Sponsors
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SOLFARCOS - Pharmaceutical and Cosmetic Solutions Ltd
OTHER
Responsible Party
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Principal Investigators
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José Costa, MD
Role: PRINCIPAL_INVESTIGATOR
Unidade Local de Saúde do Alto Minho, EPE
Locations
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Unidade Local de Saúde da Região de Aveiro, EPE
Aveiro, , Portugal
Unidade Local de Saúde de Braga, EPE, Centro Clínico Académico de Braga (2CA-Braga)
Braga, , Portugal
Unidade Local de Saúde da Guarda, EPE
Guarda, , Portugal
Unidade Local de Saúde do Alto Ave, EPE
Guimarães, , Portugal
Unidade Local de Saúde da Região de Leiria, EPE
Leiria, , Portugal
Unidade Local de Saúde do Alto Minho, EPE
Ponte de Lima, , Portugal
Unidade Local de Saúde de São João, EPE
Porto, , Portugal
Unidade Local de Saúde de Gaia e Espinho, EPE
Vila Nova de Gaia, , Portugal
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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FBL-MTX-201
Identifier Type: -
Identifier Source: org_study_id
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