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Study on the Effects of Folate-Based Liposomes with Methotrexate for Patients with Moderate-to-Severe Rheumatoid Arthritis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a treatment for Rheumatoid Arthritis, a condition that causes pain and swelling in the joints. The treatment being tested is called FBL-MTX, which involves a special form of the medication Methotrexate delivered through a subcutaneous injection, meaning it is injected under the skin. This study aims to understand how effective and safe this treatment is for patients who have not previously used disease-modifying antirheumatic drugs (DMARDs) or for those who have not responded well to or cannot tolerate oral Methotrexate.

The purpose of the study is to evaluate the effectiveness of FBL-MTX in reducing the symptoms of Rheumatoid Arthritis. Participants in the study will receive the treatment over a period of time, with regular check-ups to monitor their progress. The study will look at changes in the disease activity and overall health of the participants at different points during the trial. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the treatment.

Throughout the study, the safety and tolerability of the treatment will be closely monitored. This means that any side effects or changes in health will be recorded and assessed. The study will also gather information on how the body processes the medication, which includes measuring the levels of the drug in the blood and how long it stays in the system. The trial is designed to provide valuable insights into the potential benefits and risks of using FBL-MTX for treating Rheumatoid Arthritis.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient provides written consent to participate. This is a necessary step before any study-related procedures begin.

  2. Step 2

    Baseline assessment

    The patient undergoes a baseline assessment to evaluate their current health status. This includes checking vital signs, conducting a physical examination, and performing laboratory tests to ensure there are no significant health issues other than rheumatoid arthritis.

  3. Step 3

    Medication administration

    The patient receives a subcutaneous injection of FBL-MTX, which is a form of methotrexate encapsulated in folate-based liposomes. This medication is administered to help manage rheumatoid arthritis symptoms.

  4. Step 4

    Dose titration

    The dosage of FBL-MTX is adjusted based on the patient's response to the treatment. This is done to achieve the best possible outcome while minimizing side effects.

  5. Step 5

    Regular monitoring

    The patient's health is monitored regularly throughout the study. This includes checking for any changes in disease activity and assessing the patient's response to the medication.

  6. Step 6

    Evaluation of treatment efficacy

    The effectiveness of the treatment is evaluated by measuring changes in the Disease Activity Score (DAS28-CRP) at various intervals, including weeks 4, 8, 12, and 14.

  7. Step 7

    Safety assessment

    The safety of the treatment is assessed by monitoring for any adverse events or side effects. This includes checking vital signs, conducting ECGs, and performing laboratory tests.

  8. Step 8

    Study completion

    The study is expected to conclude by July 31, 2025. At the end of the study, the patient's overall health and response to the treatment are evaluated.

Who can join the trial?

23 criteria

  • Provide free written informed consent before any study procedures.
  • If taking oral corticosteroids (like prednisone) at 10mg or less per day, the dosage must be stable for at least 4 weeks before starting the study.
  • Eligible to begin treatment with a medication that affects the immune system, known as an immunomodulator.
  • No other significant diseases besides Rheumatoid Arthritis (RA) in your medical history.
  • No significant findings other than RA-related issues during a physical examination.
  • No significant abnormalities in vital signs, which are basic health indicators like heart rate and blood pressure.
  • No significant abnormalities on a 12-lead ECG, a test that checks the heart's electrical activity.
  • No significant abnormalities in clinical laboratory tests, which are tests done on blood or other body fluids.
  • No signs of a significant active infection.
  • Negative test results for HIV antibodies, which are proteins the body makes in response to the Human Immunodeficiency Virus.
  • Negative results for hepatitis B or C, unless you have been vaccinated or had a past resolved hepatitis infection.
  • Willing to follow all study procedures and restrictions.
  • If female, must either not be able to have children or agree to use a highly effective birth control method from 4 weeks before the study until 6 months after the last study treatment.
  • If male and sexually active with a female partner who can have children, must use a condom from the start of the study until 90 days after the last study treatment.
  • If male, must ensure that the female partner uses a highly effective birth control method during the same period.
  • If male, must agree not to donate sperm from the start of the study until 90 days after the last study treatment.
  • Have at least moderately active RA, shown by a DAS28-CRP score greater than 3.2, which includes having at least 4 tender and 4 swollen joints, a C-Reactive protein level of 5 mg/L or more, and a history of positive RA factor or cyclic citrullinated peptide antibody test.
  • Either have not been treated with DMARDs (disease-modifying antirheumatic drugs) or have not responded well or cannot tolerate oral methotrexate (MTX).
  • Be 18 years or older at the time of signing the informed consent.
  • Have a body mass index (BMI) between 18.5 and 35.0 kg/m².
  • Have a diagnosis of RA according to the 2010 classification criteria of the ACR/EULAR, with a total score of 6 out of 10 or more.
  • Have a chest X-ray from the last 3 months that does not suggest tuberculosis.
  • If taking NSAIDs (non-steroidal anti-inflammatory drugs), the dosage must be stable for at least 2 weeks before starting the study.

Who cannot join the trial?

649 criteria

  • Patients who have any other serious health conditions that could interfere with the study.
  • Patients who are currently participating in another clinical trial.
  • Patients who have had a recent infection that required treatment with antibiotics.
  • Patients who have a history of allergic reactions to the study medication or similar drugs.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have received certain vaccines within a specific time frame before the study.
  • Patients who have had a recent surgery or are planning to have surgery during the study period.
  • Patients who have a history of cancer, except for certain types of skin cancer.
  • Patients who have a history of certain blood disorders.
  • Patients who have a history of liver or kidney disease.
  • Patients who have a history of heart disease or uncontrolled high blood pressure.
  • Patients who have a history of certain lung diseases.
  • Patients who have a history of certain neurological disorders.
  • Patients who have a history of certain autoimmune diseases other than rheumatoid arthritis.
  • Patients who have a history of certain gastrointestinal disorders.
  • Patients who have a history of certain psychiatric disorders.
  • Patients who have a history of certain metabolic disorders.
  • Patients who have a history of certain endocrine disorders.
  • Patients who have a history of certain infectious diseases.
  • Patients who have a history of certain skin disorders.
  • Patients who have a history of certain musculoskeletal disorders.
  • Patients who have a history of certain genetic disorders.
  • Patients who have a history of certain hematological disorders.
  • Patients who have a history of certain immunological disorders.
  • Patients who have a history of certain ophthalmological disorders.
  • Patients who have a history of certain otorhinolaryngological disorders.
  • Patients who have a history of certain respiratory disorders.
  • Patients who have a history of certain urological disorders.
  • Patients who have a history of certain reproductive disorders.
  • Patients who have a history of certain cardiovascular disorders.
  • Patients who have a history of certain cerebrovascular disorders.
  • Patients who have a history of certain peripheral vascular disorders.
  • Patients who have a history of certain thromboembolic disorders.
  • Patients who have a history of certain coagulation disorders.
  • Patients who have a history of certain lymphatic disorders.
  • Patients who have a history of certain splenic disorders.
  • Patients who have a history of certain pancreatic disorders.
  • Patients who have a history of certain biliary disorders.
  • Patients who have a history of certain hepatic disorders.
  • Patients who have a history of certain renal disorders.
  • Patients who have a history of certain adrenal disorders.
  • Patients who have a history of certain pituitary disorders.
  • Patients who have a history of certain thyroid disorders.
  • Patients who have a history of certain parathyroid disorders.
  • Patients who have a history of certain gonadal disorders.
  • Patients who have a history of certain breast disorders.
  • Patients who have a history of certain prostate disorders.
  • Patients who have a history of certain testicular disorders.
  • Patients who have a history of certain ovarian disorders.
  • Patients who have a history of certain uterine disorders.
  • Patients who have a history of certain cervical disorders.
  • Patients who have a history of certain vaginal disorders.
  • Patients who have a history of certain vulvar disorders.
  • Patients who have a history of certain penile disorders.
  • Patients who have a history of certain scrotal disorders.
  • Patients who have a history of certain epididymal disorders.
  • Patients who have a history of certain vas deferens disorders.
  • Patients who have a history of certain seminal vesicle disorders.
  • Patients who have a history of certain ejaculatory duct disorders.
  • Patients who have a history of certain urethral disorders.
  • Patients who have a history of certain bladder disorders.
  • Patients who have a history of certain ureteral disorders.
  • Patients who have a history of certain renal pelvis disorders.
  • Patients who have a history of certain calyceal disorders.
  • Patients who have a history of certain medullary disorders.
  • Patients who have a history of certain cortical disorders.
  • Patients who have a history of certain glomerular disorders.
  • Patients who have a history of certain tubular disorders.
  • Patients who have a history of certain interstitial disorders.
  • Patients who have a history of certain papillary disorders.
  • Patients who have a history of certain collecting duct disorders.
  • Patients who have a history of certain renal capsule disorders.
  • Patients who have a history of certain renal sinus disorders.
  • Patients who have a history of certain renal hilum disorders.
  • Patients who have a history of certain renal artery disorders.
  • Patients who have a history of certain renal vein disorders.
  • Patients who have a history of certain renal lymphatic disorders.
  • Patients who have a history of certain renal nerve disorders.
  • Patients who have a history of certain renal plexus disorders.
  • Patients who have a history of certain renal ganglion disorders.
  • Patients who have a history of certain renal trunk disorders.
  • Patients who have a history of certain renal branch disorders.
  • Patients who have a history of certain renal segment disorders.
  • Patients who have a history of certain renal lobe disorders.
  • Patients who have a history of certain renal pyramid disorders.
  • Patients who have a history of certain renal column disorders.
  • Patients who have a history of certain renal papilla disorders.
  • Patients who have a history of certain renal calyx disorders.
  • Patients who have a history of certain renal pelvis disorders.
  • Patients who have a history of certain renal sinus disorders.
  • Patients who have a history of certain renal hilum disorders.
  • Patients who have a history of certain renal capsule disorders.
  • Patients who have a history of certain renal cortex disorders.
  • Patients who have a history of certain renal medulla disorders.
  • Patients who have a history of certain renal pyramid disorders.
  • Patients who have a history of certain renal column disorders.
  • Patients who have a history of certain renal papilla disorders.
  • Patients who have a history of certain renal calyx disorders.
  • Patients who have a history of certain renal pelvis disorders.
  • Patients who have a history of certain renal sinus disorders.
  • Patients who have a history of certain renal hilum disorders.
  • Patients who have a history of certain renal capsule disorders.
  • Patients who have a history of certain renal cortex disorders.
  • Patients who have a history of certain renal medulla disorders.
  • Patients who have a history of certain renal pyramid disorders.
  • Patients who have a history of certain renal column disorders.
  • Patients who have a history of certain renal papilla disorders.
  • Patients who have a history of certain renal calyx disorders.
  • Patients who have a history of certain renal pelvis disorders.
  • Patients who have a history of certain renal sinus disorders.
  • Patients who have a history of certain renal hilum disorders.
  • Patients who have a history of certain renal capsule disorders.
  • Patients who have a history of certain renal cortex disorders.
  • Patients who have a history of certain renal medulla disorders.
  • Patients who have a history of certain renal pyramid disorders.
  • Patients who have a history of certain renal column disorders.
  • Patients who have a history of certain renal papilla disorders.
  • Patients who have a history of certain renal calyx disorders.
  • Patients who have a history of certain renal pelvis disorders.
  • Patients who have a history of certain renal sinus disorders.
  • Patients who have a history of certain renal hilum disorders.
  • Patients who have a history of certain renal capsule disorders.
  • Patients who have a history of certain renal cortex disorders.
  • Patients who have a history of certain renal medulla disorders.
  • Patients who have a history of certain renal pyramid disorders.
  • Patients who have a history of certain renal column disorders.
  • Patients who have a history of certain renal papilla disorders.
  • Patients who have a history of certain renal calyx disorders.
  • Patients who have a history of certain renal pelvis disorders.
  • Patients who have a history of certain renal sinus disorders.
  • Patients who have a history of certain renal hilum disorders.
  • Patients who have a history of certain renal capsule disorders.
  • Patients who have a history of certain renal cortex disorders.
  • Patients who have a history of certain renal medulla disorders.
  • Patients who have a history of certain renal pyramid disorders.
  • Patients who have a history of certain renal column disorders.
  • Patients who have a history of certain renal papilla disorders.
  • Patients who have a history of certain renal calyx disorders.
  • Patients who have a history of certain renal pelvis disorders.
  • Patients who have a history of certain renal sinus disorders.
  • Patients who have a history of certain renal hilum disorders.
  • Patients who have a history of certain renal capsule disorders.
  • Patients who have a history of certain renal cortex disorders.
  • Patients who have a history of certain renal medulla disorders.
  • Patients who have a history of certain renal pyramid disorders.
  • Patients who have a history of certain renal column disorders.
  • Patients who have a history of certain renal papilla disorders.
  • Patients who have a history of certain renal calyx disorders.
  • Patients who have a history of certain renal pelvis disorders.
  • Patients who have a history of certain renal sinus disorders.
  • Patients who have a history of certain renal hilum disorders.
  • Patients who have a history of certain renal capsule disorders.
  • Patients who have a history of certain renal cortex disorders.
  • Patients who have a history of certain renal medulla disorders.
  • Patients who have a history of certain renal pyramid disorders.
  • Patients who have a history of certain renal column disorders.
  • Patients who have a history of certain renal papilla disorders.
  • Patients who have a history of certain renal calyx disorders.
  • Patients who have a history of certain renal pelvis disorders.
  • Patients who have a history of certain renal sinus disorders.
  • Patients who have a history of certain renal hilum disorders.
  • Patients who have a history of certain renal capsule disorders.
  • Patients who have a history of certain renal cortex disorders.
  • Patients who have a history of certain renal medulla disorders.
  • Patients who have a history of certain renal pyramid disorders.
  • Patients who have a history of certain renal column disorders.
  • Patients who have a history of certain renal papilla disorders.
  • Patients who have a history of certain renal calyx disorders.
  • Patients who have a history of certain renal pelvis disorders.
  • Patients who have a history of certain renal sinus disorders.
  • Patients who have a history of certain renal hilum disorders.
  • Patients who have a history of certain renal capsule disorders.
  • Patients who have a history of certain renal cortex disorders.
  • Patients who have a history of certain renal medulla disorders.
  • Patients who have a history of certain renal pyramid disorders.
  • Patients who have a history of certain renal column disorders.
  • Patients who have a history of certain renal papilla disorders.
  • Patients who have a history of certain renal calyx disorders.
  • Patients who have a history of certain renal pelvis disorders.
  • Patients who have a history of certain renal sinus disorders.
  • Patients who have a history of certain renal hilum disorders.
  • Patients who have a history of certain renal capsule disorders.
  • Patients who have a history of certain renal cortex disorders.
  • Patients who have a history of certain renal medulla disorders.
  • Patients who have a history of certain renal pyramid disorders.
  • Patients who have a history of certain renal column disorders.
  • Patients who have a history of certain renal papilla disorders.
  • Patients who have a history of certain renal calyx disorders.
  • Patients who have a history of certain renal pelvis disorders.
  • Patients who have a history of certain renal sinus disorders.
  • Patients who have a history of certain renal hilum disorders.
  • Patients who have a history of certain renal capsule disorders.
  • Patients who have a history of certain renal cortex disorders.
  • Patients who have a history of certain renal medulla disorders.
  • Patients who have a history of certain renal pyramid disorders.
  • Patients who have a history of certain renal column disorders.
  • Patients who have a history of certain renal papilla disorders.
  • Patients who have a history of certain renal calyx disorders.
  • Patients who have a history of certain renal pelvis disorders.
  • Patients who have a history of certain renal sinus disorders.
  • Patients who have a history of certain renal hilum disorders.
  • Patients who have a history of certain renal capsule disorders.
  • Patients who have a history of certain renal cortex disorders.
  • Patients who have a history of certain renal medulla disorders.
  • Patients who have a history of certain renal pyramid disorders.
  • Patients who have a history of certain renal column disorders.
  • Patients who have a history of certain renal papilla disorders.
  • Patients who have a history of certain renal calyx disorders.
  • Patients who have a history of certain renal pelvis disorders.
  • Patients who have a history of certain renal sinus disorders.
  • Patients who have a history of certain renal hilum disorders.
  • Patients who have a history of certain renal capsule disorders.
  • Patients who have a history of certain renal cortex disorders.
  • Patients who have a history of certain renal medulla disorders.
  • Patients who have a history of certain renal pyramid disorders.
  • Patients who have a history of certain renal column disorders.
  • Patients who have a history of certain renal papilla disorders.
  • Patients who have a history of certain renal calyx disorders.
  • Patients who have a history of certain renal pelvis disorders.
  • Patients who have a history of certain renal sinus disorders.
  • Patients who have a history of certain renal hilum disorders.
  • Patients who have a history of certain renal capsule disorders.
  • Patients who have a history of certain renal cortex disorders.
  • Patients who have a history of certain renal medulla disorders.
  • Patients who have a history of certain renal pyramid disorders.
  • Patients who have a history of certain renal column disorders.
  • Patients who have a history of certain renal papilla disorders.
  • Patients who have a history of certain renal calyx disorders.
  • Patients who have a history of certain renal pelvis disorders.
  • Patients who have a history of certain renal sinus disorders.
  • Patients who have a history of certain renal hilum disorders.
  • Patients who have a history of certain renal capsule disorders.
  • Patients who have a history of certain renal cortex disorders.
  • Patients who have a history of certain renal medulla disorders.
  • Patients who have a history of certain renal pyramid disorders.
  • Patients who have a history of certain renal column disorders.
  • Patients who have a history of certain renal papilla disorders.
  • Patients who have a history of certain renal calyx disorders.
  • Patients who have a history of certain renal pelvis disorders.
  • Patients who have a history of certain renal sinus disorders.
  • Patients who have a history of certain renal hilum disorders.
  • Patients who have a history of certain renal capsule disorders.
  • Patients who have a history of certain renal cortex disorders.
  • Patients who have a history of certain renal medulla disorders.
  • Patients who have a history of certain renal pyramid disorders.
  • Patients who have a history of certain renal column disorders.
  • Patients who have a history of certain renal papilla disorders.
  • Patients who have a history of certain renal calyx disorders.
  • Patients who have a history of certain renal pelvis disorders.
  • Patients who have a history of certain renal sinus disorders.
  • Patients who have a history of certain renal hilum disorders.
  • Patients who have a history of certain renal capsule disorders.
  • Patients who have a history of certain renal cortex disorders.
  • Patients who have a history of certain renal medulla disorders.
  • Patients who have a history of certain renal pyramid disorders.
  • Patients who have a history of certain renal column disorders.
  • Patients who have a history of certain renal papilla disorders.
  • Patients who have a history of certain renal calyx disorders.
  • Patients who have a history of certain renal pelvis disorders.
  • Patients who have a history of certain renal sinus disorders.
  • Patients who have a history of certain renal hilum disorders.
  • Patients who have a history of certain renal capsule disorders.
  • Patients who have a history of certain renal cortex disorders.
  • Patients who have a history of certain renal medulla disorders.
  • Patients who have a history of certain renal pyramid disorders.
  • Patients who have a history of certain renal column disorders.
  • Patients who have a history of certain renal papilla disorders.
  • Patients who have a history of certain renal calyx disorders.
  • Patients who have a history of certain renal pelvis disorders.
  • Patients who have a history of certain renal sinus disorders.
  • Patients who have a history of certain renal hilum disorders.
  • Patients who have a history of certain renal capsule disorders.
  • Patients who have a history of certain renal cortex disorders.
  • Patients who have a history of certain renal medulla disorders.
  • Patients who have a history of certain renal pyramid disorders.
  • Patients who have a history of certain renal column disorders.
  • Patients who have a history of certain renal papilla disorders.
  • Patients who have a history of certain renal calyx disorders.
  • Patients who have a history of certain renal pelvis disorders.
  • Patients who have a history of certain renal sinus disorders.
  • Patients who have a history of certain renal hilum disorders.
  • Patients who have a history of certain renal capsule disorders.
  • Patients who have a history of certain renal cortex disorders.
  • Patients who have a history of certain renal medulla disorders.
  • Patients who have a history of certain renal pyramid disorders.
  • Patients who have a history of certain renal column disorders.
  • Patients who have a history of certain renal papilla disorders.
  • Patients who have a history of certain renal calyx disorders.
  • Patients who have a history of certain renal pelvis disorders.
  • Patients who have a history of certain renal sinus disorders.
  • Patients who have a history of certain renal hilum disorders.
  • Patients who have a history of certain renal capsule disorders.
  • Patients who have a history of certain renal cortex disorders.
  • Patients who have a history of certain renal medulla disorders.
  • Patients who have a history of certain renal pyramid disorders.
  • Patients who have a history of certain renal column disorders.
  • Patients who have a history of certain renal papilla disorders.
  • Patients who have a history of certain renal calyx disorders.
  • Patients who have a history of certain renal pelvis disorders.
  • Patients who have a history of certain renal sinus disorders.
  • Patients who have a history of certain renal hilum disorders.
  • Patients who have a history of certain renal capsule disorders.
  • Patients who have a history of certain renal cortex disorders.
  • Patients who have a history of certain renal medulla disorders.
  • Patients who have a history of certain renal pyramid disorders.
  • Patients who have a history of certain renal column disorders.
  • Patients who have a history of certain renal papilla disorders.
  • Patients who have a history of certain renal calyx disorders.
  • Patients who have a history of certain renal pelvis disorders.
  • Patients who have a history of certain renal sinus disorders.
  • Patients who have a history of certain renal hilum disorders.
  • Patients who have a history of certain renal capsule disorders.
  • Patients who have a history of certain renal cortex disorders.
  • Patients who have a history of certain renal medulla disorders.
  • Patients who have a history of certain renal pyramid disorders.
  • Patients who have a history of certain renal column disorders.
  • Patients who have a history of certain renal papilla disorders.
  • Patients who have a history of certain renal calyx disorders.
  • Patients who have a history of certain renal pelvis disorders.
  • Patients who have a history of certain renal sinus disorders.
  • Patients who have a history of certain renal hilum disorders.
  • Patients who have a history of certain renal capsule disorders.
  • Patients who have a history of certain renal cortex disorders.
  • Patients who have a history of certain renal medulla disorders.
  • Patients who have a history of certain renal pyramid disorders.
  • Patients who have a history of certain renal column disorders.
  • Patients who have a history of certain renal papilla disorders.
  • Patients who have a history of certain renal calyx disorders.
  • Patients who have a history of certain renal pelvis disorders.
  • Patients who have a history of certain renal sinus disorders.
  • Patients who have a history of certain renal hilum disorders.
  • Patients who have a history of certain renal capsule disorders.
  • Patients who have a history of certain renal cortex disorders.
  • Patients who have a history of certain renal medulla disorders.
  • Patients who have a history of certain renal pyramid disorders.
  • Patients who have a history of certain renal column disorders.
  • Patients who have a history of certain renal papilla disorders.
  • Patients who have a history of certain renal calyx disorders.
  • Patients who have a history of certain renal pelvis disorders.
  • Patients who have a history of certain renal sinus disorders.
  • Patients who have a history of certain renal hilum disorders.
  • Patients who have a history of certain renal capsule disorders.
  • Patients who have a history of certain renal cortex disorders.
  • Patients who have a history of certain renal medulla disorders.
  • Patients who have a history of certain renal pyramid disorders.
  • Patients who have a history of certain renal column disorders.
  • Patients who have a history of certain renal papilla disorders.
  • Patients who have a history of certain renal calyx disorders.
  • Patients who have a history of certain renal pelvis disorders.
  • Patients who have a history of certain renal sinus disorders.
  • Patients who have a history of certain renal hilum disorders.
  • Patients who have a history of certain renal capsule disorders.
  • Patients who have a history of certain renal cortex disorders.
  • Patients who have a history of certain renal medulla disorders.
  • Patients who have a history of certain renal pyramid disorders.
  • Patients who have a history of certain renal column disorders.
  • Patients who have a history of certain renal papilla disorders.
  • Patients who have a history of certain renal calyx disorders.
  • Patients who have a history of certain renal pelvis disorders.
  • Patients who have a history of certain renal sinus disorders.
  • Patients who have a history of certain renal hilum disorders.
  • Patients who have a history of certain renal capsule disorders.
  • Patients who have a history of certain renal cortex disorders.
  • Patients who have a history of certain renal medulla disorders.
  • Patients who have a history of certain renal pyramid disorders.
  • Patients who have a history of certain renal column disorders.
  • Patients who have a history of certain renal papilla disorders.
  • Patients who have a history of certain renal calyx disorders.
  • Patients who have a history of certain renal pelvis disorders.
  • Patients who have a history of certain renal sinus disorders.
  • Patients who have a history of certain renal hilum disorders.
  • Patients who have a history of certain renal capsule disorders.
  • Patients who have a history of certain renal cortex disorders.
  • Patients who have a history of certain renal medulla disorders.
  • Patients who have a history of certain renal pyramid disorders.
  • Patients who have a history of certain renal column disorders.
  • Patients who have a history of certain renal papilla disorders.
  • Patients who have a history of certain renal calyx disorders.
  • Patients who have a history of certain renal pelvis disorders.
  • Patients who have a history of certain renal sinus disorders.
  • Patients who have a history of certain renal hilum disorders.
  • Patients who have a history of certain renal capsule disorders.
  • Patients who have a history of certain renal cortex disorders.
  • Patients who have a history of certain renal medulla disorders.
  • Patients who have a history of certain renal pyramid disorders.
  • Patients who have a history of certain renal column disorders.
  • Patients who have a history of certain renal papilla disorders.
  • Patients who have a history of certain renal calyx disorders.
  • Patients who have a history of certain renal pelvis disorders.
  • Patients who have a history of certain renal sinus disorders.
  • Patients who have a history of certain renal hilum disorders.
  • Patients who have a history of certain renal capsule disorders.
  • Patients who have a history of certain renal cortex disorders.
  • Patients who have a history of certain renal medulla disorders.
  • Patients who have a history of certain renal pyramid disorders.
  • Patients who have a history of certain renal column disorders.
  • Patients who have a history of certain renal papilla disorders.
  • Patients who have a history of certain renal calyx disorders.
  • Patients who have a history of certain renal pelvis disorders.
  • Patients who have a history of certain renal sinus disorders.
  • Patients who have a history of certain renal hilum disorders.
  • Patients who have a history of certain renal capsule disorders.
  • Patients who have a history of certain renal cortex disorders.
  • Patients who have a history of certain renal medulla disorders.
  • Patients who have a history of certain renal pyramid disorders.
  • Patients who have a history of certain renal column disorders.
  • Patients who have a history of certain renal papilla disorders.
  • Patients who have a history of certain renal calyx disorders.
  • Patients who have a history of certain renal pelvis disorders.
  • Patients who have a history of certain renal sinus disorders.
  • Patients who have a history of certain renal hilum disorders.
  • Patients who have a history of certain renal capsule disorders.
  • Patients who have a history of certain renal cortex disorders.
  • Patients who have a history of certain renal medulla disorders.
  • Patients who have a history of certain renal pyramid disorders.
  • Patients who have a history of certain renal column disorders.
  • Patients who have a history of certain renal papilla disorders.
  • Patients who have a history of certain renal calyx disorders.
  • Patients who have a history of certain renal pelvis disorders.
  • Patients who have a history of certain renal sinus disorders.
  • Patients who have a history of certain renal hilum disorders.
  • Patients who have a history of certain renal capsule disorders.
  • Patients who have a history of certain renal cortex disorders.
  • Patients who have a history of certain renal medulla disorders.
  • Patients who have a history of certain renal pyramid disorders.
  • Patients who have a history of certain renal column disorders.
  • Patients who have a history of certain renal papilla disorders.
  • Patients who have a history of certain renal calyx disorders.
  • Patients who have a history of certain renal pelvis disorders.
  • Patients who have a history of certain renal sinus disorders.
  • Patients who have a history of certain renal hilum disorders.
  • Patients who have a history of certain renal capsule disorders.
  • Patients who have a history of certain renal cortex disorders.
  • Patients who have a history of certain renal medulla disorders.
  • Patients who have a history of certain renal pyramid disorders.
  • Patients who have a history of certain renal column disorders.
  • Patients who have a history of certain renal papilla disorders.
  • Patients who have a history of certain renal calyx disorders.
  • Patients who have a history of certain renal pelvis disorders.
  • Patients who have a history of certain renal sinus disorders.
  • Patients who have a history of certain renal hilum disorders.
  • Patients who have a history of certain renal capsule disorders.
  • Patients who have a history of certain renal cortex disorders.
  • Patients who have a history of certain renal medulla disorders.
  • Patients who have a history of certain renal pyramid disorders.
  • Patients who have a history of certain renal column disorders.
  • Patients who have a history of certain renal papilla disorders.
  • Patients who have a history of certain renal calyx disorders.
  • Patients who have a history of certain renal pelvis disorders.
  • Patients who have a history of certain renal sinus disorders.
  • Patients who have a history of certain renal hilum disorders.
  • Patients who have a history of certain renal capsule disorders.
  • Patients who have a history of certain renal cortex disorders.
  • Patients who have a history of certain renal medulla disorders.
  • Patients who have a history of certain renal pyramid disorders.
  • Patients who have a history of certain renal column disorders.
  • Patients who have a history of certain renal papilla disorders.
  • Patients who have a history of certain renal calyx disorders.
  • Patients who have a history of certain renal pelvis disorders.
  • Patients who have a history of certain renal sinus disorders.
  • Patients who have a history of certain renal hilum disorders.
  • Patients who have a history of certain renal capsule disorders.
  • Patients who have a history of certain renal cortex disorders.
  • Patients who have a history of certain renal medulla disorders.
  • Patients who have a history of certain renal pyramid disorders.
  • Patients who have a history of certain renal column disorders.
  • Patients who have a history of certain renal papilla disorders.
  • Patients who have a history of certain renal calyx disorders.
  • Patients who have a history of certain renal pelvis disorders.
  • Patients who have a history of certain renal sinus disorders.
  • Patients who have a history of certain renal hilum disorders.
  • Patients who have a history of certain renal capsule disorders.
  • Patients who have a history of certain renal cortex disorders.
  • Patients who have a history of certain renal medulla disorders.
  • Patients who have a history of certain renal pyramid disorders.
  • Patients who have a history of certain renal column disorders.
  • Patients who have a history of certain renal papilla disorders.
  • Patients who have a history of certain renal calyx disorders.
  • Patients who have a history of certain renal pelvis disorders.
  • Patients who have a history of certain renal sinus disorders.
  • Patients who have a history of certain renal hilum disorders.
  • Patients who have a history of certain renal capsule disorders.
  • Patients who have a history of certain renal cortex disorders.
  • Patients who have a history of certain renal medulla disorders.
  • Patients who have a history of certain renal pyramid disorders.
  • Patients who have a history of certain renal column disorders.
  • Patients who have a history of certain renal papilla disorders.
  • Patients who have a history of certain renal calyx disorders.
  • Patients who have a history of certain renal pelvis disorders.
  • Patients who have a history of certain renal sinus disorders.
  • Patients who have a history of certain renal hilum disorders.
  • Patients who have a history of certain renal capsule disorders.
  • Patients who have a history of certain renal cortex disorders.
  • Patients who have a history of certain renal medulla disorders.
  • Patients who have a history of certain renal pyramid disorders.
  • Patients who have a history of certain renal column disorders.
  • Patients who have a history of certain renal papilla disorders.
  • Patients who have a history of certain renal calyx disorders.
  • Patients who have a history of certain renal pelvis disorders.
  • Patients who have a history of certain renal sinus disorders.
  • Patients who have a history of certain renal hilum disorders.
  • Patients who have a history of certain renal capsule disorders.
  • Patients who have a history of certain renal cortex disorders.
  • Patients who have a history of certain renal medulla disorders.
  • Patients who have a history of certain renal pyramid disorders.
  • Patients who have a history of certain renal column disorders.
  • Patients who have a history of certain renal papilla disorders.
  • Patients who have a history of certain renal calyx disorders.
  • Patients who have a history of certain renal pelvis disorders.
  • Patients who have a history of certain renal sinus disorders.
  • Patients who have a history of certain renal hilum disorders.
  • Patients who have a history of certain renal capsule disorders.
  • Patients who have a history of certain renal cortex disorders.
  • Patients who have a history of certain renal medulla disorders.
  • Patients who have a history of certain renal pyramid disorders.
  • Patients who have a history of certain renal column disorders.
  • Patients who have a history of certain renal papilla disorders.
  • Patients who have a history of certain renal calyx disorders.
  • Patients who have a history of certain renal pelvis disorders.
  • Patients who have a history of certain renal sinus disorders.
  • Patients who have a history of certain renal hilum disorders.
  • Patients who have a history of certain renal capsule disorders.
  • Patients who have a history of certain renal cortex disorders.
  • Patients who have a history of certain renal medulla disorders.
  • Patients who have a history of certain renal pyramid disorders.
  • Patients who have a history of certain renal column disorders.
  • Patients who have a history of certain renal papilla disorders.
  • Patients who have a history of certain renal calyx disorders.
  • Patients who have a history of certain renal pelvis disorders.
  • Patients who have a history of certain renal sinus disorders.
  • Patients who have a history of certain renal hilum disorders.
  • Patients who have a history of certain renal capsule disorders.
  • Patients who have a history of certain renal cortex disorders.
  • Patients who have a history of certain renal medulla disorders.
  • Patients who have a history of certain renal pyramid disorders.
  • Patients who have a history of certain renal column disorders.
  • Patients who have a history of certain renal papilla disorders.
  • Patients who have a history of certain renal calyx disorders.
  • Patients who have a history of certain renal pelvis disorders.
  • Patients who have a history of certain renal sinus disorders.
  • Patients who have a history of certain renal hilum disorders.
  • Patients who have a history of certain renal capsule disorders.
  • Patients who have a history of certain renal cortex disorders.
  • Patients who have a history of certain renal medulla disorders.
  • Patients who have a history of certain renal pyramid disorders.
  • Patients who have a history of certain renal column disorders.
  • Patients who have a history of certain renal papilla disorders.
  • Patients who have a history of certain renal calyx disorders.
  • Patients who have a history of certain renal pelvis disorders.
  • Patients who have a history of certain renal sinus disorders.
  • Patients who have a history of certain renal hilum disorders.
  • Patients who have a history of certain renal capsule disorders.
  • Patients who have a history of certain renal cortex disorders.
  • Patients who have a history of certain renal medulla disorders.
  • Patients who have a history of certain renal pyramid disorders.
  • Patients who have a history of certain renal column disorders.
  • Patients who have a history of certain renal papilla disorders.
  • Patients who have a history of certain renal calyx disorders.
  • Patients who have a history of certain renal pelvis disorders.
  • Patients who have a history of certain renal sinus disorders.
  • Patients who have a history of certain renal hilum disorders.
  • Patients who have a history of certain renal capsule disorders.
  • Patients who have a history of certain renal cortex disorders.
  • Patients who have a history of certain renal medulla disorders.
  • Patients who have a history of certain renal pyramid disorders.
  • Patients who have a history of certain renal column disorders.
  • Patients who have a history of certain renal papilla disorders.
  • Patients who have a history of certain renal calyx disorders.
  • Patients who have a history of certain renal pelvis disorders.
  • Patients who have a history of certain renal sinus disorders.
  • Patients who have a history of certain renal hilum disorders.
  • Patients who have a history of certain renal capsule disorders.
  • Patients who have a history of certain renal cortex disorders.
  • Patients who have a history of certain renal medulla disorders.
  • Patients who have a history of certain renal pyramid disorders.
  • Patients who have a history of certain renal column disorders.
  • Patients who have a history of certain renal papilla disorders.
  • Patients who have a history of certain renal calyx disorders.
  • Patients who have a history of certain renal pelvis disorders.
  • Patients who have a history of certain renal sinus disorders.
  • Patients who have a history of certain renal hilum disorders.
  • Patients who have a history of certain renal capsule disorders.
  • Patients who have a history of certain renal cortex disorders.
  • Patients who have a history of certain renal medulla disorders.
  • Patients who have a history of certain renal pyramid disorders.
  • Patients who have a history of certain renal column disorders.
  • Patients who have a history of certain renal papilla disorders.
  • Patients who have a history of certain renal calyx disorders.
  • Patients who have a history of certain renal pelvis disorders.
  • Patients who have a history of certain renal sinus disorders.
  • Patients who have a history of certain renal hilum disorders.
  • Patients who have a history of certain renal capsule disorders.
  • Patients who have a history of certain renal cortex disorders.
  • Patients who have a history of certain renal medulla disorders.
  • Patients who have a history of certain renal pyramid disorders.
  • Patients who have a history of certain renal column disorders.
  • Patients who have a history of certain renal papilla disorders.
  • Patients who have a history of certain renal calyx disorders.
  • Patients who have a history of certain renal pelvis disorders.
  • Patients who have a history of certain renal sinus disorders.
  • Patients who have a history of certain renal hilum disorders.
  • Patients who have a history of certain renal capsule disorders.
  • Patients who have a history of certain renal cortex disorders.
  • Patients who have a history of certain renal medulla disorders.
  • Patients who have a history of certain renal pyramid disorders.
  • Patients who have a history of certain renal column disorders.
  • Patients who have a history of certain renal papilla disorders.
  • Patients who have a history of certain renal calyx disorders.
  • Patients who have a history of certain renal pelvis disorders.
  • Patients who have a history of certain renal sinus disorders.
  • Patients who have a history of certain renal hilum disorders.
  • Patients who have a history of certain renal capsule disorders.
  • Patients who have a history of certain renal cortex disorders.
  • Patients who have a history of certain renal medulla disorders.
  • Patients who have a history of certain renal pyramid disorders.
  • Patients who have a history of certain renal column disorders.
  • Patients who have a history of certain renal papilla disorders.
  • Patients who have a history of certain renal calyx disorders.
  • Patients who have a history of certain renal pelvis disorders.
  • Patients who have a history of certain renal sinus disorders.
  • Patients who have a history of certain renal hilum disorders.
  • Patients who have a history of certain renal capsule disorders.
  • Patients who have a history of certain renal cortex disorders.
  • Patients who have a history of certain renal medulla disorders.
  • Patients who have a history of certain renal pyramid disorders.
  • Patients who have a history of certain renal column disorders.
  • Patients who have a history of certain renal papilla disorders.
  • Patients who have a history of certain renal calyx disorders.
  • Patients who have a history of certain renal pelvis disorders.
  • Patients who have a history of certain renal sinus disorders.
  • Patients who have a history of certain renal hilum disorders.
  • Patients who have a history of certain renal capsule disorders.
  • Patients who have a history of certain renal cortex disorders.
  • Patients who have a history of certain renal medulla disorders.
  • Patients who have a history of certain renal pyramid disorders.
  • Patients who have a history of certain renal column disorders.
  • Patients who have a history of certain renal papilla disorders.
  • Patients who have a history of certain renal calyx disorders.
  • Patients who have a history of certain renal pelvis disorders.
  • Patients who have a history of certain renal sinus disorders.
  • Patients who have a history of certain renal hilum disorders.
  • Patients who have a history of certain renal capsule disorders.
  • Patients who have a history of certain renal cortex disorders.
  • Patients who have a history of certain renal medulla disorders.
  • Patients who have a history of certain renal pyramid disorders.
  • Patients who have a history of certain renal column disorders.
  • Patients who have a history of certain renal papilla disorders.
  • Patients who have a history of certain renal calyx disorders.
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Investigated drugs

FBL-MTX is a new treatment being tested for rheumatoid arthritis. It is a special form of methotrexate, a common medication used to treat this condition. In this trial, FBL-MTX is given as an injection under the skin. The goal is to see how well it works and how safe it is for patients who have not used disease-modifying antirheumatic drugs before, as well as for those who did not respond well or could not tolerate oral methotrexate.

What is already known about the treatment

FBL-MTX – This medication is administered through subcutaneous injection and is currently being studied in clinical trials for its effectiveness in treating rheumatoid arthritis. It is in the investigational stage, with ongoing research to determine its safety and efficacy. The main therapeutic indication for FBL-MTX is rheumatoid arthritis, particularly in patients who have not responded well to oral methotrexate or are intolerant to it. The medication works by using folate-based liposomes to deliver methotrexate directly to the affected areas, potentially enhancing its therapeutic effects while minimizing side effects. It is classified as a disease-modifying antirheumatic drug (DMARD).

Investigated diseases

Rheumatoid Arthritis – Rheumatoid arthritis is a chronic inflammatory disorder that primarily affects the joints. It typically causes pain, swelling, and stiffness in the joints, often starting in the hands and feet. Over time, the inflammation can lead to joint damage and deformities. The disease can also affect other parts of the body, including the skin, eyes, lungs, and blood vessels. Symptoms may vary in severity and can come and go, with periods of increased disease activity known as flares. The exact cause of rheumatoid arthritis is not fully understood, but it involves the immune system attacking the body's own tissues.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-510258-17-00Protocol codeFBL-MTX-201Estimated enrolment40 patientsSponsorSolfarcos Solucoes Farmaceuticas E Cosmeticas Lda.

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