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Efficacy and safety of subcutaneous infliximab in patients with moderate to severe rheumatoid arthritis on background drug combination

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What is this trial about?

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

The study involves adults with moderate to severe Rheumatoid arthritis, a chronic condition that causes joint pain, swelling, and stiffness. Participants will continue taking their regular medicines, which may include methotrexate, hydrocortisone, ibuprofen, hydroxychloroquine, and folic acid. The investigational product is CT-P13, a biosimilar version of infliximab, given as a small injection under the skin (subcutaneous). Some participants will receive a matching placebo instead of the active drug.

The purpose of the trial is to determine whether the active injection provides a greater improvement in disease symptoms than the placebo. Participants are randomly assigned to one of the two groups and receive the assigned injection at scheduled visits over a 12‑week period, with regular check‑ups to record any changes in health and side effects.

Improvement is measured using the ACR criteria, where a 50 % improvement (called ACR50) means the participant’s joint symptoms have reduced by half. Another assessment, the HAQ-DI, is a questionnaire that asks about the ability to perform everyday activities. Throughout the study, safety is closely monitored and any adverse events are recorded.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline Visit and First Dose

    You attend the first study visit after joining the trial.

    You begin taking the background medicines: methotrexate 25 mg taken by mouth each day, hydroxychloroquine 600 mg taken by mouth each day, ibuprofen 3200 mg taken by mouth each day, and folic acid 5 mg taken by mouth each day.

    You receive a one‑time intravenous infusion of hydrocortisone 200 mg during the visit.

    You are given a subcutaneous injection of the study medication, which is either infliximab 240 mg or a matching placebo.

  2. Step 2

    Daily Oral Medication

    You continue to take the oral background medicines every day for the entire study period.

    The doses remain the same as described at the baseline visit.

  3. Step 3

    Scheduled Study Injections

    At each follow‑up visit you receive another subcutaneous injection of the study medication (either infliximab 240 mg or placebo) according to the study schedule.

    The injection is given under the skin using a pre‑filled pen.

  4. Step 4

    Regular Follow‑up Visits

    You attend clinic visits that are arranged by the study team to check your safety and to collect blood samples.

    During these visits you may also receive the scheduled injection described in the previous step.

  5. Step 5

    Week 12 Primary Assessment

    At the 12‑week visit you undergo the main effectiveness evaluation.

    Your response is measured using the ACR50 criteria, which means a 50 % improvement according to the standards of the American College of Rheumatology.

    You also complete the HAQ‑DI questionnaire, which assesses your level of disability.

  6. Step 6

    Study Completion

    After the final assessments you finish participation in the trial.

    You stop receiving the study injections but may continue the background medicines if advised by your physician.

Who can join the trial?

9 criteria

  • Be between 18 and 75 years old, regardless of gender.
  • Have a confirmed diagnosis of rheumatoid arthritis for at least 24 weeks and meet the 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification criteria, which are the standard guidelines doctors use to identify this condition.
  • Show active disease at the screening visit and at the start of the study, meaning you must have:
    • Six or more swollen joints out of the 66 joints doctors examine, and
    • Six or more tender (painful) joints out of the 68 joints examined, and
    • Either a C‑reactive protein (CRP) level of 1.0 mg/dL (10 mg/L) or higher, which is a blood test that rises when there is inflammation, or an erythrocyte sedimentation rate (ESR) of 28 mm/hour or higher, another blood test that indicates inflammation.
    • At screening, have at least one of the following:
      • A positive test for anti‑cyclic citrullinated peptide (anti‑CCP) antibodies, which are proteins in the blood that often appear in rheumatoid arthritis,
      • A positive test for rheumatoid factor (RF), another type of antibody linked to the disease, or
      • If both antibody tests are negative, show at least one area of bone damage called a bone erosion on an X‑ray of the joints.
      • Have been taking the medicine methotrexate (MTX) by mouth or injection for at least 24 weeks, and have been on a stable dose of 10 to 25 mg per week for at least the last 8 weeks before the first study medication. Methotrexate is a common drug used to control rheumatoid arthritis.

Who cannot join the trial?

7 criteria

  • Anyone who has ever been treated with infliximab (a medication used for certain autoimmune diseases) cannot join the study.
  • People who have taken other special arthritis medicines called biologic disease‑modifying antirheumatic drugs (bDMARDs) for rheumatoid arthritis and also meet any of the following:
    • have used more than two different bDMARDs before;
    • did not get enough relief from a drug that blocks tumor necrosis factor (TNF) α (a protein that causes inflammation);
    • have been treated with a B‑cell depleting agent such as rituximab (a medicine that reduces certain immune cells);
    • did not wait the required “washout period” (the time needed for a previous drug to leave the body) before starting the study drug. This waiting time is at least 4 weeks for etanercept and at least 8 weeks for drugs such as adalimumab, certolizumab, golimumab, abatacept, sarilumab and tocilizumab.
    • Anyone who has taken any investigational or approved targeted synthetic DMARDs (such as tofacitinib or baricitinib) for rheumatoid arthritis cannot participate.
    • People who are allergic to any of the inactive ingredients (excipients) in infliximab, to mouse‑derived or human proteins, or who have a severe reaction to immune‑system products called immunoglobulin products are not allowed in the study.
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Investigated drugs

  • Methotrexate

    is a medication that helps slow down the immune system’s activity that causes joint damage in rheumatoid arthritis. In this study it is given as part of the regular treatment that all patients receive, either as a pill or an injection, to keep the disease under control while the new drug is tested.

  • Hydrocortisone

    is a short‑acting steroid that reduces inflammation quickly. In the trial it is given by intravenous infusion as a background therapy to help control flare‑ups and swelling while the investigational medication is being evaluated.

  • Ibuprofen

    is a common pain reliever that belongs to the non‑steroidal anti‑inflammatory drug (NSAID) class. Participants take it orally to manage everyday joint pain and stiffness as part of their usual rheumatoid arthritis care during the study.

  • Hydroxychloroquine

    is an antimalarial drug that also works to calm the immune system in rheumatoid arthritis. It is taken by mouth and is included as a background medication to help control disease activity while the new treatment is tested.

  • Folic acid

    is a vitamin supplement that is given to patients taking methotrexate. It helps reduce side effects such as mouth sores and liver problems that can occur with methotrexate therapy.

  • Infliximab (CT‑P13)

    is the experimental medicine being studied. It is a biologic drug that blocks a protein called tumor necrosis factor‑alpha, which plays a key role in causing joint inflammation. In this trial it is given as a subcutaneous injection (under the skin) to see if it works better than placebo in improving rheumatoid arthritis symptoms.

What is already known about the treatment

  • Methotrexate

    Given by mouth at a dose of 25 mg, this medicine is an established treatment for rheumatoid arthritis and is listed in many medical guidelines. It works by lowering the activity of cells that need folate, which reduces the immune response that causes joint damage. It is classified as a disease‑modifying antirheumatic drug (DMARD) and an antimetabolite. Its long‑term use is well documented in the medical literature.

  • Hydrocortisone

    Administered as an intravenous infusion of 200 mg, hydrocortisone is a widely used steroid that mimics the body’s natural cortisol. It helps calm inflammation and can be used when rapid control of swelling is needed. It belongs to the glucocorticoid class of drugs and is approved for many inflammatory conditions. Its safety and effectiveness are well described in clinical practice.

  • Infliximab

    Delivered as a subcutaneous injection of 240 mg using a pre‑filled pen, infliximab (Remsima) is a biologic drug approved for moderate to severe rheumatoid arthritis. It binds to a protein called tumor‑necrosis factor‑alpha (TNF‑α) and blocks its action, which lowers inflammation in the joints. It is classified as an anti‑TNF monoclonal antibody. The drug has extensive study data supporting its use in rheumatology.

  • Ibuprofen

    Taken orally at a total daily dose of 3200 mg, ibuprofen is an over‑the‑counter medication for pain, fever, and inflammation. It reduces swelling by blocking enzymes that make prostaglandins, chemicals that cause pain and fever. It is a nonsteroidal anti‑inflammatory drug (NSAID). Its benefits and risks are well known from many years of use.

  • Hydroxychloroquine

    Provided by mouth at 600 mg, hydroxychloroquine is an antimalarial drug that is also approved for rheumatoid arthritis. It works by calming the activity of immune cells, which helps lessen joint inflammation. It is classified as a disease‑modifying antirheumatic drug (DMARD) and an antimalarial. Its safety profile is well recorded in medical literature.

  • Folic Acid

    Given orally at 5 mg, folic acid is a vitamin supplement often used together with methotrexate to lessen side effects. It supplies the body with folate needed for normal cell growth and DNA production. It is classified as a vitamin and dietary supplement. Its role in reducing methotrexate toxicity is well documented.

Investigated diseases

Rheumatoid arthritis - Rheumatoid arthritis is a chronic condition that causes inflammation of the joints. It typically begins in the small joints of the hands and feet and can spread to larger joints. The inflammation leads to swelling, stiffness, and pain, especially in the morning. Over time the joint lining thickens and can damage the cartilage and bone. This may result in reduced joint movement and deformities. The disease often follows periods of increased activity and quieter phases.
Trial detailsLast updated 2 Nov 2026
Age18+ yearsPhasePhase IIITrial ID2026-526538-15-00Protocol codeCT-P13 3.14Estimated enrolment296 patientsSponsorCelltrion Inc.

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