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Study on the Effectiveness and Safety of Subcutaneous Infliximab for Patients with Active Crohn's Disease or Ulcerative Colitis

Verified siteRegistered drugNo placebo
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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 Inflammatory Bowel Disease, which includes conditions like Crohn's Disease and Ulcerative Colitis. The treatment being tested is called CT-P13, which contains the active substance Infliximab. Infliximab is a type of protein used to help reduce inflammation in the body. The study will compare two forms of this treatment: one given as an infusion into a vein (intravenous) and the other as an injection under the skin (subcutaneous).

The purpose of the study is to see if the subcutaneous form of CT-P13 is as effective as the intravenous form in terms of how the body processes the drug, known as pharmacokinetics, by the sixth week of treatment. Participants in the study will receive either the subcutaneous or intravenous form of the treatment. The study will last for up to 24 weeks, during which time participants will have regular check-ups to monitor their health and the effects of the treatment.

Throughout the study, various health indicators will be measured, such as the presence of antibodies to Infliximab, levels of inflammation markers, and any side effects experienced. The study aims to provide valuable information on the safety and effectiveness of the subcutaneous form of CT-P13 for people with active Crohn's Disease or Ulcerative Colitis.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment

    The trial begins with the administration of Remsima 100 mg powder for infusion. This is a solution prepared for infusion, which means it is given through a vein. The purpose is to introduce the medication into the body to start managing the symptoms of Crohn's disease or ulcerative colitis.

  2. Step 2

    Subsequent treatment

    Following the initial infusion, the treatment continues with Remsima 120 mg solution for injection. This is administered as a subcutaneous injection, which means it is injected under the skin. This step is part of the induction therapy aimed at achieving a therapeutic level of the medication in the body.

  3. Step 3

    Monitoring and assessment at week 6

    At week 6, the concentration of the medication in the blood, known as Ctrough, is measured. This helps to understand how the body is processing the medication.

    A clinical response is evaluated. For ulcerative colitis, this involves a decrease in the partial Mayo score, which assesses disease activity. For Crohn's disease, a decrease in the CDAI score is checked.

    The IBD disability index is collected to assess the impact of the disease on daily life.

    The presence of antibodies to infliximab is checked to ensure the body is not reacting negatively to the medication.

    Adverse events, including any reactions at the injection site or hypersensitivity, are monitored.

  4. Step 4

    Monitoring and assessment at week 24

    At week 24, another measurement of Ctrough is taken, along with the AUC, which assesses the overall exposure to the medication over time.

    Clinical remission is evaluated. For ulcerative colitis, this involves a total Mayo score assessment. For Crohn's disease, the CDAI score is used.

    Fecal calprotectin levels are measured to assess inflammation in the intestines.

    The presence of antibodies to infliximab is checked again.

    The concentration of CRP, a marker of inflammation, is measured.

    Adverse events are monitored throughout the trial period.

    A Treatment Satisfaction Questionnaire for Medication (TSQM) is collected to understand the patient's satisfaction with the treatment.

Who can join the trial?

8 criteria

  • Must be a male or female who is at least 18 years old.
  • Must have been diagnosed with **inflammatory bowel disease** (a condition that causes inflammation in the digestive tract) for at least 3 months. This includes **Crohn's disease** and **Ulcerative colitis**.
  • Must have tried standard treatments for active **Ulcerative colitis** or **Crohn's disease** but did not respond to them. These treatments include medications like **corticosteroids**, **thiopurines**, and **5-aminosalicylates**.
  • Must have active **Crohn's disease** or **Ulcerative colitis** with at least one clear sign of disease activity, which can be seen through tests like blood tests, endoscopy, or imaging.
  • Must be starting treatment with **infliximab CT-P13**, which is a medication used as part of standard care for these conditions.
  • If suffering from **anal suppuration** (a condition where pus forms near the anus) related to **Crohn's disease**, the patient can still be included.
  • Must have received full information about the research and agreed to participate, including the use of their data.
  • Must be affiliated with or a beneficiary of a social security plan.

Who cannot join the trial?

1 criterion

  • Having an immune bowel disease, such as Crohn's disease or ulcerative colitis. These are conditions where the body's defense system attacks the intestines, causing inflammation and other symptoms.
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Investigated drugs

  • CT-P13 SC

    is a medication administered through a subcutaneous injection. It is being studied to see how well it works and how safe it is for patients with active Crohn's Disease or Ulcerative Colitis. The goal is to determine if this form of the medication is as effective as the intravenous version in terms of how the body absorbs and processes it.

  • CT-P13 IV

    is the intravenous form of the same medication, used as a comparison in the study. It is already known for its use in treating Crohn's Disease and Ulcerative Colitis, and the study aims to compare its effectiveness and safety with the subcutaneous version.

What is already known about the treatment

CT-P13 – This medication is administered either subcutaneously (SC) or intravenously (IV) and is currently being studied for its effectiveness and safety in treating active Crohn's disease and ulcerative colitis, which are types of immune bowel diseases. CT-P13 is a biosimilar to infliximab, a monoclonal antibody that targets and neutralizes tumor necrosis factor-alpha (TNF-alpha), a substance in the body that causes inflammation. It is classified as an immunosuppressant and is used to reduce inflammation and manage symptoms in patients with these conditions. The clinical trial aims to show that the subcutaneous form is as effective as the intravenous form in terms of how the body absorbs and processes the medication.

Investigated diseases

  • Crohn's Disease

    A chronic inflammatory condition of the gastrointestinal tract, Crohn's disease can affect any part from the mouth to the anus, but most commonly impacts the end of the small intestine and the beginning of the colon. The inflammation can penetrate deep into the layers of the bowel tissue, leading to symptoms such as abdominal pain, severe diarrhea, fatigue, weight loss, and malnutrition. The disease often progresses with periods of flare-ups and remission, where symptoms may subside or disappear. Over time, the inflammation can cause complications like strictures or fistulas. The exact cause is unknown, but it involves an abnormal immune response to intestinal bacteria in genetically susceptible individuals.

  • Ulcerative Colitis

    This is a chronic inflammatory condition that specifically affects the colon and rectum. The inflammation is usually limited to the innermost lining of the colon and rectum, leading to symptoms such as persistent diarrhea, abdominal pain, and rectal bleeding. The disease typically begins in the rectum and may extend continuously to involve the entire colon. It progresses with alternating periods of exacerbation and remission. The cause is not fully understood, but it is believed to involve an inappropriate immune response to the gut flora in genetically predisposed individuals.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508584-72-00Protocol code2023/12Estimated enrolment130 patientsSponsorCentre Medico Chirurgical Ambroise Pare Hartmann

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