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Study on Baricitinib and Anti-TNF Drug Combination for Patients with 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 combination treatment for patients with rheumatoid arthritis, a chronic inflammatory disorder that primarily affects the joints. The study will evaluate the effectiveness of combining two types of medications: baricitinib, which is taken as a 4 mg tablet daily, and anti-TNF therapies, which include adalimumab (40 mg injection every two weeks) or etanercept (50 mg injection every week). These medications are being compared to the use of baricitinib alone. Anti-TNF therapies are a class of drugs that help reduce inflammation by blocking a protein called tumor necrosis factor (TNF) that is involved in the inflammatory process.

The purpose of the study is to assess how well the combination of these treatments works over a period of 24 weeks in patients whose rheumatoid arthritis has not responded adequately to previous treatments. Participants will be randomly assigned to receive either the combination of baricitinib and an anti-TNF therapy or baricitinib alone. Some participants may receive a placebo, which is a substance with no active medication, to help compare the effects of the actual treatments. The study will monitor the participants' response to the treatment, including any changes in their symptoms and overall health.

Throughout the study, participants will have regular check-ups to track their progress and any side effects they may experience. The study aims to provide valuable information on whether the combination of baricitinib and anti-TNF therapies offers better outcomes for patients with rheumatoid arthritis compared to using baricitinib alone. This research could potentially lead to improved treatment options for those living with this condition.

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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, diagnosis of rheumatoid arthritis, and previous treatment responses.

    The assessment ensures that the patient meets the criteria, such as having an active form of rheumatoid arthritis and being treated with prednisone at a dosage of 10 mg per day or less.

  2. Step 2

    Baseline visit

    During the baseline visit, the patient's current health status is documented. This includes measuring disease activity using specific scores like DAS28-ESR.

    The dosage of prednisone is adjusted to 7.5 mg per day at the start of the study.

  3. Step 3

    Treatment initiation

    Patients are randomly assigned to one of two treatment groups: the combination group or the monotherapy group.

    In the combination group, patients receive adalimumab (40 mg every two weeks) or etanercept (50 mg every week) along with baricitinib (4 mg daily).

    In the monotherapy group, patients receive baricitinib (4 mg daily) alone.

  4. Step 4

    Follow-up visits

    Follow-up visits occur at weeks 4, 12, and 24 to monitor progress and adjust treatment if necessary.

    During these visits, the effectiveness of the treatment is evaluated using response criteria such as ACR20, ACR50, and ACR70, which measure improvement in symptoms.

  5. Step 5

    Primary evaluation

    At week 24, the primary evaluation is conducted to determine the proportion of patients achieving an ACR50 response, indicating a 50% improvement in symptoms.

    The evaluation compares the outcomes between the combination and monotherapy groups.

  6. Step 6

    Extended monitoring

    Patients continue to be monitored until week 52 to assess long-term effects and sustainability of treatment benefits.

    Additional evaluations include changes in disease activity scores and patient-reported outcomes.

Who can join the trial?

7 criteria

  • Age between 18 and 65 years old
  • Adult patient with a diagnosis of rheumatoid arthritis (RA) as defined by specific criteria from medical organizations
  • Patient who has not responded well to at least one type of medication for RA for at least 12 weeks before joining the study
  • Patient with active RA, which means their condition is currently causing symptoms and is eligible for certain medications according to guidelines
  • Patient taking a medication called prednisone at a dose of 10 mg or less per day. This dose will be reduced to 7.5 mg per day at the start of the study
  • Person must be part of or have benefits from the French social security system
  • Must provide free, informed, and written consent, signed by both the participant and the investigator, before any study-related procedures

Who cannot join the trial?

10 criteria

  • Patients who have any other serious health conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have had a recent infection that required treatment with antibiotics.
  • Patients who have a history of allergic reactions to the study medications.
  • Patients who are currently participating in another clinical trial.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have been vaccinated with a live vaccine within the last 4 weeks.
  • Patients who have a history of cancer, except for certain types of skin cancer.
  • Patients who have a history of blood disorders.
  • Patients who have a history of heart problems.
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Investigated drugs

  • Baricitinib

    is a medication used to treat rheumatoid arthritis. It works by reducing inflammation and slowing down the progression of the disease. In this trial, it is being tested both on its own and in combination with other treatments to see how effective it is in managing symptoms of rheumatoid arthritis.

  • Adalimumab

    is a type of anti-TNF therapy. It helps reduce inflammation by blocking a protein in the body that causes inflammation. In this trial, it is being used in combination with baricitinib to see if the combination is more effective than baricitinib alone in treating rheumatoid arthritis.

  • Etanercept

    is another anti-TNF therapy used to treat rheumatoid arthritis. Like adalimumab, it works by blocking the protein that causes inflammation. This trial is testing whether using etanercept with baricitinib provides better results for patients with rheumatoid arthritis compared to using baricitinib alone.

What is already known about the treatment

  • Baricitinib

    This medication is taken orally in the form of a tablet. It is currently used in the treatment of rheumatoid arthritis and is well-documented in medical literature. Baricitinib is primarily indicated for patients with rheumatoid arthritis who have not responded well to other treatments. It works by inhibiting specific enzymes known as Janus kinases, which play a role in the inflammation process. Baricitinib is classified as a Janus kinase inhibitor.

  • Adalimumab

    Administered via subcutaneous injection, adalimumab is a well-established medication in the treatment of rheumatoid arthritis. It is used to reduce inflammation and slow the progression of the disease. Adalimumab functions by blocking a protein called tumor necrosis factor (TNF), which is involved in inflammatory responses. It belongs to the class of medications known as TNF inhibitors.

  • Etanercept

    This medication is also administered through subcutaneous injection and is widely used in managing rheumatoid arthritis. Etanercept helps alleviate symptoms by targeting and neutralizing tumor necrosis factor (TNF), a substance in the body that leads to inflammation. It is classified as a TNF inhibitor and is a common choice for patients with rheumatoid arthritis.

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 small joints of 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 is believed to involve a combination of genetic and environmental factors.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511442-39-00Protocol codeCHUBX 2019/56Estimated enrolment178 patientsSponsorCentre Hospitalier Universitaire De Bordeaux

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