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Baricitinib Compared with Adalimumab and Etanercept in Patients with Rheumatoid Arthritis

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 study is being done in Rheumatoid Arthritis, a long-term disease that causes swelling, pain, and stiffness in the joints. It is comparing baricitinib, a tablet taken by mouth, with two other medicines used for this disease: adalimumab and etanercept, which are given as injections. The purpose of the study is to compare the risk of Venous Thromboembolism, which means a blood clot in a vein, in people treated with these medicines.

In the study, treatment is given over a long period of time, and people are followed while they receive one of the study medicines. The study looks at how often a blood clot in a vein happens after treatment starts. The medicines being studied are baricitinib, adalimumab, and etanercept.

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

    Study treatment start

    After joining the study, you start study treatment for rheumatoid arthritis.

    The study compares baricitinib with tnf inhibitors. tnf inhibitors are a group of medicines used to reduce inflammation.

    The study treatment options listed are baricitinib 4 mg taken by mouth, adalimumab 80 mg given as an injection, and etanercept 50 mg given as an injection.

  2. Step 2

    Treatment period

    You continue taking the assigned study medicine during the treatment period.

    Baricitinib is given as 4 mg by oral use, which means it is taken by mouth.

    Adalimumab is given as 80 mg by solution for injection, which means it is administered as an injection.

    Etanercept is given as 50 mg by solution for injection, which means it is administered as an injection.

    The primary assessment period for the study runs from the first dose of study treatment until the end of the study, which is expected to be about 5.5 years.

  3. Step 3

    Study follow-up and outcome assessment

    During the study, the main outcome is checked by measuring the time from the first dose of study treatment to the first venous thromboembolism event.

    Venous thromboembolism, often shortened to vte, means a blood clot in a vein.

    The study follows this outcome from baseline through study completion, which is planned to take approximately 5.5 years.

  4. Step 4

    Study completion

    Your participation ends when the study is completed.

    The planned study end date is 2026-02-01.

Who can join the trial?

7 criteria

  • Have rheumatoid arthritis and be a patient in the study group.
  • Have at least one of the following:
    • Medical records showing a blood clot in a vein before this study. A venous thromboembolism, or VTE, means a blood clot that forms in a vein.
    • Be 60 years of age or older.
    • Have a body mass index (BMI, a number based on height and weight) of 30 kg/m² or higher.
    • Be 50 to less than 60 years old and have a BMI of 25 to less than 30 kg/m².
    • Have had an inadequate response to at least one disease-modifying antirheumatic drug (DMARD, a medicine that helps control arthritis), or be intolerant to it, meaning the person could not take it because of side effects or other problems.
    • The DMARD used before may have been a synthetic DMARD, which is a man-made medicine, or a biologic DMARD, which is made from living cells.

Who cannot join the trial?

11 criteria

  • Any reason that makes a person not suitable for taking a TNF inhibitor (a medicine that lowers inflammation by blocking tumor necrosis factor, a body chemical involved in swelling and pain).
  • Pregnancy or breastfeeding.
  • Having had more than one VTE (venous thromboembolism, a blood clot in a vein).
  • Having cancer.
  • Having active herpes zoster (shingles, a painful rash caused by a virus).
  • Having a serious infection.
  • Having active tuberculosis (TB, a serious lung infection).
  • Having any other serious illness.
  • Having received a live vaccine within 4 weeks before the study starts. A live vaccine contains a small amount of weakened germ.
  • Having taken part in any other clinical trial within 4 weeks before the study starts.
  • Having a history in the past year of IV drug use (drug use by injection into a vein), illicit drug abuse (illegal drug misuse), or chronic alcohol abuse (ongoing heavy alcohol use).
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Investigated drugs

  • Baricitinib

    is an oral medicine taken by mouth. In this trial, it is the main study treatment being compared with other arthritis medicines to see how well it works and how safe it is, especially for the risk of blood clots in the veins.

  • Adalimumab

    is a medicine given by injection under the skin. It is used as a comparison treatment in the trial so researchers can see how baricitinib compares with a standard TNF inhibitor used for rheumatoid arthritis.

  • Etanercept

    is also given by injection under the skin. It is another comparison treatment in the study and helps researchers evaluate baricitinib against commonly used TNF inhibitor treatments for rheumatoid arthritis.

What is already known about the treatment

  • Adalimumab

    Adalimumab is a medicine given by injection under the skin, usually by a prefilled syringe or pen, and it is used as a treatment given on a regular schedule. It is a well-known and widely used biologic medicine in modern medical practice and medical literature, especially for long-term control of immune-related diseases. It is mainly used for rheumatoid arthritis and other inflammatory conditions, and it works by blocking tumor necrosis factor alpha (TNF-alpha), a natural body signal that drives swelling and joint damage. This places it in the group of TNF blockers, which are biological medicines that calm an overactive immune response.

  • Baricitinib

    Baricitinib is a tablet taken by mouth, so it is swallowed with water as an oral medicine. It is an established medicine in current medical use and has been studied widely in medical literature for immune-related diseases. It is mainly used for rheumatoid arthritis and some other inflammatory conditions, and it works by blocking enzymes called Janus kinases, or JAKs, which help pass along inflammation signals inside cells. This medicine belongs to the group of JAK inhibitors, which are targeted anti-inflammatory medicines.

  • Etanercept

    Etanercept is given by injection under the skin, usually with a prefilled syringe or autoinjector, and it is used on a regular dosing schedule. It is a well-established biologic medicine in current medicine and is well described in medical literature, especially for long-term treatment of inflammatory diseases. It is mainly used for rheumatoid arthritis and other conditions caused by an overactive immune system, and it works by binding to TNF-alpha so that this inflammation signal cannot act on the body. It is classified as a TNF blocker and is considered a biologic anti-inflammatory medicine.

Investigated diseases

Rheumatoid Arthritis - Rheumatoid arthritis is a long-lasting disease in which the immune system wrongly attacks the lining of the joints. It usually causes joint pain, swelling, stiffness, and reduced movement, often affecting the hands, wrists, and feet. The disease may begin gradually or more suddenly. Over time, it can affect more joints and lead to ongoing joint damage and deformity. Symptoms often come and go in periods of flare and relief.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508022-10-00Protocol codeI4V-MC-JAJAEstimated enrolment2 167 patientsSponsorEli Lilly & Co.

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