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Study Comparing Upadacitinib and Adalimumab for Adults with Moderate to Severe Rheumatoid Arthritis Not Responding to a Single TNF Inhibitor

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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 two medications, Upadacitinib and Adalimumab, in people with Rheumatoid Arthritis. Rheumatoid Arthritis is a condition where the immune system mistakenly attacks the joints, causing pain and swelling. The study aims to compare the effectiveness and safety of these medications in individuals who have not responded well or have had side effects from a previous treatment known as a TNF inhibitor. Participants will continue their usual treatment with a medication called Methotrexate while taking part in the study.

During the study, participants will be randomly assigned to receive either Upadacitinib, Adalimumab, or a placebo. A placebo is a substance with no active medication, used to compare the effects of the actual drugs. The study will last for about 48 weeks, and participants will receive their assigned treatment through injections or tablets. The goal is to see if these medications can help reduce the symptoms of Rheumatoid Arthritis, such as joint pain and swelling, and improve overall well-being.

Throughout the study, participants will have regular check-ups to monitor their health and the effects of the treatment. This will help researchers understand how well the medications work and if they are safe for people with Rheumatoid Arthritis. The study is designed to provide valuable information that could lead to better treatment options for those living with this condition.

The research process

The trial runs in 5 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 history with a TNF inhibitor.

    The assessment also checks the number of swollen and tender joints and measures a specific protein in the blood to confirm active rheumatoid arthritis.

  2. Step 2

    Medication administration

    Participants are randomly assigned to receive either upadacitinib or adalimumab. Upadacitinib is taken orally as a modified-release tablet, while adalimumab is administered as a subcutaneous injection.

    The dosage and frequency of administration are determined by the study protocol, and participants continue their stable background treatment with methotrexate (MTX).

  3. Step 3

    Treatment period

    The treatment period lasts for 12 weeks. During this time, participants continue to take their assigned medication and maintain their MTX therapy.

    Regular monitoring is conducted to assess the effectiveness and safety of the treatment. This includes evaluating joint counts, pain levels, and overall disease activity.

  4. Step 4

    Evaluation of primary endpoint

    At the end of 12 weeks, the primary endpoint is evaluated. This involves measuring the disease activity score to determine if it has reached a specific target level.

    The score is calculated based on joint counts, patient assessments, and blood protein levels.

  5. Step 5

    Evaluation of secondary endpoints

    Secondary endpoints are also assessed at 12 weeks. These include improvements in joint counts, pain levels, and overall physical function.

    Changes from the baseline in these measures are analyzed to determine the effectiveness of the treatment.

Who can join the trial?

5 criteria

  • Adults who are **18 years or older** at the time of screening.
  • Have been diagnosed with **Rheumatoid Arthritis (RA)** for at least **3 months** before screening. This diagnosis is based on specific criteria set by medical organizations.
  • Have been treated for at least **3 consecutive months** with one type of medication called **TNFi** (Tumor Necrosis Factor inhibitor) for RA. This includes medications like certolizumab pegol, etanercept, golimumab, or infliximab. The patient may still have active RA or may have stopped the medication due to side effects or other issues. Up to 15% of patients who couldn't tolerate one TNFi can join the study. Using different versions of the same TNFi is allowed, but switching between different TNFi types is not.
  • Meet specific **disease activity criteria**, which include having at least **6 swollen joints** and **6 tender joints** at screening and baseline. Also, have a **high level of a marker in the blood** called **hsCRP** (high-sensitivity C-reactive protein) of at least **3 mg/L** at screening.
  • Must have been on **Methotrexate (MTX)** therapy, either taken by mouth or by injection, for at least **3 consecutive months**. The dose should be stable between **15 to 25 mg per week** (or at least **10 mg per week** for those who can't tolerate higher doses) for at least **4 weeks** before starting the study medication. Additionally, all participants should take a **dietary supplement** of folic acid or folinic acid during the study.

Who cannot join the trial?

10 criteria

  • Patients who have a history of severe allergic reactions to the study medications.
  • Patients with active infections that require treatment.
  • Patients with a history of certain types of cancer.
  • Patients who are pregnant or breastfeeding.
  • Patients with liver disease or abnormal liver function tests.
  • Patients with a history of heart problems, such as heart attack or heart failure.
  • Patients who have used other investigational drugs within a certain period before the study.
  • Patients with a history of blood disorders.
  • Patients with uncontrolled high blood pressure.
  • Patients with a history of alcohol or drug abuse.
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Investigated drugs

  • Upadacitinib

    is a medication used in this trial to treat adults with moderate to severe rheumatoid arthritis. It works by targeting specific pathways in the immune system to reduce inflammation and pain in the joints. This medication is being tested to see how effective and safe it is for patients who have not responded well to other treatments.

  • Adalimumab

    is another medication involved in the trial, also used for treating moderate to severe rheumatoid arthritis. It helps by blocking a protein in the body that causes inflammation, thereby reducing joint pain and swelling. The trial aims to compare the effectiveness and safety of adalimumab with upadacitinib in patients who have not had success with previous treatments.

  • MTX (Methotrexate)

    is a standard medication that participants in the trial are already taking. It is commonly used to treat rheumatoid arthritis by slowing down the immune system to decrease inflammation and joint damage. In this study, MTX is used as a background treatment to see how well the other medications work in combination with it.

What is already known about the treatment

  • Upadacitinib

    This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating rheumatoid arthritis. It is a Janus kinase (JAK) inhibitor, which works by blocking specific enzymes involved in the inflammatory process, thereby reducing inflammation and pain in the joints. Upadacitinib is classified as a disease-modifying antirheumatic drug (DMARD) and is being compared to other treatments to assess its safety and efficacy.

  • Adalimumab

    This medication is administered via subcutaneous injection and is widely used in the treatment of rheumatoid arthritis. It is a monoclonal antibody that targets and neutralizes tumor necrosis factor-alpha (TNF-alpha), a substance in the body that causes inflammation and joint damage. Adalimumab is classified as a biologic DMARD and has been extensively studied and documented in medical literature for its effectiveness in reducing symptoms and slowing disease progression in rheumatoid arthritis patients.

Investigated diseases

Rheumatoid Arthritis – Rheumatoid arthritis is a chronic inflammatory disorder that primarily affects the joints. It occurs when the immune system mistakenly attacks the body's own tissues, leading to inflammation. Over time, this inflammation can cause damage to the cartilage and bones within the joint. The disease often starts with small joints, such as those in the fingers and toes, and can progress to larger joints like the wrists, knees, and ankles. Symptoms typically include joint pain, swelling, stiffness, and loss of joint function. The progression of rheumatoid arthritis can vary, with periods of increased disease activity, known as flares, and periods of remission.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2022-502578-18-00Protocol codeM23-700Estimated enrolment463 patientsSponsorAbbVie Deutschland GmbH & Co. KG

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