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Study on Nipocalimab and Certolizumab for Patients with Active Rheumatoid Arthritis After Advanced Therapy

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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 therapy for people with Rheumatoid Arthritis, a condition that causes pain and swelling in the joints. The study will test a new treatment using two medications: Nipocalimab and Certolizumab. Nipocalimab, also known by its code name JNJ-80202135, is given as a solution for infusion, which means it is administered directly into the bloodstream. Certolizumab, marketed as Cimzia, is given as an injection under the skin.

The purpose of the study is to evaluate how effective the combination of Nipocalimab and Certolizumab is compared to using Certolizumab alone in people who have active Rheumatoid Arthritis despite previous treatments. Participants will be randomly assigned to receive either the combination therapy or Certolizumab alone. The study will be conducted in a double-blind manner, meaning neither the participants nor the researchers will know who is receiving which treatment, to ensure unbiased results.

Participants will be monitored over a period of time to assess changes in their condition, specifically looking at improvements in joint swelling and tenderness. The study aims to provide insights into whether the combination therapy can offer better outcomes for those with moderate to severe Rheumatoid Arthritis who have not responded well to other advanced therapies. The trial will help determine the safety and effectiveness of this new treatment approach.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, medical stability, and a diagnosis of rheumatoid arthritis (RA) according to specific criteria.
The assessment checks for moderate to severe active RA, characterized by a certain number of swollen and tender joints, and confirms positivity for specific antibodies.
Step 2
Baseline measurements
Baseline measurements are taken to establish a starting point for the study. This includes recording the Disease Activity Score (DAS28-CRP), which measures RA activity.
Step 3
Treatment phase
Participants receive a combination therapy of nipocalimab and certolizumab or certolizumab alone. Nipocalimab is administered intravenously, while certolizumab is given as a subcutaneous injection.
The treatment aims to evaluate the effectiveness of the combination therapy compared to certolizumab alone over a period of 12 weeks.
Step 4
Follow-up assessments
Regular follow-up assessments are conducted to monitor the participant's response to the treatment. These assessments include measuring changes in the DAS28-CRP score.
The primary endpoint is the change in DAS28-CRP from baseline at week 12.
Step 5
End of study
The study concludes with a final assessment to evaluate the overall effectiveness and safety of the treatment.
Participants are provided with information on their health status and any necessary follow-up care.

Who can join the trial?

5 criteria

Participants must be between 18 and 75 years old.
Participants should be in a medically stable condition based on lab tests done during the screening process.
Participants must have been diagnosed with Rheumatoid Arthritis (RA) and meet specific criteria set by medical organizations for at least 12 weeks before the screening.
Participants should have moderate to severe active RA, which means they have ongoing symptoms with at least 6 swollen joints and 6 tender joints at the time of screening and at the start of the study.
Participants need to test positive for ACPA (anti-citrullinated protein antibodies) or RF (rheumatoid factor) in a lab test at the time of screening. These are specific markers in the blood that help confirm the presence of RA.

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 similar medications.
Patients who are currently participating in another clinical trial.
Patients who have a history of drug or alcohol abuse.
Patients who have received certain vaccines recently.
Patients who have a history of cancer, except for some types of skin cancer.
Patients who have a history of certain blood disorders.
Patients who have had a recent surgery or are planning to have surgery during the study.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH
Verified
Hamburg, Germany
Vasarhelyi Sarkanyfu Kft.
Verified
Hodmezovasarhely, Hungary
Vital Medical Center
Verified
Veszprem, Hungary

Trial locations

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Investigated drugs

Nipocalimab
is a medication being studied for its potential to help people with rheumatoid arthritis, a condition that causes pain and swelling in the joints. It is being tested to see if it can work together with another medication to improve symptoms in patients who have not had enough relief from other advanced treatments.
Certolizumab
is a medication already used to treat rheumatoid arthritis. It helps reduce inflammation and pain in the joints. In this study, it is being used both alone and in combination with another medication to see if the combination can provide better results for patients who have not responded well to other treatments.

Sulfasalazine

What is already known about the treatment

Nipocalimab
This medication is administered intravenously and is currently being studied in clinical trials for its potential use in treating rheumatoid arthritis. It is not yet widely used in medical practice, as it is still under investigation. Nipocalimab works by targeting and modulating the immune system to reduce inflammation, which is a key factor in rheumatoid arthritis. It is classified as an immunomodulatory agent.
Certolizumab
This medication is administered via subcutaneous injection and is already approved for use in treating rheumatoid arthritis. It is well-documented in medical literature and is used to help manage symptoms of this condition. Certolizumab works by blocking a specific protein in the body that causes inflammation, thereby reducing pain and swelling. It is classified as a tumor necrosis factor (TNF) inhibitor.

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 hands and feet, and can progress to larger joints. Symptoms typically include joint pain, swelling, and stiffness, particularly in the morning or after periods of inactivity. As the disease progresses, it can lead to joint deformity and loss of function.