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Testing the Safety of Combining Tocilizumab with Other Biologic Drugs in Patients with Rheumatoid Arthritis or Psoriatic 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 clinical trial is studying two conditions called Rheumatoid Arthritis and Psoriatic Arthritis. These are long-term conditions where the body's immune system mistakenly attacks the joints, causing pain, swelling, and stiffness. The treatment being tested involves combining two types of biologic drugs that work in different ways to control inflammation. Patients in the study will continue taking their current Tumour Necrosis Factor inhibitor medication, which is a type of biologic drug that blocks a protein in the body that causes inflammation. To this existing treatment, a second medication called tocilizumab will be added. Tocilizumab is given as an injection under the skin using a pre-filled pen and works by blocking a different protein called interleukin-6 that also contributes to inflammation and joint damage.

The purpose of this study is to find out whether combining these two different biologic medications is safe and whether it works better at controlling disease activity than current treatments alone. The study will specifically measure how many patients achieve remission, which means their disease becomes much less active or shows minimal signs of inflammation. The researchers want to test whether blocking two different inflammation pathways at the same time can help more patients reach this state of very low disease activity.

During the study, patients will receive the combination treatment for a period of time while their disease activity is regularly monitored. The main assessment will take place at week 24 to see how well the combination therapy has worked. Throughout the study, doctors will also carefully watch for any side effects or safety concerns that might occur when using these two medications together. The study will collect information about how well patients tolerate the combination treatment and whether their symptoms improve according to standard measurement tools used to assess arthritis activity.

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

    Treatment phase with combination therapy

    During this phase, your current treatment with a TNF inhibitor (a type of biologic drug that blocks a protein called tumor necrosis factor, which causes inflammation) will be continued.

    In addition to your existing treatment, tocilizumab will be added to your therapy regimen. Tocilizumab is administered as a subcutaneous injection (an injection given under the skin) using a pre-filled pen containing 162 mg of the medication.

    This combination treatment phase will continue for 24 weeks.

    The purpose of adding tocilizumab is to block another protein called interleukin-6, which also contributes to inflammation in your joints.

  2. Step 2

    Disease activity assessments

    Throughout the study, your disease activity will be regularly monitored using specific measurement tools.

    If you have rheumatoid arthritis, your disease activity will be measured using the Clinical Disease Activity Index (CDAI), which assesses the number of swollen and tender joints, along with your overall assessment and your doctor's assessment of disease activity.

    If you have psoriatic arthritis, your disease activity will be measured using the Disease Activity in Psoriatic Arthritis (DAPSA) score, which evaluates joint tenderness, joint swelling, and your overall well-being.

    These assessments will help determine whether the combination treatment is effective in reducing your disease activity.

  3. Step 3

    Primary outcome evaluation at week 24

    At the end of week 24, your disease activity will be evaluated to determine if you have achieved remission (a state where disease activity is minimal or absent).

    For rheumatoid arthritis, remission is defined as a CDAI score of 2.8 or lower.

    For psoriatic arthritis, remission is defined as a DAPSA score of less than 4.

    This evaluation represents the main goal of the study and will help determine whether the combination therapy is effective.

  4. Step 4

    Safety monitoring

    Throughout the entire study period, your safety will be monitored continuously.

    Any side effects or adverse reactions related to the combination of medications will be recorded and assessed.

    This monitoring will provide important information about the safety and tolerability of combining these two types of biologic drugs.

Who can join the trial?

5 criteria

  • You must be an adult, 18 years old or older, with no maximum age limit
  • You must have a confirmed diagnosis of either Rheumatoid Arthritis (a condition where your immune system attacks your joints causing pain and swelling) or Psoriatic Arthritis (joint inflammation that occurs in some people with psoriasis, a skin condition), according to specific classification criteria used by doctors
  • You must currently be receiving treatment with an approved TNF inhibitor (a type of medicine that blocks a protein in your body that causes inflammation)
  • You must have active arthritis, which means your disease is currently causing symptoms. This is measured by: if you have Rheumatoid Arthritis, your DAS28 score (a measurement system doctors use to assess disease activity) must be greater than 3.2, or if you have Psoriatic Arthritis, your DAPSA score (another measurement system for disease activity) must be greater than 14
  • You must be willing and able to sign an informed consent form, which is a document showing you understand the study and agree to participate

Who cannot join the trial?

1 criterion

  • The study does not list specific exclusion criteria, which means the reasons why patients cannot participate have not been provided in the available information.
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Investigated drugs

  • Clinical Disease Activity Index (CDAI)

    is a scoring system used to measure how active rheumatoid arthritis is in a patient. It helps doctors understand how well the disease is being controlled during the trial.

  • Disease Activity in Psoriatic Arthritis (DAPSA)

    is a scoring system used to measure how active psoriatic arthritis is in a patient. It helps doctors assess the severity of the disease and whether treatment is working.

What is already known about the treatment

I apologize, but I cannot complete this task as requested. The source data provided does not contain any specific medication trade names or information about particular drugs being studied in this clinical trial. The trial data only includes information about the medical conditions being studied (Rheumatoid Arthritis and Psoriatic Arthritis) and the trial's objective, but does not specify which medications are being tested. To create the medication descriptions in the requested format, I would need the actual names of the medications or investigational products being used in this clinical trial. Without this essential information, I cannot provide accurate descriptions of medication forms, administration methods, mechanisms of action, or pharmacological classifications. If you can provide the specific medication names from this trial, I would be happy to create the descriptions in the format you requested.

Investigated diseases

  • Rheumatoid Arthritis

    Rheumatoid arthritis is a long-term condition where the body's immune system mistakenly attacks the joints, causing inflammation. It typically affects multiple joints on both sides of the body, especially in the hands, wrists, and knees. The joints become swollen, stiff, and painful, particularly in the morning or after periods of rest. Over time, the inflammation can damage the joint tissues, cartilage, and bone. The disease progresses in episodes called flares, where symptoms worsen, followed by periods of reduced symptoms. It can also affect other parts of the body, including the skin, eyes, lungs, and blood vessels.

  • Psoriatic Arthritis

    Psoriatic arthritis is a form of joint inflammation that occurs in some people who have psoriasis, a skin condition that causes red, scaly patches. The condition causes pain, swelling, and stiffness in the joints, which can affect any part of the body including fingertips and spine. Symptoms can range from mild to severe and may affect one or multiple joints. The disease often develops gradually, but it can also appear suddenly with acute symptoms. Joint stiffness is typically worse in the morning or after rest. The condition can cause permanent changes to the joints if inflammation continues over time.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-518011-19-01Protocol codeSPON 2002-24Estimated enrolment40 patientsSponsorCardiff University

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