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Study of Tocilizumab Subcutaneous Injection to Evaluate Bone Healing in Adult 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 focuses on patients with rheumatoid arthritis, a condition that causes inflammation in joints and can lead to bone damage. The research examines how tocilizumab, given as an injection under the skin, affects bone erosions (areas where bone has been damaged by the disease) over a 12-month period.

The medication being studied is RoActemra, which contains tocilizumab and comes in the form of a solution for injection in pre-filled syringes. Each injection contains 162 mg of the medicine, which is administered through subcutaneous injection (under the skin). The purpose of this study is to evaluate how bone erosions change in size and depth when patients are treated with this medication.

During the study, detailed images of the bones in patients' hands will be taken using special scanning techniques to measure changes in bone damage. The study will also look at other effects of the treatment, including changes in bone density and structure, as well as how well the treatment controls the symptoms of rheumatoid arthritis.

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 treatment start

    You will receive tocilizumab (RoActemra) as a solution for injection under the skin (subcutaneous injection)

    The medication will be administered using a pre-filled syringe containing 162 mg of the drug

    Treatment can be given alone or combined with other medications for rheumatoid arthritis

  2. Step 2

    Bone scanning procedures

    Your joints will be examined using a special high-resolution scanner (HR-pQCT) that takes detailed pictures of your bones

    The scan will focus on specific joints in your hands, particularly the second and third knuckles

    Additional bone density scan (DXA) will be performed to check your spine and hip bones

  3. Step 3

    Regular assessments

    Your joint activity and symptoms will be monitored using various assessment tools

    Ultrasound examinations will be performed to check joint inflammation

    Additional scan of the leg bone (tibia) will be conducted to examine bone structure

  4. Step 4

    Treatment duration

    The treatment and monitoring period will continue for 12 months

    The main focus will be tracking changes in bone damage (erosions) throughout the treatment period

    Regular check-ups will assess how well the treatment is working

  5. Step 5

    Final evaluation

    After 12 months, final scans will be performed to measure changes in bone erosions

    Bone density and structure measurements will be compared to initial readings

    Overall treatment response will be evaluated

Who can join the trial?

7 criteria

  • Must have active rheumatoid arthritis diagnosed within the last 10 years according to established medical criteria
  • Must have a DAS 28 score above 3.2 (DAS 28 is a measure of disease activity that considers joint tenderness and swelling) despite current treatment with standard medications
  • Must have at least one bone erosion (damage) visible on X-rays of the second or third knuckle joints of either hand
  • If taking oral corticosteroids (like prednisone), the dose must be 10 mg or less per day and must have been stable for at least one month
  • Must be eligible for treatment with tocilizumab (a medication that reduces inflammation) either alone or in combination with other arthritis medications
  • Must be at least 18 years old
  • Both men and women can participate

Who cannot join the trial?

14 criteria

  • Active infections or history of serious infections in the past 6 months
  • History of tuberculosis or positive TB test
  • Presence of any other autoimmune diseases (conditions where the immune system attacks the body)
  • Active liver disease or significant liver function test abnormalities
  • Significant heart conditions including heart failure or uncontrolled high blood pressure
  • History of cancer within the past 5 years
  • Currently pregnant or breastfeeding women
  • Treatment with other biological medications (specialized drugs that target the immune system) within the past 3 months
  • History of allergic reactions to similar medications
  • Participation in other clinical trials within the past 30 days
  • Severe kidney disease requiring dialysis
  • Uncontrolled diabetes (high blood sugar levels)
  • Active substance abuse or mental health conditions that could interfere with the study
  • Unable to follow study procedures or attend regular visits
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Investigated drugs

Tocilizumab is a medication used to treat rheumatoid arthritis, a condition where the immune system attacks the joints. This medication works by blocking a protein in the body that causes inflammation. It helps reduce joint pain, swelling, and damage to the bones. The medication is given as an injection under the skin (subcutaneous injection). It helps slow down the progression of joint damage and can improve daily activities for people with rheumatoid arthritis. HR-pQCT (High-Resolution peripheral Quantitative Computed Tomography) is an imaging technique used in this study to measure bone damage. While this is not a medication, it is an important part of the trial as it helps doctors see detailed images of the bones and measure how the treatment affects bone healing.

What is already known about the treatment

Tocilizumab - A biologic medication administered through subcutaneous injection that belongs to the class of monoclonal antibodies used primarily in the treatment of rheumatoid arthritis. It works by blocking interleukin-6 (IL-6) receptors, thereby reducing inflammation and preventing joint damage in patients with rheumatoid arthritis. The medication has shown significant effectiveness in clinical trials for managing moderate to severe rheumatoid arthritis, particularly in cases where other treatments have failed, and is notable for its ability to potentially help repair bone erosions that occur as a result of the disease.

Investigated diseases

Rheumatoid Arthritis - A chronic inflammatory disease that primarily affects the joints throughout the body. The condition causes the immune system to mistakenly attack the joint linings, leading to inflammation, swelling, and pain. Over time, this ongoing inflammation can cause damage to the joint tissue and bones, resulting in joint deformity and reduced mobility. The disease typically affects multiple joints symmetrically, meaning if one hand is affected, the other hand is usually affected as well. Rheumatoid arthritis often begins gradually, with symptoms developing over weeks or months, and tends to affect smaller joints first, such as those in the fingers and toes. The condition can also cause fatigue, general weakness, and occasional fever.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-517686-17-01Protocol codeCHRO-2014-03Estimated enrolment60 patientsSponsorCentre Hospitalier Universitaire D Orleans

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