Katholieke Universiteit te Leuven
Leuven, Belgium
Not recruiting
Study on Secukinumab and Prednisone for Patients with Polymyalgia Rheumatica Who Have Recently Relapsed
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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 a condition called Polymyalgia Rheumatica (PMR), which is a disorder that causes muscle pain and stiffness, especially in the shoulders. The study is testing a treatment using a medication called Secukinumab, also known by its code name AIN457. Secukinumab is given as an injection under the skin. The trial also involves a medication called Prednisone, which is a type of glucocorticoid, a drug that helps reduce inflammation and suppress the immune system. Participants in the study will receive either Secukinumab or a placebo, along with a tapering dose of Prednisone over a period of 24 weeks.
The purpose of the study is to determine if Secukinumab, when combined with a glucocorticoid taper regimen, is more effective than a placebo in helping patients with PMR achieve sustained remission, which means the symptoms of the disease are reduced or disappear for a period of time. The study will last for up to 52 weeks, during which participants will be monitored to see how well they respond to the treatment. The trial is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo, to ensure unbiased results.
Throughout the study, participants will have regular check-ups to assess their health and the effectiveness of the treatment. The main goal is to see how many participants achieve sustained remission by the end of the study. Additionally, the study will look at the overall safety and tolerability of the treatment, including any side effects that may occur. This research aims to provide valuable information on the potential benefits of Secukinumab for people with Polymyalgia Rheumatica.
The research process
The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
11 criteria
- You must provide written informed consent, which means you agree to take part in the study after understanding all the details.
- You must be male or a female who is not currently pregnant or breastfeeding.
- You must be at least 50 years old.
- You must have been diagnosed with Polymyalgia Rheumatica (PMR), a condition that causes muscle pain and stiffness.
- Your diagnosis must be confirmed by specific medical signs, including pain in both shoulders and high levels of certain markers in your blood, such as C-reactive protein (CRP) or erythrocyte sedimentation rate (ESR), which are tests used to measure inflammation (swelling and irritation) in the body.
- You may also need to show signs like morning stiffness lasting more than 45 minutes, hip pain, or specific blood test results that rule out other conditions.
- You must have previously taken prednisone (a type of glucocorticoid, which is a medicine used to reduce inflammation) at a dose of at least 10 mg per day for at least 8 weeks in a row.
- You must have experienced a relapse, which means your symptoms returned, within the last 12 weeks while you were trying to lower your dose of prednisone.
- A relapse is defined as the return of pain and stiffness in both shoulders and/or hips that the doctor determines is caused by your condition and not by other issues like osteoarthritis (wear and tear of the joints) or fibromyalgia (a condition causing widespread muscle pain).
- At the time you enter the study, you must be taking a dose of prednisone between 7.5 mg and 25 mg per day.
- The doctor must agree that a dose of 10 mg or 15 mg of prednisone is medically appropriate for you at the start of the study.
Who cannot join the trial?
9 criteria
- People who have or have had Giant Cell Arteritis (GCA), which is a condition involving inflammation of the lining of the arteries, especially those in the head. Symptoms may include constant headaches, pain in the scalp or temples, jaw pain when chewing, vision problems, or signs of a stroke.
- People with rheumatoid arthritis or other types of inflammatory arthritis (joint swelling and pain caused by the immune system).
- People with connective tissue diseases, which are disorders where the body's immune system attacks its own tissues; examples include systemic lupus erythematosus, systemic sclerosis, vasculitis (inflammation of blood vessels), myositis (muscle inflammation), mixed connective tissue disease, or ankylosing spondylitis (a type of arthritis affecting the spine).
- People with neuropathic muscular diseases (conditions affecting the nerves and muscles) or fibromyalgia (a condition causing widespread muscle pain and tenderness).
- People with hypothyroidism that is not being managed well, such as when symptoms continue or TSH (a hormone that tells the body how much thyroid hormone to make) levels do not return to normal despite taking medicine.
- People who have previously used secukinumab or other biologic drugs (medicines made from living organisms) that specifically target IL-17 (a protein in the immune system that causes inflammation) or its receptor.
- People who have used tocilizumab or other IL-6 inhibitors (medicines that block a specific inflammatory protein called IL-6) within the last 12 weeks or a specific period based on how long the drug stays in the body. This also excludes those who did not respond to or had a relapse while taking these medicines.
- People with a history of hypersensitivity (an allergic reaction) or any reason why they should not take the study medicines or their excipients (inactive ingredients used to make the medicine).
- People who have had a major ischemic event, such as a myocardial infarction (heart attack) or a stroke (interruption of blood flow to the brain), or a transient ischemic attack (TIA) (a temporary period of symptoms similar to a stroke) within the last 12 weeks.
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Investigated drugs
Secukinumab
is the main medication being tested in this study. It is given as an injection under the skin to see how well it works in treating the symptoms of polymyalgia rheumatica.
Prednisone
is a type of steroid medication that is taken by mouth. In this trial, it is used as a background treatment that is gradually reduced over time to help manage the condition.
What is already known about the treatment
Prednisone
This medication is taken by mouth as a pill and is widely used in medicine to manage various inflammatory conditions. It belongs to a class of drugs called corticosteroids, which work by reducing swelling and calming an overactive immune system. In this study, it is used as a background treatment to help control inflammation in patients with polymyalgia rheumatica.
Secukinumab
This is an injectable medication administered through a needle just under the skin. It is a specialized biological therapy used to treat certain autoimmune diseases by targeting and blocking a specific protein called interleukin-17A that causes inflammation. By neutralizing this protein, the drug helps to reduce the body's inflammatory response and alleviate symptoms.
Investigated diseases
Polymyalgia rheumatica - This condition involves inflammation that primarily affects the muscles around the shoulders and hips. It typically causes stiffness and aching in these areas, especially during the morning hours. The symptoms often develop gradually and can impact the ability to perform daily movements. As the condition progresses, the discomfort and stiffness may fluctuate or persist over time. In some instances, the symptoms may return after an initial period of improvement.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501895-25-00Protocol codeCAIN457C22301Estimated enrolment405 patientsSponsorNovartis Pharma AG
sourced from the EU Clinical Trials Register and site verification
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