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Efficacy and safety of sarilumab plus prednisone versus prednisone alone in adults with early polymyalgia rheumatica

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study looks at adults with early polymyalgia rheumatica, an inflammatory condition that causes muscle pain and stiffness mainly in the shoulders and hips. The investigational medicine being tested is sarilumab, given as a solution for injection, and it is used together with a gradual reduction (taper) of the steroid prednisone. Participants may receive either the active medicine or a placebo that looks the same but does not contain the active drug.

The aim of the trial is to determine whether the combination of sarilumab and a 52‑week prednisone taper works better than prednisone taper alone in achieving lasting symptom control. Participants are randomly assigned to receive one of two dose levels of the study drug (150 mg or 200 mg) every two weeks, while all continue the steroid taper for one year, and they are followed for the same period to see how they respond.

Throughout the year, researchers check whether participants reach “remission,” meaning they have no significant pain or stiffness, and they record any side effects or laboratory changes. They also track how long remission lasts, whether symptoms return (a “flare”), and how the condition affects physical and mental well‑being using standard questionnaires. Safety is monitored continuously, and any serious problems are reported promptly.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline visit and randomization

    You attend the first study visit after enrollment. during this visit, baseline measurements are taken and you are randomly assigned to receive either sarilumab or a matching placebo. the assignment is unknown to you and the study staff.

    The study medication will be prepared in a pre‑filled syringe for subcutaneous injection.

  2. Step 2

    Start of study medication and prednisone

    On day 1 you receive the first sarilumab injection (200 mg) administered under the skin. if you are assigned to the placebo group, you receive an injection that looks identical but contains no active drug.

    You also begin taking prednisone tablets (15 mg) by mouth once daily. the prednisone dose will be reduced gradually over the next 52 weeks according to a taper schedule provided by the study team.

  3. Step 3

    Regular subcutaneous injections

    Every two weeks you return to the clinic for a follow‑up visit during which a new injection of sarilumab (200 mg) or placebo is given. the injection schedule continues for a total of 52 weeks.

    Each visit includes a brief physical check, review of any side effects, and collection of blood samples for safety monitoring.

  4. Step 4

    Prednisone taper

    You continue taking the prednisone tablet each day, but the dose is lowered stepwise over the 52‑week period. the exact reduction schedule is individualized but follows a gradual decrease to reach a dose of zero by the end of week 52.

    The taper is intended to assess whether disease control can be maintained with reduced steroid use.

  5. Step 5

    Interim assessments

    In addition to the bi‑weekly injection visits, you have scheduled study visits at weeks 4, 8, 12, 24, and 36. during these visits, the study team records disease activity, asks you to complete questionnaires about symptoms and quality of life, and performs laboratory tests.

    These assessments help determine whether you achieve remission and monitor safety.

  6. Step 6

    Final assessment and study completion

    At week 52 you attend the final study visit. the last sarilumab or placebo injection is given, and the prednisone taper is completed, aiming for a dose‑free state.

    Comprehensive evaluations are performed to determine if sustained remission has been achieved, and all safety data are collected before the study ends.

Who can join the trial?

4 criteria

  • You must be an adult older than 50 years and have a condition called polymyalgia rheumatica (a disease that causes muscle pain and stiffness) that meets the official EULAR/ACR classification criteria (a set of guidelines doctors use to confirm the diagnosis).
  • You must either be newly diagnosed with PMR (you have taken corticosteroid medicines for less than 6 weeks before joining the study) or have early relapsing PMR (you started corticosteroid treatment within the past year, have been on prednisone at a dose of 10 mg or more each day for at least 8 weeks, and have had a worsening of symptoms, called a flare, in the last 12 weeks while taking more than 5 mg of prednisone each day).
  • You must be willing and able to take prednisone at a dose of 15 mg per day when you are randomly assigned to a treatment group.
  • You must use birth‑control methods that follow the rules of your country, for both men and women, as required for participants in clinical studies.

Who cannot join the trial?

8 criteria

  • You cannot join the study if you have been diagnosed with Giant Cell Arteritis (GCA), which is a type of inflammation of the blood vessels.
  • You cannot join if you have rheumatoid arthritis, other inflammatory arthritis, connective tissue diseases, or fibromyalgia, all of which cause joint pain and inflammation.
  • You cannot join if you have hypothyroidism that is not being treated well; this means your thyroid gland is not making enough hormones.
  • You cannot join if you have current or past tuberculosis (TB) or serious infections such as opportunistic infections, hepatitis B, hepatitis C, HIV, or repeated/active herpes zoster (shingles).
  • You cannot join if you have uncontrolled diabetes, shown by a blood‑sugar measure called HbA1c ≥9%.
  • You cannot join if you are taking immunosuppressive therapies, including systemic corticosteroids, which are medicines that lower the activity of your immune system.
  • You cannot join if you have any form of malignancy, which means a cancer diagnosis.
  • You cannot join if you are an organ transplant recipient, meaning you have received a donated organ.
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Investigated drugs

  • sarilumab

    is an injectable medication that works by blocking a protein called interleukin‑6, which is involved in inflammation. In this study, participants received sarilumab by injection to see if it can reduce the symptoms of early polymyalgia rheumatica better than the standard treatment alone. The drug was given regularly throughout the 52‑week period while participants also followed a tapering schedule of prednisone.

  • prednisone

    is an oral steroid that helps lower inflammation and control pain. In the trial, all participants took prednisone for a year, with the dose gradually reduced over time. This steroid served as the background therapy, allowing researchers to compare the added benefit of sarilumab against prednisone alone.

What is already known about the treatment

  • sarilumab

    This medication is given as a clear solution for injection in a pre‑filled syringe, usually administered under the skin. It is an approved drug for rheumatoid arthritis and is now being studied for early polymyalgia rheumatica. Sarilumab works by blocking the interleukin‑6 (IL‑6) receptor, which helps lower the body’s inflammatory response. It belongs to the class of interleukin‑6 receptor antagonists, a type of monoclonal antibody.

  • prednisone

    Prednisone is taken as an oral tablet, typically at a dose of 15 mg per day. It is a long‑standing, widely used corticosteroid approved for many inflammatory and autoimmune conditions, including polymyalgia rheumatica. The drug mimics the natural hormone cortisol, reducing immune activity and swelling throughout the body. It is classified as a glucocorticoid.

  • placebo matching sarilumab

    The placebo is supplied as a solution for injection that looks identical to sarilumab but contains no active drug. It is used only in clinical trials to compare the effects of the real medication against an inert substance. The placebo has no therapeutic effect and is not a marketed medicine. It serves as a control and does not belong to any pharmacological class.

Investigated diseases

Polymyalgia rheumatica - Polymyalgia rheumatica is an inflammatory condition that causes pain and stiffness in the shoulders, neck, and hips. It typically begins suddenly and is most common in older adults. The stiffness is usually worse in the morning and improves with movement. Over weeks to months, symptoms may spread to other muscle groups and can fluctuate, with periods of improvement followed by relapses. The condition progresses slowly and can persist for many months if not managed.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511296-15-00Protocol codeEFC18055Estimated enrolment375 patientsSponsorSanofi-Aventis Recherche & Developpement

sourced from the EU Clinical Trials Register and site verification

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