Sarilumab and Prednisone in Adults with Early Polymyalgia Rheumatica: A Randomized Double‑Blind Placebo‑Controlled Study of Efficacy and Safety

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What is this study about?

The study focuses on adults with early polymyalgia rheumatica, a condition that causes pain and stiffness in the shoulders, hips, and neck. The investigational medication sarilumab is given as an injection every two weeks, together with a standard steroid called prednisone that is gradually reduced over a year.

The purpose of the study is to determine whether adding the injection to the steroid taper provides better and longer‑lasting remission than the steroid taper alone. Participants are randomly assigned to receive either the injection or a matching inactive substance, and neither the participants nor the study staff know which one is given. Over 52 weeks, participants continue the steroid at decreasing doses while attending regular check‑ins to monitor symptoms and safety.

The inactive substance used for comparison is a placebo, which looks the same as the active injection but does not contain the medication. Throughout the year, patients are evaluated for sustained remission, any flare‑ups, and overall well‑being using simple questionnaires and routine lab tests. Safety is closely watched for any side effects or unusual laboratory results.

1 baseline visit

the first visit after joining the study is the baseline visit. during this visit a short medical questionnaire is completed and blood is drawn for laboratory tests.

the first subcutaneous injection is given. the injection contains either sarilumab 200 mg in a pre‑filled syringe or a matching placebo injection. the injection is administered under the skin by a health professional.

2 initiation of background medication

immediately after the baseline visit a daily oral tablet of prednisone 15 mg is started. the tablet is taken once each day with water.

3 bi‑weekly injections

every two weeks (q2w) a subcutaneous injection is received. the injection contains the same product as the baseline injection, either sarilumab 200 mg or the matching placebo.

the injection schedule continues for the full 52‑week period of the study.

4 prednisone taper over 52 weeks

the daily dose of prednisone is reduced gradually over the 52‑week period. the reduction is performed stepwise according to a predefined schedule until the tablet is stopped at week 52.

the taper is designed to lower the dose in small amounts each week or month, aiming for a corticosteroid‑free state by the end of the study.

5 regular assessment visits

clinic visits are scheduled at week 12, week 24, week 36 and week 52. at each visit a physical examination, symptom questionnaire and blood tests are performed to evaluate disease activity and safety.

the week 24 visit also includes a specific assessment of remission status.

6 final study visit

at week 52 the final study visit is completed. the visit includes the last injection, the final assessment of remission, and collection of all remaining safety data.

after week 52 no further study medication is provided.

Who Can Join the Study?

  • Be 50 years of age or older and have polymyalgia rheumatica (PMR) that meets the official classification rules set by the European League Against Rheumatism (EULAR) and the American College of Rheumatology (ACR), which are a set of signs and test results doctors use to confirm the disease.
  • Fit into one of two disease groups: newly diagnosed PMR (you have taken corticosteroids, a type of anti‑inflammatory medicine, for less than 6 weeks before the study) or early relapsing PMR (you started corticosteroids within the past year, have been taking at least 10 mg of prednisone each day for at least 8 weeks, and have had a symptom flare, meaning a worsening of symptoms, in the last 12 weeks while taking more than 5 mg of prednisone daily).
  • Be willing and able to take a daily dose of 15 mg of prednisone (a steroid medication) when you are randomly assigned to a treatment group.
  • Use birth‑control methods that follow the rules of your country; both men and women must follow local regulations for contraception while taking part in the study.

Who Cannot Join the Study?

  • Having a diagnosis of Giant Cell Arteritis (GCA), which is a type of inflammation of the blood vessels.
  • Having other joint or tissue diseases at the same time, such as rheumatoid arthritis, other inflammatory arthritis, connective tissue diseases, or fibromyalgia (a condition causing widespread muscle pain).
  • Having an underactive thyroid (hypothyroidism) that is not being treated well enough.
  • Having a current or recent serious infection, including tuberculosis (TB), infections that take advantage of a weak immune system (opportunistic infections), ongoing hepatitis B, hepatitis C, HIV, or repeated/shingles (herpes zoster) outbreaks.
  • Having diabetes that is not under good control, shown by a blood test called HbA1c that is 9 % or higher.
  • Taking medicines that suppress the immune system, such as systemic corticosteroids (steroids taken by mouth or injection).
  • Having a history of cancer (malignancy).
  • Being a recipient of an organ transplant.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Frisius Heerenveen The Netherlands
Medical University Of Vienna Vienna Austria
Medical University Of Graz Graz Austria
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Medizinische Universitaet Innsbruck Innsbruck Austria
Oncopole Claudius Regaud Toulouse France
Katholieke Universiteit te Leuven Leuven Belgium
Zuyderland Medisch Centrum Stichting Geleen The Netherlands
Université Libre de Bruxelles – Hôpital Erasme Brussels Belgium

Other Sites

Site Name City Country Status
Revmatologicky Ustav Prague Czechia
Hippokration Hospital Athens Greece
Virgen del Rocío University Hospital Sevilla Spain
Maasstad Ziekenhuis Stichting Rotterdam The Netherlands
Az St-Jan Brugge-Oostende A.V. Brugge Belgium
Semmelweis University Budapest Hungary
Hospital Universitario Quironsalud Madrid Pozuelo De Alarcon Spain
Centre Hospitalier Universitaire De Montpellier Montpellier France
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Centre Hospitalier Universitaire De Nantes Nantes France
University Of Szeged Szeged Hungary
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr Herne Germany
Anima Alken Belgium
Hospital Universitario De Canarias La Laguna Spain
Centre hospitalier universitaire de Liege Liege Belgium
Universitair Ziekenhuis Gent Gent Belgium
Hopital Beaujon Clichy France
Hospital Universitario 12 De Octubre Madrid Spain
Medical Plus s.r.o. Uherske Hradiste Czechia
Stichting Viecuri Medisch Centrum voor Noord-Limburg Venlo The Netherlands
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH Hamburg Germany
PV-Medical s.r.o. Zlin Czechia
Ziekenhuisgroep Twente Stichting Almelo The Netherlands
L.K.N. Arthrocentrum s.r.o. Hlucin Czechia
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara Chaidari Greece
Reumacentrum Genk Genk Belgium
CAIR – Centrum für Angewandte Immunologie & Rheumatologie Heidelberg Germany
Asklepios Klinikum Bad Abbach Germany
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Mhpvieidf Mobcvhi gpaex Munich Germany
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Hyiujigr Ubnxcmaifbbzx dl A Ciwwvq A Coruna Galicia Spain
Kydvhkkq dwc Uptnjokzmjmt Mbnbgbxb Ayz Munich Germany
Umpdwtfttcwhiwetnwcqj Wxmggfybq Ato Wuerzburg Germany
Izmwxvtxijqzqbqftbra Gadc Berlin Germany
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Adrcxnufg sfvmqi Trebovice Czechia

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not yet recruiting
01.07.2026
Belgium Belgium
Not yet recruiting
01.07.2026
Czechia Czechia
Not yet recruiting
01.07.2026
France France
Not yet recruiting
01.07.2026
Germany Germany
Not yet recruiting
01.07.2026
Greece Greece
Not yet recruiting
01.07.2026
Hungary Hungary
Not yet recruiting
01.07.2026
Spain Spain
Not yet recruiting
01.07.2026
The Netherlands The Netherlands
Not yet recruiting
01.07.2026

Trial locations

Investigated drugs:

Sarilumab is an injectable medicine that works by blocking a part of the immune system called the interleukin‑6 receptor. In this study it is being tested to see if it can help reduce the symptoms of early polymyalgia rheumatica when used together with a gradual reduction of steroids over a year. Participants receive the drug by a pre‑filled syringe under the skin, and the trial compares two different dose levels of sarilumab to determine which works best.

Prednisone is an oral steroid tablet that is commonly used to lower inflammation and control pain. In this trial every participant takes prednisone at the start of the study, and the dose is slowly lowered (tapered) over 52 weeks. The steroid serves as the background treatment that all patients receive, allowing the researchers to see how much additional benefit the sarilumab injection may provide.

Polymyalgia rheumatica – Polymyalgia rheumatica is an inflammatory condition that causes pain and stiffness in the shoulders, neck, and hips. It usually begins gradually and is most common in older adults. The stiffness is typically worst in the morning and improves with movement. Over weeks to months, the pain may spread to other muscle groups and can limit daily activities. The disease often follows a pattern of flare-ups and periods of milder symptoms.

Trial ID:
2024-511296-15-00
Protocol code:
EFC18055
Trial Phase:
Therapeutic confirmatory (Phase III)

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