Study on Secukinumab and Prednisone for Patients with Polymyalgia Rheumatica Who Have Recently Relapsed

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What is this study about?

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.

Who Can Join the Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Sydvestjysk Sygehus Esbjerg Denmark
CENTRUM MEDYCZNE REUMA PARK Warsaw Poland
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Technische Universitaet Dresden Dresden Germany
Katholieke Universiteit te Leuven Leuven Belgium

Other Sites

Site Name City Country Status
Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher Warsaw Poland
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Centre Hospitalier De Colmar Colmar France
Universitetssykehuset Nord-Norge HF Tromsø Norway
HIA Sainte Anne Toulon France
Sanos A/S Gandrup Denmark
Ospedale San Raffaele S.r.l. Milan Italy
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Centre Hospitalier Le Mans Le Mans France
Centre Hospitalier De Cholet Cholet France
Reumed Sp. z o.o. Lublin Poland
Region Stockholm – SLSO Stockholm Sweden
L.K.N. Arthrocentrum s.r.o. Hlucin Czechia
Centre Hospitalier Sud Francilien Corbeil Essonnes France
Central Hospital Of Bolzano Bolzano Italy
Revmatologicky Ustav Prague Czechia
Revita Kft. Budapest Hungary
Virgen del Rocío University Hospital Sevilla Spain
Maasstad Ziekenhuis Stichting Rotterdam The Netherlands
Az St-Jan Brugge-Oostende A.V. Brugge Belgium
University Hospital Galway Galway Ireland
Turku University Hospital Turku Finland
Centre Hospitalier Universitaire De Montpellier Montpellier France
Sygehus Lillebaelt Vejle Sygehus Vejle Denmark
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhaza Hungary
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Centre Hospitalier Universitaire De Nantes Nantes France
Region Midtjylland Aarhus Denmark
Ospedale Galeazzi S.p.A. Milan Italy
Centre hospitalier universitaire de Liege Liege Belgium
Charite Research Organisation GmbH Berlin Germany
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Santa Maria Della Misericordia Perugia Italy
Asst Centro Specialistico Ortopedico Traumatologico Gaetano Pini Cto Milan Italy
Hospital Universitario Basurto Bilbao Spain
Medical Plus s.r.o. Uherske Hradiste Czechia
PV-Medical s.r.o. Zlin Czechia
Ziekenhuisgroep Twente Stichting Almelo The Netherlands
Rheuma Medicus Sp. z o.o. Warsaw Poland
Szpital Specjalistyczny Nr I W Bytomiu SPZOZ Bytom Poland
Centre Hospitalier Du Pays D Aix Centre Hospitalier Intercommunal Aix-Pertuis Aix En Provence France
University Of Szeged Szeged Hungary
Rheumazentrum Ratingen Ratingen Germany
Beaumont Hospital Dublin Ireland
Hopital Purpan Toulouse France
Vital Medical Center Veszprem Hungary
MUDR. Zuzana URBANOVA Prague Czechia
Pzvp Tasaq Hxxngtij Uycgoyzpwtys Sabadell Spain
Cxacsr Hmhtffmbkyk Uowjdkmfbdceq Dg Dgqfm Dijon France
Cfhh Udnhjmpuja Hvhygjxr Cork Ireland
Nefilhwz Pzdvqn Gxcl Herne Germany
Rhlnnywadgciiain Saakhhayqjtwwbfsr Erqgrpof Erlangen Germany
Cvvm di Tjkmyo Hjddpec Todkslybj Chambray Les Tours France
Rctsxwiegmdgiwah Strytbrnqpjrcgong Dvu Jpcrlz Wkhlep Rendsburg Germany
Cazkaq Hjleufbxwof Eo Uwhwiprvcxtjl Ds Lxlptsv Limoges France
Auubsexfqa Plukwulh Hdhwkqmc Dm Pkbwt Paris France
Unsythovuyphxtnsbolyk Wcmrxwmut Ayi Wuerzburg Germany
Aputacr Uik Imqml Dy Rdtpux Evkzng Reggio Emilia Italy
Iqsxswrnfbrnekwgjxxu Gokb Berlin Germany
Hzkbocsk Ds Lg Sxtra Czmq I Slnz Prl Barcelona Spain
Cpteym Htmzznczuoy Ugspvkoguspgh Regbn Reims France
Unmooyjlzlmm Munvoat Cxpuobn Grvednceu Groningen The Netherlands
Ctndev Hranhyfghtt Rfoiycns Dlaznuktdgzxbh Angers France
Ufcmsyotcu Hpnnahbns Ppkuj Syvgqjlxtim Cfzaeph Fbry Paris France
Rrqgjzipicgk sknngs Brno-Sever Czechia
Hniewspc Ubscwnnaaaezp dx A Cgjxrk A Coruna Galicia Spain
Hmtznnfi Uimgtvparousca Soejozaezp &qmfxva Houbqrn dr Hgdovyuekjr STRASBOURG, Alsace France

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
11.05.2023
Czechia Czechia
Not recruiting
11.05.2023
Denmark Denmark
Not recruiting
11.05.2023
Finland Finland
Not recruiting
11.05.2023
France France
Not recruiting
11.05.2023
Germany Germany
Not recruiting
11.05.2023
Hungary Hungary
Not recruiting
11.05.2023
Iceland Iceland
Not recruiting
11.05.2023
Ireland Ireland
Not recruiting
11.05.2023
Italy Italy
Not recruiting
11.05.2023
Norway Norway
Not recruiting
11.05.2023
Poland Poland
Not recruiting
11.05.2023
Spain Spain
Not recruiting
11.05.2023
Sweden Sweden
Not recruiting
11.05.2023
The Netherlands The Netherlands
Not recruiting
11.05.2023

Trial locations

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.

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 ID:
2022-501895-25-00
Protocol code:
CAIN457C22301
Trial Phase:
Therapeutic confirmatory (Phase III)

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