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

3 1 1

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
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Technische Universitaet Dresden Dresden Germany
Katholieke Universiteit te Leuven Leuven Belgium
CENTRUM MEDYCZNE REUMA PARK Warsaw Poland

Other Sites

Site Name City Country Status
Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher Warsaw Poland
Show more
Ospedale San Raffaele S.r.l. Milan Italy
Turku University Hospital Turku Finland
Sygehus Lillebaelt Vejle Sygehus Vejle Denmark
Centre Hospitalier Universitaire De Nantes Nantes France
Hospital General Universitario Gregorio Maranon Madrid Spain
Region Stockholm – SLSO Stockholm Sweden
Revita Kft. Budapest Hungary
Centre Hospitalier Sud Francilien Corbeil Essonnes France
Sanos A/S Gandrup Denmark
Hopital Purpan Toulouse France
Central Hospital Of Bolzano Bolzano Italy
Centre Hospitalier Le Mans Le Mans France
Az St-Jan Brugge-Oostende A.V. Brugge Belgium
Rheuma Medicus Sp. z o.o. Warsaw Poland
MUDR. Zuzana URBANOVA Prague Czechia
MuDr. Zuzana Stejfova Prague Czechia
Rheumatologische Schwerpunktpraxis Erlangen Erlangen Germany
Rheumatologische Schwerpunktpraxis Dr. Jochen Walter Rendsburg Germany
Rtjwrzsueblzpz Ujqxx Prague Czechia
Uagxgulhrqtplohswzlax Nfbkbifaet Hq Tromsø Norway
Bksjpgjp Hoxveseq Dublin Ireland
Hlieugse Ubudzqzwjpaqd dx A Czkqhn A Coruna Galicia Spain
Vhhudk ddd Rqxmd Usvxvujysg Hyofngjo Sevilla Spain
Fwesycozss Itpoj Pbnjrrjbxtk Syh Mmvajx Pavia Italy
Crqbrs Hrgfusbiypf Ulydvfudcfxfh Df Mfiublxiusm Montpellier France
Mnczfte Crhzbt &tfbeoy Utrcorvfak Oo Frpamjyq Freiburg Im Breisgau Germany
Uxxqijrrpskmjqwjuylgn Wqlstyrgw Abq Wuerzburg Germany
Rddcue Mxmvtojelsh Aarhus Denmark
Umeywdjzex Ol Sxxvas Szeged Hungary
Hxyqxccg De Lx Sklvh Cbre I Svri Psk Barcelona Spain
Cyjiux hjnpevgxovc ufxvoftqzbrou dz Lekur Liege Belgium
Uapltelgvyds Mmzgwry Cuwtwcc Gdpnptsgz Groningen The Netherlands
Cmafes Hhlrtgwvjuw Rfaozpkf Dkpgikfcsqytwv Angers France
Hjgfofei Udfcanoivbrxqj Sgvypqpdih &gjplpa Hmxmfjr dp Hlckqznleym STRASBOURG, Alsace France
Cotemg Hamqrzbkqso Dq Cejcyi Colmar France
Pwic Ttwkw Hodrdypa Upfxszuymvpq Sabadell Spain
Hga Sqqtqz Afpd Toulon France
Ncbbpbmo Pozaea Gcac Herne Germany
Cnpg dm Tscgqp Haplrhn Tqvgxchov Chambray Les Tours France
Cmqgxi Hpxczmhtqmz Ey Udjiqwkzjdlaz Dl Lwzyynw Limoges France
Aqaxylmgpn Prdrvcih Hupdzzkm Do Plyme Paris France
Cnqgbw Hqpcyzvfsnw Uvbbhahbnirpf Df Drvzl Dijon France
Muqfixkn Zfcnwiyiuk Skthftgeq Rotterdam The Netherlands
Uqalhgzasr Hujfzusn Gwubym Galway Ireland
Sciizzdjmjjhdcxfecjcpa Vkkppyomo Orlhmnojopbd Nyiregyhaza Hungary
Cmqnvx Hxcxgcbjbur Dt Cwyxra Cholet France
Abvvedc Uff Itnvg Dx Rioewt Eubhba Reggio Emilia Italy
Ijlbistjsvyjxvinugen Ginm Berlin Germany
Cgwbfc Hykffupoudk Uictbcezynoev Rvlxp Reims France
Olqdbcga Gbddaevk Spgdgh Milan Italy
Cfueeef Rsgbdlzp Ocvujwperzje Gtsu Berlin Germany
Hsjbpqmq Sxucc Mlwvx Dulgn Mzdjnkdnrzvs Perugia Italy
Cwsl Udfluaacki Hmxvzrqj Cork Ireland
Uldidsakrx Hbyqzitrt Psdhw Spdvcdltcaw Cxtgoqi Fjlz Paris France
Awxb Cxznkm Sdjcyzekyjehz Oplrlbqtqn Taaqekdtgxlwtx Gfgbvor Pbfq Cgd Milan Italy
Heiiljru Uhfaupruunrvu Bpbbcxx Bilbao Spain
Mubdasd Psui soayuq Uherske Hradiste Czechia
Rpimzu Sem z otxj Lublin Poland
Pyxehkbjmz sowyjp Zlin Czechia
Rjgsmpysgwaf skhiel Brno-Sever Czechia
Zwhuqdjunjapnjw Timvaa Spjgvgqdb Almelo The Netherlands
Slojeot Sdvrtvejlctkgmz Nm I W Bzetjcs Ssvkk Bytom Poland
Lraabg Auoitnorlnlzs shscsp Hlucin Czechia
Czqbqk Hpsekkhemin Dy Pdqh D Afh Cfypyw Htqvyvwukdd Iknbqlsnzcfks Afmvvfucueh Aix En Provence France
Vwovyeawtsxfda Kuzo Veszprem Hungary
Rpzkmlgfrahas Rqckdwhn Ratingen Germany

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)

Other Trials to Consider

  • A Study of Brenipatide Compared to Placebo for Adults with Uncontrolled Moderate to Severe Asthma

    Recruiting

    2 1
    Investigated Drugs:
    France Germany The Netherlands Poland
  • A Study of Depemokimab Compared to Placebo in Adults with Chronic Obstructive Pulmonary Disease and Type 2 Inflammation

    Recruiting

    3 1 1
    Austria Bulgaria Czechia Germany Greece Italy +2