Study on Long-Term Safety of Secukinumab for Patients with Polymyalgia Rheumatica

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What is this study about?

This clinical trial is focused on studying the long-term safety and tolerability of a medication called secukinumab in individuals with Polymyalgia Rheumatica (PMR). PMR is a condition that causes muscle pain and stiffness, especially in the shoulders. The medication, secukinumab, is given as an injection under the skin and is being tested to see how safe it is for long-term use in people with this condition.

The purpose of the study is to monitor any side effects or serious side effects that may occur while using secukinumab. Participants in this study have previously completed a 52-week treatment period in an earlier study and have experienced a return of symptoms during a follow-up period without treatment. This study aims to provide further information on the safety of continuing secukinumab treatment over a longer period.

Participants will receive secukinumab injections and will be monitored for any adverse effects. The study will help determine if the benefits of using secukinumab outweigh any potential risks for individuals with PMR. The study is expected to continue until 2028, providing valuable data on the long-term use of this medication.

1 joining the study

Participation begins after completing a 52-week treatment period in a previous study of secukinumab for polymyalgia rheumatica (PMR).

Eligibility requires experiencing a relapse during the treatment-free follow-up period of the previous study without receiving rescue treatment.

2 treatment administration

The medication used in this study is secukinumab, administered subcutaneously, which means it is injected under the skin.

The study aims to evaluate the long-term safety and tolerability of secukinumab in patients with PMR.

3 monitoring and evaluation

The primary objective is to monitor the occurrence of adverse events (AEs) and serious adverse events (SAEs) throughout the study.

Regular assessments will be conducted to ensure the safety and well-being of participants.

4 study duration

The estimated end date for the study is May 8, 2028.

Participants will be involved in the study until this date, unless otherwise specified by the study protocol.

Who Can Join the Study?

  • Participants must have completed a 52-week treatment period in a previous Novartis study for Polymyalgia Rheumatica (PMR). PMR is a condition that causes muscle pain and stiffness.
  • Participants must have experienced a relapse during the treatment-free follow-up period of the previous study. A relapse means the return of symptoms of PMR or signs of a new condition called Giant Cell Arteritis (GCA), which requires changes in treatment.
  • Participants must not have been on rescue treatment. Rescue treatment is an emergency treatment given when symptoms worsen.
  • The participant should potentially benefit from the study medication, secukinumab, and the benefits should outweigh any risks, as judged by the study doctor.
  • Both male and female participants are eligible.
  • The study includes participants from certain age groups, typically adults and older adults.
  • The study may include individuals considered part of a vulnerable population, which means they might need special protection or care.

Who Cannot Join the Study?

  • Patients who have a different condition than Polymyalgia Rheumatica cannot participate.
  • Individuals who are not within the specified age range cannot participate. The age range is not specified here, but it is important for eligibility.
  • Both males and females are eligible, so gender is not a reason for exclusion.
  • Individuals who are considered part of a vulnerable population may not be eligible. A vulnerable population includes groups like children, pregnant women, or those unable to give consent.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

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

Other Sites

Site Name City Country Status
Revmatologicky Ustav Prague Czechia
Centre Hospitalier De Colmar Colmar France
Sanos A/S Gandrup Denmark
Centre hospitalier universitaire de Liege Liege Belgium
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
Reumed Sp. z o.o. Lublin Poland
Ziekenhuisgroep Twente Stichting Almelo The Netherlands
L.K.N. Arthrocentrum s.r.o. Hlucin Czechia
Revita Kft. Budapest Hungary
PV-Medical s.r.o. Zlin Czechia
Medical Plus s.r.o. Uherske Hradiste Czechia
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
Ospedale Galeazzi S.p.A. Milan Italy
Centre Hospitalier Sud Francilien Corbeil Essonnes France
HIA Sainte Anne Toulon France
Virgen del Rocío University Hospital Sevilla Spain
Ospedale San Raffaele S.r.l. Milan Italy
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Central Hospital Of Bolzano Bolzano Italy
Centre Hospitalier Le Mans Le Mans France
Maasstad Ziekenhuis Stichting Rotterdam The Netherlands
Centre Hospitalier Universitaire De Montpellier Montpellier France
Sygehus Lillebaelt Vejle Sygehus Vejle Denmark
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier De Cholet Cholet France
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr Herne Germany
Hopital Beaujon Clichy France
University Of Szeged Szeged Hungary
Rheumazentrum Ratingen Ratingen Germany
Vital Medical Center Veszprem Hungary
MUDR. Zuzana URBANOVA Prague Czechia
Cqjslt Hfsymdmdklw Uvderpfjtccmf Radqm Reims France
Uvcrytzhnovq Mqgltnq Cyzkxkw Garhkadwr Groningen The Netherlands
Rrmxrzbxvnjp sjgbpn Brno-Sever Czechia
Racltewqddqkdyfc Slsfmcrxctzfkwyxj Ebyeaghj Erlangen Germany
Rbovrhdpggvlrubw Suszncriahsdkqwvn Dsp Jffbrh Wnoszw Rendsburg Germany
Nbdjeuba Ibybeeuv Geuoxxqiw Rqywkvoijggy I Rfrytzhdlebck In Pifkh Df Hzfs Mcpp Ezxuafjj Rhccwnx Warsaw Poland
Pbbo Tfbwo Hpemfggy Uagzaqfuhlrg Sabadell Spain
Cybytz Hsjptfoywvu Ew Uxydzkzffqwwh Dh Lcpchpb Limoges France
Cmplgo Hezrxjvodtk Ujxofjbdfdaur Dk Dwgnk Dijon France
Cenwpn Hrxkylcwuvp Rddcwgxy Urgjmldzxjric Dw Tfntf Tours France
Uzxjzpbpjrrjdkbivrlpj Wnxavoeij Auf Wuerzburg Germany
Afdmfyf Uvs Ilwsy Dg Ruchod Ejmyqi Reggio Emilia Italy
Ighqrbccghdhujvradok Gucm Berlin Germany
Hgblxnta Dn La Sqegw Cqje I Syij Pwj Barcelona Spain
Cdfelu Hyrqoxxowhw Rhmiocfx Dnuccdpnodfobh Angers France
Hitlwypt Uavcoeryniuii df A Ceicrl A Coruna Galicia Spain
Hxcgfwzz Uamtsuqujqtzab Soggsxymzj &eeoyjz Hcjppxi df Hfpcrwbmami 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
13.09.2024
Czechia Czechia
Not recruiting
13.09.2024
Denmark Denmark
Not recruiting
13.09.2024
France France
Not recruiting
13.09.2024
Germany Germany
Not recruiting
13.09.2024
Hungary Hungary
Not recruiting
13.09.2024
Italy Italy
Not recruiting
13.09.2024
Poland Poland
Not recruiting
13.09.2024
Spain Spain
Not recruiting
13.09.2024
The Netherlands The Netherlands
Not recruiting
13.09.2024

Trial locations

Investigated drugs:

Secukinumab is a medication used in this clinical trial. It is administered through an injection under the skin. The purpose of using secukinumab in this study is to evaluate its long-term safety and how well it is tolerated by patients with polymyalgia rheumatica, a condition that causes muscle pain and stiffness.

Polymyalgia Rheumatica – Polymyalgia Rheumatica is an inflammatory disorder that primarily affects older adults, causing muscle pain and stiffness, especially in the shoulders and hips. The symptoms often appear suddenly and are more severe in the morning or after periods of inactivity. As the condition progresses, individuals may experience fatigue, mild fever, and a general feeling of being unwell. The stiffness and pain can lead to difficulty in performing daily activities, such as getting dressed or rising from a chair. Although the exact cause is unknown, it is believed to involve an immune system response. The condition can last for several months to a few years, with symptoms fluctuating in intensity.

Trial ID:
2023-508077-85-00
Protocol code:
CAIN457C22301E1
NCT ID:
NCT06331312
Trial Phase:
Therapeutic confirmatory (Phase III)

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