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

3 1 1 1

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
Cqpcfj Hupzdpfmpbm Uzqlhtozgtjqj Rfips Reims France
Uzflfljswywc Mcfxnnp Cmnzfrf Gaeiiaibz Groningen The Netherlands
Rmovycunqsgn srkfko Brno-Sever Czechia
Rmbblqtzxgjhsbcy Spmyexqnzkwxlcven Eesvuhtq Erlangen Germany
Rdcdbustbcjrmpmu Sunqmelejokicxgyd Dwr Jftaii Wlrcgb Rendsburg Germany
Nisdxore Ivoaqeyi Guadglujr Rnfdpkpxlpyu I Rskihmpsuvbii Ii Pdifi Do Hmsf Mlqx Ekxummwa Rqkqhpv Warsaw Poland
Pqcg Tckeq Hyokunet Uzlqocenydhb Sabadell Spain
Cwuwsr Hmeiofszqgk Es Ufmziwedctrtg Dl Lvvrwty Limoges France
Ctbroo Hujdsfrnzzm Uvzmimfzhboey Dd Dqzhy Dijon France
Cwojvt Hcrsuzmfzjt Rcryhdbe Utmnbwgzzcimx Dp Tmmqq Tours France
Uoeckvojptkpknzfifxct Wugjbezij Aqe Wuerzburg Germany
Afswmfc Ukg Iomlo Dh Rzbdeo Ebsaek Reggio Emilia Italy
Ihqdfkjzzdxxxdjcxitc Gmyv Berlin Germany
Huhgcgol Dj Lv Szgbj Cmtj I Sllm Pux Barcelona Spain
Cnqxgk Hujzirdyioa Rmbyktvr Dlmyogzyqwdzhx Angers France
Hptrqizn Udwroldhftpjd dh A Cerzrx A Coruna Galicia Spain
Hfzpfdig Ucxhxbqkbxxhhi Srabhfmzzr &ubkrxa Hpzyzjq dw Hyavufftucy 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)

Other Trials to Consider

  • Venetoclax with drug combination for children with relapsed acute myeloid leukemia

    Recruiting

    3 1 1 1
    Austria Belgium Czechia Denmark Finland France +8
  • A study to evaluate the efficacy and safety of depemokimab and salbutamol sulfate in patients with chronic obstructive pulmonary disease and type 2 inflammation.

    Recruiting

    3 1 1
    Belgium Bulgaria Denmark France Germany Greece +6