Study of secukinumab and prednisone combination therapy for patients with giant cell arteritis (GCA): Evaluation of treatment effectiveness and safety

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What is this study about?

This study focuses on patients with Giant Cell Arteritis (GCA), a condition that causes inflammation of blood vessels, typically affecting people over 50 years of age. The study tests two medications: secukinumab, which is given as an injection under the skin, and prednisone, which is taken as tablets by mouth. The purpose is to determine if secukinumab combined with a shorter prednisone treatment course works better than using a longer prednisone treatment with placebo in treating GCA.

During the study, participants will receive either secukinumab injections (150 mg or 300 mg) or placebo injections under the skin. All participants will also take prednisone tablets, but the duration of prednisone treatment will vary between groups. One group will take prednisone for 26 weeks while another will take it for 52 weeks. The total study duration is planned for approximately 52 weeks.

Throughout the study, doctors will monitor participants to see if their GCA symptoms improve and stay under control. They will also track how much prednisone each participant needs and watch for any side effects from the treatments. The study will measure various aspects of participants’ health, including their energy levels, overall well-being, and any treatment-related health issues.

1 Initial treatment phase

You will receive either secukinumab (150mg or 300mg) or a placebo through an injection under the skin (subcutaneous injection)

You will also receive prednisone (a steroid medication) taken by mouth, starting at a dose between 20-60mg daily

The initial phase begins after completing all required medical tests and examinations

2 Treatment continuation

The treatment continues for 52 weeks (one year)

If you receive secukinumab, your prednisone dose will be gradually reduced over 26 weeks

If you receive placebo, your prednisone dose will be gradually reduced over 52 weeks

Regular blood tests will monitor your ESR (a blood test measuring inflammation) and CRP (a protein indicating inflammation levels)

3 Monitoring and assessments

Your health status will be regularly evaluated throughout the study

Physical examinations and laboratory tests will be performed to monitor your condition

You will complete questionnaires about your fatigue levels and quality of life

Any side effects or health changes will be recorded and monitored

4 Final evaluation

At week 52, final assessments will be conducted to evaluate the treatment’s effectiveness

The total amount of prednisone taken during the study will be calculated

Your overall health status, including any side effects from the medications, will be evaluated

The study team will assess whether your giant cell arteritis (GCA) is in remission (reduced or absent symptoms)

Who Can Join the Study?

  • Must sign an informed consent before participating in the study
  • Must be able to communicate with the study doctor and follow study requirements
  • Must be at least 50 years old (men and non-pregnant, non-breastfeeding women)
  • Must have a diagnosis of Giant cell arteritis (GCA) with:
    • Disease starting at age 50 or older
    • Clear symptoms like new headaches, tender scalp, vision problems, jaw pain while chewing, or shoulder/hip pain with morning stiffness
    • Positive biopsy or imaging tests (ultrasound, MRI, CT, or PET-CT) showing blood vessel inflammation
  • Must have active disease within 6 weeks before study start, shown by:
    • Active symptoms of GCA
    • High levels of inflammation in blood tests (ESR ≥ 30 mm/hr or CRP ≥ 10 mg/L)
  • Must have either:
    • Newly diagnosed GCA (within 6 weeks before study start)
    • Relapsing GCA (diagnosed more than 6 weeks ago with symptoms returning after initial treatment)
  • Must be able to safely take prednisone (a steroid medication) at doses between 20-60 mg daily
  • If taking methotrexate (MTX), must be on a stable dose (up to 25 mg/week) for at least 4 weeks before study start and taking folic acid

Who Cannot Join the Study?

  • Active or chronic infection, including tuberculosis, HIV, or hepatitis B/C
  • History of cancer within the past 5 years (except for successfully treated skin cancers)
  • Pregnant women or women planning pregnancy during the study period
  • Breastfeeding mothers
  • Severe heart conditions or uncontrolled high blood pressure
  • History of severe allergic reactions to medications
  • Current treatment with other biological medications
  • Severe kidney or liver problems
  • Mental health conditions that could interfere with study participation
  • Use of live vaccines within 6 weeks before starting the study
  • Previous participation in this specific clinical trial
  • Alcohol or drug abuse within the past 6 months
  • Any condition that, in the investigator’s opinion, makes the patient unsuitable for the study
  • Unable to follow study procedures or attend scheduled visits
  • Treatment with other investigational drugs within 30 days before starting the study

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Unidade Local De Saúde De Santa Maria, E.P.E. Lisbon Portugal
Sydvestjysk Sygehus Esbjerg Denmark
Medical University Of Graz Graz Austria
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Medizinische Universitaet Innsbruck Innsbruck Austria
Azienda Ospedaliero Universitaria Careggi Florence Italy
Oncopole Claudius Regaud Toulouse France
Technische Universitaet Dresden Dresden Germany
Katholieke Universiteit te Leuven Leuven Belgium
Hospital Universitario Y Politecnico La Fe Valencia Spain
Hospital Universitario De Navarra Pamplona Spain

Other Sites

Site Name City Country Status
Revmatologicky Ustav Prague Czechia
Hippokration Hospital Athens Greece
University Of Debrecen Debrecen Hungary
Universitaetsklinikum Erlangen AöR Erlangen Germany
Ospedale San Raffaele S.r.l. Milan Italy
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Region Skane Skanes Universitetssjukhus Lund Sweden
Hospital Clinic De Barcelona Barcelona Spain
Fakultni Nemocnice Brno Brno Czechia
Semmelweis University Budapest Hungary
Turku University Hospital Turku Finland
Sygehus Lillebaelt Vejle Sygehus Vejle Denmark
Universidade De Santiago De Compostela Santiago De Compostela Spain
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Centre Hospitalier Universitaire De Nantes Nantes France
University Of Szeged Szeged Hungary
Centre hospitalier universitaire de Liege Liege Belgium
Hospital General Universitario Gregorio Maranon Madrid Spain
Hopital Beaujon Clichy France
Universita Degli Studi Di Brescia Brescia Italy
Universita’ Degli Studi Di Ferrara Ferrara Italy
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy Bydgoszcz Poland
Affidea Praha s.r.o. Prague Czechia
Hopital Huriez Lille France
Universita’ Campus Bio-medico Di Roma Rome Italy
Centre Hospitalier Le Mans Le Mans France
Region Skane Kristianstad Central Hospital Kristianstad Sweden
University Multiprophy Hospital For Active Treatment – Plovdiv AD Plovdiv Bulgaria
Hopital Saint Joseph Marseille France
East Tallinn Central Hospital Tallin Estonia
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr Herne Germany
MediTrials OÜ Tartu Estonia
University Of Pecs Pecs Hungary
Satucon Oy Kuopio Finland
Staedtisches Klinikum Dresden Dresden Germany
Klinikum der Stadt Ludwigshafen am Rhein gGmbH Ludwigshafen Am Rhein Germany
Hospital Universitario Basurto Bilbao Spain
Medical Plus s.r.o. Uherske Hradiste Czechia
University Multiprofile Hospital For Active Treatment Kaspela EOOD Plovdiv Bulgaria
Malopolskie Badania Kliniczne Sp. z o.o. Cracow Poland
Unidade Local De Saude Do Alto Minho E.P.E. Ponte De Lima Portugal
Martina Hansens Hospital AS Gjettum Norway
Hcenymao Ujfxpiqrev Cjvviyb Hdfignly Helsinki Finland
Uacvzscjckdofjfxeokjg Wfndihexf Aic Wuerzburg Germany
Hywjykce Ds Lu Spxfu Czbb I Svqe Pur Barcelona Spain
Hnfhynel Ussfyrnnizcvs Muinwmh Dw Veeaucexgn Santander Spain
Ftqohqtzi Pvud Le Iazsgytcitzij Bdcxpjrqx Dzt Htuebtaf Uyrckxxdbuecw Lc Prl Madrid Spain
Hdcpsjmj Updeqzegjcucrd Spelppkoat &cnbyfc Hgunlgw dz Hiwrstsblku STRASBOURG, Alsace France
Prgn Thyyi Hioupexb Ucrfoymupfns Sabadell Spain
Pwcezzguduepxsii hazwpakiirngtyf Lahti Finland
Skbitlhfg Øuoasul Hbw Mdte Moss Norway
Cnrldw Hwwqkoddlsl Eb Uecwkhnemossk Dz Lpuycil Limoges France
Cojmxq Hodzemwodrh Ufqzoezyfxacs Dk Dwsze Dijon France
Armqya Uhhksaotdr Heotuthx Aarhus Denmark
Ixmfocdcjfuqqeiedmrs Gxgu Berlin Germany
Hkmhjocd Uagtmapwbljsp Hpwyqudc Tizsn y Pddger Ijjgtfxe Cntbgs dlwjizgbcvktadorx (zkjd Badalona Spain

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

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
06.09.2021
Belgium Belgium
Not recruiting
06.09.2021
Bulgaria Bulgaria
Not recruiting
06.09.2021
Czechia Czechia
Not recruiting
06.09.2021
Denmark Denmark
Not recruiting
06.09.2021
Estonia Estonia
Not recruiting
06.09.2021
Finland Finland
Not recruiting
06.09.2021
France France
Not recruiting
06.09.2021
Germany Germany
Not recruiting
06.09.2021
Greece Greece
Not recruiting
06.09.2021
Hungary Hungary
Not recruiting
06.09.2021
Italy Italy
Not recruiting
06.09.2021
Norway Norway
Not recruiting
06.09.2021
Poland Poland
Not recruiting
06.09.2021
Portugal Portugal
Not recruiting
06.09.2021
Spain Spain
Not recruiting
06.09.2021
Sweden Sweden
Not recruiting
06.09.2021

Trial locations

Investigated Drugs:

Secukinumab is a medication that works by targeting and blocking a protein in the body that causes inflammation. It is given as an injection under the skin (subcutaneously) and is used to treat giant cell arteritis, which is a condition that causes inflammation in blood vessels. This medication helps reduce inflammation and manage symptoms of the disease.

Glucocorticoids are a type of steroid medications that help reduce inflammation throughout the body. In this trial, they are used in a gradually decreasing dose (called a taper regimen) alongside the main treatment. Glucocorticoids are commonly used to treat inflammatory conditions and help control symptoms while other treatments begin to work.

Investigated Diseases:

Giant cell arteritis – A chronic inflammatory condition that affects large and medium-sized blood vessels, particularly those in the head, neck, and arms. The disease causes inflammation of the arteries’ lining, which leads to swelling and thickening of arterial walls. This condition typically develops gradually and commonly affects the temporal arteries running along the temples. The inflammation can cause symptoms such as persistent headaches, scalp tenderness, jaw pain during chewing, and general fatigue. Giant cell arteritis most frequently occurs in adults over 50 years of age, with women being affected more commonly than men.

Trial ID:
2024-510744-31-00
Protocol code:
CAIN457R12301
NCT ID:
NCT04930094
Trial Phase:
Therapeutic confirmatory (Phase III)

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