Study Description
The purpose of this extension study is to assess the safety and tolerability of secukinumab when administered long-term in patients with polymyalgia rheumatica. The study will consist of an up to 4-week screening period, an up to 2-year Treatment Period which includes two Treatment Periods, and a 16-week treatment-free follow-up period (20 weeks post last dose of secukinumab).
Treatment period:
There will be two Treatment Periods (TPs): TP1 will be from the first dose administration of secukinumab (Baseline) to Week 24, where visits will occur every 4 weeks, and TP2 will be from post Week 24 visit (post-dose) to up to 2 years. Participants will return to the study site every 4 weeks from Baseline until Week 24 (Weeks 16 and 20 visits are optional on-site visits and needed when participants are unwilling/uncomfortable to self-administer study treatment at home/offsite), then every 12 weeks afterwards in TP2 for resupply of study medication but may return earlier if needed (i.e., those participants who are unwilling/uncomfortable to self-administer study treatment can continue to visit site every 4 weeks for drug administration if they wish to do so).
Follow-up period: An EoS visit (20 weeks after last administration of secukinumab) will be done for all participants, regardless of whether they complete the entire study as planned, or they discontinue prematurely.
Interventions
Secukinumab
Eligibility Criteria
Inclusion Criteria:
* Participants who have completed 52-week Treatment Period as per protocol in a Novartis study of secukinumab in PMR patients (the "core study" - Study CAIN457C22301), AND
* who have experienced a relapse during the treatment-free follow-up period of the core study, AND
* who have not been on rescue treatment.
* The participant would potentially derive benefit from secukinumab, and the benefit outweighs the risk, based on the investigator's judgement.
Exclusion Criteria:
* Use of prohibited medications, as specified in the protocol
* History of ongoing, chronic or recurrent infectious disease (i.e., human immunodeficiency virus (HIV), hepatitis B (HBV), hepatitis C (HCV), active tuberculosis infection (TB))
* History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 5 years (except for basal cell carcinoma or actinic keratosis that have been treated with no evidence of recurrence in the past 3 months carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed).
* Live vaccinations (e.g., monkey pox vaccine, oral polio vaccine, varicella/zoster vaccines) within 6 weeks prior to Baseline
* Subjects whose participation in the extension study could expose them to an undue safety risk
Novartis Investigative Site
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Buenos Aires,C1055aaf,Argentina
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Quilmes,Buenos Aires,B1878geg,Argentina
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Heidelberg Heights,Victoria,3081,Australia
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Parramatta,New South Wales,2150,Australia
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Southport,Queensland,4215,Australia
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Liège,4000,Belgium
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Leuven,3000,Belgium
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São Paulo,01409-902,Brazil
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Porto Alegre,Rio Grande do Sul,90480-000,Brazil
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Cali,Valle del Cauca Department,760042,Colombia
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Barranquilla,Atlántico,080002,Colombia
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Barranquilla,Atlántico,080020,Colombia
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Bogotá,110221,Colombia
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Brno,638 00,Czechia
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Zlín,760 01,Czechia
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Uherské Hradiště,686 01,Czechia
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Prague,Czech Republic,140 00,Czechia
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Hlučín,748 01,Czechia
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Vejle,Dk-7100,Denmark
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Esbjerg,6700,Denmark
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Dijon,21034,France
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Toulon,Val De Marne,83800,France
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Montpellier,34295,France
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Toulouse,31059,France
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Cholet,49325,France
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Limoges,Haute Vienne,87000,France
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Le Mans,72000,France
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Nantes,44093,France
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Rendsburg,24768,Germany
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Dresden,Saxony,01307,Germany
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Ratingen,40878,Germany
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Herne,44649,Germany
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Szeged,6725,Hungary
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Budapest,1027,Hungary
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Ramat Gan,5265601,Israel
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Pavia,PV,27100,Italy
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Perugia,PG,06129,Italy
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Reggio Emilia,RE,42123,Italy
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Bolzano,BZ,39100,Italy
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Milan,MI,20100,Italy
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Milan,MI,20132,Italy
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Yokohama,Kanagawa,222-0036,Japan
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Fukuoka,Fukuoka,814 0180,Japan
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Kita-gun,Kagawa-ken,761-0793,Japan
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Fuchū,Tokyo,183-8524,Japan
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Ōme,Tokyo,198-0042,Japan
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Chūō,Yamanashi,409-3898,Japan
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Okayama,700-8607,Japan
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Guadalajara,Jalisco,44650,Mexico
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Rotterdam,South Holland,3079 dz,Netherlands
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Bytom,41 902,Poland
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Lublin,20-607,Poland
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Cape Town,7405,South Africa
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Panorama,7500,South Africa
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Madrid,28009,Spain
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Sabadell,Barcelona,08208,Spain
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Barcelona,08041,Spain
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Valencia,46010,Spain
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Wolverhampton,Wv10 0qp,United Kingdom
Kansas City Physician Partners
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Kansas City,Missouri,64111,United States
Tina Shah
Naishi Kachhadiya
Orrin Troum MD and Medical Associates
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Santa Monica,California,90404,United States
Orrin Troum
Dartmouth Hitchcock Medical Center
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Lebanon,New Hampshire,03756,United States
William Rigby
Klein and Associates
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Hagerstown,Maryland,21740,United States
Mary Howell
Arthritis Center of North Georgia
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Gainesville,Georgia,30501,United States
Brent Flickinger
Clinical Research Inst of MI
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Saint Clair Shores,Michigan,48081,United States
Andrew Sulich
UF Health Cancer Center
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Gainesville,Florida,32610,United States
Emily Sanz
Roland Staud
Massachusetts General Hospital
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Boston,Massachusetts,02114,United States
Sebastian Unizony
Paramount Med Rsrch and Consult LLC
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Middleburg Heights,Ohio,44130,United States
Isam Diab
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