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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Quilmes,Buenos Aires,B1878geg,Argentina
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Ciudad Autonoma de Bs As,Buenos Aires,C1055aaf,Argentina
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Heidelberg Heights,Victoria,3081,Australia
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Parramatta,2150,Australia
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Southport,Queensland,4215,Australia
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Leuven,3000,Belgium
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Liège,4000,Belgium
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São Paulo,São Paulo,04038-002,Brazil
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São Paulo,01409-902,Brazil
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Québec,Quebec,G1v 3m7,Canada
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Santiago,7500571,Chile
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Santiago,8420383,Chile
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Viña del Mar,Región de Valparaíso,2531172,Chile
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Santiago,RM,8380465,Chile
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Bogotá,110221,Colombia
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Barranquilla,Atlántico,080002,Colombia
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Barranquilla,Atlántico,080020,Colombia
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Prague,128 50,Czechia
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Uherské Hradiště,686 01,Czechia
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Brno,63800,Czechia
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Prague,140 00,Czechia
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Hlučín,748 01,Czechia
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Zlín,760 01,Czechia
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Gandrup,9362,Denmark
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Vejle,Dk-7100,Denmark
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Cholet,49325,France
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Toulouse,31059,France
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Toulon,Val De Marne,83800,France
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Reims,51092,France
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Strasbourg,67000,France
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Dijon,21034,France
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Brest,29200,France
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Colmar,68024,France
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Montpellier,34295,France
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Le Mans,72000,France
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Nantes,44093,France
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Limoges,Haute Vienne,87000,France
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Berlin,13125,Germany
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Berlin,13353,Germany
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Ratingen,40878,Germany
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Herne,44649,Germany
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Dresden,01307,Germany
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Freiburg im Breisgau,79106,Germany
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Rendsburg,24768,Germany
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Veszprém,8200,Hungary
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Budapest,1027,Hungary
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Szeged,6720,Hungary
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Ramat Gan,5265601,Israel
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Reggio Emilia,RE,42123,Italy
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Perugia,PG,06129,Italy
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Pavia,PV,27100,Italy
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Milan,MI,20100,Italy
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Milan,MI,20132,Italy
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Bolzano,BZ,39100,Italy
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Asahikawa,Hokkaido,070-8644,Japan
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Fuchū,Tokyo,183-8524,Japan
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Ōme,Tokyo,198-0042,Japan
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Okayama,700-8607,Japan
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Fukuoka,Fukuoka,814 0180,Japan
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Kawachi-Nagano,Osaka,586-8521,Japan
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Shimonoseki,Yamaguchi,750-0041,Japan
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Chūō,Yamanashi,409-3898,Japan
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Sagamihara,Kanagawa,252-0392,Japan
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Nagano,Nagano,380-8582,Japan
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Yokohama,Kanagawa,222-0036,Japan
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Osaka,534-0021,Japan
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Kita-gun,Kagawa-ken,761-0793,Japan
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Guadalajara,Jalisco,44650,Mexico
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Almelo,7609 pp,Netherlands
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Groningen,9713 gz,Netherlands
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Rotterdam,3079 dz,Netherlands
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Warsaw,02 118,Poland
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Warsaw,02-665,Poland
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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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Sabadell,Barcelona,08208,Spain
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Madrid,28009,Spain
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Barcelona,08041,Spain
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Seville,Andalusia,41013,Spain
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Bilbao,Bizkaia,48013,Spain
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A Coruña,15006,Spain
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Valencia,46010,Spain
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Basel,4031,Switzerland
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Sankt Gallen,9007,Switzerland
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Hull,Hu3 2rw,United Kingdom
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Wolverhampton,Wv10 0qp,United Kingdom
Accurate Clinical Research Inc
Recruiting
San Antonio,Texas,78229,United States
Eli Torok
Philip Waller
Center for Rheumatology Research
Recruiting
West Hills,California,91307,United States
Crystal Ortiz
Nazanin Firooz
Klein and Associates
Recruiting
Hagerstown,Maryland,21740,United States
Mary Howell
Advanced Rheumatology of Houston
Recruiting
Spring,Texas,77382,United States
Tamar Brionez
Rheumatology Associates of South Florida
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Boca Raton,Florida,33486,United States
Shawn Baca
Clinical Research Inst of MI
Recruiting
Saint Clair Shores,Michigan,48081,United States
Andrew Sulich
Sun Valley Arthritis Center Ltd
Recruiting
Peoria,Arizona,85381,United States
Joy Schechtman
Arthritis Center of North Georgia
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Gainesville,Georgia,30501,United States
Brent Flickinger
Arizona Arthritis and Rheumatology Associates PLLC
Recruiting
Avondale,Arizona,85392,United States
Swati Bharadwaj
West Broward Rheumatology Associates Inc
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Tamarac,Florida,33321,United States
Alan R Alberts
Orrin Troum MD and Medical Associates
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Santa Monica,California,90404,United States
Orrin Troum
Millennium Clinical Trials
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Westlake Village,California,91361,United States
Edward B Portnoy
Jasmine Medina
Dartmouth Hitchcock Medical Center
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Lebanon,New Hampshire,03756,United States
William Rigby
Prolato Clinical Research Center
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Houston,Texas,77054,United States
Michelle Eisenberg
Massachusetts General Hospital
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Boston,Massachusetts,02114,United States
Sebastian Unizony
UF Health Cancer Center
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Gainesville,Florida,32610,United States
Emily Sanz
Roland Staud
Paramount Med Rsrch and Consult LLC
Recruiting
Middleburg Heights,Ohio,44130,United States
Isam Diab
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