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
Recruiting
Quilmes,Buenos Aires,B1878geg,Argentina
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Parramatta,2150,Australia
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Southport,Queensland,4215,Australia
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Heidelberg Heights,Victoria,3081,Australia
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Quebec,G1v 3m7,Canada
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Santiago,7500571,Chile
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Barranquilla,080020,Colombia
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Bogota,110221,Colombia
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Praha 2,128 50,Czechia
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Uherske Hradiste,686 01,Czechia
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Brno,63800,Czechia
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Gandrup,9362,Denmark
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Vejle,Dk-7100,Denmark
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Toulon Cedex 9,Val De Marne,83800,France
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Reims,51092,France
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Strasbourg,67000,France
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Cholet,49325,France
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Toulouse,31059,France
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Herne,44649,Germany
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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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Veszprem,8200,Hungary
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Budapest,1027,Hungary
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Pavia,PV,27100,Italy
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Reggio Emilia,RE,42123,Italy
Novartis Investigative Site
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Perugia,PG,06129,Italy
Novartis Investigative Site
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Asahikawa-city,Hokkaido,070-8644,Japan
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Bunkyo ku,Tokyo,113-8431,Japan
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Fukuoka city,Fukuoka,814 0180,Japan
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Fuchu,Tokyo,183-8524,Japan
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Kawachinagano,Osaka,586-8521,Japan
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Ome,Tokyo,198-0042,Japan
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Shimonoseki,Yamaguchi,750-0041,Japan
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Okayama,700-8607,Japan
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Chuo,Yamanashi,409-3898,Japan
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Ashrafieh,166830,Lebanon
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Valencia,Comunidad Valenciana,46010,Spain
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Madrid,28009,Spain
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La Coruna,Galicia,15006,Spain
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Sabadell,Barcelona,08208,Spain
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Basel,4031,Switzerland
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St Gallen,9007,Switzerland
Rheumatology Associates of South Florida
Recruiting
Boca Raton,Florida,33486,United States
Shawn Baca
Sun Valley Arthritis Center Ltd
Recruiting
Peoria,Arizona,85381,United States
Joy Schechtman
Klein and Associates
Recruiting
Hagerstown,Maryland,21740,United States
Mary Howell
Arthritis Center of North Georgia
Recruiting
Gainesville,Georgia,30501,United States
Brent Flickinger
Sarasota Arthritis Res Ctr
Recruiting
Sarasota,Florida,34239,United States
Jesse Boodoo
Advanced Rheumatology of Houston
Recruiting
Spring,Texas,77382,United States
Tamar Brionez
Accurate Clinical Research Inc
Recruiting
San Antonio,Texas,78229,United States
Philip Waller
Viet Ta
Clinical Research Inst of MI
Recruiting
Saint Clair Shores,Michigan,48081,United States
Andrew Sulich
Center for Rheumatology Research
Recruiting
West Hills,California,91307,United States
Lauren Jackson
Nazanin Firooz
Worldwide Contacts
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