Phase
Condition
Collagen Vascular Diseases
Connective Tissue Diseases
Polymyalgia Rheumatica (Pmr)
Treatment
Secukinumab
Clinical Study ID
Ages 50-100 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants who have completed 52-week Treatment Period as per protocol in aNovartis study of secukinumab in PMR patients (the "core study" - StudyCAIN457C22301), AND
who have experienced a relapse during the treatment-free follow-up period ofthe core study, AND
who have not been on rescue treatment.
The participant would potentially derive benefit from secukinumab, and the benefitoutweighs the risk, based on the investigator's judgement.
Exclusion
Exclusion Criteria:
Use of prohibited medications, as specified in the protocol
History of ongoing, chronic or recurrent infectious disease (i.e., humanimmunodeficiency virus (HIV), hepatitis B (HBV), hepatitis C (HCV), activetuberculosis infection (TB))
History of lymphoproliferative disease or any known malignancy or history ofmalignancy of any organ system within the past 5 years (except for basal cellcarcinoma or actinic keratosis that have been treated with no evidence of recurrencein the past 3 months carcinoma in situ of the cervix or non-invasive malignant colonpolyps that have been removed).
Live vaccinations (e.g., monkey pox vaccine, oral polio vaccine, varicella/zostervaccines) within 6 weeks prior to Baseline
Subjects whose participation in the extension study could expose them to an unduesafety risk
Study Design
Study Description
Connect with a study center
Novartis Investigative Site
Quilmes, Buenos Aires B1878GEG
ArgentinaSite Not Available
Novartis Investigative Site
Buenos Aires, C1055AAF
ArgentinaSite Not Available
Novartis Investigative Site
Parramatta, New South Wales 2150
AustraliaSite Not Available
Novartis Investigative Site
Heidelberg Heights, Victoria 3081
AustraliaSite Not Available
Novartis Investigative Site
Liège, 4000
BelgiumSite Not Available
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul 90480-000
BrazilSite Not Available
Novartis Investigative Site
Sao Paulo, SP 04038-002
BrazilActive - Recruiting
Novartis Investigative Site
São Paulo 3448439, São Paulo 3448433 04038-002
BrazilSite Not Available
Novartis Investigative Site
São Paulo, 01409-902
BrazilSite Not Available
Novartis Investigative Site
Québec, Quebec G1V 3M7
CanadaSite Not Available
Novartis Investigative Site
Santiago, Santiago Metropolitan 7500571
ChileSite Not Available
Novartis Investigative Site
Santiago 3871336, Santiago Metropolitan 3873544 8420383
ChileSite Not Available
Novartis Investigative Site
Viña del Mar, Valparaiso 2531172
ChileSite Not Available
Novartis Investigative Site
Barranquilla, Atlántico 080002
ColombiaSite Not Available
Novartis Investigative Site
Barranquilla 3689147, Atlántico 3689436 080002
ColombiaActive - Recruiting
Novartis Investigative Site
Bogota, Cundinamarca 110221
ColombiaSite Not Available
Novartis Investigative Site
Praha 4, Czech Republic 140 00
CzechiaActive - Recruiting
Novartis Investigative Site
Brno, 638 00
CzechiaSite Not Available
Novartis Investigative Site
Hlučín, 748 01
CzechiaSite Not Available
Novartis Investigative Site
Prague, 128 00
CzechiaSite Not Available
Novartis Investigative Site
Prague 3067696, 140 00
CzechiaSite Not Available
Novartis Investigative Site
Uherské Hradiště, 686 01
CzechiaSite Not Available
Novartis Investigative Site
Esbjerg, 6700
DenmarkSite Not Available
Novartis Investigative Site
Gandrup, 9362
DenmarkSite Not Available
Novartis Investigative Site
Vejle, DK-7100
DenmarkSite Not Available
Novartis Investigative Site
Toulon, Val De Marne 83800
FranceSite Not Available
Novartis Investigative Site
Brest, 29200
FranceSite Not Available
Novartis Investigative Site
Colmar, 68024
FranceSite Not Available
Novartis Investigative Site
Dijon, 21000
FranceSite Not Available
Novartis Investigative Site
Dijon 3021372, 21034
FranceActive - Recruiting
Novartis Investigative Site
Reims, 51092
FranceSite Not Available
Novartis Investigative Site
Strasbourg, 67000
FranceSite Not Available
Novartis Investigative Site
Toulouse, 31059
FranceSite Not Available
Novartis Investigative Site
Freiburg im Breisgau, Baden-Wurttemberg 79106
GermanySite Not Available
Novartis Investigative Site
Würzburg, Bavaria 97080
GermanySite Not Available
Novartis Investigative Site
Berlin, 13353
GermanySite Not Available
Novartis Investigative Site
Berlin 2950159, 13125
GermanySite Not Available
Novartis Investigative Site
Herne, 44649
GermanySite Not Available
Novartis Investigative Site
Budapest, 1027
HungarySite Not Available
Novartis Investigative Site
Szeged, 6725
HungarySite Not Available
Novartis Investigative Site
Veszprém, 8200
HungarySite Not Available
Novartis Investigative Site
Bolzano, BZ 39100
ItalySite Not Available
Novartis Investigative Site
Milan, MI 20100
ItalySite Not Available
Novartis Investigative Site
Milan 6951411, MI 20100
ItalyActive - Recruiting
Novartis Investigative Site
Milano, MI 20132
ItalyActive - Recruiting
Novartis Investigative Site
Perugia, PG 06129
ItalySite Not Available
Novartis Investigative Site
Fukuoka, Fukuoka 8140180
JapanSite Not Available
Novartis Investigative Site
Fukuoka 1863967, Fukuoka 1863958 814 0180
JapanActive - Recruiting
Novartis Investigative Site
Asahikawa, Hokkaido 0708644
JapanSite Not Available
Novartis Investigative Site
Asahikawa 2130629, Hokkaido 2130037 070-8644
JapanSite Not Available
Novartis Investigative Site
Kita-gun, Kagawa-ken 7610793
JapanSite Not Available
Novartis Investigative Site
Sagamihara, Kanagawa 2520392
JapanSite Not Available
Novartis Investigative Site
Yokohama, Kanagawa 222-0036
JapanSite Not Available
Novartis Investigative Site
Nagano, Nagano 3808582
JapanSite Not Available
Novartis Investigative Site
Nagano 1856215, Nagano 1856210 380-8582
JapanSite Not Available
Novartis Investigative Site
Kawachi-Nagano, Osaka 5868521
JapanSite Not Available
Novartis Investigative Site
Kawachi-Nagano 6825498, Osaka 1853904 586-8521
JapanSite Not Available
Novartis Investigative Site
Bunkyo Ku, Tokyo 1138431
JapanSite Not Available
Novartis Investigative Site
Bunkyo ku, Tokyo 113-8431
JapanSite Not Available
Novartis Investigative Site
Fuchū, Tokyo 1838524
JapanSite Not Available
Novartis Investigative Site
Ōme, Tokyo 198-0042
JapanSite Not Available
Novartis Investigative Site
Fuchū 11611632, Tokyo 1850144 183-8524
JapanActive - Recruiting
Novartis Investigative Site
Chūō, Yamanashi 409-3898
JapanSite Not Available
Novartis Investigative Site
Okayama, 700-8607
JapanSite Not Available
Novartis Investigative Site
Osaka, 5340021
JapanSite Not Available
Novartis Investigative Site
Osaka 1853909, 534-0021
JapanSite Not Available
Novartis Investigative Site
Guadalajara, Jalisco 44650
MexicoSite Not Available
Novartis Investigative Site
Almelo, Overijssel 7609 PP
NetherlandsSite Not Available
Novartis Investigative Site
Rotterdam, South Holland 3079 DZ
NetherlandsSite Not Available
Novartis Investigative Site
Lublin, 20-607
PolandSite Not Available
Novartis Investigative Site
Warsaw, 02-665
PolandSite Not Available
Novartis Investigative Site
Warsaw 756135, 02-665
PolandSite Not Available
Novartis Investigative Site
Warszawa, 02 118
PolandActive - Recruiting
Novartis Investigative Site
Cape Town, Western Cape 7500
South AfricaSite Not Available
Novartis Investigative Site
Cape Town 3369157, Western Cape 1085599 7500
South AfricaSite Not Available
Novartis Investigative Site
Sabadell, Barcelona 08208
SpainSite Not Available
Novartis Investigative Site
Bilbao, Bizkaia 48013
SpainSite Not Available
Novartis Investigative Site
A Coruña, 15006
SpainSite Not Available
Novartis Investigative Site
Madrid, 28009
SpainSite Not Available
Novartis Investigative Site
Seville, 41013
SpainSite Not Available
Novartis Investigative Site
Valencia, 46010
SpainSite Not Available
Novartis Investigative Site
Sankt Gallen, 9007
SwitzerlandSite Not Available
Novartis Investigative Site
Barnet, EN5 3DJ
United KingdomSite Not Available
Novartis Investigative Site
Wolverhampton, WV10 0QP
United KingdomSite Not Available
Arizona Arthritis and Rheumatology Associates PLLC
Avondale, Arizona 85392
United StatesSite Not Available
Sun Valley Arthritis Center Ltd
Peoria, Arizona 85381
United StatesSite Not Available
Center for Rheumatology Research
West Hills, California 91307
United StatesSite Not Available
Millennium Clinical Trials
Westlake Village, California 91361
United StatesSite Not Available
Rheumatology Associates of South Florida
Boca Raton, Florida 33486
United StatesSite Not Available
Sarasota Arthritis Research Center
Sarasota, Florida 34239
United StatesActive - Recruiting
West Broward Rheumatology Associates Inc
Tamarac, Florida 33321
United StatesSite Not Available
Arthritis Center of North Georgia
Gainesville, Georgia 30501
United StatesSite Not Available
Klein and Associates
Hagerstown, Maryland 21740
United StatesSite Not Available
Clinical Research Inst of MI
Saint Clair Shores, Michigan 48081
United StatesSite Not Available
Clinical Research Institute of Michigan LLC
Saint Clair Shores, Michigan 48081
United StatesActive - Recruiting
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire 03756
United StatesSite Not Available
Paramount Med Rsrch and Consult LLC
Middleburg Heights, Ohio 44130
United StatesSite Not Available
Accurate Clinical Research Inc
Houston, Texas 77089
United StatesSite Not Available
Prolato Clinical Research Center
Houston, Texas 77054
United StatesSite Not Available
Accurate Clinical Research Inc .
San Antonio, Texas 78229
United StatesActive - Recruiting
Advanced Rheumatology of Houston
Spring, Texas 77382
United StatesSite Not Available

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