Open-label, Long-term Safety Study of Secukinumab in Polymyalgia Rheumatica (PMR)

Last updated: March 10, 2026
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Recruiting

Phase

3

Condition

Collagen Vascular Diseases

Connective Tissue Diseases

Polymyalgia Rheumatica (Pmr)

Treatment

Secukinumab

Clinical Study ID

NCT06331312
CAIN457C22301E1
2023-508077-85-00
  • Ages 50-100
  • All Genders

Study Summary

The purpose of this extension study is to assess the safety and tolerability of secukinumab when administered long-term in patients with polymyalgia rheumatica.

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

Total Participants: 288
Treatment Group(s): 1
Primary Treatment: Secukinumab
Phase: 3
Study Start date:
June 28, 2024
Estimated Completion Date:
August 22, 2028

Study Description

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.

Connect with a study center

  • Novartis Investigative Site

    Ciudad Autonoma de Bs As, Buenos Aires C1055AAF
    Argentina

    Site Not Available

  • Novartis Investigative Site

    Quilmes, Buenos Aires B1878GEG
    Argentina

    Site Not Available

  • Novartis Investigative Site

    Quilmes 3429652, Buenos Aires 3435907 B1878GEG
    Argentina

    Site Not Available

  • Novartis Investigative Site

    Buenos Aires, C1055AAF
    Argentina

    Site Not Available

  • Novartis Investigative Site

    Buenos Aires 3435910, C1055AAF
    Argentina

    Site Not Available

  • Novartis Investigative Site

    Parramatta, New South Wales 2150
    Australia

    Site Not Available

  • Novartis Investigative Site

    Parramatta 7281840, New South Wales 2155400 2150
    Australia

    Site Not Available

  • Novartis Investigative Site

    Southport, Queensland 4215
    Australia

    Active - Recruiting

  • Novartis Investigative Site

    Southport 2148928, Queensland 2152274 4215
    Australia

    Site Not Available

  • Novartis Investigative Site

    Heidelberg Heights, Victoria 3081
    Australia

    Site Not Available

  • Novartis Investigative Site

    Heidelberg Heights 9972412, Victoria 2145234 3081
    Australia

    Site Not Available

  • Novartis Investigative Site

    Leuven, 3000
    Belgium

    Site Not Available

  • Novartis Investigative Site

    Leuven 2792482, 3000
    Belgium

    Site Not Available

  • Novartis Investigative Site

    Liege, 4000
    Belgium

    Site Not Available

  • Novartis Investigative Site

    Liège, 4000
    Belgium

    Site Not Available

  • Novartis Investigative Site

    Liège 2792413, 4000
    Belgium

    Site Not Available

  • Novartis Investigative Site

    Porto Alegre, Rio Grande do Sul 90480-000
    Brazil

    Site Not Available

  • Novartis Investigative Site

    Porto Alegre 3452925, Rio Grande do Sul 3451133 90480-000
    Brazil

    Site Not Available

  • Novartis Investigative Site

    Sao Paulo, 01409-902
    Brazil

    Site Not Available

  • Novartis Investigative Site

    São Paulo, 01409-902
    Brazil

    Site Not Available

  • Novartis Investigative Site

    São Paulo 3448439, 01409-902
    Brazil

    Site Not Available

  • Novartis Investigative Site

    Québec, Quebec G1V 3M7
    Canada

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  • Novartis Investigative Site

    Québec 6325494, Quebec 6115047 G1V 3M7
    Canada

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  • Novartis Investigative Site

    Quebec, G1V 3M7
    Canada

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  • Novartis Investigative Site

    Vina del Mar, Region De Valparaiso 2520598
    Chile

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  • Novartis Investigative Site

    Viña del Mar, Región de Valparaíso 2531172
    Chile

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    Viña del Mar 3868121, Región de Valparaíso 3868621 2531172
    Chile

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  • Novartis Investigative Site

    Santiago, Santiago Metropolitan 8380465
    Chile

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  • Novartis Investigative Site

    Santiago 3871336, Santiago Metropolitan 3873544 8380465
    Chile

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    Vina Del Mar, Valparaiso 2531172
    Chile

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    Barranquilla, Atlántico 080020
    Colombia

    Active - Recruiting

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    Barranquilla 3689147, Atlántico 3689436 080020
    Colombia

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  • Novartis Investigative Site

    Bogota, Cundinamarca 110221
    Colombia

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    Cali, Valle del Cauca Department 760042
    Colombia

    Active - Recruiting

  • Novartis Investigative Site

    Cali 3687925, Valle del Cauca Department 3666313 760042
    Colombia

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    Bogotá 3688689, 110221
    Colombia

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    Brno, 638 00
    Czechia

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    Brno 3078610, 638 00
    Czechia

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  • Novartis Investigative Site

    Hlucin, 748 01
    Czechia

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  • Novartis Investigative Site

    Hlučín, 748 01
    Czechia

    Site Not Available

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    Hlučín 3075716, 748 01
    Czechia

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  • Novartis Investigative Site

    Prague, 140 00
    Czechia

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    Prague 3067696, 128 00
    Czechia

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    Praha 2, 128 50
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    Praha 4, 140 00
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    Uherske Hradiste, 686 01
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    Uherské Hradiště, 686 01
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    Uherské Hradiště 3063739, 686 01
    Czechia

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    Zlin, 760 01
    Czechia

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    Zlín, 760 01
    Czechia

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    Zlín 3061370, 760 01
    Czechia

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    Esbjerg, 6700
    Denmark

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    Esbjerg 2622447, 6700
    Denmark

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    Gandrup, 9362
    Denmark

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    Gandrup 2621618, 9362
    Denmark

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    Vejle, DK-7100
    Denmark

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    Vejle 2610613, DK-7100
    Denmark

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    Limoges, Haute Vienne 87000
    France

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    Limoges 2998286, Haute Vienne 87000
    France

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    Toulon, Val De Marne 83800
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    Toulon Cedex 9, Val De Marne 83800
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    Brest, 29200
    France

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    Brest 3030300, 29200
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    Cholet, 49325
    France

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    Cholet 3025053, 49325
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    Colmar, 68024
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    Colmar Cedex, 68024
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    Dijon, 21000
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    Dijon 3021372, 21000
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    Le Mans, 72000
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    Le Mans 3003603, 72000
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    Montpellier, 34295
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  • Novartis Investigative Site

    Montpellier 2992166, 34295
    France

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    Montpellier 5, 34295
    France

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  • Novartis Investigative Site

    Nantes, 44093
    France

    Active - Recruiting

  • Novartis Investigative Site

    Nantes 2990969, 44093
    France

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    Nantes Cedex 1, 44093
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    Reims, 51092
    France

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    Reims 2984114, 51092
    France

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  • Novartis Investigative Site

    Strasbourg, 67000
    France

    Completed

  • Novartis Investigative Site

    Strasbourg 2973783, 67000
    France

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    Toulouse, 31059
    France

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  • Novartis Investigative Site

    Toulouse 2972315, 31059
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  • Novartis Investigative Site

    Freiburg im Breisgau, Baden-Wurttemberg 79106
    Germany

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  • Novartis Investigative Site

    Freiburg im Breisgau 2925177, Baden-Wurttemberg 2953481 79106
    Germany

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  • Novartis Investigative Site

    Würzburg, Bavaria 97080
    Germany

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  • Novartis Investigative Site

    Würzburg 2805615, Bavaria 2951839 97080
    Germany

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  • Novartis Investigative Site

    Dresden, Saxony 01307
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  • Novartis Investigative Site

    Dresden 2935022, Saxony 2842566 01307
    Germany

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  • Novartis Investigative Site

    Berlin, 13353
    Germany

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  • Novartis Investigative Site

    Berlin 2950159, 13353
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    Freiburg, 79106
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    Herne, 44649
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    Herne 2905891, 44649
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    Ratingen, 40878
    Germany

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    Ratingen 2850174, 40878
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    Rendsburg, 24768
    Germany

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    Rendsburg 2848245, 24768
    Germany

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  • Novartis Investigative Site

    Budapest, 1027
    Hungary

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  • Novartis Investigative Site

    Budapest 3054643, 1027
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  • Novartis Investigative Site

    Szeged, 6725
    Hungary

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  • Novartis Investigative Site

    Szeged 715429, 6725
    Hungary

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  • Novartis Investigative Site

    Veszprem, 8200
    Hungary

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  • Novartis Investigative Site

    Veszprém, 8200
    Hungary

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  • Novartis Investigative Site

    Veszprém 3042929, 8200
    Hungary

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  • Novartis Investigative Site

    Ramat Gan, 5265601
    Israel

    Site Not Available

  • Novartis Investigative Site

    Ramat Gan 293788, 5265601
    Israel

    Site Not Available

  • Novartis Investigative Site

    Bolzano, BZ 39100
    Italy

    Active - Recruiting

  • Novartis Investigative Site

    Bolzano 3181913, BZ 39100
    Italy

    Site Not Available

  • Novartis Investigative Site

    Milan, MI 20132
    Italy

    Site Not Available

  • Novartis Investigative Site

    Milan 6951411, MI 20132
    Italy

    Site Not Available

  • Novartis Investigative Site

    Milano, MI 20100
    Italy

    Site Not Available

  • Novartis Investigative Site

    Perugia, PG 06129
    Italy

    Site Not Available

  • Novartis Investigative Site

    Perugia 3171180, PG 06129
    Italy

    Site Not Available

  • Novartis Investigative Site

    Pavia, PV 27100
    Italy

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  • Novartis Investigative Site

    Pavia 3171366, PV 27100
    Italy

    Site Not Available

  • Novartis Investigative Site

    Reggio Emilia, RE 42123
    Italy

    Active - Recruiting

  • Novartis Investigative Site

    Reggio Emilia 3169522, RE 42123
    Italy

    Site Not Available

  • Novartis Investigative Site

    Fukuoka, Fukuoka 8140180
    Japan

    Site Not Available

  • Novartis Investigative Site

    Fukuoka city, Fukuoka 814 0180
    Japan

    Site Not Available

  • Novartis Investigative Site

    Fukuoka 1863967, Fukuoka 1863958 8140180
    Japan

    Site Not Available

  • Novartis Investigative Site

    Asahikawa, Hokkaido 0708644
    Japan

    Site Not Available

  • Novartis Investigative Site

    Asahikawa-city, Hokkaido 070-8644
    Japan

    Site Not Available

  • Novartis Investigative Site

    Asahikawa 2130629, Hokkaido 2130037 708644
    Japan

    Site Not Available

  • Novartis Investigative Site

    Kita-gun, Kagawa-ken 7610793
    Japan

    Site Not Available

  • Novartis Investigative Site

    Sagamihara, Kanagawa 252-0392
    Japan

    Site Not Available

  • Novartis Investigative Site

    Sagamihara-city, Kanagawa 252-0392
    Japan

    Site Not Available

  • Novartis Investigative Site

    Yokohama, Kanagawa 222-0036
    Japan

    Site Not Available

  • Novartis Investigative Site

    Sagamihara 11611609, Kanagawa 1860291 252-0392
    Japan

    Site Not Available

  • Novartis Investigative Site

    Yokohama 1848354, Kanagawa 1860291 222-0036
    Japan

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  • Novartis Investigative Site

    Nagano, Nagano 3808582
    Japan

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  • Novartis Investigative Site

    Nagano-city, Nagano 380-8582
    Japan

    Site Not Available

  • Novartis Investigative Site

    Nagano 1856215, Nagano 1856210 3808582
    Japan

    Site Not Available

  • Novartis Investigative Site

    Kawachi-Nagano, Osaka 5868521
    Japan

    Site Not Available

  • Novartis Investigative Site

    Kawachinagano, Osaka 586-8521
    Japan

    Site Not Available

  • Novartis Investigative Site

    Kawachi-Nagano 6825498, Osaka 1853904 5868521
    Japan

    Site Not Available

  • Novartis Investigative Site

    Bunkyo Ku, Tokyo 1138431
    Japan

    Completed

  • Novartis Investigative Site

    Bunkyo ku, Tokyo 113-8431
    Japan

    Site Not Available

  • Novartis Investigative Site

    Fuchu, Tokyo 183-8524
    Japan

    Site Not Available

  • Novartis Investigative Site

    Fuchū, Tokyo 1838524
    Japan

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  • Novartis Investigative Site

    Ome, Tokyo 198-0042
    Japan

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  • Novartis Investigative Site

    Ōme, Tokyo 198-0042
    Japan

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  • Novartis Investigative Site

    Fuchū 11611632, Tokyo 1850144 1838524
    Japan

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  • Novartis Investigative Site

    Ōme 1854162, Tokyo 1850144 198-0042
    Japan

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  • Novartis Investigative Site

    Shimonoseki, Yamaguchi 750-0041
    Japan

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  • Novartis Investigative Site

    Shimonoseki 1852225, Yamaguchi 1848681 750-0041
    Japan

    Site Not Available

  • Novartis Investigative Site

    Chuo, Yamanashi 409-3898
    Japan

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  • Novartis Investigative Site

    Chūō, Yamanashi 409-3898
    Japan

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  • Novartis Investigative Site

    Chūō 11612585, Yamanashi 1848649 409-3898
    Japan

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  • Novartis Investigative Site

    Okayama, 700-8607
    Japan

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  • Novartis Investigative Site

    Okayama 1854383, 700-8607
    Japan

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    Osaka, 5340021
    Japan

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  • Novartis Investigative Site

    Osaka 1853909, 5340021
    Japan

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  • Novartis Investigative Site

    Ashrafieh, 166830
    Lebanon

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    Beirut, 166830
    Lebanon

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  • Novartis Investigative Site

    Beirut 276781, 166830
    Lebanon

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  • Novartis Investigative Site

    Guadalajara, Jalisco 44650
    Mexico

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  • Novartis Investigative Site

    Guadalajara 4005539, Jalisco 4004156 44650
    Mexico

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  • Novartis Investigative Site

    Almelo, Overijssel 7609 PP
    Netherlands

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  • Novartis Investigative Site

    Almelo 2759887, Overijssel 2748838 7609 PP
    Netherlands

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  • Novartis Investigative Site

    Rotterdam, South Holland 3079 DZ
    Netherlands

    Active - Recruiting

  • Novartis Investigative Site

    Rotterdam 2747891, South Holland 2743698 3079 DZ
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    Groningen, 9713 GZ
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    Groningen 2755251, 9713 GZ
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    Bytom, 41 902
    Poland

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    Bytom 3101950, 41 902
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    Lublin, 20-607
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    Lublin 765876, 20-607
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    Warsaw, 02-665
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    Warsaw 756135, 02-118
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    Warszawa, 02-665
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    Cape Town, Western Cape 7405
    South Africa

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    Cape Town 3369157, Western Cape 1085599 7405
    South Africa

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    Panorama, 7500
    South Africa

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    Panorama 966305, 7500
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    Sevilla, Andalucia 41013
    Spain

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    Sabadell, Barcelona 08208
    Spain

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    Sabadell 3111199, Barcelona 08208
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    Bilbao, Bizkaia 48013
    Spain

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    Bilbao 3128026, Bizkaia 48013
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    La Coruna, Galicia 15006
    Spain

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    A Coruna, 15006
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    A Coruña, 15006
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    A Coruña 3119841, 15006
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    Barcelona, 08041
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    Barcelona 3128760, 08041
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    Madrid, 28009
    Spain

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    Madrid 3117735, 28009
    Spain

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    Seville, 41013
    Spain

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    Seville 2510911, 41013
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    Valencia, 46010
    Spain

    Active - Recruiting

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    Valencia 2509954, 46010
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    Basel, 4031
    Switzerland

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    Basel 2661604, 4031
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    Sankt Gallen, 9007
    Switzerland

    Completed

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    Sankt Gallen 2658822, 9007
    Switzerland

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    St Gallen, 9007
    Switzerland

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    Barnet, EN5 3DJ
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    Barnet 2656295, EN5 3DJ
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    Hull, HU3 2RW
    United Kingdom

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    Hull 2645425, HU3 2RW
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    Wolverhampton, WV10 0QP
    United Kingdom

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    Wolverhampton 2633691, WV10 0QP
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  • Arizona Arthritis and Rheumatology Associates PLLC

    Avondale, Arizona 85392
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    Peoria, Arizona 85381
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    Avondale 5552301, Arizona 5551752 85392
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    Peoria 5308480, Arizona 5551752 85381
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    Santa Monica, California 90404
    United States

    Active - Recruiting

  • Center for Rheumatology Research

    West Hills, California 91307
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  • Millennium Clinical Trials

    Westlake Village, California 91361
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  • Orrin Troum MD and Medical Associates

    Santa Monica 5393212, California 5332921 90404
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  • Center for Rheumatology Research

    West Hills 8030162, California 5332921 91307
    United States

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  • Millennium Clinical Trials

    Westlake Village 5408395, California 5332921 91361
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  • Rheumatology Associates of South Florida

    Boca Raton, Florida 33486
    United States

    Site Not Available

  • UF Health Cancer Center

    Gainesville, Florida 32610
    United States

    Active - Recruiting

  • Sarasota Arthritis Res Ctr

    Sarasota, Florida 34239
    United States

    Site Not Available

  • Sarasota Arthritis Research Center

    Sarasota, Florida 34239
    United States

    Active - Recruiting

  • West Broward Rheumatology Associates Inc

    Tamarac, Florida 33321
    United States

    Site Not Available

  • Rheumatology Associates of South Florida

    Boca Raton 4148411, Florida 4155751 33486
    United States

    Site Not Available

  • UF Health Cancer Center

    Gainesville 4156404, Florida 4155751 32610
    United States

    Site Not Available

  • Sarasota Arthritis Res Ctr

    Sarasota 4172131, Florida 4155751 34239
    United States

    Site Not Available

  • West Broward Rheumatology Associates Inc

    Tamarac 4174738, Florida 4155751 33321
    United States

    Site Not Available

  • Arthritis Center of North Georgia

    Gainesville, Georgia 30501
    United States

    Active - Recruiting

  • Arthritis Center of North Georgia

    Gainesville 4196586, Georgia 4197000 30501
    United States

    Site Not Available

  • Klein and Associates

    Hagerstown, Maryland 21740
    United States

    Site Not Available

  • Klein and Associates

    Hagerstown 4357141, Maryland 4361885 21740
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston 4930956, Massachusetts 6254926 02114
    United States

    Site Not Available

  • Clinical Research Inst of MI

    Saint Clair Shores, Michigan 48081
    United States

    Active - Recruiting

  • Clinical Research Institute of Michigan LLC

    Saint Clair Shores, Michigan 48081
    United States

    Active - Recruiting

  • Shores Rheumatology

    Saint Clair Shores, Michigan 48081
    United States

    Site Not Available

  • Clinical Research Inst of MI

    Saint Clair Shores 5010978, Michigan 5001836 48081
    United States

    Site Not Available

  • Kansas City Physician Partners

    Kansas City, Missouri 64111
    United States

    Active - Recruiting

  • Kansas City Physician Partners

    Kansas City 4393217, Missouri 4398678 64111
    United States

    Site Not Available

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire 03756
    United States

    Completed

  • Dartmouth Hitchcock Medical Center

    Lebanon 5088597, New Hampshire 5090174 03756
    United States

    Site Not Available

  • Paramount Med Rsrch and Consult LLC

    Middleburg Heights, Ohio 44130
    United States

    Active - Recruiting

  • Paramount Med Rsrch and Consult LLC

    Middleburg Heights 5162851, Ohio 5165418 44130
    United States

    Site Not Available

  • Prolato Clinical Research Center

    Houston, Texas 77054
    United States

    Site Not Available

  • Accurate Clinical Research Inc

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Accurate Clinical Research Inc .

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Advanced Rheumatology of Houston

    Spring, Texas 77382
    United States

    Completed

  • Prolato Clinical Research Center

    Houston 4699066, Texas 4736286 77054
    United States

    Site Not Available

  • Accurate Clinical Research Inc

    San Antonio 4726206, Texas 4736286 78229
    United States

    Site Not Available

  • Advanced Rheumatology of Houston

    Spring 4733624, Texas 4736286 77382
    United States

    Site Not Available

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