Sarilumab Efficacy and Safety in Adults With Early Polymyalgia Rheumatica
Start Date
5/12/2026
Completion Date
7/16/2029
Summary
This is a randomized, double-blind, placebo-controlled, parallel-group, Phase 4, 3-group study to assess whether treatment with sarilumab at either 150 mg q2w (once every two weeks) or at 200 mg q2w, each given with a 52-week prednisone taper, is superior to placebo given with a 52-week prednisone taper in participants with early polymyalgia rheumatica (PMR) and to determine the safety and tolerability of the sarilumab regimens. The study will consist of the following visits: Visit 1 (D-42 to D-1): Screening, Visit 2 (D1): Baseline, randomization, first study drug administration, Visit 3 to 12 (Week 2 to Week 52): Treatment period, Visit 13 (Week 52): End of Treatment (EOT) visit, Visit 14 (Week 58): End of Study (EOS) visit.
Eligibility Criteria
Age Range: 50 years to No maximum
Interventions
Sarilumab
Sarilumab
Placebo
Conditions
Locations
Arizona Arthritis & Rheumatology Research - West Beverly Lane- Site Number : 8400055
Avondale, Arizona 85392
United States
Arizona Arthritis & Rheumatology Associates - East Bell Road- Site Number : 8400010
Phoenix, Arizona 85032
United States
Arizona Arthritis & Rheumatology Associates - Tucson- Site Number : 8400039
Tucson, Arizona 85704
United States
Care Access - Huntington Beach- Site Number : 8400087
Huntington Beach, California 92648
United States
Southland Arthritis- Site Number : 8400047
Temecula, California 92592
United States
Cohen Medical Centers- Site Number : 8400023
Thousand Oaks, California 91360
United States
Solace Clinical Research - Tustin- Site Number : 8400101
Tustin, California 92780
United States
Comprehensive Rheumatology Center- Site Number : 8400060
West Hills, California 91307
United States
Denver Arthritis Clinic - Lowry- Site Number : 8400001
Denver, Colorado 80230
United States
Arthritis and Rheumatic Disease Specialties- Site Number : 8400014
Aventura, Florida 33180
United States
Clinical Research of West Florida - Phase I Unit- Site Number : 8400024
Clearwater, Florida 33765
United States
Omega Research Consultants - Debary - North Charles Richard Beall Boulevard- Site Number : 8400092
DeBary, Florida 32713
United States
University of Florida Health - Gainesville- Site Number : 8400035
Gainesville, Florida 32606
United States
Life Clinical Trials - Margate - Colonial Drive- Site Number : 8400034
Margate, Florida 33063
United States
Vitalia Medical Research - Margate- Site Number : 8400021
Margate, Florida 33063
United States
Rheumwell Comprehensive Rheumatology- Site Number : 8400004
Miami, Florida 33143
United States
Florida Research Center- Site Number : 8400084
Miami, Florida 33174
United States
Innovia Research Center- Site Number : 8400029
Miramar, Florida 33027
United States
Discovery Clinical Research - Plantation- Site Number : 8400091
Plantation, Florida 33324
United States
Sarasota Arthritis Center- Site Number : 8400073
Sarasota, Florida 34239
United States
Vantage Clinical Trials - Tampa- Site Number : 8400064
Tampa, Florida 33614
United States
Arthritis & Rheumatology Center Pc- Site Number : 8400038
Cumming, Georgia 30040
United States
Arthritis Center of North Georgia - Gainesville- Site Number : 8400102
Gainesville, Georgia 30501
United States
Willow Rheumatology and Wellness- Site Number : 8400012
Willowbrook, Illinois 60527
United States
Klein and Associates- Site Number : 8400003
Hagerstown, Maryland 21740
United States
Arthritis And Rheumatism Associates- Site Number : 8400083
Rockville, Maryland 20850
United States
Arthritis Consultants - St. Louis- Site Number : 8400063
St Louis, Missouri 63141
United States
Logan Health Research - Glacier View Research Institute - Oncology- Site Number : 8400056
Kalispell, Montana 59901
United States
Inspire Santa Fe Medical Group- Site Number : 8400077
Santa Fe, New Mexico 87505
United States
Arthritis and Osteoporosis Consultants of the Carolinas- Site Number : 8400005
Charlotte, North Carolina 28207
United States
Digestive Health Associates - Rowan Diagnostic Clinic- Site Number : 8400019
Salisbury, North Carolina 28144
United States
Altoona Center for Clinical Research - Duncansville- Site Number : 8400018
Duncansville, Pennsylvania 16635
United States
Rheumatology Specialty Center - Willow Grove- Site Number : 8400042
Willow Grove, Pennsylvania 19090
United States
Pennsylvania Regional Center for Arthritis and Osteoporosis Research- Site Number : 8400013
Wyomissing, Pennsylvania 19610
United States
West Tennessee Research Institute- Site Number : 8400009
Jackson, Tennessee 38305
United States
Murfreesboro Medical Clinic - Shores Road- Site Number : 8400040
Murfreesboro, Tennessee 37128
United States
Lone Star Arthritis & Rheumatology - Denton- Site Number : 8400044
Denton, Texas 76205
United States
Stryde Consulting- Site Number : 8400070
Frisco, Texas 75033
United States
Prolato Clinical Research Center- Site Number : 8400045
Houston, Texas 77054
United States
TAD Clinical Research - Lufkin- Site Number : 8400069
Lufkin, Texas 75904
United States
Rheumatology Associates Of South Texas- Site Number : 8400050
San Antonio, Texas 78258
United States
Accurate Clinical Management - Sugar Land- Site Number : 8400061
Sugar Land, Texas 77479
United States
Overlake Arthritis and Osteoporosis Center- Site Number : 8400002
Bellevue, Washington 98004
United States
Investigational Site Number : 0400003
Graz, 8036
Austria
Investigational Site Number : 0400001
Vienna, 1090
Austria
Investigational Site Number : 0560006
Bruges, 8000
Belgium
Investigational Site Number : 0560004
Brussels, 1070
Belgium
Investigational Site Number : 0560002
Genk, 3600
Belgium
Investigational Site Number : 0560007
Ghent, 9000
Belgium
Investigational Site Number : 0560001
Leuven, 3000
Belgium
Investigational Site Number : 0560003
Liège, 4000
Belgium
Investigational Site Number : 1240003
Sherbrooke, Quebec J1G 2E8
Canada
Investigational Site Number : 1240002
Trois-Rivières, Quebec G8Z 1Y2
Canada
Investigational Site Number : 2030005
Hlučín, 748 01
Czechia
Investigational Site Number : 2030004
Ostrava, 722 00
Czechia
Investigational Site Number : 2030001
Prague, 128 00
Czechia
Investigational Site Number : 2030002
Uherské Hradiště, 686 01
Czechia
Investigational Site Number : 2030003
Zlín, 760 01
Czechia
Investigational Site Number : 2500006
Toulouse, 31059
France
Investigational Site Number : 2760010
Berlin, 13125
Germany
Investigational Site Number : 2760003
Hamburg, 20095
Germany
Investigational Site Number : 2760001
Herne, 44649
Germany
Investigational Site Number : 2760009
Würzburg, 97080
Germany
Investigational Site Number : 5280003
Almelo, 7609 PP
Netherlands
Investigational Site Number : 5280002
Leeuwarden, 8934 AD
Netherlands
Investigational Site Number : 5280004
Rotterdam, 3079 DZ
Netherlands
Investigational Site Number : 5280001
Venlo, 5912 BL
Netherlands
Investigational Site Number : 7240005
Barcelona, Catalunya [Cataluña] 08035
Spain
Investigational Site Number : 7240006
A Coruña, Galicia [Galicia] 15006
Spain
Investigational Site Number : 7240004
Madrid, Madrid, Comunidad de 28046
Spain
Investigational Site Number : 7240009
San Cristóbal de La Laguna, Santa Cruz De Tenerife 38320
Spain
Investigational Site Number : 7240002
Madrid, 28041
Spain
Investigational Site Number : 7240008
Málaga, 29010
Spain
Investigational Site Number : 7240001
Sabadell, 08208
Spain