A Multi-center, Open-label Extension Study of Subcutaneous Secukinumab to Evaluate the Long-term Safety and Tolerability in Polymyalgia Rheumatica (PMR)

Status: Recruiting
Location: See all (108) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 100
Healthy Volunteers: f
View:

• 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.

Locations
United States
Arizona
Arizona Arthritis and Rheumatology Associates PLLC
ACTIVE_NOT_RECRUITING
Avondale
Sun Valley Arthritis Center Ltd
ACTIVE_NOT_RECRUITING
Peoria
California
Orrin Troum MD and Medical Associates
RECRUITING
Santa Monica
Center for Rheumatology Research
ACTIVE_NOT_RECRUITING
West Hills
Millennium Clinical Trials
ACTIVE_NOT_RECRUITING
Westlake Village
Florida
Rheumatology Associates of South Florida
ACTIVE_NOT_RECRUITING
Boca Raton
UF Health Cancer Center
RECRUITING
Gainesville
Sarasota Arthritis Res Ctr
ACTIVE_NOT_RECRUITING
Sarasota
West Broward Rheumatology Associates Inc
ACTIVE_NOT_RECRUITING
Tamarac
Georgia
Arthritis Center of North Georgia
RECRUITING
Gainesville
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Maryland
Klein and Associates
RECRUITING
Hagerstown
Michigan
Clinical Research Inst of MI
RECRUITING
Saint Clair Shores
Missouri
Kansas City Physician Partners
RECRUITING
Kansas City
New Hampshire
Dartmouth Hitchcock Medical Center
RECRUITING
Lebanon
Ohio
Paramount Med Rsrch and Consult LLC
RECRUITING
Middleburg Heights
Texas
Prolato Clinical Research Center
ACTIVE_NOT_RECRUITING
Houston
Accurate Clinical Research Inc
ACTIVE_NOT_RECRUITING
San Antonio
Advanced Rheumatology of Houston
COMPLETED
Spring
Other Locations
Argentina
Novartis Investigative Site
RECRUITING
Buenos Aires
Novartis Investigative Site
RECRUITING
Quilmes
Australia
Novartis Investigative Site
RECRUITING
Heidelberg Heights
Novartis Investigative Site
RECRUITING
Parramatta
Novartis Investigative Site
RECRUITING
Southport
Belgium
Novartis Investigative Site
RECRUITING
Leuven
Novartis Investigative Site
RECRUITING
Liège
Brazil
Novartis Investigative Site
RECRUITING
Porto Alegre
Novartis Investigative Site
RECRUITING
São Paulo
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
São Paulo
Canada
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Québec
Chile
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Santiago
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Santiago
Novartis Investigative Site
WITHDRAWN
Santiago
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Viña Del Mar
Colombia
Novartis Investigative Site
RECRUITING
Barranquilla
Novartis Investigative Site
RECRUITING
Barranquilla
Novartis Investigative Site
RECRUITING
Bogotá
Novartis Investigative Site
RECRUITING
Cali
Denmark
Novartis Investigative Site
RECRUITING
Esbjerg
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Gandrup
Novartis Investigative Site
RECRUITING
Vejle
France
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Brest
Novartis Investigative Site
RECRUITING
Cholet
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Colmar
Novartis Investigative Site
RECRUITING
Dijon
Novartis Investigative Site
RECRUITING
Le Mans
Novartis Investigative Site
RECRUITING
Limoges
Novartis Investigative Site
RECRUITING
Montpellier
Novartis Investigative Site
RECRUITING
Nantes
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Reims
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Strasbourg
Novartis Investigative Site
RECRUITING
Toulon
Novartis Investigative Site
RECRUITING
Toulouse
Germany
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Berlin
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Berlin
Novartis Investigative Site
RECRUITING
Dresden
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Freiburg Im Breisgau
Novartis Investigative Site
RECRUITING
Herne
Novartis Investigative Site
RECRUITING
Ratingen
Novartis Investigative Site
RECRUITING
Rendsburg
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Würzburg
Hungary
Novartis Investigative Site
RECRUITING
Budapest
Novartis Investigative Site
RECRUITING
Szeged
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Veszprém
Israel
Novartis Investigative Site
RECRUITING
Ramat Gan
Italy
Novartis Investigative Site
RECRUITING
Bolzano
Novartis Investigative Site
RECRUITING
Milan
Novartis Investigative Site
RECRUITING
Milan
Novartis Investigative Site
RECRUITING
Pavia
Novartis Investigative Site
RECRUITING
Perugia
Novartis Investigative Site
RECRUITING
Reggio Emilia
Japan
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Asahikawa
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Bunkyo Ku
Novartis Investigative Site
RECRUITING
Chūō
Novartis Investigative Site
RECRUITING
Fuchū
Novartis Investigative Site
RECRUITING
Fukuoka
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Kawachi-nagano
Novartis Investigative Site
RECRUITING
Kita-gun
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Nagano
Novartis Investigative Site
RECRUITING
Okayama
Novartis Investigative Site
RECRUITING
Ōme
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Osaka
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Sagamihara
Novartis Investigative Site
WITHDRAWN
Shimonoseki
Novartis Investigative Site
RECRUITING
Yokohama
Lebanon
Novartis Investigative Site
WITHDRAWN
Beirut
Mexico
Novartis Investigative Site
RECRUITING
Guadalajara
Netherlands
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Almelo
Novartis Investigative Site
WITHDRAWN
Groningen
Novartis Investigative Site
RECRUITING
Rotterdam
Poland
Novartis Investigative Site
RECRUITING
Bytom
Novartis Investigative Site
RECRUITING
Lublin
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Warsaw
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Warsaw
South Africa
Novartis Investigative Site
RECRUITING
Cape Town
Novartis Investigative Site
RECRUITING
Panorama
Spain
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
A Coruña
Novartis Investigative Site
RECRUITING
Barcelona
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Bilbao
Novartis Investigative Site
RECRUITING
Madrid
Novartis Investigative Site
RECRUITING
Sabadell
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Seville
Novartis Investigative Site
RECRUITING
Valencia
Switzerland
Novartis Investigative Site
WITHDRAWN
Basel
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Sankt Gallen
United Kingdom
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Barnet
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Hull
Novartis Investigative Site
RECRUITING
Wolverhampton
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
1-888-669-6682
Backup
Novartis Pharmaceuticals
+41613241111
Time Frame
Start Date: 2024-06-28
Estimated Completion Date: 2028-08-23
Participants
Target number of participants: 300
Treatments
Experimental: Secukinumab 300mg
All eligible participants will receive secukinumab 300 mg s.c. (2 x 150mg/1mL PFS secukinumab) from baseline and every 4 weeks up to 2 years. The study medication may be modified/adjusted after the initial doses of 300mg s.c. (decreased to 150mg s.c. q4w or increased again from 150mg s.c. q4w to 300mg s.c. q4w) if deemed appropriate by the investigator. Dose modification/adjustment may only occur from Week 24 visit onwards. The modification/adjustment of the study medication will be determined at a site visit.
Sponsors
Leads: Novartis Pharmaceuticals

This content was sourced from clinicaltrials.gov

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