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 (38) 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
California
Center for Rheumatology Research
RECRUITING
West Hills
Florida
Rheumatology Associates of South Florida
RECRUITING
Boca Raton
Sarasota Arthritis Res Ctr
RECRUITING
Sarasota
Maryland
Klein and Associates
RECRUITING
Hagerstown
Michigan
Clinical Research Inst of MI
RECRUITING
Saint Clair Shores
Texas
Accurate Clinical Research Inc
RECRUITING
San Antonio
Advanced Rheumatology of Houston
RECRUITING
Spring
Other Locations
Argentina
Novartis Investigative Site
RECRUITING
Quilmes
Australia
Novartis Investigative Site
RECRUITING
Heidelberg Heights
Novartis Investigative Site
RECRUITING
Parramatta
Novartis Investigative Site
RECRUITING
Southport
Chile
Novartis Investigative Site
RECRUITING
Santiago
Novartis Investigative Site
RECRUITING
Vina Del Mar
Colombia
Novartis Investigative Site
RECRUITING
Bogota
Denmark
Novartis Investigative Site
RECRUITING
Gandrup
France
Novartis Investigative Site
RECRUITING
Cholet
Novartis Investigative Site
RECRUITING
Reims
Novartis Investigative Site
RECRUITING
Strasbourg
Novartis Investigative Site
RECRUITING
Toulon Cedex 9
Novartis Investigative Site
RECRUITING
Toulouse
Germany
Novartis Investigative Site
RECRUITING
Berlin
Novartis Investigative Site
RECRUITING
Berlin
Novartis Investigative Site
RECRUITING
Ratingen
Hungary
Novartis Investigative Site
RECRUITING
Veszprem
Italy
Novartis Investigative Site
RECRUITING
Reggio Emilia
Japan
Novartis Investigative Site
RECRUITING
Asahikawa-city
Novartis Investigative Site
RECRUITING
Chuo
Novartis Investigative Site
RECRUITING
Fuchu
Novartis Investigative Site
RECRUITING
Fukuoka City
Novartis Investigative Site
RECRUITING
Kawachinagano
Novartis Investigative Site
RECRUITING
Okayama
Novartis Investigative Site
RECRUITING
Ome
Novartis Investigative Site
RECRUITING
Shimonoseki
Lebanon
Novartis Investigative Site
RECRUITING
Ashrafieh
Spain
Novartis Investigative Site
RECRUITING
La Coruna
Novartis Investigative Site
RECRUITING
Sabadell
Switzerland
Novartis Investigative Site
RECRUITING
Basel
Novartis Investigative Site
RECRUITING
St Gallen
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: 2028-02-10
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.
Related Therapeutic Areas
Sponsors
Leads: Novartis Pharmaceuticals