Open-label, Long-term Safety Study of Secukinumab in Polymyalgia Rheumatica (PMR)
Phase 3 – large-scale trial before approval
Conditions:
Polymyalgia Rheumatica
Sponsor: Novartis Pharmaceuticals
trial.available_in:
БГ
Overview
The purpose of this extension study is to assess the safety and tolerability of secukinumab when administered long-term in patients with polymyalgia rheumatica.
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.
Who can participate
Inclusion Criteria:
* 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.
Exclusion Criteria:
* Use of prohibited medications, as specified in the protocol
* History of ongoing, chronic or recurrent infectious disease (i.e., human immunodeficiency virus (HIV), hepatitis B (HBV), hepatitis C (HCV), active tuberculosis infection (TB))
* History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 5 years (except for basal cell carcinoma or actinic keratosis that have been treated with no evidence of recurrence in the past 3 months carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed).
* Live vaccinations (e.g., monkey pox vaccine, oral polio vaccine, varicella/zoster vaccines) within 6 weeks prior to Baseline
* Subjects whose participation in the extension study could expose them to an undue safety risk
Locations
21
Argentina (1)
Novartis Investigative Site
Quilmes , Buenos Aires
Australia (1)
Novartis Investigative Site
Parramatta , New South Wales
Belgium (1)
Novartis Investigative Site
Liège
Brazil (1)
Novartis Investigative Site
Porto Alegre , Rio Grande do Sul
Canada (1)
Novartis Investigative Site
Québec , Quebec
Chile (1)
Novartis Investigative Site
Santiago , Santiago Metropolitan
Colombia (1)
Novartis Investigative Site
Barranquilla , Atlántico
Czech Republic (1)
Novartis Investigative Site
Prague , Czech Republic
Denmark (1)
Novartis Investigative Site
Esbjerg
France (1)
Novartis Investigative Site
Toulon , Val De Marne
Hungary (1)
Novartis Investigative Site
Budapest
Italy (1)
Novartis Investigative Site
Bolzano , BZ
Japan (1)
Novartis Investigative Site
Fukuoka , Fukuoka
Mexico (1)
Novartis Investigative Site
Guadalajara , Jalisco
Netherlands (1)
Novartis Investigative Site
Almelo , Overijssel
Poland (1)
Novartis Investigative Site
Lublin
South Africa (1)
Novartis Investigative Site
Cape Town , Western Cape
Spain (1)
Novartis Investigative Site
Sabadell , Barcelona
Switzerland (1)
Novartis Investigative Site
Sankt Gallen
United Kingdom (1)
Novartis Investigative Site
Barnet
United States (1)
Arizona Arthritis and Rheumatology Associates PLLC