Clinical Trials in Canada / NCT06331312
Active, not recruiting
Phase 3
Open-label, Long-term Safety Study of Secukinumab in Polymyalgia Rheumatica (PMR)
NCT06331312 · tracked via the Priya Life Science Canada tracker
Condition(s) studied
Polymyalgia Rheumatica
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
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
Primary outcome measure(s)
- Incidences of treatment emergent adverse events (AEs) and serious adverse events (SAEs) — After the first dose of study treatment and within 84 days after the last dose
The number and percentage of participants with treatment emergent AEs/SAEs will be summarized. No hypothesis testing will be performed.
Trial sites (85)
| Facility | City | Region | Status |
|---|---|---|---|
| Arizona Arthritis and Rheumatology Associates PLLC | Avondale | Arizona | |
| Sun Valley Arthritis Center Ltd | Peoria | Arizona | |
| Millennium Clinical Trials | Westlake Village | California | |
| Center for Rheumatology Research | Woodland Hills | California | |
| Rheumatology Associates of South Florida | Boca Raton | Florida | |
| West Broward Rheumatology Associates Inc | Tamarac | Florida | |
| Klein and Associates | Hagerstown | Maryland | |
| Clinical Research Inst of MI | Saint Clair Shores | Michigan | |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | |
| Paramount Med Rsrch and Consult LLC | Middleburg Heights | Ohio | |
| Prolato Clinical Research Center | Houston | Texas | |
| Accurate Clinical Research Inc | Houston | Texas | |
| Advanced Rheumatology of Houston | The Woodlands | Texas | |
| Novartis Investigative Site | Quilmes | Buenos Aires | |
| Novartis Investigative Site | Buenos Aires | Argentina | |
| Novartis Investigative Site | Parramatta | New South Wales | |
| Novartis Investigative Site | Heidelberg Heights | Victoria | |
| Novartis Investigative Site | Liège | Belgium | |
| Novartis Investigative Site | Porto Alegre | Rio Grande do Sul | |
| Novartis Investigative Site | São Paulo | São Paulo | |
| Novartis Investigative Site | São Paulo | Brazil | |
| Novartis Investigative Site | Québec | Quebec | |
| Novartis Investigative Site | Santiago | Santiago Metropolitan | |
| Novartis Investigative Site | Santiago | Santiago Metropolitan | |
| Novartis Investigative Site | Viña del Mar | Valparaiso | |
| Novartis Investigative Site | Bogota | Cundinamarca | |
| Novartis Investigative Site | Prague | Czech Republic | |
| Novartis Investigative Site | Brno | Czechia | |
| Novartis Investigative Site | Hlučín | Czechia | |
| Novartis Investigative Site | Prague | Czechia | |
| Novartis Investigative Site | Prague | Czechia | |
| Novartis Investigative Site | Uherské Hradiště | Czechia | |
| Novartis Investigative Site | Esbjerg | Denmark | |
| Novartis Investigative Site | Gandrup | Denmark | |
| Novartis Investigative Site | Vejle | Denmark | |
| Novartis Investigative Site | Toulon | Val De Marne | |
| Novartis Investigative Site | Brest | France | |
| Novartis Investigative Site | Cholet | France | |
| Novartis Investigative Site | Colmar | France | |
| Novartis Investigative Site | Dijon | France |
+ 45 more sites — see the full list on the official registry below.
On this site
📄 Cosentyx (secukinumab) drug profile →More Novartis Pharmaceuticals trials in Canada
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06331312 on ClinicalTrials.gov ↗ ← All trials in Canada