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Open-label, Long-term Safety Study of Secukinumab in Polymyalgia Rheumatica (PMR)
Open-label, Long-term Safety Study of Secukinumab in Polymyalgia Rheumatica (PMR)

NCT06331312

Active Not RecruitingPhase 3

Sponsor: Novartis Pharmaceuticals

Conditions: Polymyalgia Rheumatica

Interventions: Secukinumab

Countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, Colombia

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 overview

Sex: ALL

Age: 50 Years to 100 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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 (86)
  • Avondale, Arizona, United States
  • Peoria, Arizona, United States
  • West Hills, California, United States
  • Westlake Village, California, United States
  • Boca Raton, Florida, United States
  • Tamarac, Florida, United States
  • Hagerstown, Maryland, United States
  • Saint Clair Shores, Michigan, United States
  • Lebanon, New Hampshire, United States
  • Middleburg Heights, Ohio, United States
  • Houston, Texas, United States
  • Houston, Texas, United States
  • The Woodlands, Texas, United States
  • Quilmes, Buenos Aires, Argentina
  • Buenos Aires, Argentina
  • Parramatta, New South Wales, Australia
  • Heidelberg Heights, Victoria, Australia
  • Liège, Belgium
  • Porto Alegre, Rio Grande do Sul, Brazil
  • São Paulo, São Paulo, Brazil
  • São Paulo, Brazil
  • Québec, Quebec, Canada
  • Santiago, Santiago Metropolitan, Chile
  • Santiago, Santiago Metropolitan, Chile
  • Viña del Mar, Valparaiso, Chile
  • Bogota, Cundinamarca, Colombia
  • Prague, Czech Republic, Czechia
  • Brno, Czechia
  • Hlučín, Czechia
  • Prague, Czechia
  • + 56 more on CT.gov