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

Ki vehet részt

• 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

Ki nem vehet részt

• Use of prohibited medications, as specified in the protocol
• Live vaccinations (e.g., monkey pox vaccine, oral polio vaccine, varicella/zoster vaccines) within 6 weeks prior to Baseline
• 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)
• Subjects whose participation in the extension study could expose them to an undue safety risk