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

Launched by NOVARTIS PHARMACEUTICALS · Mar 20, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at the long-term safety and tolerability of a medication called secukinumab for patients with polymyalgia rheumatica (PMR), a condition that causes muscle pain and stiffness. The study is currently recruiting participants who have previously completed a related study and experienced a relapse after stopping treatment. To be eligible, participants need to be at least 18 years old and should not have received certain medications or have specific health conditions that could put them at risk.

If you join this study, you will receive secukinumab and will be monitored for how well you tolerate the medication over time. The researchers want to ensure that the benefits of taking secukinumab outweigh any potential risks. It's important to know that participants will not be able to take certain medications or receive live vaccines during the study. Overall, this trial aims to gather more information about how safe secukinumab is for people with PMR when used for a longer period.

Gender

ALL

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