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

This study is open to adults aged 50 to 100 years old. To join, you must have already taken part in a specific previous Novartis study looking at secukinumab for PMR. During that earlier study, you would have completed the 52-week treatment period.

It's important that your PMR symptoms came back after you stopped treatment in that first study, and that you haven't started any new rescue treatments since then. Your doctor will also need to review your overall health to make sure that taking secukinumab would likely benefit you, and that the potential benefits outweigh any possible risks.

However, you wouldn't be able to join if you have certain active infections, like HIV or hepatitis, or if you've had certain types of cancer within the last five years. Also, if you've recently had certain live vaccines or are taking specific medications that aren't allowed in the study, you wouldn't be eligible.

If you join this study, your involvement could last for up to two years and four months in total. First, there will be a screening period of about four weeks to check if the study is right for you. If you qualify, you'll start the treatment period, which can last up to two years.

During the first six months (24 weeks) of treatment, you will visit the study site every four weeks. After that, for the rest of the two-year period, you'll mainly visit every 12 weeks to get more medication. However, if you prefer, or if you're not comfortable giving yourself the medication at home, you can continue to visit the clinic every four weeks for your medication. Throughout this time, your health will be regularly checked by the study team.

After you stop taking the study medication, there will be a follow-up period of about 16 weeks. You'll have one final visit about 20 weeks after your last dose of secukinumab, even if you stop the study early for any reason.