Study Description
The purpose of this extension study is to assess the safety and tolerability of
secukinumab when administered long-term in patients with polymyalgia rheumatica. The study will consist of an up to 4-week screening period, an up to 2-year Treatment
Period which includes two Treatment Periods, and a 16-week treatment-free follow-up
period (20 weeks post last dose of secukinumab).
Treatment period:
There will be two Treatment Periods (TPs): TP1 will be from the first dose administration
of secukinumab (Baseline) to Week 24, where visits will occur every 4 weeks, and TP2 will
be from post Week 24 visit (post-dose) to up to 2 years. Participants will return to the
study site every 4 weeks from Baseline until Week 24 (Weeks 16 and 20 visits are optional
on-site visits and needed when participants are unwilling/uncomfortable to
self-administer study treatment at home/offsite), then every 12 weeks afterwards in TP2
for resupply of study medication but may return earlier if needed (i.e., those
participants who are unwilling/uncomfortable to self-administer study treatment can
continue to visit site every 4 weeks for drug administration if they wish to do so).
Follow-up period: An EoS visit (20 weeks after last administration of secukinumab) will
be done for all participants, regardless of whether they complete the entire study as
planned, or they discontinue prematurely.
Interventions
Secukinumab
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
Study Location
Novartis Investigative Site
Recruiting
Parramatta,2150,Australia
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