RecruitingPhase 3NCT06331312
Open-label, Long-term Safety Study of Secukinumab in Polymyalgia Rheumatica (PMR)
A Multi-center, Open-label Extension Study of Subcutaneous Secukinumab to Evaluate the Long-term Safety and Tolerability in Polymyalgia Rheumatica (PMR)
Sponsor
Novartis Pharmaceuticals
Enrollment
288 participants
Start Date
Jun 28, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
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
Min Age: 50 YearsMax Age: 100 Years
Inclusion Criteria4
- 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 Criteria5
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
BIOLOGICALSecukinumab
2 x 150mg/1mL PFS secukinumab
Locations(115)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06331312
Related Trials
Effect of Supplemental Hydrocortisone During Stress in Prednisolone-induced Adrenal Insufficiency
NCT054357813 locations
Rheumatology Patient Registry and Biorepository
NCT044020861 location
A Qualitative Assessment of the Severity and Impact of Rheumatic Immune-Related Adverse Events Following Immune Checkpoint Inhibitor Immunotherapy
NCT066471341 location
Induction and Tapering Therapy With Tofacitinib and Glucocorticoid in Patients With Polymyalgia Rheumatica
NCT061723611 location
Assessing Biomarker in Giant Cell Arteritis and Polymyalgia Rheumatic
NCT064601421 location