Status:
RECRUITING
Open-label, Long-term Safety Study of Secukinumab in Polymyalgia Rheumatica (PMR)
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Polymyalgia Rheumatica
Eligibility:
All Genders
50-100 years
Phase:
PHASE3
Brief 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.
Detailed Description
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 dos...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 28 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 22 2028
Estimated Enrollment :
288 Patients enrolled
Trial Details
Trial ID
NCT06331312
Start Date
June 28 2024
End Date
August 22 2028
Last Update
March 11 2026
Active Locations (115)
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1
Arizona Arthritis and Rheumatology Associates PLLC
Avondale, Arizona, United States, 85392
2
Sun Valley Arthritis Center Ltd
Peoria, Arizona, United States, 85381
3
Orrin Troum MD and Medical Associates
Santa Monica, California, United States, 90404
4
Center for Rheumatology Research
West Hills, California, United States, 91307