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Active Not Recruiting NCT06331312

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

Conditions: Polymyalgia Rheumatica

Sex: All
Ages: 50 Years – 100 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 162
Sponsor: Novartis Pharmaceuticals

Location: Arizona Arthritis and Rheumatology Associates PLLC Avondale Arizona

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 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06331312). StuddyBuddy aggregates publicly available trial information.