Polymyalgia Rheumatica
Conditions
Interventions
Biological: Secukinumab
2 x 150mg/1mL PFS secukinumab
Sponsors
Maruyama Hideki
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidences of treatment emergent adverse events (AEs) and serious adverse events (SAEs) | — |
Countries
Australia, Japan
Contacts
Public ContactHideki Maruyama
Novartis Pharma. K.K.
Outcome results
None listed