A multi-center, open-label extension study of subcutaneous secukinumab to evaluate the long-term safety and tolerability in polymyalgia rheumatica (PMR)

JRCT ID: jRCT2031240079

Registered date:13/05/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Polymyalgia Rheumatica
• Date of first enrollment: 27/05/2024
• Target sample size: 27
• Countries of recruitment: Australia,Japan
• Study type: Interventional

Intervention(s)

Biological: Secukinumab
2 x 150mg/1mL PFS secukinumab

Outcome(s)

• Primary Outcome: Incidences of treatment emergent adverse events (AEs) and serious adverse events (SAEs)

Key inclusion & exclusion criteria

• Age minimum: >= 50age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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

Related Information

• Primary Sponsor: Maruyama Hideki
• Secondary ID(s): NCT06331312