A Study to Assess the Safety of Subcutaneous Secukinumab for Treatment in Adult Indian Participants With Axial Spondyloarthritis (axSpA),... | NCT07737730

NCT07737730

Overview

NCT ID: NCT07737730
Lead Sponsor: Novartis PharmaceuticalsINDUSTRY
Official Title: A Prospective, Observational, Multicentre Study to Assess the Safety of Subcutaneous Secukinumab 150 mg Solution for Treatment in Adult Indian Participants With Axial Spondyloarthritis (axSpA), Ankylosing Spondylitis (AS), and Non-Radiographic Axial Spondyloarthritis (nr-axSpA) Over a Period of 16 Weeks
Brief Summary: The aim of this study is to assess the safety of secukinumab in Indian adult participants with axSpA, AS, and nr-axSpA over a 16-week treatment period. The present study is being undertaken to fulfill the Post Marketing Surveillance (PMS) mandate by the Health Authority (HA) to evaluate the safety of secukinumab solution for injection administered subcutaneously in a pre-filled pen in the indicated population under real-world clinical practice conditions.
Conditions: Axial Spondyloarthritis
Ankylosing Spondylitis

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion criteria:

Participant or his/her legally acceptable representative (LAR) who are willing to voluntarily provide signed informed consent for participation in the study.

Adult male or female participants (≥18 years) diagnosed with axSpA, AS, and nr-axSpA.

Exclusion criteria:

Participants who meet any contraindication outlined in the current Prescribing Information (PI)/Package Insert for secukinumab at the time of screening.

Pregnant or lactating women.

Any surgical and/or medical condition, which in the opinion of the treating physician, may place the participant at higher risk of his/her participation in the study, or is likely to prevent the participant from complying with the requirements of the study or completing the study.

Central Contacts: Novartis PharmaceuticalsContact
novartis.email@novartis.com+41613241111