A Study to Assess the Safety of Subcutaneous Secukinumab for Treatment in Adult Indian Participants With Axial Spondyloarthritis (axSpA), Ankylosing Spondylitis (AS), and Non-Radiographic Axial Spondyloarthritis (nr-axSpA)

NCT07737730 | Not Yet Recruiting

• 1 other identifier: CAIN457FIN02
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

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; Non-Radiographic Axial Spondyloarthritis

Keywords

Axial Spondyloarthritis,; Ankylosing Spondylitis,; Non-Radiographic Axial Spondyloarthritis; Secukinumab; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Number and Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)

  Baseline through Week 20

Secondary Outcomes (1)

• Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

  Baseline, Weeks 4, 8, 12, and 16

Study Arms (1)

Secukinumab Cohort

Adult participants diagnosed with axSpA, AS, and nr-axSpA for whom the treating physician prescribes treatment with secukinumab 150 mg subcutaneous as per approved label.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult participants with axSpA, AS, and nr-axSpA for whom the treating physician prescribes treatment with secukinumab 150 mg subcutaneous as part of routine clinical care.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Conditions

Axial Spondyloarthritis; Spondylitis, Ankylosing; Non-Radiographic Axial Spondyloarthritis

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2026
• First Posted: July 30, 2026
• Study Start (Estimated): September 30, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share