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NCT Number: NCT07737730

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)

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.

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Key information

Conditions

Axial Spondyloarthritis Ankylosing Spondylitis Ankylosis Arthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Non-Radiographic Axial Spondyloarthritis Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: Baseline through Week 20

Secondary outcomes

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

    Time frame: Baseline, Weeks 4, 8, 12, and 16

    The BASDAI is a validated diagnostic tool used to assess disease activity and effectiveness of treatment in AS participants. It consists of 6 questions pertaining to the 5 major symptoms of AS:

    • Fatigue
    • Spinal pain
    • Joint pain/swelling
    • Areas of localized tenderness
    • Morning stiffness severity
    • Morning stiffness duration

    Participants answer each question using a Visual Analog Scale (VAS) with 0 being no problem and 10 being the worst problem. The scores from questions 1-4 are summed and added to the mean score of questions 4 and 5. The resulting 0-50 score is divided by 5 to obtain the overall BASDAI score. Higher BASDAI scores indicate higher disease activity.

Study contacts

Contact information is provided by the study sponsor or research team.

Novartis Pharmaceuticals

CONTACT

[email protected]

+41613241111

Novartis Pharmaceuticals

CONTACT

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 30, 2026
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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