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)

N/ANot Yet RecruitingNCT07737730

Novartis Pharmaceuticals60 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Axial Spondyloarthritis Ankylosing Spondylitis Non-Radiographic Axial Spondyloarthritis

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

Inclusion criteria: 1. Participant or his/her legally acceptable representative (LAR) who are willing to voluntarily provide signed informed consent for participation in the study. 2. Adult male or female participants (≥18 years) diagnosed with axSpA, AS, and nr-axSpA. Exclusion criteria: 1. Participants who meet any contraindication outlined in the current Prescribing Information (PI)/Package Insert for secukinumab at the time of screening. 2. Pregnant or lactating women. 3. 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.

Outcomes

Primary Outcomes

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

Time frame: Baseline through Week 20

Secondary Outcomes

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

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: 1. Fatigue 2. Spinal pain 3. Joint pain/swelling 4. Areas of localized tenderness 5. Morning stiffness severity 6. 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.

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