Ankylosing Spondylitis, Axial Spondyloarthritis, Non-Radiographic Axial Spondyloarthritis
Conditions
Keywords
Axial Spondyloarthritis,, Ankylosing Spondylitis,, Non-Radiographic Axial Spondyloarthritis, Secukinumab, Quality of Life
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.
Interventions
None listed
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number and Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | Baseline through Week 20 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | 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: 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. |
Contacts
CONTACTNovartis Pharmaceuticals
STUDY_DIRECTORNovartis Pharmaceuticals
Novartis Pharmaceuticals
Outcome results
None listed