Ankylosing Spondylitis Clinical Trials

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A Multicenter Study Evaluating the Efficacy and Safety of Secukinumab 300mg in Chinese Adults With Active Ankylosing Spondylitis.

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

The purpose of this study is to evaluate the safety and efficacy of secukinumab 300mg in Chinese adults participants with active ankylosing spondylitis (AS) who have had an inadequate response to at least 2 non-steroidal anti-inflammatory drugs (NSAIDs) or intolerance to or a contraindication for NSAIDs, and who are naïve to biologic disease-modifying anti-rheumatic drugs (bDMARD).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Participant with a clinical diagnosis of ankylosing spondylitis (AS) and meeting the modified New York criteria for AS.

• Participant must have baseline disease activity as defined by having a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score \>= 4 and a Patient's Assessment of ●Total Back Pain score \>= 4 based on a 0 - 10 numeric rating scale (NRS) at the Screening and Baseline visits.

• Participant has had an inadequate response to at least two nonsteroidal anti-inflammatory drugs (NSAIDs) over an at least 4-week period in total at maximum recommended or tolerated doses, or participant has an intolerance to or contraindication for NSAIDs as defined by the Investigator.

• If entering the study on concomitant methotrexate (MTX), leflunomide, sulfasalazine (SSZ), and/or hydroxychloroquine, participant must be on a stable dose of MTX (\<= 25 mg/week) and/or SSZ (\<= 3 g/day) and/or hydroxychloroquine (\<= 400 mg/day) or leflunomide (\<= 20 mg/day) for at least 28 days prior to the Baseline visit. A combination of up to two background conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) is allowed except the combination of MTX and leflunomide.

• If entering the study on concomitant oral corticosteroids, participant must be on a stable dose of prednisone (\<= 10 mg/day), or oral corticosteroid equivalents, for at least 14 days prior to the Baseline visit.

• If entering the study on concomitant NSAIDs, tramadol, combination of acetaminophen and codeine or hydrocodone, and/or non-opioid analgesics, participant must be on stable dose(s) for at least 14 days prior to the Baseline visit.

Locations
Other Locations
China
Department of RheumatologyTongji Hospital
RECRUITING
Wuhan
Tongji Hospital
RECRUITING
Wuhan
Tongji Hospital
RECRUITING
Wuhan
Contact Information
Primary
YU YIKAI, M.D
yuyikai@163.com
15671678920
Time Frame
Start Date: 2024-06-14
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 100
Treatments
Experimental: Secukinumab 300mg
Induction with secukinumab 150 mg s.c. once per week (Week 0, 1, 2, 3 and 4) followed by maintenance with secukinumab 300 mg s.c. every 4 weeks for an additional 48 weeks.
Active_comparator: Secukinumab 150 mg
Induction with secukinumab 150 mg s.c. once per week (Week 0, 1, 2, 3 and 4) followed by maintenance with secukinumab 150 mg s.c. every 4 weeks for an additional 48 weeks.
Related Therapeutic Areas
Sponsors
Collaborators: Johns Hopkins Bloomberg School of Public Health, Wuhan Hospital of Traditional Chinese Medicine, Wuhan Central Hospital, Novartis
Leads: Tongji Hospital

This content was sourced from clinicaltrials.gov