NCT05527444

The Clinical Efficacy and the Changes of Immune Cells Subsets With Bioagents in Ankylosing Spondylitis Patients

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Qilu Hospital of Shandong University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the clinical efficacy, safety and immunological changes of secukinumab(sec) compared to adalimumab(ada) in patients with active ankylosing spondylitis(AS), who previously have an inadequate response to non-steroidal anti-inflammatory drugs (NSAIDs) or bioagents.

Detailed description

Biologic naïve participants will be randomly assigned in a 2:1 ratio to receive secukinumab or adalimumab for 24 weeks. Participants with a history of an inadequate response to secukinumab or adalimumab, will be treated with the alternative drug (adalimumab or secukinumab) for 24 weeks. The disease activity and index of inmunology will be evaluated at weeks 0, 12, 24 up to 96 weeks.

Conditions

• Ankylosing Spondylitis

Interventions

Type	Name	Description
DRUG	Secukinumab 150 mg/ml	Secukinumab 150 mg will be administered at Baseline, Week 1, 2, 3, 4, 6, 8 followed by dosing every 4 weeks until Week 24
DRUG	Adalimumab Ab	adalimumab biosimilar 40 mg will be administered at Baseline followed by dosing every 2 weeks until Week 24
DRUG	NSAID	stable dose
DRUG	Thalidomide Pill	If patients have inadequate response to bioagents, thalidomide 50 mg will be administered at 12 week followed by dosing everyday until Week 24.

Timeline

• Start date: 2022-03-15
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2022-09-02
• Last updated: 2023-11-18

Locations

1 site across 1 country: China