NCT05164198

REduCed Dose of TNFi in Patients With Ankylosing SpondyliTis (RECAST)

Multicenter, Prospective Clinical Trial for Optimizing TNF Inhibitor Dose Adjustment in Ankylosing Spondylitis Patients With Stable Disease Activity

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 448 (estimated)
• Sponsor: Hanyang University Seoul Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Participants maintaining stable disease activity of Ankylosing Spondylitis (AS) with standard-dose tumor necrosis factor inhibitor (TNFi) treatment will randomly split into two groups: maintaining standard-dose TNFi, versus reduced-dose TNFi. The proportion of participants not underwent flare between the two groups will be analyzed.

Conditions

• Ankylosing Spondylitis
• Axial Spondyloarthritis

Interventions

Type	Name	Description
BIOLOGICAL	Adalimumab and its biosimilars	1. Active substance: Adalimumab 2. Pharmaceutical form: Prefilled syringe 3. Concentration: 100mg/mL 4. Route of administration: Subcutaneous injection
BIOLOGICAL	Biological: Etanercept and its biosimilars	1. Active substance: Etanercept 2. Pharmaceutical form: Prefilled syringe 3. Concentration: 50mg/mL 4. Route of administration: Subcutaneous injection
BIOLOGICAL	Golimumab	1. Active substance: Adalimumab 2. Pharmaceutical form: Prefilled syringe 3. Concentration: 100mg/mL 4. Route of administration: Subcutaneous injection
BIOLOGICAL	Infliximab biosimilar	1. Active substance: Infliximab 2. Pharmaceutical form: Prefilled syringe 3. Concentration: 120mg/mL 4. Route of administration: Subcutaneous injection

Timeline

• Start date: 2022-01-15
• Primary completion: 2024-10-31
• Completion: 2024-10-31
• First posted: 2021-12-20
• Last updated: 2021-12-20

Regulatory

• FDA-regulated drug study