NCT02489760

Etanercept Versus Adalimumab in the Treatment of Patients With Ankylosing Spondylitis. A Switch Study

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Chung Shan Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

To determine the safety and efficacy of switch effects to adalimumab in etanercept-treated AS patients.

Detailed description

This single-centre, open-labeled randomized controlled study will evaluate the safety and efficacy of adalimumab in etanercept-treated Ankylosing Spondylitis(AS) patients. Thirty patients will be enrolled and randomized equally into two arms. Dosage and Administration：For standard dose(etanercept 50 mg weekly) treated patients, the treatment arm will receive adalimumab 40 mg subcutaneously biweekly for 8 weeks. The control arm will continue etanercept 25 mg subcutaneously twice a week for 8 weeks. At week 8, the control arm will be switched to adalimumab 40 mg subcutaneously biweekly for another 8 weeks.For half dose(etanercept 25 mg weekly) treated patients, the treatment arm will receive adalimumab 40 mg subcutaneously monthly for 8 weeks. The control arm will continue etanercept 25 mg subcutaneously weekly for 8 weeks. At week 8, the control arm will be switched to adalimumab 40 mg subcutaneously monthly for another 8 weeks.

Conditions

• Ankylosing Spondylitis

Interventions

Type	Name	Description
BIOLOGICAL	Adalimumab	The treatment arm will receive adalimumab 40 mg subcutaneously biweekly
BIOLOGICAL	Etanercept	The control arm will continue etanercept 25 mg subcutaneously twice a week

Timeline

• Start date: 2008-07-01
• Primary completion: 2015-12-01
• Completion: 2016-10-01
• First posted: 2015-07-03
• Last updated: 2016-01-20

Locations

1 site across 1 country: Taiwan