Ankylosing Spondylitis Clinical Trial
Official title:
Etanercept Versus Adalimumab in the Treatment of Patients With Ankylosing Spondylitis. A Switch Study
To determine the safety and efficacy of switch effects to adalimumab in etanercept-treated AS patients.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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