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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
The treatment arm will receive adalimumab 40 mg subcutaneously biweekly
The control arm will continue etanercept 25 mg subcutaneously twice a week
Chung Shan Medical University Hospital
Taichung, Taiwan
Bath AS disease activity index (BASDAI)
The score of BASDAI on weeks 8
Time frame: weeks 8
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