Etanercept Versus Adalimumab in the Treatment of Patients With Ankylosing Spondylitis. A Switch Study
This trial is active, not recruiting.
|Sponsor||Chung Shan Medical University|
|Start date||July 2008|
|End date||December 2015|
|Trial size||30 participants|
|Trial identifier||NCT02489760, CS08019|
To determine the safety and efficacy of switch effects to adalimumab in etanercept-treated AS patients.
|Endpoint classification||safety/efficacy study|
|Intervention model||crossover assignment|
Bath AS disease activity index (BASDAI)
time frame: weeks 8
Male or female participants from 18 years up to 70 years old.
- Diagnosis of AS, as defined by 1984 Modified New York Criteria for AS.
- Stable background therapy as non-steroid anti-inflammatory for 2 weeks.
- Stable glucocorticoid for 4 weeks.
- Stable disease-modifying anti-rheumatic drugs, eg. sulphasalazine, methotrexate for 8 weeks.
- Stable anti-TNF biologics for 4 weeks.
- Written informed consent.
- Serum creatinine ≥3.0 mg/dl.
- GPT≥5 times the laboratory's upper limit of normal.
- Pregnant or breast-feeding women.
|Official title||Etanercept Versus Adalimumab in the Treatment of Patients With Ankylosing Spondylitis. A Switch Study|
|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.|
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