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

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

Detailed Description
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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.

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

Conditions
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Ankylosing Spondylitis

Intervention / Treatment
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* Biological: Adalimumab
* Biological: Etanercept


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Serum creatinine ≥3.0 mg/dl. GPT≥5 times the laboratory's upper limit of normal. Pregnant or breast-feeding women.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adalimumab switch to Etanercept<br>At week 8, the treatment arm will be switched to etanercept 25 mg subcutaneously biweekly for another 8 weeks. | Biological: Adalimumab<br>* The treatment arm will receive adalimumab 40 mg subcutaneously biweekly<br>* Other names: Humira;Biological: Etanercept<br>* The control arm will continue etanercept 25 mg subcutaneously twice a week<br>* Other names: Enbrel;|
| Experimental: Etanercept switch to Adalimumab<br>At week 8, the control arm will be switched to adalimumab 40 mg subcutaneously biweekly for another 8 weeks. | Biological: Adalimumab<br>* The treatment arm will receive adalimumab 40 mg subcutaneously biweekly<br>* Other names: Humira;Biological: Etanercept<br>* The control arm will continue etanercept 25 mg subcutaneously twice a week<br>* Other names: Enbrel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bath AS disease activity index (BASDAI) | The score of BASDAI on weeks 8 | weeks 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Etanercept, Adalimumab, Ankylosing Spondylitis, Switch Study