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

Chung Shan Medical University

Status and phase: Unknown; Phase 4

Conditions: Ankylosing Spondylitis

Treatments: Biological: Etanercept; Biological: Adalimumab

Study type: Interventional

Funder types: Other

Identifiers

NCT02489760

CS08019

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Adalimumab switch to Etanercept

Experimental group

Description:

At week 8, the treatment arm will be switched to etanercept 25 mg subcutaneously biweekly for another 8 weeks.

Treatment:

Biological: Adalimumab

Biological: Etanercept

Etanercept switch to Adalimumab

Experimental group

Description:

At week 8, the control arm will be switched to adalimumab 40 mg subcutaneously biweekly for another 8 weeks.

Treatment:

Biological: Adalimumab

Biological: Etanercept