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

Phase 4

• Conditions: Ankylosing Spondylitis
• Interventions: Biological: Adalimumab; Biological: Etanercept

• Registration Number: NCT02489760
• Lead Sponsor: Chung Shan Medical University

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2015-06-27
• Study First Submitted QC: 2015-07-01
• Study First Posted: 2015-07-03
• Primary Completion: 2015-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-18
• Last Update Posted: 2016-01-20
• Study Completion: 2016-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Etanercept switch to Adalimumab	Etanercept	At week 8, the control arm will be switched to adalimumab 40 mg subcutaneously biweekly for another 8 weeks.
Etanercept switch to Adalimumab	Adalimumab	At week 8, the control arm will be switched to adalimumab 40 mg subcutaneously biweekly for another 8 weeks.
Adalimumab switch to Etanercept	Adalimumab	At week 8, the treatment arm will be switched to etanercept 25 mg subcutaneously biweekly for another 8 weeks.
Adalimumab switch to Etanercept	Etanercept	At week 8, the treatment arm will be switched to etanercept 25 mg subcutaneously biweekly for another 8 weeks.

Primary Outcome Measures

Name	Time	Method
Bath AS disease activity index (BASDAI)	weeks 8	The score of BASDAI on weeks 8

Trial Locations

Locations (1)

Chung Shan Medical University Hospital; 🇨🇳 Taichung, Taiwan