Overview

This trial is active, not recruiting.

Condition ankylosing spondylitis
Treatments adalimumab, etanercept
Phase phase 4
Target TNF-alpha
Sponsor Chung Shan Medical University
Start date July 2008
End date December 2015
Trial size 30 participants
Trial identifier NCT02489760, CS08019

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
At week 8, the treatment arm will be switched to etanercept 25 mg subcutaneously biweekly for another 8 weeks.
adalimumab Humira
The treatment arm will receive adalimumab 40 mg subcutaneously biweekly
etanercept Enbrel
The control arm will continue etanercept 25 mg subcutaneously twice a week
(Experimental)
At week 8, the control arm will be switched to adalimumab 40 mg subcutaneously biweekly for another 8 weeks.
adalimumab Humira
The treatment arm will receive adalimumab 40 mg subcutaneously biweekly
etanercept Enbrel
The control arm will continue etanercept 25 mg subcutaneously twice a week

Primary Outcomes

Measure
Bath AS disease activity index (BASDAI)
time frame: weeks 8

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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.

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Chung Shan Medical University.