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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02489760

Enrollment

Registered

2015-07-03

Start date

2008-07-31

Completion date

2016-10-31

Last updated

2016-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankylosing Spondylitis

Keywords

Etanercept, Adalimumab, Ankylosing Spondylitis, Switch Study

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.

Interventions

BIOLOGICALAdalimumab

The treatment arm will receive adalimumab 40 mg subcutaneously biweekly

BIOLOGICALEtanercept

The control arm will continue etanercept 25 mg subcutaneously twice a week

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Bath AS disease activity index (BASDAI)	weeks 8	The score of BASDAI on weeks 8

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026