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

Ankylosing Spondylitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02489760
• Other study ID #: CS08019
• Status: Active, not recruiting
• Phase: Phase 4
• First received: June 27, 2015
• Last updated: January 18, 2016
• Start date: July 2008
• Est. completion date: October 2016

Study information

• Verified date: January 2016
• Source: Chung Shan Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: October 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Biological:
• Adalimumab
The treatment arm will receive adalimumab 40 mg subcutaneously biweekly
• Etanercept
The control arm will continue etanercept 25 mg subcutaneously twice a week

Locations

Country	Name	City	State
Taiwan	Chung Shan Medical University Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
Chung Shan Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bath AS disease activity index (BASDAI)	The score of BASDAI on weeks 8	weeks 8	Yes