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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 1 February 2016
Main ID:  NCT02489760
Date of registration: 27/06/2015
Prospective Registration: No
Primary sponsor: Chung Shan Medical University
Public title: Etanercept Versus Adalimumab in the Treatment of Patients With Ankylosing Spondylitis. A Switch Study
Scientific title: Etanercept Versus Adalimumab in the Treatment of Patients With Ankylosing Spondylitis. A Switch Study
Date of first enrolment: July 2008
Target sample size: 30
Recruitment status: Active, not recruiting
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  Phase 4
Countries of recruitment
Name:     Wei C- C, M.D.
Affiliation:  Chung Shan Medical University
Key inclusion & exclusion criteria

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

- 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.

Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Ankylosing Spondylitis
Biological: Adalimumab
Biological: Etanercept
Primary Outcome(s)
Bath AS disease activity index (BASDAI) [Time Frame: weeks 8]
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results available:
Date Posted:
Date Completed:
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