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

• Register: ClinicalTrials.gov
• 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
• URL: https://clinicaltrials.gov/show/NCT02489760
• 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

Taiwan

Contacts

• 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
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.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Ankylosing Spondylitis

Intervention(s)

Biological: Etanercept

Biological: Adalimumab

Primary Outcome(s)

Bath AS disease activity index (BASDAI) [Time Frame: weeks 8]

Secondary ID(s)

CS08019

Source(s) of Monetary Support

Please refer to primary and secondary sponsors