Treat-to-Target Strategy With Etanercept for Ankylosing Spondylitis

• Status: Completed
• Trial end date: 2014-09-30
• Target enrollment: 0
• Participant gender: All

Summary

Evaluate the disease activity guided tapering and discontinuation strategies of etanercept (ETN) in patients with ankylosing spondylitis (AS) in 48 weeks.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Collaborators: First Affiliated Hospital of Wenzhou Medical University; Ningbo Medical Center Lihuili Hospital; Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine; Shanghai Jiao Tong University Affiliated Sixth People's Hospital; Shaoxing People's Hospital; Shaoxing Second Hospital; The First Hospital of Jiaxing; Wenzhou Central Hospital; Zhejiang Provincial People's Hospital; Zhejiang Provincial People’s Hospital
• Treatments: Etanercept

Criteria

Inclusion Criteria:

• aged between 18 years old and 65 years old with AS, according to 1984-revised New York classification criteria.

• an active disease of ASDAS with C reactive protein (ASDAS-CRP) ≥2.1.

• a disease duration of 6 months to 30 years.

• no exposure to biologics in recent 6 months before recruitment. Concomitant medications with NSAIDs, conventional disease modifying anti-rheumatic drugs (cDMARDs), or prednisone or a prednisone equivalent (≤10mg/day), were allowed to continue if they were maintained at a stable dose for 4 weeks or more from baseline.

Exclusion Criteria:

• late-stage patients with spinal fusion.

• patients with severe cardiac, hepatic, renal, hematologic or endocrine diseases.

• patients with a history of multiple sclerosis, current or past malignancy.

• patients who were pregnant, or planning to become pregnant, or breastfeeding.

• patients with active or recurrent infections, or those who required oral antibiotics 2 weeks or intravenous antibiotics 4 weeks before screening.

• patients with current or past or potential tuberculosis.