Etanercept and Celecoxib Alone/Combined Treatment in Effectiveness and Safety of Active Ankylosing Spondylitis

• Status: Completed
• Trial end date: 2017-01-30
• Target enrollment: 0
• Participant gender: All

Summary

This is a multi-center, open label, randomized clinical trial of etanercept and celecoxib alone/combined treatment in effectiveness and safety on active ankylosing spondylitis (AS). Subjects will be randomly assigned in a 1:1:1 ratio to one of the three groups (celexocib 200mg bid, etanercept 50mg qw, etanercept plus Celecoxib group) for 54 weeks. Primary endpoints are the magnetic resonance imaging (MRI) Spondyloarthritis Research Consortium of Canada (SPARCC) score of sacroiliac(SI) joint and spine, as well as the Assessment of SpondyloArthritis International Society (ASAS)20 response rate at 52 weeks.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Celecoxib; Etanercept

Criteria

Inclusion Criteria:

• 18 to 65 years

• Meet 1984 NewYork modified criteria for AS

• BASDAI≥4 or ASDAS score ≥ 2.1

• CRP>6 mg/L or ESR>28 mm/h

• Syndesmophyte quantity ≥2 and <16 of spine

• Sexually active women of childbearing potential must agree and commit to use a medically accepted form of contraception

• No active or latent tuberculosis infection.

Exclusion Criteria:

• Pregnant or breastfeeding women

• current or previous history of psoriasis or inflammatory bowel disease.

• infection with clinical significance within 24 weeks before screening

• receipt any bio-agents treatment within 12 weeks before screening

• corticosteroids intra-articular injections in last 3 months before the trial

• Significant concurrent medical events including: Gastrointestinal ulcer, myocardial infarction within 12 months before the screening visit, unstable angina pectoris, congestive heart failure.

• Alcohol and drug abuse