Status:
UNKNOWN
Treat-to-target Strategy in Ankylosing Spondylitis Using Etanercept and Conventional Synthetic DMARDs
Lead Sponsor:
Nanfang Hospital, Southern Medical University
Conditions:
Ankylosing Spondylitis
Spondyloarthritis
Eligibility:
All Genders
18-50 years
Phase:
PHASE4
Brief Summary
This study evaluates clinical responses and cost-effectiveness of using etanercept (ETN) and conventional synthetic Disease modifying anti-rheumatic drugs (csDMARDs) with treat-to-target strategy in a...
Detailed Description
The tumor necrosis factor inhibitors(TNFi) like etanercept(ETN) has been always recommended as the primary treatment option for active AS. But when sustained applied in daily clinical practices, it is...
Eligibility Criteria
Inclusion
- Capability to understand and voluntarily give written informed consent that is signed and dated, before any specific procedure of the protocol is performed.
- Patients 18 to 45 years of age.
- Proven AS according to the modified New York criteria.
- Acute phase of disease with ASDAS score ≥1.3.
- Ability to reconstitute the drug and self-inject it or have a person who can do so.
- Ability to store injectable test article at 2º to 8º C.
Exclusion
- Patients with a history of active tuberculosis, hepatitis, gastrointestinal hemorrhage, tumors, infectious diseases or combined with other rheumaimmune systemic diseases or osteoarthritis diseases.
- Pregnancy/lactation.
- Receipt of any live (attenuated) vaccines within 4 weeks before the screening visit.
- Significant concurrent medical diseases including uncompensated congestive heart failure (NYHA III-IV), myocardial infarction within 12 months, stable or unstable angina pectoris, uncontrolled hypertension, severe pulmonary disease, history of human immunodeficiency virus (HIV) infection.
- Participation in trials of other investigational medications within 30 days of entering the study.
- Clinical examination showing significant abnormalities of clinical relevance.
Key Trial Info
Start Date :
October 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 2 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04077957
Start Date
October 7 2019
End Date
July 2 2022
Last Update
September 26 2019
Active Locations (1)
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1
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510515