Treat-to-target Strategy in Ankylosing Spondylitis Using Etanercept and Conventional Synthetic DMARDs

• Status: Not yet recruiting
• Trial end date: 2022-07-02
• Target enrollment: 0
• Participant gender: All

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 ankylosing spondylitis patients. Half of participants will be used treat-to-target strategy with ETN and csDMARDs, while the others will be used conventional therapy scheme with ETN only.

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

Details

• Lead Sponsor: Nanfang Hospital of Southern Medical University
• Treatments: Antirheumatic Agents; Etanercept; Hydroxychloroquine; Methotrexate; Sulfasalazine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.