Sequential Application of Yisaipu® and Disease Modifying Anti-Rheumatic Drugs (DMARDs) in Treating Mild-to-Moderate Ankylosing Spondylitis: the Mid-term Follow-up Result
Overview
- Phase
- Phase 4
- Intervention
- Yisaipu®
- Conditions
- Ankylosing Spondylitis
- Sponsor
- Nanfang Hospital, Southern Medical University
- Enrollment
- 76
- Locations
- 1
- Primary Endpoint
- ASAS 20
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The drug regimes in treating ankylosing spondylitis(AS) have limitations. The tumor necrosis factor inhibitors(TNFi) was effective but expensive. Disease modifying anti-rheumatic drugs (DMARDs) were cheap but insufficient. This study proposed a sequential usage of TNFi, the Yisaipu®, and DMARDs, and aims to evaluate the mid-term therapeutic effect of this new scheme in treating the mild-to-moderate AS.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1.Clinical diagnosis of Ankylosing Spondylitis(AS) based on modified New York diagnostic criteria for AS (1984) 2.At the mild-to-moderate stage of AS disease 3.At the active phase of AS disease
Exclusion Criteria
- •1.Active tuberculosis, hepatitis, tumors, infection diseases or combine with other rheumaimmune systemic diseases or osteoarthritis diseases 2.Pregnant or breastfeeding women
Arms & Interventions
Experimental
Yisaipu® was introduced only during the active state and was switched to DMARDs, methotrexate(MTX), sulfasalazine(SSZ) and hydroxychloroquine(HCQ), after disease remission (ESR \& CRP reduce to normal and BASDAI\<4) maintenance.
Intervention: Yisaipu®
Outcomes
Primary Outcomes
ASAS 20
Time Frame: 12 months after
Improvement of \>20% and \>1 unit in at least 3 domains on a scale of 10;No worsening of \>20% and \>1 unit in remaining domain on a scale of 10 compare to the baseline status
ASAS 40
Time Frame: 12 months after
Improvement of \>40% and \>2 unit in at least 3 domains on a scale of 10;No worsening at all in remaining domain compare to the baseline status
Secondary Outcomes
- BASDAI(baseline,3 months after,6 months after,12 months after)
- Patient Global Assessment(baseline,3 months after,6 months after,12 months after)
- CRP(baseline,3 months after,6 months after,12 months after)
- ESR(baseline,3 months after,6 months after,12 months after)
- BASFI(baseline,3 months after,6 months after,12 months after)
- SQOL-AS(baseline,3 months after,6 months after,12 months after)