Ankylosing Spondylitis
Conditions
Keywords
ankylosing spondylitis(AS), TNFi, Yisaipu®, Disease modifying anti-rheumatic drugs (DMARDs)
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.
Interventions
DRUGYisaipu®
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.
Sponsors
Nanfang Hospital, Southern Medical University
Study design
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ASAS 20 | 3 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 | 3 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
| Measure | Time frame | Description |
|---|---|---|
| Patient Global Assessment | baseline,3 months after,6 months after,12 months after | Measuring disease activity by using the visual analogue scales (VAS) on which patients rated the severity of their symptoms from 0 (none) to 10 (most severe) . |
| CRP | baseline,3 months after,6 months after,12 months after | acute-phase reactant(C-reactive protein) |
| BASDAI | baseline,3 months after,6 months after,12 months after | Bath Ankylosing Spondylitis Disease Activity Index |
| SQOL-AS | baseline,3 months after,6 months after,12 months after | SQOL-AS(The Scale of Quality of Life for Ankylosing Spondylitis) questionnaire consists of physiological function, psychological state, social adaptation and self-awareness 4 dimensions. There are 5 to 8 questions in every dimension. The score ranges are 8 to 40 for physiological function, 6 to 30 for psychological state, 5 to 25 for social adaptation and 6 to 30 for self-awareness. The more score that patients got means the better state they were in that dimension, namely, the batter quality of life. |
| ESR | baseline,3 months after,6 months after,12 months after | acute-phase reactant(Erythrocyte Sedimentation rate ) |
| BASFI | baseline,3 months after,6 months after,12 months after | BASDAI Bath Ankylosing Spondylitis Functional Index |
Countries
China
Outcome results
None listed