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.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
76
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.
Nanfang Hospital
Guangzhou, Guangdong, China
ASAS 20
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
Time frame: 3 months after
ASAS 20
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
Time frame: 6 months after
ASAS 20
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
Time frame: 12 months after
ASAS 40
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
Time frame: 3 months after
ASAS 40
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
Time frame: 6 months after
ASAS 40
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
Time frame: 12 months after
BASDAI
Bath Ankylosing Spondylitis Disease Activity Index
Time frame: baseline,3 months after,6 months after,12 months after
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
BASFI
BASDAI Bath Ankylosing Spondylitis Functional Index
Time frame: baseline,3 months after,6 months after,12 months after
Patient Global Assessment
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) .
Time frame: baseline,3 months after,6 months after,12 months after
CRP
acute-phase reactant(C-reactive protein)
Time frame: baseline,3 months after,6 months after,12 months after
ESR
acute-phase reactant(Erythrocyte Sedimentation rate )
Time frame: baseline,3 months after,6 months after,12 months after
SQOL-AS
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.
Time frame: baseline,3 months after,6 months after,12 months after