Sequential Application of Yisaipu® and DMARDs in Treating Mild-to-Moderate AS

Phase 4

Completed

• Conditions: Ankylosing Spondylitis
• Interventions: Drug: Yisaipu®

• Registration Number: NCT03411798
• Lead Sponsor: Nanfang Hospital, Southern Medical University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-14
• Study Start: 2017-12-15
• Study First Submitted QC: 2018-01-19
• Study First Posted: 2018-01-26
• Status Verified: 2019-07
• Primary Completion: 2019-07-01
• Study Completion: 2019-07-01
• Last Update Submitted: 2019-08-21
• Last Update Posted: 2019-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Experimental	Yisaipu®	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.

Primary Outcome Measures

Name	Time	Method
ASAS 20	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	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 Outcome Measures

Name	Time	Method
BASDAI	baseline,3 months after,6 months after,12 months after	Bath Ankylosing Spondylitis Disease Activity Index
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)
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
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.

Trial Locations

Locations (1)

Nanfang Hospital; 🇨🇳 Guangzhou, Guangdong, China