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

Ankylosing Spondylitis Clinical Trial

Official title:

Sequential Application of Yisaipu® and Disease Modifying Anti-Rheumatic Drugs (DMARDs) in Treating Mild-to-Moderate Ankylosing Spondylitis: the Mid-term Follow-up Result

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03411798
• Other study ID #: NFEC-201711-K6
• Status: Completed
• Phase: Phase 4
• Start date: December 15, 2017
• Est. completion date: July 1, 2019

Study information

• Verified date: July 2019
• Source: Nanfang Hospital of Southern Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: July 1, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Nanfang Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 months after
Primary	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	6 months after
Primary	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	12 months after
Primary	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	3 months after
Primary	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	6 months after
Primary	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	12 months after
Secondary	BASDAI	Bath Ankylosing Spondylitis Disease Activity Index	baseline,3 months after,6 months after,12 months after
Secondary	BASFI	BASDAI Bath Ankylosing Spondylitis Functional Index	baseline,3 months after,6 months after,12 months after
Secondary	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) .	baseline,3 months after,6 months after,12 months after
Secondary	CRP	acute-phase reactant(C-reactive protein)	baseline,3 months after,6 months after,12 months after
Secondary	ESR	acute-phase reactant(Erythrocyte Sedimentation rate )	baseline,3 months after,6 months after,12 months after
Secondary	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.	baseline,3 months after,6 months after,12 months after