Skip to main content
OpenTrials
Completed

NCT Number: NCT03411798

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ankylosing Spondylitis Ankylosis Arthritis Axial Spondyloarthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Nanfang Hospital

Guangzhou, Guangdong, 510515, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Yisaipu®

Drug

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.

Other names: methotrexate(MTX), sulfasalazine(SSZ), hydroxychloroquine(HCQ)

Primary outcomes

  1. ASAS 20

    Time frame: 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

  2. ASAS 20

    Time frame: 6 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

  3. 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

  4. ASAS 40

    Time frame: 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

  5. ASAS 40

    Time frame: 6 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

  6. 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

  1. BASDAI

    Time frame: baseline,3 months after,6 months after,12 months after

    Bath Ankylosing Spondylitis Disease Activity Index

  2. BASFI

    Time frame: baseline,3 months after,6 months after,12 months after

    BASDAI Bath Ankylosing Spondylitis Functional Index

  3. Patient Global Assessment

    Time frame: 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) .

  4. CRP

    Time frame: baseline,3 months after,6 months after,12 months after

    acute-phase reactant(C-reactive protein)

  5. ESR

    Time frame: baseline,3 months after,6 months after,12 months after

    acute-phase reactant(Erythrocyte Sedimentation rate )

  6. SQOL-AS

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 26, 2018
Registry last updated
Aug 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.