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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03411798
Other study ID # NFEC-201711-K6
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


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
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