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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03411798 |
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Date of registration:
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14/12/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Sequential Application of Yisaipu® and DMARDs in Treating Mild-to-Moderate AS
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Scientific title:
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Sequential Application of Yisaipu® and Disease Modifying Anti-Rheumatic Drugs (DMARDs) in Treating Mild-to-Moderate Ankylosing Spondylitis: the Mid-term Follow-up Result |
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Date of first enrolment:
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December 15, 2017 |
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Target sample size:
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76 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03411798 |
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Study type:
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Interventional |
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Study design:
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Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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China
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Key inclusion & exclusion criteria
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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
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Ankylosing Spondylitis
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Intervention(s)
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Drug: Yisaipu®
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Primary Outcome(s)
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ASAS 20
[Time Frame: 12 months after]
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ASAS 20
[Time Frame: 6 months after]
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ASAS 40
[Time Frame: 6 months after]
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ASAS 20
[Time Frame: 3 months after]
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ASAS 40
[Time Frame: 12 months after]
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ASAS 40
[Time Frame: 3 months after]
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Secondary Outcome(s)
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BASFI
[Time Frame: baseline,3 months after,6 months after,12 months after]
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Patient Global Assessment
[Time Frame: baseline,3 months after,6 months after,12 months after]
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SQOL-AS
[Time Frame: baseline,3 months after,6 months after,12 months after]
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ESR
[Time Frame: baseline,3 months after,6 months after,12 months after]
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BASDAI
[Time Frame: baseline,3 months after,6 months after,12 months after]
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CRP
[Time Frame: baseline,3 months after,6 months after,12 months after]
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Secondary ID(s)
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NFEC-201711-K6
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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