Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03411798
Recruitment Status : Completed
First Posted : January 26, 2018
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
Nanfang Hospital of 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.

Condition or disease Intervention/treatment Phase
Ankylosing Spondylitis Drug: Yisaipu® Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Intervention Model: Sequential Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 15, 2017
Actual Primary Completion Date : July 1, 2019
Actual Study Completion Date : July 1, 2019


Arm Intervention/treatment
Experimental: Experimental
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.
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.
Other Names:
  • methotrexate(MTX)
  • sulfasalazine(SSZ)
  • hydroxychloroquine(HCQ)




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03411798


Locations
Layout table for location information
China, Guangdong
Nanfang Hospital
Guangzhou, Guangdong, China, 510515
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
Layout table for additonal information
Responsible Party: Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT03411798    
Other Study ID Numbers: NFEC-201711-K6
First Posted: January 26, 2018    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Nanfang Hospital of Southern Medical University:
ankylosing spondylitis(AS)
TNFi
Yisaipu®
Disease modifying anti-rheumatic drugs (DMARDs)
Additional relevant MeSH terms:
Layout table for MeSH terms
Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis
Hydroxychloroquine
Sulfasalazine
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors