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Relapse of Ankylosing Spondylitis Patients Withdrawal Etanercept After Clinical Remission: a Following-up Study

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ClinicalTrials.gov Identifier: NCT02915354
Recruitment Status : Completed
First Posted : September 27, 2016
Last Update Posted : November 16, 2016
Sponsor:
Information provided by (Responsible Party):
Gu Jieruo, Sun Yat-sen University

Brief Summary:
The inclusion criteria was patients who aged 18 or older with ankylosing spondylitis, fulfilled the 1984 modified New York criteria for AS. Inclusion criteria enriched the AS patients with clinical remission, including the following definition: 1. Administration of etanercept 50 mg for 6-week period at least; 2. Acquisition of Assessment of SpondyloArthritis International Society criteria 20(ASAS20) response at the end of the treatment. We excluded patients who have developed to complete spinal fusion. We also excluded patients with kidney disease induced by other conditions; pregnancy; suckle; accompany other chronic diseases; various infections in acute stage; and other infectious diseases. At the end of the trial, patients who fulfilled the inclusions would stop etanercept treatment. Cotherapy with disease modifying anti-rheumatic drugs or non-steroidal anti-inflammatory drugs could be continued if maintained at a stable dose;Patients were followed up from the time of etanercept withdrawal per 6 weeks for 3 years by telephone. If symptoms suggestive of relapse or other problems occurred, patients were invited to come back to the center. Relapse after etanercept withdrawal was defined as an increase Bath Spondylitis Disease Activity Index(BASDAI)15 score goes back to 80 percentages of it at the beginning of the trial16. The following data were collected: demographic and disease characteristics, therapeutic modification, clinical values (BASFI, Bath Ankylosing Spondylitis Global Score (BAS-G)), Ankylosing Spondylitis Disease Activity Score (ASDAS)1718) and biologic values at baseline of the trial and the time of relapse. Adverse events and other safety measures were also collected.

Condition or disease Intervention/treatment Phase
Spondylitis, Ankylosing Recurrence Drug: Etanercept Phase 4

Detailed Description:

Patients were followed up 6 weeks by telephone. The sample size was at least 30 people. If symptoms suggestive of relapse or other problems occurred, patients were invited to come back to the center. Relapse after etanercept withdrawal was defined as an increase Bath Spondylitis Disease Activity Index(BASDAI) score goes back to 80 percentages of it at the beginning of the trial16. The following data were collected: demographic and disease characteristics, therapeutic modification, clinical values (BASFI, Bath Ankylosing Spondylitis Global Score (BAS-G)), Ankylosing Spondylitis Disease Activity Score (ASDAS) and biologic values at baseline of the trial and the time of relapse. Adverse events and other safety measures were also collected.

Demographic and baseline disease characteristics were summarized with descriptive statistics and analysed with one-way ANOVA for continuous for continuous variables and χ2 tests for categorical variables. The Kaplan-Meier method was used to estimate the time-to-relapse rate after etanercept withdrawal. Time-to-relapse curves were compared between the group of patients received 12-week and 6-week treatment of etanercept through log-rank test. The influence of the following variables including age,duration of disease, onset age, BASDAI, ASDAS-CRP, C reaction protein(CRP), and erythrocyte sedimentation rate(ESR) was examined using the Cox proportional hazards model to evaluate at etanercept withdrawal on time-to-relapse. Every continuous variable was divided into 3 categories at approximately the 33% and 67% at first19. If the relative relapse rates were not significantly different in 2 contiguous categories, they were gathered together. If no clear difference was observed in 3 categories, the median was used as a cut-off point. Normal value such as 6 mg/L for CRP level were tested. The proportional hazards model was used to study the effect of each factor on time-to-relapse and identify the independent prognostic factors. Relapse rates are presented as estimate with standard error (SE), follow-up times as median (interquartile range), and hazard ratio as estimate with 95% confidence interval.

All analyses were performed using SPSS software v16.0 (SPSS, Inc, Chicago, IL).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Relapse of Ankylosing Spondylitis Patients Withdrawal Etanercept After Clinical Remission: a Three Years' Following-up Study
Study Start Date : July 2007
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Etanercept

Arm Intervention/treatment
Experimental: Etanercept, AS
The patients were diagnosed with ankylosing spondylitis and obtained the ASAS20 response after etanercept treatment. Then they were discontinued to etanercept and received no treatment except DMARDs or NSAIDs which had used before.
Drug: Etanercept
Etanercept must be discontinued. Cotherapy with disease modifying anti-rheumatic drugs or non-steroidal anti-inflammatory drugs could be continued if maintained at a stable dose for at least 4 weeks.
Other Name: enbrel




Primary Outcome Measures :
  1. The status of relapse [ Time Frame: 3 years ]
    The cumulative probabilities of relapse at 1, 2, and 3 years were 45.7%,57.1% and 60.0%, respectively.


Secondary Outcome Measures :
  1. Bath Spondylitis Disease Activity Index(BASDAI) score [ Time Frame: 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of ankylosing spondylitis(1984 modified New York criteria).
  • Administration of etanercept 50 mg for 6-week or 12-week.
  • Acquisition of ASAS20 response at the end of the treatment.

Exclusion Criteria:

  • Complete spinal fusion.
  • Kidney disease induced by other conditions; pregnancy; suckle; accompany other chronic diseases; various infections in acute stage; and other infectious diseases.
  • Refused to discontinue etanercept treatment.

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): NCT02915354


Locations
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China, Guangdong
Rheumatology Department, the Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510630
Sponsors and Collaborators
Sun Yat-sen University
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gu Jieruo, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02915354    
Other Study ID Numbers: [2006]37
First Posted: September 27, 2016    Key Record Dates
Last Update Posted: November 16, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data will be published on the Journals.
Additional relevant MeSH terms:
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Spondylitis
Spondylitis, Ankylosing
Recurrence
Disease Attributes
Pathologic Processes
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis
Etanercept
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors