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

November 15, 2016 updated by: Gu Jieruo, Sun Yat-sen University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510630
        • Rheumatology Department, the Third Affiliated Hospital of Sun Yat-sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • enbrel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Bath Spondylitis Disease Activity Index(BASDAI) score
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

September 23, 2016

First Submitted That Met QC Criteria

September 23, 2016

First Posted (Estimate)

September 27, 2016

Study Record Updates

Last Update Posted (Estimate)

November 16, 2016

Last Update Submitted That Met QC Criteria

November 15, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • [2006]37

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data will be published on the Journals.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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