Etanercept and Celecoxib Alone/Combined Treatment in Effectiveness and Safety of Active Ankylosing Spondylitis

June 14, 2018 updated by: Gu Jieruo, Sun Yat-sen University

A Multi-center, Open Label, Random Clinical Trial of Etanercept and Celecoxib Alone/Combined Treatment in Effectiveness and Safety of Active Ankylosing Spondylitis

This is a multi-center, open label, randomized clinical trial of etanercept and celecoxib alone/combined treatment in effectiveness and safety on active ankylosing spondylitis (AS). Subjects will be randomly assigned in a 1:1:1 ratio to one of the three groups (celexocib 200mg bid, etanercept 50mg qw, etanercept plus Celecoxib group) for 54 weeks. Primary endpoints are the magnetic resonance imaging (MRI) Spondyloarthritis Research Consortium of Canada (SPARCC) score of sacroiliac(SI) joint and spine, as well as the Assessment of SpondyloArthritis International Society (ASAS)20 response rate at 52 weeks.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A multi-center, open label, randomized clinical trial evaluating the effectiveness and safety of etanercept and celecoxib alone/combined treatment will be conducted on active ankylosing spondylitis (AS) patients. Disease activity is defined as fulfilling three aspects below: BASDAI ≥ 4 or ASDAS≥ 2.1；CRP>6 mg/L or ESR 28 mm/1st hour；more than 2 and less than 16 syndesmophyts between cervical spine and lumber spine detected by X-ray. All patients were randomly assigned in a 1:1:1 ratio to one of the three treatment groups：celecoxib 200mg bid，etanercept 50mg qw and combined therapy for 52 weeks. Primary endpoints are the magnetic resonance imaging (MRI) Spondyloarthritis Research Consortium of Canada (SPARCC) score of sacroiliac(SI) joint and spine, as well as the Assessment of SpondyloArthritis International Society (ASAS) 20 response rate at 52 weeks. Key secondary Endpoints include the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS), Spondyloarthritis Research Consortium of Canada (SPRACC) SI joint structural score (SSS), BASDAI, ASDAS, ASAS40, ASAS70 and ASAS5/6 response rate at 52 weeks.

Study Type

Interventional

Enrollment (Actual)

150

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

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 to 65 years
  • Meet 1984 NewYork modified criteria for AS
  • BASDAI≥4 or ASDAS score ≥ 2.1
  • CRP>6 mg/L or ESR>28 mm/h
  • Syndesmophyte quantity ≥2 and <16 of spine
  • Sexually active women of childbearing potential must agree and commit to use a medically accepted form of contraception
  • No active or latent tuberculosis infection.

Exclusion Criteria:

  • Pregnant or breastfeeding women
  • current or previous history of psoriasis or inflammatory bowel disease.
  • infection with clinical significance within 24 weeks before screening
  • receipt any bio-agents treatment within 12 weeks before screening
  • corticosteroids intra-articular injections in last 3 months before the trial
  • Significant concurrent medical events including: Gastrointestinal ulcer, myocardial infarction within 12 months before the screening visit, unstable angina pectoris, congestive heart failure.
  • Alcohol and drug abuse

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: celebrex
celebrex capsule, 0.2 gram bid, 52 weeks
Drug: celebrex
Other Names:
  • celecoxib
Active Comparator: Enbrel
etanercept injection, 25mg per injection, 50mg/week, 52 weeks
Drug: Enbrel
Other Names:
  • etanercept
Active Comparator: Enbrel plus Celebrex
50mg/week Enbrel by hypodermic injection plus Celebrex 0.2 gram bid, 52 weeks
Drug: Enbrel plus Celebrex
Other Names:
  • celecoxib plus etanercept

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the SPARCC score of spine and SI joint
Time Frame: 52th weeks
the MRI SPARCC score of spine and SI joint on 52th week
52th weeks
ASAS20 response rate
Time Frame: 52th week
ASAS20 response rate on 52th week
52th week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ASAS40 response rate
Time Frame: 52th week
ASAS40 response rate on 52th week
52th week
ASAS70 response
Time Frame: 52th week
ASAS70 response rate on 52th week
52th week
ASDAS
Time Frame: 52th week
ASDAS major improvement ASDAS clinically important improvement on 52th week
52th week
mSASSS score of spine
Time Frame: 52th week
the mSASSS score of spine on 52th week
52th week
Spondyloarthritis Research Consortium of Canada (SPRACC) SI joint structural score (SSS)
Time Frame: 52th week
the MRI SPARCC SSS score of spine on 52th week
52th week

Collaborators and Investigators

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

Sponsor

Sun Yat-sen University

Investigators

  • Study Director: Jieruo Gu, Prof, Department of Rheumatology ,Third Affiliated Hospital of 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 (Actual)

September 24, 2014

Primary Completion (Actual)

September 23, 2015

Study Completion (Actual)

January 30, 2017

Study Registration Dates

First Submitted

August 17, 2013

First Submitted That Met QC Criteria

August 29, 2013

First Posted (Estimate)

September 4, 2013

Study Record Updates

Last Update Posted (Actual)

June 18, 2018

Last Update Submitted That Met QC Criteria

June 14, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • [2013]2-93

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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