Etanercept Versus Adalimumab in the Treatment of Patients With Ankylosing Spondylitis. A Switch Study

January 18, 2016 updated by: GCRC, Chung Shan Medical University
To determine the safety and efficacy of switch effects to adalimumab in etanercept-treated AS patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This single-centre, open-labeled randomized controlled study will evaluate the safety and efficacy of adalimumab in etanercept-treated Ankylosing Spondylitis(AS) patients.

Thirty patients will be enrolled and randomized equally into two arms.

Dosage and Administration：For standard dose(etanercept 50 mg weekly) treated patients, the treatment arm will receive adalimumab 40 mg subcutaneously biweekly for 8 weeks. The control arm will continue etanercept 25 mg subcutaneously twice a week for 8 weeks. At week 8, the control arm will be switched to adalimumab 40 mg subcutaneously biweekly for another 8 weeks.For half dose(etanercept 25 mg weekly) treated patients, the treatment arm will receive adalimumab 40 mg subcutaneously monthly for 8 weeks. The control arm will continue etanercept 25 mg subcutaneously weekly for 8 weeks. At week 8, the control arm will be switched to adalimumab 40 mg subcutaneously monthly for another 8 weeks.

Study Type

Interventional

Enrollment (Actual)

30

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

  • Taiwan
      • Taichung, Taiwan
        • Chung Shan Medical University Hospital

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 to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of AS, as defined by 1984 Modified New York Criteria for AS.
  • Stable background therapy as non-steroid anti-inflammatory for 2 weeks.
  • Stable glucocorticoid for 4 weeks.
  • Stable disease-modifying anti-rheumatic drugs, eg. sulphasalazine, methotrexate for 8 weeks.
  • Stable anti-TNF biologics for 4 weeks.
  • Written informed consent.

Exclusion Criteria:

  • Serum creatinine ≥3.0 mg/dl.
  • GPT≥5 times the laboratory's upper limit of normal.
  • Pregnant or breast-feeding women.

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: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adalimumab switch to Etanercept
At week 8, the treatment arm will be switched to etanercept 25 mg subcutaneously biweekly for another 8 weeks.
Biological: Adalimumab
The treatment arm will receive adalimumab 40 mg subcutaneously biweekly
Other Names:
  • Humira
Biological: Etanercept
The control arm will continue etanercept 25 mg subcutaneously twice a week
Other Names:
  • Enbrel
Experimental: Etanercept switch to Adalimumab
At week 8, the control arm will be switched to adalimumab 40 mg subcutaneously biweekly for another 8 weeks.
Biological: Adalimumab
The treatment arm will receive adalimumab 40 mg subcutaneously biweekly
Other Names:
  • Humira
Biological: Etanercept
The control arm will continue etanercept 25 mg subcutaneously twice a week
Other Names:
  • Enbrel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bath AS disease activity index (BASDAI)
Time Frame: weeks 8
The score of BASDAI on weeks 8
weeks 8

Collaborators and Investigators

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

Sponsor

Chung Shan Medical University

Investigators

  • Study Director: Wei C- C, M.D., Chung Shan Medical 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, 2008

Primary Completion (Actual)

December 1, 2015

Study Completion (Anticipated)

October 1, 2016

Study Registration Dates

First Submitted

June 27, 2015

First Submitted That Met QC Criteria

July 1, 2015

First Posted (Estimate)

July 3, 2015

Study Record Updates

Last Update Posted (Estimate)

January 20, 2016

Last Update Submitted That Met QC Criteria

January 18, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CS08019

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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