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

Primary Purpose

Ankylosing Spondylitis

Status
Unknown status
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Adalimumab
Etanercept
Sponsored by
Chung Shan Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankylosing Spondylitis focused on measuring Etanercept, Adalimumab, Ankylosing Spondylitis, Switch Study

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Chung Shan Medical University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Adalimumab switch to Etanercept

Etanercept switch to Adalimumab

Arm Description

At week 8, the treatment arm will be switched to etanercept 25 mg subcutaneously biweekly for another 8 weeks.

At week 8, the control arm will be switched to adalimumab 40 mg subcutaneously biweekly for another 8 weeks.

Outcomes

Primary Outcome Measures

Bath AS disease activity index (BASDAI)
The score of BASDAI on weeks 8

Secondary Outcome Measures

Full Information

First Posted
June 27, 2015
Last Updated
January 18, 2016
Sponsor
Chung Shan Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02489760
Brief Title
Etanercept Versus Adalimumab in the Treatment of Patients With Ankylosing Spondylitis. A Switch Study
Official Title
Etanercept Versus Adalimumab in the Treatment of Patients With Ankylosing Spondylitis. A Switch Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2008 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
October 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chung Shan Medical University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To determine the safety and efficacy of switch effects to adalimumab in etanercept-treated AS patients.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankylosing Spondylitis
Keywords
Etanercept, Adalimumab, Ankylosing Spondylitis, Switch Study

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adalimumab switch to Etanercept
Arm Type
Experimental
Arm Description
At week 8, the treatment arm will be switched to etanercept 25 mg subcutaneously biweekly for another 8 weeks.
Arm Title
Etanercept switch to Adalimumab
Arm Type
Experimental
Arm Description
At week 8, the control arm will be switched to adalimumab 40 mg subcutaneously biweekly for another 8 weeks.
Intervention Type
Biological
Intervention Name(s)
Adalimumab
Other Intervention Name(s)
Humira
Intervention Description
The treatment arm will receive adalimumab 40 mg subcutaneously biweekly
Intervention Type
Biological
Intervention Name(s)
Etanercept
Other Intervention Name(s)
Enbrel
Intervention Description
The control arm will continue etanercept 25 mg subcutaneously twice a week
Primary Outcome Measure Information:
Title
Bath AS disease activity index (BASDAI)
Description
The score of BASDAI on weeks 8
Time Frame
weeks 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei C- C, M.D.
Organizational Affiliation
Chung Shan Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Chung Shan Medical University Hospital
City
Taichung
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
33195311
Citation
Wei JC, Tsou HK, Leong PY, Chen CY, Huang JX. Head-to-Head Comparison of Etanercept vs. Adalimumab in the Treatment of Ankylosing Spondylitis: An Open-Label Randomized Controlled Crossover Clinical Trial. Front Med (Lausanne). 2020 Oct 30;7:566160. doi: 10.3389/fmed.2020.566160. eCollection 2020.
Results Reference
derived

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

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