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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02489760
Recruitment Status : Unknown
Verified January 2016 by GCRC, Chung Shan Medical University.
Recruitment status was:  Active, not recruiting
First Posted : July 3, 2015
Last Update Posted : January 20, 2016
Sponsor:
Information provided by (Responsible Party):
GCRC, Chung Shan Medical University

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

Condition or disease Intervention/treatment Phase
Ankylosing Spondylitis Biological: Adalimumab Biological: Etanercept Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Etanercept Versus Adalimumab in the Treatment of Patients With Ankylosing Spondylitis. A Switch Study
Study Start Date : July 2008
Actual Primary Completion Date : December 2015
Estimated Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


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 Name: Humira

Biological: Etanercept
The control arm will continue etanercept 25 mg subcutaneously twice a week
Other Name: 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 Name: Humira

Biological: Etanercept
The control arm will continue etanercept 25 mg subcutaneously twice a week
Other Name: Enbrel




Primary Outcome Measures :
  1. Bath AS disease activity index (BASDAI) [ Time Frame: weeks 8 ]
    The score of BASDAI on weeks 8



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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): NCT02489760


Locations
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Taiwan
Chung Shan Medical University Hospital
Taichung, Taiwan
Sponsors and Collaborators
Chung Shan Medical University
Investigators
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Study Director: Wei C- C, M.D. Chung Shan Medical University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: GCRC, Etanercept versus Adalimumab in the Treatment of Patients with Ankylosing Spondylitis. A Switch Study., Chung Shan Medical University
ClinicalTrials.gov Identifier: NCT02489760    
Other Study ID Numbers: CS08019
First Posted: July 3, 2015    Key Record Dates
Last Update Posted: January 20, 2016
Last Verified: January 2016
Keywords provided by GCRC, Chung Shan Medical University:
Etanercept
Adalimumab
Ankylosing Spondylitis
Switch Study
Additional relevant MeSH terms:
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Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis
Adalimumab
Etanercept
Anti-Inflammatory Agents
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors