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Treat-to-Target Strategy With Etanercept for Ankylosing Spondylitis (T2TEAS)

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: NCT03880968
Recruitment Status : Completed
First Posted : March 19, 2019
Last Update Posted : March 19, 2019
Sponsor:
Collaborators:
Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
First Affiliated Hospital of Wenzhou Medical University
The First Hospital of Jiaxing
Shaoxing Second Hospital
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Ningbo Medical Center Lihuili Hospital
Wenzhou Central Hospital
Zhejiang Provincial People's Hospital
Shaoxing People's Hospital
Information provided by (Responsible Party):
Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary:
Evaluate the disease activity guided tapering and discontinuation strategies of etanercept (ETN) in patients with ankylosing spondylitis (AS) in 48 weeks.

Condition or disease Intervention/treatment Phase
Spondylitis, Ankylosing Drug: tapering or discontinuation of etanercept Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 311 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: Treat-to-Target Strategy With Etanercept for Ankylosing Spondylitis: a Prospective, Randomized Multicentric Study on Disease Activity Guided Etanercept Tapering or Discontinuation
Actual Study Start Date : March 1, 2012
Actual Primary Completion Date : September 30, 2014
Actual Study Completion Date : September 30, 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Etanercept

Arm Intervention/treatment
Active Comparator: inactive - half dosage tapering
Active AS patients with AS disease activity score (ASDAS)≥2.1 were recruited from ten hospitals, initially managed with ETN 50mg weekly for 12 weeks, and then randomized into subgroups with different tapering or discontinuation strategies according to ASDAS at week 12. Patients in this arm were those who achieved inactive disease (ASDAS<1.3, group A) at week 12 and assigned to sequential tapering group (A1).
Drug: tapering or discontinuation of etanercept
Active AS patients initially managed with ETN 50mg weekly for 12 weeks, and then randomized into subgroups with different tapering or discontinuation strategies according to ASDAS at week 12. Patients who achieved inactive disease (ASDAS<1.3, group A) at week 12 were either assigned to sequential tapering group (A1) or discontinuation group (A2), and those who reached low disease activity (LDA) (1.3≤ASDAS<2.1, group B) were designated to sequential tapering group (B1), delayed tapering group (B2) or discontinuation group (B3).

Sham Comparator: inactive - discontinuation
Active AS patients with AS disease activity score (ASDAS)≥2.1 were recruited from ten hospitals, initially managed with ETN 50mg weekly for 12 weeks, and then randomized into subgroups with different tapering or discontinuation strategies according to ASDAS at week 12. Patients in this arm were those who achieved inactive disease (ASDAS<1.3, group A) at week 12 and then assigned to discontinuation group (A2).
Drug: tapering or discontinuation of etanercept
Active AS patients initially managed with ETN 50mg weekly for 12 weeks, and then randomized into subgroups with different tapering or discontinuation strategies according to ASDAS at week 12. Patients who achieved inactive disease (ASDAS<1.3, group A) at week 12 were either assigned to sequential tapering group (A1) or discontinuation group (A2), and those who reached low disease activity (LDA) (1.3≤ASDAS<2.1, group B) were designated to sequential tapering group (B1), delayed tapering group (B2) or discontinuation group (B3).

Active Comparator: low disease activity - half dosage tapering
Active AS patients with AS disease activity score (ASDAS)≥2.1 were recruited from ten hospitals, initially managed with ETN 50mg weekly for 12 weeks, and then randomized into subgroups with different tapering or discontinuation strategies according to ASDAS at week 12. Patients in this arm were those who reached low disease activity (LDA) (1.3≤ASDAS<2.1, group B) and designated to sequential tapering group (B1).
Drug: tapering or discontinuation of etanercept
Active AS patients initially managed with ETN 50mg weekly for 12 weeks, and then randomized into subgroups with different tapering or discontinuation strategies according to ASDAS at week 12. Patients who achieved inactive disease (ASDAS<1.3, group A) at week 12 were either assigned to sequential tapering group (A1) or discontinuation group (A2), and those who reached low disease activity (LDA) (1.3≤ASDAS<2.1, group B) were designated to sequential tapering group (B1), delayed tapering group (B2) or discontinuation group (B3).

Active Comparator: low disease activity - full dosage tapering
Active AS patients with AS disease activity score (ASDAS)≥2.1 were recruited from ten hospitals, initially managed with ETN 50mg weekly for 12 weeks, and then randomized into subgroups with different tapering or discontinuation strategies according to ASDAS at week 12. Patients in this arm were those who reached low disease activity (LDA) (1.3≤ASDAS<2.1, group B) and designated to delayed tapering group (B2) with extra 12 weeks of full dose ETN.
Drug: tapering or discontinuation of etanercept
Active AS patients initially managed with ETN 50mg weekly for 12 weeks, and then randomized into subgroups with different tapering or discontinuation strategies according to ASDAS at week 12. Patients who achieved inactive disease (ASDAS<1.3, group A) at week 12 were either assigned to sequential tapering group (A1) or discontinuation group (A2), and those who reached low disease activity (LDA) (1.3≤ASDAS<2.1, group B) were designated to sequential tapering group (B1), delayed tapering group (B2) or discontinuation group (B3).

Sham Comparator: low disease activity - discontinuation
Active AS patients with AS disease activity score (ASDAS)≥2.1 were recruited from ten hospitals, initially managed with ETN 50mg weekly for 12 weeks, and then randomized into subgroups with different tapering or discontinuation strategies according to ASDAS at week 12. Patients in this arm were those who reached low disease activity (LDA) (1.3≤ASDAS<2.1, group B) and designated to discontinuation group (B3).
Drug: tapering or discontinuation of etanercept
Active AS patients initially managed with ETN 50mg weekly for 12 weeks, and then randomized into subgroups with different tapering or discontinuation strategies according to ASDAS at week 12. Patients who achieved inactive disease (ASDAS<1.3, group A) at week 12 were either assigned to sequential tapering group (A1) or discontinuation group (A2), and those who reached low disease activity (LDA) (1.3≤ASDAS<2.1, group B) were designated to sequential tapering group (B1), delayed tapering group (B2) or discontinuation group (B3).




Primary Outcome Measures :
  1. Cumulative flare rates at week 48 with different tapering or discontinuation strategies [ Time Frame: 48 weeks ]
    Cumulative flare rates at week 48 with different tapering or discontinuation strategies



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • aged between 18 years old and 65 years old with AS, according to 1984-revised New York classification criteria.
  • an active disease of ASDAS with C reactive protein (ASDAS-CRP) ≥2.1.
  • a disease duration of 6 months to 30 years.
  • no exposure to biologics in recent 6 months before recruitment. Concomitant medications with NSAIDs, conventional disease modifying anti-rheumatic drugs (cDMARDs), or prednisone or a prednisone equivalent (≤10mg/day), were allowed to continue if they were maintained at a stable dose for 4 weeks or more from baseline.

Exclusion Criteria:

  • late-stage patients with spinal fusion.
  • patients with severe cardiac, hepatic, renal, hematologic or endocrine diseases.
  • patients with a history of multiple sclerosis, current or past malignancy.
  • patients who were pregnant, or planning to become pregnant, or breastfeeding.
  • patients with active or recurrent infections, or those who required oral antibiotics 2 weeks or intravenous antibiotics 4 weeks before screening.
  • patients with current or past or potential tuberculosis.

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): NCT03880968


Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
First Affiliated Hospital of Wenzhou Medical University
The First Hospital of Jiaxing
Shaoxing Second Hospital
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Ningbo Medical Center Lihuili Hospital
Wenzhou Central Hospital
Zhejiang Provincial People's Hospital
Shaoxing People's Hospital
Investigators
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Principal Investigator: Huaxiang Wu wuhx8855@sina.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT03880968    
Other Study ID Numbers: 2012-13
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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
Etanercept
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors