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

June 29, 2021 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

Treat-to-Target Strategy With Etanercept for Ankylosing Spondylitis: a Prospective, Randomized Multicentric Study on Disease Activity Guided Etanercept Tapering or Discontinuation

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Ankylosing spondylitis (AS), a subset of axial spondyloarthritis (axSpA), is a chronic inflammatory disorder characterized by inflammatory back pain and predominant involvement of sacroiliac joints and spine, leading to bony fusion of vertebrae and eventually disability in some patients. Nonsteroidal anti-inflammatory drugs (NSAIDs) are recognized as a first-line therapy for AS, but the overall response rates to NSAIDs are considerably unsatisfactory. With the advent of biologics, the outcomes of AS patients have been greatly improved. Biologics including tumor necrosis factor α (TNFα) inhibitors (TNFi) have been included in many recommendations for the treatment of AS. Etanercept, a recombinant human TNFα receptor, is capable of binding to TNFα and blocking its biological activities. It is effective in relieving symptoms, improving physical function, and reducing disease activity in patients with AS, and generally no severe adverse effects have been reported. However, the high expense of biologics restricts their long-term use, which urges a viable strategy to reduce the dosage of biologics while maintaining an optimal therapeutic efficacy. To investigate the stepwise tapering and discontinuation of TNFi based on disease activity in patients with AS, a 48-week, prospective, randomized, multicentric study was conducted. An etanercept biosimilar, rhTNFR:Fc (recombinant TNF receptor: Fc fusion protein, Yisaipu), which is one of the most widely used biosimilars in China, was used in this study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
311

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with AS were recruited in this study. Eligible patients were aged between 18 years old and 65 years old, and were diagnosed with AS according to 1984 revised New York classification criteria. Only patients meet both inclusion and exclusion criteria were included.

Description

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.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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).
Other Names:
  • rhTNFR:Fc, Yisaipu
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).
Other Names:
  • rhTNFR:Fc, Yisaipu
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).
Other Names:
  • rhTNFR:Fc, Yisaipu
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).
Other Names:
  • rhTNFR:Fc, Yisaipu
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).
Other Names:
  • rhTNFR:Fc, Yisaipu

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
48 weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ningbo Medical Center Lihuili Hospital
Zhejiang Provincial People's Hospital
First Affiliated Hospital of Wenzhou Medical University
Shaoxing People's Hospital
Shaoxing Second Hospital
Wenzhou Central Hospital
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
First Affiliated Hospital of Jiaxing University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Huaxiang Wu, wuhx8855@sina.com

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 12, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 19, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 1, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2012-13

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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