Treat-to-Target Strategy With Etanercept for Ankylosing Spondylitis

Spondylitis, Ankylosing Clinical Trial

— T2TEAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03880968
• Other study ID #: 2012-13
• Status: Completed
• Start date: March 1, 2012
• Est. completion date: September 30, 2014

Study information

• Verified date: March 2019
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 311
• Est. completion date: September 30, 2014
• Est. primary completion date: September 30, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Spondylitis
• Spondylitis, Ankylosing

Intervention

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).

Locations

Country	Name	City	State
n/a

Sponsors (10)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University	First Affiliated Hospital of Wenzhou Medical University, Ningbo Medical Center Lihuili Hospital, Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shaoxing People's Hospital, Shaoxing Second Hospital, The First Hospital of Jiaxing, Wenzhou Central Hospital, Zhejiang Provincial People's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative flare rates at week 48 with different tapering or discontinuation strategies	Cumulative flare rates at week 48 with different tapering or discontinuation strategies	48 weeks