Treat-to-Target Strategy With Etanercept for Ankylosing Spondylitis

NCT03880968 | Completed

• 1 other identifier: 2012-13
• Study Type: observational
• Target: 311
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Spondylitis, Ankylosing

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (5)

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

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

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

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

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

Interventions

tapering or discontinuation of etanercept DRUG

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).

Also known as: rhTNFR:Fc, Yisaipu

inactive - discontinuation; inactive - half dosage tapering; low disease activity - discontinuation; low disease activity - full dosage tapering; low disease activity - half dosage tapering

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Related Publications (1)

• Zhang T, Zhu J, He D, Chen X, Wang H, Zhang Y, Xue Q, Liu W, Xiang G, Li Y, Yu Z, Wu H. Disease activity guided stepwise tapering or discontinuation of rhTNFR:Fc, an etanercept biosimilar, in patients with ankylosing spondylitis: a prospective, randomized, open-label, multicentric study. Ther Adv Musculoskelet Dis. 2020 Jun 2;12:1759720X20929441. doi: 10.1177/1759720X20929441. eCollection 2020.

  PMID: 32536984 DERIVED

MeSH Terms

Conditions

Spondylitis, Ankylosing

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Study Officials

• Huaxiang Wu

  wuhx8855@sina.com

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2019
• First Posted: March 19, 2019
• Study Start: March 1, 2012
• Primary Completion: September 30, 2014
• Study Completion: September 30, 2014
• Last Updated: July 1, 2021

Record last verified: 2019-03