Clinical trial NCT04077957: Treat-to-target Strategy in Ankylosing Spondylitis Using Etanercept and Conventional Synthetic DMARDs
Official title: Treat-to-target Strategy in Ankylosing Spondylitis Using Etanercept and Conventional Synthetic DMARDs, a Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Ankylosing Spondylitis
Spondyloarthritis
Keywords: disease modifying anti-rheumatic drugs(DMARDs)
etanercept
ankylosing spondylitis
spondyloarthritis
treat-to-target
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2019-09-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All enrolled participants will be randomly divided into 2 groups evenly. Participants in Group 1 will be treated with etanercept and conventional synthetic DMARDs based on treat-to-target strategy, while the others in Group 2 will be treated with conventional therapy scheme using etanercept only.
Primary purpose: TREATMENT

Brief summary: This study evaluates clinical responses and cost-effectiveness of using etanercept (ETN) and conventional synthetic Disease modifying anti-rheumatic drugs (csDMARDs) with treat-to-target strategy in ankylosing spondylitis patients. Half of participants will be used treat-to-target strategy with ETN and csDMARDs, while the others will be used conventional therapy scheme with ETN only.

Detailed description: The tumor necrosis factor inhibitors(TNFi) like etanercept(ETN) has been always recommended as the primary treatment option for active AS. But when sustained applied in daily clinical practices, it is unaffordable for patients in developing countries in most cases due to the high expense of TNFi. On this ground, this study proposes a new scheme dividing AS treatment into relatively active phase and relatively stable phase, and sequentially introducing TNFi and conventional synthetic Disease modifying anti-rheumatic drugs (csDMARDs) in each phase respectively. Taking full advantages of the rapid and precise efficacy of TNFi when short-term application in active AS and then csDMARDs combination was prescribed to maintain the remission cause by TNFi. Drug regimes are adjusted according to the different responses of individual patient based on treat-to-target strategy. TNFi is reintroduced if there is a reactive tendency and then switching to csDMARDs again when patients are in remission. Thus, the continuous low activity or remission of AS may be promising through this treating management and the treatment cost will reduce for csDMARDs partially replace TNFi in the management of relatively stable phase.

This study is designed as a prospective randomized, positive controlled, 48-week clinical trial, involving 100 patients with active ankylosing spondylitis. All enrolled patients will randomly assign to 2 groups for the comparison of the clinical responses and cost-effectiveness of our treatment scheme with that of the conventional therapy scheme of TNFi (etanercept). Multiple clinical indexes will be measured to evaluate the therapeutic effect, including Patient's Global Assessment, BASDAI and ASDAS-CRP for disease activity, BASFI for functional state, EQ-5D and SF-36 for quality-of-life assessment, SPARCC and SPARCC Sacroiliac Joint Structural Score (SSS) for sacroiliac joint invasion. We expect to assess the feasibility of our new treatment scheme in AS disease controlling and cost-effectiveness improving through this one-year follow-up study.

Eligibility criteria: Inclusion Criteria:

* Capability to understand and voluntarily give written informed consent that is signed and dated, before any specific procedure of the protocol is performed.
* Patients 18 to 45 years of age.
* Proven AS according to the modified New York criteria.
* Acute phase of disease with ASDAS score ≥1.3.
* Ability to reconstitute the drug and self-inject it or have a person who can do so.
* Ability to store injectable test article at 2º to 8º C.

Exclusion Criteria:

* Patients with a history of active tuberculosis, hepatitis, gastrointestinal hemorrhage, tumors, infectious diseases or combined with other rheumaimmune systemic diseases or osteoarthritis diseases.
* Pregnancy/lactation.
* Receipt of any live (attenuated) vaccines within 4 weeks before the screening visit.
* Significant concurrent medical diseases including uncompensated congestive heart failure (NYHA III-IV), myocardial infarction within 12 months, stable or unstable angina pectoris, uncontrolled hypertension, severe pulmonary disease, history of human immunodeficiency virus (HIV) infection.
* Participation in trials of other investigational medications within 30 days of entering the study.
* Clinical examination showing significant abnormalities of clinical relevance.

Primary outcomes:
measure: Percentage of Participants With Assessment in Ankylosing Spondylitis 20 (ASAS-20) Response
timeFrame: Week 12, 24, 36, 48
measure: Percentage of Participants With Assessment in Ankylosing Spondylitis 40 (ASAS-40) Response
timeFrame: Week 12, 24, 36, 48
Secondary outcomes:
measure: Mean Change From Baseline in C-Reactive Protein (CRP)
timeFrame: Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48
measure: Mean Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
timeFrame: Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48
measure: Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score
timeFrame: Baseline, Week 12, 24, 36, 48
measure: Mean Change From Baseline in Ankylosing Spondylitis Disease Activity (ASDAS) Score
timeFrame: Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48
measure: Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score
timeFrame: Baseline, Week 12, 24, 36, 48
measure: Mean Change From Baseline in Euro Quality of Life-5 Dimensions (EQ-5D) Score
timeFrame: Baseline, Week 12, 24, 36, 48
measure: Mean Change From Baseline in Short Form-36 Health Survey (SF-36) Score
timeFrame: Baseline, Week 12, 24, 36, 48
measure: Mean Change From Baseline in SpondyloArthritis Research Consortium of Canada (SPARCC) Score for the Sacroiliac Joint
timeFrame: Baseline, Week 4, 12, 24, 48
measure: Percentage of Participants with Serious Adverse Events (SAEs) or Adverse Events (AEs) by Co-morbidity From Baseline
timeFrame: Baseline, Week 12, 24, 36, 48
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical University
state: Guangdong
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Jun Xiao
role: PRINCIPAL_INVESTIGATOR
References: