NCT04077957

Treat-to-target Strategy in Ankylosing Spondylitis Using Etanercept and Conventional Synthetic DMARDs

Treat-to-target Strategy in Ankylosing Spondylitis Using Etanercept and Conventional Synthetic DMARDs, a Prospective Randomized Controlled Study

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Nanfang Hospital, Southern Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ankylosing Spondylitis
• Spondyloarthritis

Interventions

Type	Name	Description
DRUG	Methotrexate	Methotrexate 10mg per week will be the background therapy in participants in Group 1. Experimental.
DRUG	Sulfasalazine	Sulfasalazine 2.25g per day will be the background therapy in participants in Group 1. Experimental.
DRUG	Hydroxychloroquine	Hydroxychloroquine 0.2g per day will be the background therapy in participants in Group 1. Experimental.
DRUG	Etanercept (50mg per week, for 4 weeks)	Participants in Group 1. Experimental who satisfied the criteria for high disease activity (ASDAS≥2.1) at every follow-up point will receive etanercept (50mg per week, for 4 weeks) in the next 4 weeks.
DRUG	Etanercept (50mg per week, for 2 weeks)	Participants in Group 1. Experimental who satisfied the criteria for low disease activity (2.1\>ASDAS≥1.3) at every follow-up point will receive etanercept (50mg per week, for 4 weeks) in the next 2 weeks.
DRUG	Etanercept (50mg per week)	Participants in Group 2. Positive Control will receive etanercept (50mg per week, for 12 weeks) for 48 weeks.

Timeline

• Start date: 2019-10-07
• Primary completion: 2021-10-31
• Completion: 2022-07-02
• First posted: 2019-09-04
• Last updated: 2019-09-26

Locations

1 site across 1 country: China