MedTrace Logo

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

NCT04077957 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2019-09-26

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Nanfang Hospital, Southern Medical University

    lead OTHER

Principal Investigators

  • Jun Xiao · Nanfang Hospital, Southern Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-07
Primary Completion
2021-10-31
Completion
2022-07-02

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04077957 on ClinicalTrials.gov