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Dose Reduction of Etanercept in Patients With Ankylosing Spondylitis

NCT02638896 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2015-12-28

No results posted yet for this study

Summary

The primary objective of this study is to evaluate the efficacy of safety of etanercept dose reduction combined with sulfasalazine in ankylosing spondylitis (AS) patients who have achieved a significant clinical response.

Conditions

Interventions

DRUG

etanercept (Half-Dose)

AS patients who satisfied the criteria for disease remission (ASDAS\<1.3) will be randomized to one of the three treatment arms. In the dose reduction arm, patients will receive etanercept 50 mg subcutaneous injections every other weeks .

DRUG

etanercept (Full-Dose)

AS patients who satisfied the criteria for disease remission (ASDAS\<1.3) will be randomized to one of the three treatment arms. In the dose maintenance arm, patients will receive etanercept 50 mg subcutaneous injections every weeks.

DRUG

Sulfasalazine

AS patients who satisfied the criteria for disease remission (ASDAS\<1.3) will take sulfasalazine (2g/d) from week12 to week48.

DRUG

Celecoxib

Celecoxib (0.4g/d) will be the background therapy.

Sponsors & Collaborators

  • Zhixiang Huang

    lead OTHER_GOV

Principal Investigators

  • Tianwang Li, MD · Guangdong No.2 Provincial People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2017-02-28
Completion
2017-04-30

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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 NCT02638896 on ClinicalTrials.gov