Combination Therapy Prevents the Relapse of RA

Not Applicable

• Conditions: Recurrence (Disease Attribute)
• Interventions: Drug: Entanercept; Drug: MTX; Drug: HCQ

• Registration Number: NCT02320630
• Lead Sponsor: Peking University First Hospital

Brief Summary

This trial aims to compare the cost effective and effect of preventing recurrence by different treatment of TFP and HCQ combined SSZ for remittent RA.

Detailed Description

patients were divided into 3groups: Group A:TFP+MTX (week0-week60) Group B:TFP+MTX+HCQ+SSZ(week0-week12) and then MTX+HCQ+SSZ(week13-week60) Group C:TFP+MTX (week0-week12) and then MTX (week13-week60)

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2014-12-16
• Study First Submitted QC: 2014-12-18
• Study First Posted: 2014-12-19
• Study Start: 2015-10
• Primary Completion: 2017-02
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-18
• Last Update Posted: 2020-06-22
• Study Completion: 2020-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• Fulfill 2010 EULAR/ACR RA dignose criteria
• Age18-70 years old
• Have been teated regularly for 3 months
• Disease duration > 6months
• DAS28>3.2

Read More

Exclusion Criteria

• Received surgical operation in 8 weeks
• Received other biological agent (eg. rituximab, anti-TNF agents, anti-IL6 agents)in 6 months;
• Injection of steroid in 4 weeks
• Coexisting with other CTD except for SS
• With severe and not controled cardiac vescular disease, neurological disease, pulmonary disease (including COPD and ILD), renal disease, liver disease, endocrine disease and Gastric Intestinal Disease
• With not controled diseases including asthma, IBD and psoriasis needing oral or injection of steroid
• Active infection with T>38℃. Patients need admitted into hospital or biotics injection in 4 weeks or need oral biotics in 2 weeks
• Malignant history.
• Serum creatinine >130 µmol/L
• AST/ALT higher than 2 times upper level
• platelet count<100 x 109/L，or white blood count<3 x 109/L
• Interstitail lung disease: Chest X Ray
• Hands X Ray ACR radiology staging shows IV stage RA
• Pregnancy or planing to pregnant in 2 years or suckling period women.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	MTX	Maintenance treatment group
B	Entanercept	Combination treatment group
B	HCQ	Combination treatment group
C	Entanercept	Single drug group
A	Entanercept	Maintenance treatment group
B	MTX	Combination treatment group
C	MTX	Single drug group

Primary Outcome Measures

Name	Time	Method
the rate of recurrence	60 weeks

Trial Locations

Locations (1)

Rheumatology and Immunology Department,Peking University First Hospital; 🇨🇳 Beijing, Beijing, China