Combination Therapy Prevents the Relapse of RA

The Efficacy, Safety and Cost-effectiveness of Hydroxychloroquine, Sulfasalazine, Methotrexate Triple Therapy in Preventing Relapse Among Patients With Rheumatoid Arthritis Achieving Clinical Remission or Low Disease Activity

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.

Study Overview

• Status: Unknown
• Conditions: Recurrence (Disease Attribute)
• Intervention / Treatment: Drug: Entanercept; Drug: MTX; Drug: HCQ

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)

• Study Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhuoli Zhang, Pro.; Phone Number: 13901094780; Email: zhuoli.zhang@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100034
      • Recruiting
      • Rheumatology and Immunology Department,Peking University First Hospital
      • Contact: Zhuoli Zhang, Pro; Phone Number: 13901094780; Email: zhuoli.zhang@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A; Maintenance treatment group	Drug: Entanercept; Both Entanercept and MTX were given to patients for 60weeks (Week0-Week60).; Other Names: MTX; Drug: MTX; MTX was given to patients for 60weeks (Week0-Week60). Entanercept was given to patients for 12 weeks (Week0-Week12).; Other Names: Entanercept
Experimental: B; Combination treatment group	Drug: Entanercept; Both Entanercept and MTX were given to patients for 60weeks (Week0-Week60).; Other Names: MTX; Drug: MTX; MTX was given to patients for 60weeks (Week0-Week60). Entanercept was given to patients for 12 weeks (Week0-Week12).; Other Names: Entanercept; Drug: HCQ; Combination of HCQ+SSZ+MTX were given to patients for 60weeks (Week0-Week60).Entanercept was given to patients for 12 weeks (Week0-Week12).; Other Names: MTX; TFP; SSZ
Experimental: C; Single drug group	Drug: Entanercept; Both Entanercept and MTX were given to patients for 60weeks (Week0-Week60).; Other Names: MTX; Drug: MTX; MTX was given to patients for 60weeks (Week0-Week60). Entanercept was given to patients for 12 weeks (Week0-Week12).; Other Names: Entanercept

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the rate of recurrence	60 weeks

Collaborators and Investigators

• Sponsor: Peking University First Hospital
• Collaborators: Peking University People's Hospital; Peking University Third Hospital; Peking University Shougang Hospital; Beijing Hospital; Beijing Shijitan Hospital, Capital Medical University; Beijing Jishuitan Hospital

Publications and helpful links

General Publications

• Zhao J, Zhou W, Wu Y, Ji P, Yang L, Yan X, Zhang Z. The efficacy, safety and cost-effectiveness of hydroxychloroquine, sulfasalazine, methotrexate triple therapy in preventing relapse among patients with rheumatoid arthritis achieving clinical remission or low disease activity: the study protocol of a randomized controlled clinical Trial (ESCoRT study). BMC Med Inform Decis Mak. 2021 Mar 4;21(1):83. doi: 10.1186/s12911-021-01449-2.
• Fan Y, Yang X, Zhao J, Sun X, Xie W, Huang Y, Li G, Hao Y, Zhang Z. Cysteine-rich 61 (Cyr61): a biomarker reflecting disease activity in rheumatoid arthritis. Arthritis Res Ther. 2019 May 21;21(1):123. doi: 10.1186/s13075-019-1906-y.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2015
• Primary Completion (Actual): February 1, 2017
• Study Completion (Anticipated): September 1, 2020

Study Registration Dates

• First Submitted: December 16, 2014
• First Submitted That Met QC Criteria: December 18, 2014
• First Posted (Estimate): December 19, 2014

Study Record Updates

• Last Update Posted (Actual): June 22, 2020
• Last Update Submitted That Met QC Criteria: June 18, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Recurrence; Disease Attributes
• Other Study ID Numbers: PUCRP201305