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Combination Therapy Prevents the Relapse of RA

Primary Purpose

Recurrence (Disease Attribute)

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Entanercept
HCQ
MTX
Sponsored by
Peking University First Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrence (Disease Attribute)

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Rheumatology and Immunology Department,Peking University First HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

A

B

C

Arm Description

Maintenance treatment group

Combination treatment group

Single drug group

Outcomes

Primary Outcome Measures

the rate of recurrence

Secondary Outcome Measures

Full Information

First Posted
December 16, 2014
Last Updated
June 18, 2020
Sponsor
Peking University First Hospital
Collaborators
Peking University People's Hospital, Peking University Third Hospital, Beijing Hospital, Beijing Jishuitan Hospital, Peking University Shougang Hospital, Beijing Shijitan Hospital, Capital Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02320630
Brief Title
Combination Therapy Prevents the Relapse of RA
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (Actual)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
September 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University First Hospital
Collaborators
Peking University People's Hospital, Peking University Third Hospital, Beijing Hospital, Beijing Jishuitan Hospital, Peking University Shougang Hospital, Beijing Shijitan Hospital, Capital Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrence (Disease Attribute)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Maintenance treatment group
Arm Title
B
Arm Type
Experimental
Arm Description
Combination treatment group
Arm Title
C
Arm Type
Experimental
Arm Description
Single drug group
Intervention Type
Drug
Intervention Name(s)
Entanercept
Other Intervention Name(s)
MTX
Intervention Description
Both Entanercept and MTX were given to patients for 60weeks (Week0-Week60).
Intervention Type
Drug
Intervention Name(s)
HCQ
Other Intervention Name(s)
SSZ, MTX, TFP
Intervention Description
Combination of HCQ+SSZ+MTX were given to patients for 60weeks (Week0-Week60).Entanercept was given to patients for 12 weeks (Week0-Week12).
Intervention Type
Drug
Intervention Name(s)
MTX
Other Intervention Name(s)
Entanercept
Intervention Description
MTX was given to patients for 60weeks (Week0-Week60). Entanercept was given to patients for 12 weeks (Week0-Week12).
Primary Outcome Measure Information:
Title
the rate of recurrence
Time Frame
60 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhuoli Zhang, Pro.
Phone
13901094780
Email
zhuoli.zhang@126.com
Facility Information:
Facility Name
Rheumatology and Immunology Department,Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhuoli Zhang, Pro
Phone
13901094780
Email
zhuoli.zhang@126.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
33663487
Citation
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.
Results Reference
derived
PubMed Identifier
31113467
Citation
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.
Results Reference
derived

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Combination Therapy Prevents the Relapse of RA

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