NCT02320630

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 19, 2014

Completed
10 months until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

June 22, 2020

Status Verified

June 1, 2020

Enrollment Period

1.3 years

First QC Date

December 16, 2014

Last Update Submit

June 18, 2020

Conditions

Recurrence (Disease Attribute)

Outcome Measures

Primary Outcomes (1)

  • the rate of recurrence

    60 weeks

Study Arms (3)

A

EXPERIMENTAL

Maintenance treatment group

Drug: EntanerceptDrug: MTX

B

EXPERIMENTAL

Combination treatment group

Drug: EntanerceptDrug: HCQDrug: MTX

C

EXPERIMENTAL

Single drug group

Drug: EntanerceptDrug: MTX

Interventions

EntanerceptDRUG

Both Entanercept and MTX were given to patients for 60weeks (Week0-Week60).

Also known as: MTX
ABC
HCQDRUG

Combination of HCQ+SSZ+MTX were given to patients for 60weeks (Week0-Week60).Entanercept was given to patients for 12 weeks (Week0-Week12).

Also known as: SSZ, MTX, TFP
B
MTXDRUG

MTX was given to patients for 60weeks (Week0-Week60). Entanercept was given to patients for 12 weeks (Week0-Week12).

Also known as: Entanercept
ABC

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rheumatology and Immunology Department,Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

Related Publications (3)

  • Zhao J, Zhou W, Wu Y, Yan X, Yang L, Zhang Z. Efficacy, safety, and cost-effectiveness of triple therapy in preventing relapse in rheumatoid arthritis: A randomized controlled trial (ESCoRT study). Chin Med J (Engl). 2022 Sep 20;135(18):2200-2209. doi: 10.1097/CM9.0000000000002336.

    PMID: 36525606DERIVED

  • 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.

    PMID: 33663487DERIVED

  • 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.

    PMID: 31113467DERIVED

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Zhuoli Zhang, Pro.

CONTACT

13901094780zhuoli.zhang@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Rheumatology and Immunology Department

Study Record Dates

First Submitted

December 16, 2014

First Posted

December 19, 2014

Study Start

October 1, 2015

Primary Completion

February 1, 2017

Study Completion

September 1, 2020

Last Updated

June 22, 2020

Record last verified: 2020-06

Locations

CN(1)