ClinicalTrials.Veeva

Menu

Combination Therapy Prevents the Relapse of RA

P

Peking University

Status

Unknown

Conditions

Recurrence (Disease Attribute)

Treatments

Drug: MTX
Drug: HCQ
Drug: Entanercept

Study type

Interventional

Funder types

Other

Identifiers

NCT02320630
PUCRP201305

Details and patient eligibility

About

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.

Full 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)

Enrollment

240 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

240 participants in 3 patient groups

A
Experimental group
Description:
Maintenance treatment group
Treatment:
Drug: Entanercept
Drug: MTX
B
Experimental group
Description:
Combination treatment group
Treatment:
Drug: Entanercept
Drug: HCQ
Drug: MTX
C
Experimental group
Description:
Single drug group
Treatment:
Drug: Entanercept
Drug: MTX

Trial contacts and locations

1

Loading...

Central trial contact

Zhuoli Zhang, Pro.

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems