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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02320630

Enrollment

240

Registered

2014-12-19

Start date

2015-10-31

Completion date

2020-09-30

Last updated

2020-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrence (Disease Attribute)

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)

Interventions

DRUGEntanercept

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

DRUGHCQ

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

DRUGMTX

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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.

Design outcomes

Primary

Measure	Time frame
the rate of recurrence	60 weeks

Countries

China

Contacts

Primary ContactZhuoli Zhang, Pro.

zhuoli.zhang@126.com13901094780

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026