Combination Therapy Prevents the Relapse of RA

Recurrence (Disease Attribute) Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02320630
• Other study ID #: PUCRP201305
• Status: Recruiting
• Phase: N/A
• Start date: October 2015
• Est. completion date: September 2020

Study information

• Verified date: June 2020
• Source: Peking University First Hospital
• Contact: Zhuoli Zhang, Pro.
• Phone: 13901094780
• Email: zhuoli.zhang[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: September 2020
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Disease Attributes
• Recurrence
• Recurrence (Disease Attribute)

Intervention

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

Locations

Country	Name	City	State
China	Rheumatology and Immunology Department,Peking University First Hospital	Beijing	Beijing

Sponsors (7)

Lead Sponsor	Collaborator
Peking University First Hospital	Beijing Hospital, Beijing Jishuitan Hospital, Beijing Shijitan Hospital, Peking University People's Hospital, Peking University Shougang Hospital, Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the rate of recurrence		60 weeks