Combination Therapy Prevents the Relapse of RA

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)

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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