Combination Therapy Prevents the Relapse of RA

Study Overview
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Brief Summary
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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
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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)

Official Title
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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

Conditions
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Recurrence (Disease Attribute)

Intervention / Treatment
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* Drug: Entanercept
* Drug: HCQ
* Drug: MTX


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Maintenance treatment group | Drug: Entanercept<br>* Both Entanercept and MTX were given to patients for 60weeks (Week0-Week60).<br>* Other names: MTX;Drug: MTX<br>* MTX was given to patients for 60weeks (Week0-Week60). Entanercept was given to patients for 12 weeks (Week0-Week12).<br>* Other names: Entanercept;|
| Experimental: B<br>Combination treatment group | Drug: Entanercept<br>* Both Entanercept and MTX were given to patients for 60weeks (Week0-Week60).<br>* Other names: MTX;Drug: HCQ<br>* Combination of HCQ+SSZ+MTX were given to patients for 60weeks (Week0-Week60).Entanercept was given to patients for 12 weeks (Week0-Week12).<br>* Other names: TFP;Drug: MTX<br>* MTX was given to patients for 60weeks (Week0-Week60). Entanercept was given to patients for 12 weeks (Week0-Week12).<br>* Other names: Entanercept;|
| Experimental: C<br>Single drug group | Drug: Entanercept<br>* Both Entanercept and MTX were given to patients for 60weeks (Week0-Week60).<br>* Other names: MTX;Drug: MTX<br>* MTX was given to patients for 60weeks (Week0-Week60). Entanercept was given to patients for 12 weeks (Week0-Week12).<br>* Other names: Entanercept;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the rate of recurrence |  | 60 weeks |