Combination Therapy Prevents the Relapse of RA

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2020-09-30

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.

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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)

Conditions

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Recurrence (Disease Attribute)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Maintenance treatment group

Group Type EXPERIMENTAL

Entanercept

Intervention Type DRUG

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

MTX

Intervention Type DRUG

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

B

Combination treatment group

Group Type EXPERIMENTAL

Entanercept

Intervention Type DRUG

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

HCQ

Intervention Type DRUG

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

MTX

Intervention Type DRUG

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

C

Single drug group

Group Type EXPERIMENTAL

Entanercept

Intervention Type DRUG

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

MTX

Intervention Type DRUG

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

Interventions

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Entanercept

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

Intervention Type DRUG

HCQ

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

Intervention Type DRUG

MTX

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

Intervention Type DRUG

Other Intervention Names

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MTX SSZ MTX TFP Entanercept

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No