Efficacy of Chinese Herbal Medicine Qing Re Huo Xue in Patients With Rheumatoid Arthritis

Study Overview
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Brief Summary
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This study is a multicenter, randomized, double-blinded, controlled trial with two parallel arms. The aim of the study is to evaluate whether Chinese herbal medicine Qing Re Huo Xue (QRHX) combined with methotrexate (MTX) might be better than MTX alone for patients with active rheumatoid arthritis (RA).

Detailed Description
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To compare the efficacy and safety of Chinese herbal medicine Qing Re Huo Xue (QRHX) and methotrexate (MTX) for patients with active rheumatoid arthritis (RA), a multicenter, randomized controlled trial will be conducted. Two hundred and four patients with active RA will be randomly allocated (1:1) to treatment with QRHX 10mg bid and MTX 10 mg once a week for 24 weeks, or MTX plus dummy QRHX. The primary outcome is he OMERACT rheumatoid arthritis MRI scoring system (RAMRIS) at week 24.

Official Title
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Efficacy of Chinese Herbal Medicine Qing Re Huo Xue in Patients With Rheumatoid Arthritis: A Randomized Controlled Trial

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: Qing Re Huo Xue (QRHX)
* Drug: Methotrexate
* Drug: dummy Qing Re Huo Xue (QRHX)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has had a confirmed diagnosis of rheumatoid arthritis according to 2010 ACR/EULAR RA classification criteria. Subject has a DAS28 CRP disease activity score of >3.2 at screening. Subject also experienced the following signs and symptoms: swelling, joint pain, and heat in the joints. Subject has had no prior exposure to oral glucocorticoids at a daily dose greater than 10 mg or to any biologic agents. Subject may has had previous exposure to nonsteroidal anti-inflammatory drugs (NSAIDs) prior to screening and must be on stable dose. Exclusion Criteria: History or presence of a clinically significant medical disorder other than RA that, in the opinion of the investigator and medical monitor, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion. Subject has inflammatory, rheumatological disorders other than RA, where arthritis may be a prominent feature. Subject has received treatment with the prohibited therapies listed in the protocol, or changes to those treatments, within the prescribed timeframe. Pregnant or nursing an infant or with a life partner who is pregnant, nursing, or planning to become pregnant.

Ages Eligible for Study
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Minimum Age: 18 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Qing Re Huo Xue (QRHX) plus methotrexate (MTX)<br>QRHX XXmg bid and methotrexate (MTX) 10 mg once a week for 24 weeks | Drug: Qing Re Huo Xue (QRHX)<br>* Qing Re Huo Xue (QRHX) XXmg bid for 24 weeks<br>* Other names: GAM;Drug: Methotrexate<br>* Oral methotrexate 10 mg per week for 24 weeks.<br>* Other names: XINYI Pharm;|
| Active Comparator: Methotrexate (MTX) plus dummy Qing Re Huo Xue (QRHX)<br>Methotrexate (MTX) plus dummy Qing Re Huo Xue (QRHX) | Drug: Methotrexate<br>* Oral methotrexate 10 mg per week for 24 weeks.<br>* Other names: XINYI Pharm;Drug: dummy Qing Re Huo Xue (QRHX)<br>* dummy Qing Re Huo Xue (QRHX) XXmg bid for 24 weeks<br>* Other names: GAM;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in OMERACT RAMRIS | Bone erosions will be assessed by OMERACT-RAMRIS scoring system | week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of ACR20 | Percentage of Participants With American College of Rheumatology 20% (ACR20) | week 24 | 
| Percentage of ACR50 | Percentage of Participants With American College of Rheumatology 50% (ACR50) | week 24 | 
| Percentage of ACR70 | Percentage of Participants With American College of Rheumatology 70% (ACR70) | week 24 | 
| Change From Baseline in Modified Total Sharp X-Ray Score at Week 24 | Modified Total Sharp Score (mTSS) is a measure of joint health, used in evaluation of inhibition of radiographic progression of disease | week 24 | 
| Chinese Patient-reported Activity Index with RA scale (PRO) | Patient-Reported Outcomes Scale,The self-rating scale consists of 12 items,Each item was rated 0, 1, 2 and 3 on the scale of asymptomatic to aggravating symptoms, respectively. | week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rheumatoid Arthritis, Qing Re Huo Xue, Methotrexate, Randomized controlled trial