Efficacy and Safety of Colquhounia Root Tablet in Patients With Rheumatoid Arthritis

Study Overview
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Brief Summary
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This study is a multi-center, randomized, double-blinded, controlled trial with two parallel arms. The aim of the study is to evaluate whether Colquhounia Root Tablet combined with methotrexate (MTX) might be better than MTX alone for patients with active rheumatoid arthritis (RA).

Official Title
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Efficacy and Safety of Colquhounia Root Tablet in Patients With Rheumatoid Arthritis：A Randomized Controlled Trial

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: Colquhounia Root Tablet
* Drug: Methotrexate tablets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject understood the whole process of the trial and signed the informed consent voluntarily. Subject has had a confirmed diagnosis of rheumatoid arthritis according to 2010 ACR/EULAR RA classification criteria. Subjects aged between 45-70years who were the males without fertility requirements or menopausal women. Subject has a DAS28 CRP disease activity score greater than 2.6 and less than 5.1. Subject did not participate in any drug trials within 1 month before enrollment. Exclusion Criteria: Pregnant women, women planning to become pregnant or breastfeeding. Severe systemic involvement, such as severe pericardial effusion, interstitial lung disease, renal tubular acidosis, autoimmune liver disease. Active liver disease or abnormal liver function, ALT and AST are more than 1.5 times the upper limit of normal. Renal impairment, serum creatinine greater than the upper limit of normal. Bone marrow hematopoietic dysfunction, peripheral blood leukocytes <3.0×109/L, or definite anemia (hemoglobin less than 80g/L), or platelets <80×109/L, or other blood system diseases. Active gastric and duodenal ulcers. Uncontrolled severe hypertension, metabolic diseases. malignant tumors. Acute and/or chronic infectious diseases. Severe cardiac arrhythmia found on electrocardiogram. Mental illness, history of alcoholism, drug or other substance abuse. Diagnosed with other connective tissue disease. Those who have used immunosuppressants, biological agents, Colquhounia Root Tablet or drugs containing Tripterygium wilfordii within 1 month before enrollment. Those who have previously used methotrexate or preparations containing tripterygium wilfordii for 12 weeks or more ,but their condition is not under control. Adverse reactions have occurred in the past using Colquhounia Root Tablet or drugs containing Tripterygium wilfordii.

Ages Eligible for Study
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Minimum Age: 45 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Colquhounia Root Tablet plus methotrexate (MTX)<br>Colquhounia Root Tablet 0.9g tid and methotrexate (MTX) 10 mg oncea week for the first 12 weeks，Colquhounia Root Tablet 0.54g tid and methotrexate (MTX) 10 mg once a week for the after 12 weeks. | Drug: Colquhounia Root Tablet<br>* Colquhounia Root Tablet is a tripterygium preparation<br>Drug: Methotrexate tablets<br>* Methotrexate is a drug used to treat rheumatoid arthritis<br>|
| Placebo Comparator: placedo of Colquhounia Root Tablet plus methotrexate (MTX)<br>placedo of Colquhounia Root Tablet 0.9g tid and methotrexate (MTX) 10 mg oncea week for the first 12 weeks，placedo of Colquhounia Root Tablet 0.54g tid and methotrexate (MTX) 10 mg once a week for the after 12 weeks. | Drug: Methotrexate tablets<br>* Methotrexate is a drug used to treat rheumatoid arthritis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of ACR20 | Percentage of Participants With American College of Rheumatology 20% (ACR20) | week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| DAS28-ESR | 28-joint disease activity score | 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, Colquhounia Root Tablet, Methotrexate, Randomized controlled trial