Efficacy and Safety of TwHF and MTX in Patients With Rheumatoid Arthritis

Phase 2

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Treatment of MTX; Drug: Treatment of MTX and TwHF

• Registration Number: NCT03324412
• Lead Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Brief Summary

Rheumatoid Arthritis (RA) is an autoimmune disease that results in a chronic inflammatory disorder that may affect many synovial joints, and may cause serious disability. It has been confirmed that Tripterygium Wilfordii has effects of anti-inflammatory, immunosuppressive and cartilage protection. This is a multicenter ,double Blind, randomized study to evaluated the efficacy and safety of Tripterygium Wilfordii in treating of patients with rheumatoid arthritis (RA) and establish a prediction model for Tripterygium Wilfordii response of rheumatoid arthritis (RA).

Detailed Description

Two arms were included in this study. Active Comparator: treatment of MTX Patients were treated with methotrexate (MTX)and Tripterygium wilfordii Hook F（TwHF）placebo.Experimental: treatment of TwHF Patients were treated with methotrexate (MTX) and Tripterygium wilfordii Hook F（TwHF).

Study Timeline

• Status Verified: 2017-10
• Study First Submitted: 2017-10-25
• Study First Submitted QC: 2017-10-25
• Last Update Submitted: 2017-10-25
• Study First Posted: 2017-10-27
• Last Update Posted: 2017-10-27
• Study Start: 2017-10-28
• Primary Completion: 2019-05-31
• Study Completion: 2019-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 216

Inclusion Criteria

• Diagnosed with rheumatoid arthritis as determined by the 1987 or 2010 ACR classification criteria;
• No male or female fertility requirements, or around menopause women;
• Patients with mild-to-moderate activity, 2.6 < DAS28≤5.1;
• No serious system involved, such as severe pericardial effusion, interstitial lung disease, renal tubular acidosis, atrophic gastritis, autoimmune liver disease, etc;
• Within a month before the selected participants did not attend any drugs

Exclusion Criteria

• Patients with cancer or other malignant disease such as cardiovascular, hematopoietic, liver and kidney disease, and psychopath
• Active or chronic infection, including HIV, hepatitis C virus, hepatitis B virus, tuberculosis
• Previous treated with tripterygii, glucocorticoid or biologic disease-modifying antirheumatic drug (DMARD) in 3 months.
• Previous treated with Tripterygium Wilfordii or MTX
• Patients with retinopathy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment of MTX	Treatment of MTX	Patients were treated with methotrexate (MTX)and Tripterygium wilfordii Hook F（TwHF）placebo.
Treatment of MTX and TwHF	Treatment of MTX and TwHF	Patients were treated with methotrexate (MTX)and Tripterygium wilfordii Hook F（TwHF).

Primary Outcome Measures

Name	Time	Method
The change from Baseline to week 24 in Disease Activity Score (DAS28)	0 weeks, 4 weeks，12 weeks, 24 weeks,52 weeks	Disease Activity Score for 28-joint counts was based on the erythrocyte sedimentation rate(ESR) (DAS28-4\[ESR\])

Secondary Outcome Measures

Name	Time	Method
The proportion of patients achieving ACR20/50/70	0 weeks, 4 weeks，12 weeks, 24 weeks	ACR20/50/70 is referred to American College of Rheumatology Criteria
The change in Health Assessment Questionnaire (HAQ) score	0 weeks, 4 weeks，12 weeks, 24 weeks,52 weeks	HAQ scores ranges from 0 to 3, with higher scores indicating greater disability
The change in Sharp score	0 week,24 weeks,52 weeks	The change in X-Ray from baseline to week 24 and 52.
The number of adverse events	24 weeks	The number of adverse events that are related to treatment