A Specification Clinical Application Research of Tripterygium Wilfordii Treating Rheumatoid Arthritis

Overview

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).

Full Title of Study: “A 24-Week, Multicenter ,Double Blind, Randomized Study to Determine the Effects and Security of Tripterygium Wilfordii Treating Rheumatoid Arthritis and Establish A Prediction Model”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: March 31, 2019

Detailed Description

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

Interventions

  • Drug: Treatment of MTX and TwHF placebo
    • Methotrexate: 10-15mg per week according to patient’s weight, oral, for 24 weeks.Tripterygium wilfordii Hook F(TwHF)placebo:20mg,3 times a day, oral, for 24 weeks.
  • Drug: Treatment of TwHF and MTX placebo
    • Tripterygium wilfordii Hook F(TwHF):20mg,3 times a day, oral, for 24 weeks.Methotrexate (MTX)placebo: 10-15mg per week according to patient’s weight, oral, for 24 weeks.

Arms, Groups and Cohorts

  • Active Comparator: Treatment of MTX and TwHF placebo
    • Patients were treated with Methotrexate (MTX) and Tripterygium wilfordii Hook F(TwHF)placebo.
  • Experimental: Treatment of TwHF and MTX placebo
    • Patients were treated with Tripterygium wilfordii Hook F(TwHF)and Methotrexate (MTX) placebo.

Clinical Trial Outcome Measures

Primary Measures

  • The change in Disease Activity Score (DAS28)
    • Time Frame: 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 Measures

  • The proportion of patients achieving ACR20/50/70
    • Time Frame: 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
    • Time Frame: 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 scoring system of van der Heijde(Sharp) score
    • Time Frame: 0 week,24 weeks,52 weeks
    • The change in Sharp score from baseline to week 24 and 52.According to the revised Sharp scoring system of van der Heijde, the joint gap score was scored in 30 regions of the hands (score range 0-120 points), and the bone erosion score was conducted in 32 areas (score range 0-160).The higher the score, the more serious the joint destruction.
  • The number of adverse events
    • Time Frame: 24 weeks
    • The number of adverse events that are related to treatment

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 45 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Guang’anmen Hospital of China Academy of Chinese Medical Sciences
  • Provider of Information About this Clinical Study
    • Principal Investigator: Quan Jiang, director – Guang’anmen Hospital of China Academy of Chinese Medical Sciences
  • Overall Official(s)
    • Jiang Quan, MD, Study Director, Guang’anmen Hospital of China Academy of Chinese Medical Sciences
  • Overall Contact(s)
    • Jiang Quan, MD, 010-88001060, doctor@126.com

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