A Specification Clinical Application Research of Tripterygium Wilfordii Treating Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03337815
• Other study ID #: Z161100000516020-1
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: October 22, 2017
• Last updated: November 8, 2017
• Start date: October 28, 2017
• Est. completion date: September 30, 2019

Study information

• Verified date: November 2017
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: Jiang Quan, MD
• Phone: 010-88001060
• Email: doctor[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 264
• Est. completion date: September 30, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Guang'anmen Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in Disease Activity Score (DAS28)	Disease Activity Score for 28-joint counts was based on the erythrocyte sedimentation rate(ESR) (DAS28-4[ESR])	0 weeks, 4 weeks,12 weeks, 24 weeks,52 weeks
Secondary	The proportion of patients achieving ACR20/50/70	ACR20/50/70 is referred to American College of Rheumatology Criteria	0 weeks, 4 weeks,12 weeks, 24 weeks
Secondary	The change in Health Assessment Questionnaire (HAQ) score	HAQ scores ranges from 0 to 3, with higher scores indicating greater disability	0 weeks, 4 weeks,12 weeks, 24 weeks,52 weeks
Secondary	The change in Sharp scoring system of van der Heijde(Sharp) score	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.	0 week,24 weeks,52 weeks
Secondary	The number of adverse events	The number of adverse events that are related to treatment	24 weeks