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

A 24-Week, Multicenter ,Double Blind, Randomized Study to Determine the Effects and Security of TwHF and MTX Treating Rheumatoid Arthritis

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).

Study Overview

• Status: Unknown
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: Treatment of MTX; Drug: Treatment of MTX and TwHF

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 Type: Interventional
• Enrollment (Anticipated): 216
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Jiang Quan, MD; Phone Number: 010-88001060; Email: doctor@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treatment of MTX; Patients were treated with methotrexate (MTX)and Tripterygium wilfordii Hook F（TwHF）placebo.	Drug: Treatment of MTX; 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.
Experimental: Treatment of MTX and TwHF; Patients were treated with methotrexate (MTX)and Tripterygium wilfordii Hook F（TwHF).	Drug: Treatment of MTX and TwHF; Methotrexate : 10-15mg per week according to patient's weight, oral, for 24 weeks.Tripterygium wilfordii Hook F（TwHF）：20mg， 3 times a day, oral, for 24 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change from Baseline to week 24 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
The change in Sharp score	The change in X-Ray from baseline to week 24 and 52.	0 week,24 weeks,52 weeks
The number of adverse events	The number of adverse events that are related to treatment	24 weeks

Collaborators and Investigators

• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Study record dates

Study Major Dates

• Study Start (Anticipated): October 28, 2017
• Primary Completion (Anticipated): May 31, 2019
• Study Completion (Anticipated): September 30, 2019

Study Registration Dates

• First Submitted: October 25, 2017
• First Submitted That Met QC Criteria: October 25, 2017
• First Posted (Actual): October 27, 2017

Study Record Updates

• Last Update Posted (Actual): October 27, 2017
• Last Update Submitted That Met QC Criteria: October 25, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: Z161100000516020-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No