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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03324412
• Other study ID #: Z161100000516020-2
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• First received: October 25, 2017
• Last updated: October 25, 2017
• Start date: October 28, 2017
• Est. completion date: September 30, 2019

Study information

• Verified date: October 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: 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 216
• Est. completion date: September 30, 2019
• Est. primary completion date: May 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
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 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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 score	The change in X-Ray from baseline to week 24 and 52.	0 week,24 weeks,52 weeks
Secondary	The number of adverse events	The number of adverse events that are related to treatment	24 weeks