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

Last updated: October 25, 2017
Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Overall Status: Trial Status Unknown

Phase

2/3

Condition

Arthritis And Arthritic Pain

Dermatomyositis (Connective Tissue Disease)

Joint Injuries

Treatment

N/A

Clinical Study ID

NCT03324412
Z161100000516020-2
  • Ages 45-70
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosed with rheumatoid arthritis as determined by the 1987 or 2010 ACRclassification 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 lungdisease, renal tubular acidosis, atrophic gastritis, autoimmune liver disease, etc;

  • Within a month before the selected participants did not attend any drugs

Exclusion

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-modifyingantirheumatic drug (DMARD) in 3 months.

  • Previous treated with Tripterygium Wilfordii or MTX

  • Patients with retinopathy.

Study Design

Total Participants: 216
Study Start date:
October 28, 2017
Estimated Completion Date:
September 30, 2019

Study 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).