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

• Status: Unknown status
• Trial end date: 2019-09-30
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

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.