Overview

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.