Rheumatoid Arthritis
Conditions
Brief 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).
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).
Interventions
DRUGTreatment 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.
DRUGTreatment 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.
Sponsors
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
45 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change from Baseline to week 24 in Disease Activity Score (DAS28) | 0 weeks, 4 weeks，12 weeks, 24 weeks,52 weeks | Disease Activity Score for 28-joint counts was based on the erythrocyte sedimentation rate(ESR) (DAS28-4\[ESR\]) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of patients achieving ACR20/50/70 | 0 weeks, 4 weeks，12 weeks, 24 weeks | ACR20/50/70 is referred to American College of Rheumatology Criteria |
| The change in Health Assessment Questionnaire (HAQ) score | 0 weeks, 4 weeks，12 weeks, 24 weeks,52 weeks | HAQ scores ranges from 0 to 3, with higher scores indicating greater disability |
| The change in Sharp score | 0 week,24 weeks,52 weeks | The change in X-Ray from baseline to week 24 and 52. |
| The number of adverse events | 24 weeks | The number of adverse events that are related to treatment |
Contacts
Primary ContactJiang Quan, MD
Outcome results
None listed