Efficacy and Safety of TwHF and MTX in Patients With Rheumatoid Arthritis
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Treatment of MTX Patients were treated with methotrexate (MTX)and Tripterygium wilfordii Hook F（TwHF）placebo. |
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.
|
| Experimental: Treatment of MTX and TwHF Patients were treated with methotrexate (MTX)and Tripterygium wilfordii Hook F（TwHF). |
Drug: 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.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Investigators
- Study Director: Jiang Quan, MD, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Z161100000516020-2