Rheumatoid Arthritis
Conditions
Brief summary
This is prospective randomized, controlled study to evaluate the efficacy and safety of Qingre Huoxue comprehensive therapy in treating of patients with early Rheumatoid Arthritis (RA). The major outcome index is the change from baseline to week 24 in Disease Activity Score (DAS28), and minor outcome indexes include American College of Rheumatology (ACR)20/50/70, PRO score, Sharp score and OMERACT RAMRIS score. The adverse events at any time were recorded to evaluate the safety.
Detailed description
Three arms were included in this study, and treatment with MTX and HCQ is defined as active comparator. Treatment of TCM，including Qingre Huoxue granule, Qingre Huoxue external preparation, MTX placebo and HCQ placebo, is defined as one experimental arm. Treatment of integrative medicine，including Qingre Huoxue granule, Qingre Huoxue external preparation, MTX and HCQ, is defined as another experimental arm.
Interventions
DRUGTreatment of MTX and HCQ
Methotrexate: 10-15mg per week according to patient's weight, oral, for 24 weeks. Hydroxychloroquine: 200mg, 2 times a day, oral, for 24 weeks. Qingre Huoxue granule placebo: 10g, 2 times a day, oral, for 24 weeks. Qingre Huoxue external preparation placebo: 20g, 1 times a day, external, for 4 weeks, then 10g, 1 times a day, external, for 8 weeks.
DRUGTreatment of TCM
Qingre Huoxue granule: 10g, 2 times a day, oral, for 24 weeks. Qingre Huoxue external preparation: 20g, 1 times a day, external, for 4 weeks, then 10g, 1 times a day, external, for 8 weeks. Methotrexate placebo: 10-15mg per week according to patient's weight, oral, for 24 weeks. Hydroxychloroquine placebo: 200mg, 3 times a day, oral, for 24 weeks.
Qingre Huoxue granule: 10g, 2 times a day, oral, for 24 weeks. Qingre Huoxue external preparation: 20g, 1 times a day, external, for 4 weeks, then 10g, 1 times a day, external, for 8 weeks. Methotrexate: 10-15mg per week according to patient's weight, oral, for 24 weeks. Hydroxychloroquine: 200mg, 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
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed with rheumatoid arthritis as determined by the 1987 ACR classification criteria. * Diagnosed with TCM dampness heat and blood stasis syndrome * The course of RA is not more than 5 years. * Swollen joint (SJC)≥2 and tender joint count(TJC)≥3. * Erythrocyte Sedimentation Rate（ESR）≥20 mm/hr * Patients who take disease-modifying antirheumatic drugs for at least 3 months on a stable dose, and retain the same treatment during the study. * Age 18-65 years with informed consent
Exclusion criteria
* Patients with skin burst or allergies. * 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 MTX or HCQ * Patients with retinopathy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change from Baseline to week 24 in Disease Activity Score (DAS28) | 0 weeks, 12 weeks, 24 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 week, 12 weeks, 24 weeks | ACR20/50/70 is referred to American College of Rheumatology Criteria. |
| The change from baseline to week 24 in the score on the patient report outcome (PRO) | 0 week, 12 weeks, 24 weeks | PRO scores ranges from 0 to 3, with higher scores indicating greater disability |
| The change in Sharp score | 0 week, 52 weeks | The change in X-Ray from baseline to week 52. |
| The change in OMERACT RAMRIS score | 0 week, 24 weeks | The change in Magnetic Resonance Imaging from baseline to week 24. |
| The number of adverse events | 24 weeks | The number of adverse events that are related to treatment |
Countries
China
Outcome results
None listed