Clinical trial NCT02551575: Efficacy and Safety of Traditional Chinese Medicine (TCM) Comprehensive Therapy in Patients With Rheumatoid Arthritis
Official title: Efficacy and Safety of Qingre Huoxue Comprehensive Therapy in the Treatment of Rheumatoid Arthritis (RA): A Randomized, Double-blind, Double-dummy, Multi-center Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2015-09-16
Enrollment: 468
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The change from Baseline to week 24 in Disease Activity Score (DAS28)
timeFrame: 0 weeks, 12 weeks, 24 weeks
Secondary outcomes:
measure: The proportion of patients achieving ACR20/50/70
timeFrame: 0 week, 12 weeks, 24 weeks
measure: The change from baseline to week 24 in the score on the patient report outcome (PRO)
timeFrame: 0 week, 12 weeks, 24 weeks
measure: The change in Sharp score
timeFrame: 0 week, 52 weeks
measure: The change in OMERACT RAMRIS score
timeFrame: 0 week, 24 weeks
measure: The number of adverse events
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Bei Jing
country: China
facility: Guang'anmen Hospital
state: Beijing
Study officials:
affiliation: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
name: Jiang Quan, MD
role: STUDY_DIRECTOR
References:
citation: Gong X, Liu WX, Tang XP, Wang J, Liu J, Huang QC, Liu W, Fang YF, He DY, Liu Y, Gao ML, Wu QJ, Chen S, Li ZB, Wang Y, Xie YM, Zhang JL, Zhou CY, Ma L, Wang XC, Zhang C, Jiang Q. Traditional Chinese Medicine Qingre Huoxue Treatment vs. the Combination of Methotrexate and Hydroxychloroquine for Active Rheumatoid Arthritis: A Multicenter, Double-Blind, Randomized Controlled Trial. Front Pharmacol. 2021 May 25;12:679588. doi: 10.3389/fphar.2021.679588. eCollection 2021.