drugset / Trial / NCT02764515
Kunxian for the Treatment of Rheumatoid Arthritis
Phase 4
Unknown
428 enrolled
Chinese SLE Treatment And Research Group
CHENLIJI Pharmaceutical Company,Guangzhou Pharmaceutical Group · collabCHINESE RHEUMATISM DATA CENTER · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
This is a multicenter, randomized, double blind, double-dummy and controlled clinical trial aimed to compare the clinical efficacy and safety of Kunxian Capsule, a compound of Chinese traditional medicine, and the active comparator,Methotrexate for the treatment of rheumatoid arthritis. The primary end-point is that Kunxian Capsule is not inferior to Methotrexate both in efficacy and safety.
Timeline
- Start
- 2015-09
- Primary completion
- 2017-09
- Completion
- 2017-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Kunxian Capsule | Traditional medicine (herbal / TCM) | 0.6 g | Oral |
| Comparator | Methotrexate | Small molecule | 10 mg | Oral |