NCT02764515

Kunxian for the Treatment of Rheumatoid Arthritis

Comparison of the Efficacy and Safety of Kunxian Capsule and Methotrexate for the Treatment of Rheumatoid Arthritis

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 428 (estimated)
• Sponsor: Chinese SLE Treatment And Research Group · Academic / Other
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective, multicenter, randomized, double blind, double-dummy and controlled clinical trial.The goal is to compare the clinical efficacy and safety of Kunxian Capsule, a compound of 4 ingredients of Chinese herb-derived medication, and the active comparator, Methotrexate for the treatment of mild to moderate active rheumatoid arthritis.This study is basically non-inferiority in design, so 428 subjects will be enrolled. All subjects need to fulfill the inclusion criteria and without exclusion criteria. Subjects are randomized into the Kunxian Capsule treatment group and Methotrexate treatment group.The dosage of Kunxian Capsule used in this study is 0.6g twice daily and the methotrexate dosage is 10mg per week. All subjects will take the medication for 24 weeks. Diclofenic is used as the salvage therapy in case patients experience joint pain. The primary end-point is the proportion of patients who could achieve disease remission or low disease activity treated with Kunxian Capsule and Methotrexate. All patients will be followed at week 2,4,12 and 24 after screening. Baseline information for disease activity measures such as DAS28 score,CDAI score, SDAI score, ACR20, ACR50, ACR70 improvement, HAQ score, patient's VAS score for pain, and lab tests such as CRP, ESR, RF, CCP, blood and urine routine tests, liver as well as renal function tests were collected and recorded. All these measures are performed at each follow-up visit except RF and CCP. In addition, any adverse events or withdrawal happened during each visit will be recorded for data analysis.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Kunxian Capsule	Patients in the Kunxian Capsule group will take Kunxian Capsule 0.6gm orally twice daily for 24weeks
DRUG	Methotrexate	the Methotrexate group will take Methotrexate 10mg orally every week for 24 weeks

Timeline

• Start date: 2015-09-01
• Primary completion: 2017-09-01
• Completion: 2017-11-01
• First posted: 2016-05-06
• Last updated: 2017-03-09

Locations

16 sites across 1 country: China