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Kunxian for the Treatment of Rheumatoid Arthritis

NCT02764515 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 428

Last updated 2017-03-09

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • CHENLIJI Pharmaceutical Company,Guangzhou Pharmaceutical Group

    collaborator UNKNOWN

  • CHINESE RHEUMATISM DATA CENTER

    collaborator UNKNOWN

  • Chinese SLE Treatment And Research Group

    lead OTHER

Principal Investigators

  • XIAOFENG ZENG, MD · Peking Union Medical College Hospital

  • XINPING TIAN, MD · Peking Union Medical College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2017-09-30
Completion
2017-11-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02764515 on ClinicalTrials.gov