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Efficacy and Safety of TwHF and MTX in Patients With Rheumatoid Arthritis

NCT03324412 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 216

Last updated 2017-10-27

No results posted yet for this study

Summary

Rheumatoid Arthritis (RA) is an autoimmune disease that results in a chronic inflammatory disorder that may affect many synovial joints, and may cause serious disability. It has been confirmed that Tripterygium Wilfordii has effects of anti-inflammatory, immunosuppressive and cartilage protection. This is a multicenter ,double Blind, randomized study to evaluated the efficacy and safety of Tripterygium Wilfordii in treating of patients with rheumatoid arthritis (RA) and establish a prediction model for Tripterygium Wilfordii response of rheumatoid arthritis (RA).

Conditions

Interventions

DRUG

Treatment of MTX

Methotrexate: 10-15mg per week according to patient's weight, oral, for 24 weeks.Tripterygium wilfordii Hook F（TwHF）placebo：20mg， 3 times a day, oral, for 24 weeks.

DRUG

Treatment of MTX and TwHF

Methotrexate : 10-15mg per week according to patient's weight, oral, for 24 weeks.Tripterygium wilfordii Hook F（TwHF）：20mg， 3 times a day, oral, for 24 weeks.

Sponsors & Collaborators

  • Guang'anmen Hospital of China Academy of Chinese Medical Sciences

    lead OTHER

Principal Investigators

  • Jiang Quan, MD · Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-10-28
Primary Completion
2019-05-31
Completion
2019-09-30

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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 NCT03324412 on ClinicalTrials.gov