Topical Compound Tripterygium Wilfordii Hook F for Patients With Active Rheumatoid Arthritis

N/ACompletedNCT01961505

Guang'anmen Hospital of China Academy of Chinese Medical Sciences70 enrolled

Overview

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 Hook F has effects of anti-inflammatory, immunosuppressive and cartilage protection. This is a prospective randomized controlled study to evaluated the efficacy and safety of external application with compound Tripterygium wilfordii Hook F in treating of patients with rheumatoid arthritis (RA).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Active Rheumatoid Arthritis

Interventions

Topical compound tripterygium

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Documented diagnosis of rheumatoid arthritis, as defined by the American Rheumatism Association 1987 Revised Criteria or European League Against Rheumatism criteria (2009). * Patients must have moderately to severely active RA,and the DAS-28 score should be from 3.2 to 5.1. * If taking disease modifying antirheumatic drug (DMARDs)(e.g.Methotrexate), subject must have been on a stable dose for ≥ 3 months prior to randomization. * If taking non-steroidal anti-inflammatory drugs (NSAIDs), subject must have been on a stable dose for ≥ 4 weeks prior to randomization. * 16 to 65 years old, having signed the informed consent. Exclusion Criteria: * Patients who have skin burst or allergies. * Patients with sever diseases in Cardiovascular, brain, lung, liver, kidney and hematopoietic system. * Patients who have been treated by tripterygium, hormones or biological agents. * Patients who have not been treated by DMARDs before. * Patients who are unwilling to comply with all study procedures.

Outcomes

Primary Outcomes

ACR20 criteria

To meet the criteria, a patient must have 20% or greater improvement in both tender and swollen joints (28 tender and 28 swollen joints were assessed) and 20% or greater improvement in 3 or more of the following: the physician's or patient's assessment of global health status, the patient's assessment of pain on a visual analogue scale, the patient's assessment of function using a modified version of the Health Assessment Questionnaire (HAQ), and the ESR or serum C-reactive protein (CRP) level.

Time frame: Week 4

Secondary Outcomes

ACR50 criteria

To meet the criteria, a patient must have 50% or greater improvement in both tender and swollen joints (28 tender and 28 swollen joints were assessed) and 50% or greater improvement in 3 or more of the following: the physician's or patient's assessment of global health status, the patient's assessment of pain on a visual analogue scale, the patient's assessment of function using a modified version of the Health Assessment Questionnaire (HAQ), and the ESR or serum C-reactive protein (CRP) level.

Time frame: Week 4

28-joint count Disease Activity Score (DAS28)

Time frame: Baselin and week 4