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

Not Applicable

Completed

• Conditions: Active Rheumatoid Arthritis
• Interventions: Drug: Topical compound tripterygium; Drug: Placebo

• Registration Number: NCT01961505
• Lead Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Brief 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 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2013-09-23
• Study First Submitted QC: 2013-10-09
• Study First Posted: 2013-10-11
• Primary Completion: 2015-09
• Study Completion: 2016-12
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-27
• Last Update Posted: 2017-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Topical Tripterygium group	Topical compound tripterygium	Patients were treated with topical compound tripterygium for 1 hour, twice per day. Area dosages were as followed that each 1st to 5th metacarpophalangeal joints (MCPJs), 1st to 5th proximal interphalangeal joints (PIPJs) and wrist was 3 ml, each elbow and ankle was 5 ml, each knee was 10 ml.
Topical Placebo group	Placebo	Patients were treated with topical placebo for 1 hour, twice per day. The dosage was the same as the topical tripterygium group.

Primary Outcome Measures

Name	Time	Method
ACR20 criteria	Week 4	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.

Secondary Outcome Measures

Name	Time	Method
ACR50 criteria	Week 4	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.
28-joint count Disease Activity Score (DAS28)	Baselin and week 4