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

NCT03324412 | Unknown Phase 2 DMC

• 1 other identifier: Z161100000516020-2
• Study Type: interventional
• Target: 216
• Locations: 0 countries
• Sites: N/A

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 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

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• The change from Baseline to week 24 in Disease Activity Score (DAS28)

  Disease Activity Score for 28-joint counts was based on the erythrocyte sedimentation rate(ESR) (DAS28-4\[ESR\])

  0 weeks, 4 weeks，12 weeks, 24 weeks,52 weeks

Secondary Outcomes (4)

• The proportion of patients achieving ACR20/50/70

  0 weeks, 4 weeks，12 weeks, 24 weeks

• The change in Health Assessment Questionnaire (HAQ) score

  0 weeks, 4 weeks，12 weeks, 24 weeks,52 weeks

• The change in Sharp score

  0 week,24 weeks,52 weeks

• The number of adverse events

  24 weeks

Study Arms (2)

Treatment of MTX

ACTIVE COMPARATOR

Patients were treated with methotrexate (MTX)and Tripterygium wilfordii Hook F（TwHF）placebo.

Drug: Treatment of MTX

Treatment of MTX and TwHF

EXPERIMENTAL

Patients were treated with methotrexate (MTX)and Tripterygium wilfordii Hook F（TwHF).

Drug: Treatment of MTX and TwHF

Interventions

Treatment of MTX DRUG

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.

Treatment of MTX

Treatment of MTX and TwHF DRUG

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.

Treatment of MTX and TwHF

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with rheumatoid arthritis as determined by the 1987 or 2010 ACR classification criteria;
• No male or female fertility requirements, or around menopause women;
• Patients with mild-to-moderate activity, 2.6 \< DAS28≤5.1;
• No serious system involved, such as severe pericardial effusion, interstitial lung disease, renal tubular acidosis, atrophic gastritis, autoimmune liver disease, etc;
• Within a month before the selected participants did not attend any drugs

You may not qualify if:

• Patients with cancer or other malignant disease such as cardiovascular, hematopoietic, liver and kidney disease, and psychopath
• Active or chronic infection, including HIV, hepatitis C virus, hepatitis B virus, tuberculosis
• Previous treated with tripterygii, glucocorticoid or biologic disease-modifying antirheumatic drug (DMARD) in 3 months.
• Previous treated with Tripterygium Wilfordii or MTX
• Patients with retinopathy.

Sponsors & Collaborators

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

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Jiang Quan, MD

  Guang'anmen Hospital of China Academy of Chinese Medical Sciences

  STUDY DIRECTOR

Central Study Contacts

Jiang Quan, MD

CONTACT

010-88001060; doctor@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director

Study Record Dates

• First Submitted: October 25, 2017
• First Posted: October 27, 2017
• Study Start: October 28, 2017
• Primary Completion: May 31, 2019
• Study Completion: September 30, 2019
• Last Updated: October 27, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share