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A Specification Clinical Application Research of Tripterygium Wilfordii Treating Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03337815
Recruitment Status : Unknown
Verified November 2017 by Quan Jiang, Guang'anmen Hospital of China Academy of Chinese Medical Sciences.
Recruitment status was:  Recruiting
First Posted : November 9, 2017
Last Update Posted : November 9, 2017
Sponsor:
Information provided by (Responsible Party):
Quan Jiang, 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 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).

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Treatment of MTX and TwHF placebo Drug: Treatment of TwHF and MTX placebo Phase 2 Phase 3

Detailed Description:
Two arms were included in this study. Active Comparator: Patients were treated with Methotrexate (MTX)and Tripterygium wilfordii Hook F(TwHF)placebo.Experimental:Patients were treated with Methotrexate (MTX) placebo and Tripterygium wilfordii Hook F(TwHF)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 264 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A 24-Week, Multicenter ,Double Blind, Randomized Study to Determine the Effects and Security of Tripterygium Wilfordii Treating Rheumatoid Arthritis and Establish A Prediction Model
Actual Study Start Date : October 28, 2017
Estimated Primary Completion Date : March 31, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Treatment of MTX and TwHF placebo
Patients were treated with Methotrexate (MTX) and Tripterygium wilfordii Hook F(TwHF)placebo.
Drug: Treatment of MTX and TwHF placebo
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.

Experimental: Treatment of TwHF and MTX placebo
Patients were treated with Tripterygium wilfordii Hook F(TwHF)and Methotrexate (MTX) placebo.
Drug: Treatment of TwHF and MTX placebo
Tripterygium wilfordii Hook F(TwHF):20mg,3 times a day, oral, for 24 weeks.Methotrexate (MTX)placebo: 10-15mg per week according to patient's weight, oral, for 24 weeks.




Primary Outcome Measures :
  1. The change in Disease Activity Score (DAS28) [ Time Frame: 0 weeks, 4 weeks,12 weeks, 24 weeks,52 weeks ]
    Disease Activity Score for 28-joint counts was based on the erythrocyte sedimentation rate(ESR) (DAS28-4[ESR])


Secondary Outcome Measures :
  1. The proportion of patients achieving ACR20/50/70 [ Time Frame: 0 weeks, 4 weeks,12 weeks, 24 weeks ]
    ACR20/50/70 is referred to American College of Rheumatology Criteria

  2. The change in Health Assessment Questionnaire (HAQ) score [ Time Frame: 0 weeks, 4 weeks,12 weeks, 24 weeks,52 weeks ]
    HAQ scores ranges from 0 to 3, with higher scores indicating greater disability

  3. The change in Sharp scoring system of van der Heijde(Sharp) score [ Time Frame: 0 week,24 weeks,52 weeks ]
    The change in Sharp score from baseline to week 24 and 52.According to the revised Sharp scoring system of van der Heijde, the joint gap score was scored in 30 regions of the hands (score range 0-120 points), and the bone erosion score was conducted in 32 areas (score range 0-160).The higher the score, the more serious the joint destruction.

  4. The number of adverse events [ Time Frame: 24 weeks ]
    The number of adverse events that are related to treatment



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Ages Eligible for Study:   45 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03337815


Contacts
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Contact: Jiang Quan, MD 010-88001060 doctor@126.com

Locations
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China, Beijing
Guang'anmen Hospital Recruiting
Beijing, Beijing, China, 100053
Contact: Quan Jiang    +8688001060    doctorjq@126.com   
Sponsors and Collaborators
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Investigators
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Study Director: Jiang Quan, MD Guang'anmen Hospital of China Academy of Chinese Medical Sciences
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Responsible Party: Quan Jiang, director, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT03337815    
Other Study ID Numbers: Z161100000516020-1
First Posted: November 9, 2017    Key Record Dates
Last Update Posted: November 9, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases