Back to resultsEfficacy and Safety of TwHF and MTX in Patients With Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Treatment of MTX
Treatment of MTX and TwHF
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Treatment of MTX
Treatment of MTX and TwHF
Arm Description
Patients were treated with methotrexate (MTX)and Tripterygium wilfordii Hook F（TwHF）placebo.
Patients were treated with methotrexate (MTX)and Tripterygium wilfordii Hook F（TwHF).
Outcomes
Primary Outcome Measures
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])
Secondary Outcome Measures
The proportion of patients achieving ACR20/50/70
ACR20/50/70 is referred to American College of Rheumatology Criteria
The change in Health Assessment Questionnaire (HAQ) score
HAQ scores ranges from 0 to 3, with higher scores indicating greater disability
The change in Sharp score
The change in X-Ray from baseline to week 24 and 52.
The number of adverse events
The number of adverse events that are related to treatment
Full Information
NCT ID
NCT03324412
First Posted
October 25, 2017
Last Updated
October 25, 2017
Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT03324412
Brief Title
Efficacy and Safety of TwHF and MTX in Patients With Rheumatoid Arthritis
Official Title
A 24-Week, Multicenter ,Double Blind, Randomized Study to Determine the Effects and Security of TwHF and MTX Treating Rheumatoid Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 28, 2017 (Anticipated)
Primary Completion Date
May 31, 2019 (Anticipated)
Study Completion Date
September 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
Detailed Description
Two arms were included in this study. Active Comparator: treatment of MTX Patients were treated with methotrexate (MTX)and Tripterygium wilfordii Hook F（TwHF）placebo.Experimental: treatment of TwHF Patients were treated with methotrexate (MTX) and Tripterygium wilfordii Hook F（TwHF).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
216 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment of MTX
Arm Type
Active Comparator
Arm Description
Patients were treated with methotrexate (MTX)and Tripterygium wilfordii Hook F（TwHF）placebo.
Arm Title
Treatment of MTX and TwHF
Arm Type
Experimental
Arm Description
Patients were treated with methotrexate (MTX)and Tripterygium wilfordii Hook F（TwHF).
Intervention Type
Drug
Intervention Name(s)
Treatment of MTX
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Treatment of MTX and TwHF
Intervention Description
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.
Primary Outcome Measure Information:
Title
The change from Baseline to week 24 in Disease Activity Score (DAS28)
Description
Disease Activity Score for 28-joint counts was based on the erythrocyte sedimentation rate(ESR) (DAS28-4[ESR])
Time Frame
0 weeks, 4 weeks，12 weeks, 24 weeks,52 weeks
Secondary Outcome Measure Information:
Title
The proportion of patients achieving ACR20/50/70
Description
ACR20/50/70 is referred to American College of Rheumatology Criteria
Time Frame
0 weeks, 4 weeks，12 weeks, 24 weeks
Title
The change in Health Assessment Questionnaire (HAQ) score
Description
HAQ scores ranges from 0 to 3, with higher scores indicating greater disability
Time Frame
0 weeks, 4 weeks，12 weeks, 24 weeks,52 weeks
Title
The change in Sharp score
Description
The change in X-Ray from baseline to week 24 and 52.
Time Frame
0 week,24 weeks,52 weeks
Title
The number of adverse events
Description
The number of adverse events that are related to treatment
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiang Quan, MD
Phone
010-88001060
Email
doctor@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiang Quan, MD
Organizational Affiliation
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
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Efficacy and Safety of TwHF and MTX in Patients With Rheumatoid Arthritis
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