search
Back to results

Efficacy and Safety of Tripterygium Wilfordii in Patients With Rheumatoid Arthritis (TRIFRA)

Primary Purpose

Arthritis, Rheumatoid

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Tripterygium wilfordii Hook F
Methotrexate
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis, Rheumatoid focused on measuring Rheumatoid Arthritis, Methotrexate, Tripterygium

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18-65 years with informed consent
  • Diagnosed with rheumatoid arthritis as determined by meeting the 2010 ACR/EULAR classification criteria and has had rheumatoid arthritis for at least 6 weeks
  • Swollen joint (SJC)≥3 and tender joint count(TJC)≥5
  • ESR >28 mm/hr or C-reactive protein > 20 mg/L

Exclusion Criteria:

  • Pregnant, lactating or further fertility requirements
  • Previous treated with methotrexate or biologic DMARD.
  • Active or chronic infection, including HIV, HCV, HBV, tuberculosis
  • Patient with cancer

Sites / Locations

  • Deptment of Rheumatology, Peking Union Medical College Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Methotrexate

T2

MTX+T2

Arm Description

Patients were treated with methotrexate alone.

Patients were treated with oral T2 (chloroform/methanol extract of Tripterygium wilfordii Hook F).

The patients were treated with methotrexate and T2.

Outcomes

Primary Outcome Measures

ACR50
The proportion of patients achieving ACR50.

Secondary Outcome Measures

Radiology outcome
The change in X-Ray from baseline to week 24.
DAS28
The change in DAS score from baseline to week 24.
ACR20/70
The proportion of patients achieving ACR20 & ACR70.

Full Information

First Posted
June 4, 2012
Last Updated
August 2, 2013
Sponsor
Peking Union Medical College Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01613079
Brief Title
Efficacy and Safety of Tripterygium Wilfordii in Patients With Rheumatoid Arthritis
Acronym
TRIFRA
Official Title
Evaluation of Oral T2 (Chloroform/Methanol Extract of Tripterygium Wilfordii Hook F) in the Treatment of RA Patients With Clinical Efficacy and Safety.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking Union Medical College Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Evaluation of oral T2 (chloroform/methanol extract of Tripterygium wilfordii Hook F) in the treatment of RA patients with clinical efficacy and safety.Open-labeled, randomized, prospective multi-center clinical trial. Observation period of 24 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Rheumatoid
Keywords
Rheumatoid Arthritis, Methotrexate, Tripterygium

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
201 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Methotrexate
Arm Type
Placebo Comparator
Arm Description
Patients were treated with methotrexate alone.
Arm Title
T2
Arm Type
Experimental
Arm Description
Patients were treated with oral T2 (chloroform/methanol extract of Tripterygium wilfordii Hook F).
Arm Title
MTX+T2
Arm Type
Experimental
Arm Description
The patients were treated with methotrexate and T2.
Intervention Type
Drug
Intervention Name(s)
Tripterygium wilfordii Hook F
Intervention Description
Oral T2(Tripterygium wilfordii Hook F) 20mg thrice daily for 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Description
Oral methotrexate 7.5-12.5mg per week for 24 weeks. The starting dose was 7.5mg per week, then increased to 12.5mg（max 0.3mg/Kg） per week in 4 weeks. Folic acid at the dose of 10mg per week were applied to all patients.
Primary Outcome Measure Information:
Title
ACR50
Description
The proportion of patients achieving ACR50.
Time Frame
24 weeks.
Secondary Outcome Measure Information:
Title
Radiology outcome
Description
The change in X-Ray from baseline to week 24.
Time Frame
24 weeks
Title
DAS28
Description
The change in DAS score from baseline to week 24.
Time Frame
24 weeks
Title
ACR20/70
Description
The proportion of patients achieving ACR20 & ACR70.
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-65 years with informed consent Diagnosed with rheumatoid arthritis as determined by meeting the 2010 ACR/EULAR classification criteria and has had rheumatoid arthritis for at least 6 weeks Swollen joint (SJC)≥3 and tender joint count(TJC)≥5 ESR >28 mm/hr or C-reactive protein > 20 mg/L Exclusion Criteria: Pregnant, lactating or further fertility requirements Previous treated with methotrexate or biologic DMARD. Active or chronic infection, including HIV, HCV, HBV, tuberculosis Patient with cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xuan Zhang, MD
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Deptment of Rheumatology, Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100032
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
29636089
Citation
Zhou YZ, Zhao LD, Chen H, Zhang Y, Wang DF, Huang LF, Lv QW, Liu B, Li Z, Wei W, Li H, Liao X, Liu H, Liu X, Jin H, Wang J, Fei YY, Wu QJ, Zhang W, Shi Q, Zheng WJ, Zhang FC, Tang FL, Lipsky PE, Zhang X. Comparison of the impact of Tripterygium wilfordii Hook F and Methotrexate treatment on radiological progression in active rheumatoid arthritis: 2-year follow up of a randomized, non-blinded, controlled study. Arthritis Res Ther. 2018 Apr 10;20(1):70. doi: 10.1186/s13075-018-1563-6.
Results Reference
derived
PubMed Identifier
24733191
Citation
Lv QW, Zhang W, Shi Q, Zheng WJ, Li X, Chen H, Wu QJ, Jiang WL, Li HB, Gong L, Wei W, Liu H, Liu AJ, Jin HT, Wang JX, Liu XM, Li ZB, Liu B, Shen M, Wang Q, Wu XN, Liang D, Yin YF, Fei YY, Su JM, Zhao LD, Jiang Y, Li J, Tang FL, Zhang FC, Lipsky PE, Zhang X. Comparison of Tripterygium wilfordii Hook F with methotrexate in the treatment of active rheumatoid arthritis (TRIFRA): a randomised, controlled clinical trial. Ann Rheum Dis. 2015 Jun;74(6):1078-86. doi: 10.1136/annrheumdis-2013-204807. Epub 2014 Apr 14.
Results Reference
derived

Learn more about this trial

Efficacy and Safety of Tripterygium Wilfordii in Patients With Rheumatoid Arthritis

We'll reach out to this number within 24 hrs