NCT01613079

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
201

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 4, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 6, 2012

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

August 5, 2013

Status Verified

August 1, 2013

Enrollment Period

1.1 years

First QC Date

June 4, 2012

Last Update Submit

August 2, 2013

Conditions

Arthritis, Rheumatoid

Keywords

Rheumatoid ArthritisMethotrexateTripterygium

Outcome Measures

Primary Outcomes (1)

  • ACR50

    The proportion of patients achieving ACR50.

    24 weeks.

Secondary Outcomes (3)

  • Radiology outcome

    24 weeks

  • DAS28

    24 weeks

  • ACR20/70

    24 weeks

Study Arms (3)

Methotrexate

PLACEBO COMPARATOR

Patients were treated with methotrexate alone.

Drug: Methotrexate

T2

EXPERIMENTAL

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

Drug: Tripterygium wilfordii Hook F

MTX+T2

EXPERIMENTAL

The patients were treated with methotrexate and T2.

Drug: Tripterygium wilfordii Hook FDrug: Methotrexate

Interventions

Tripterygium wilfordii Hook FDRUG

Oral T2(Tripterygium wilfordii Hook F) 20mg thrice daily for 24 weeks.

MTX+T2T2
MethotrexateDRUG

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.

MTX+T2Methotrexate

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Deptment of Rheumatology, Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100032, China

Location

Related Publications (2)

  • 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.

    PMID: 29636089DERIVED

  • 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.

    PMID: 24733191DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Methotrexate

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

AminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Xuan Zhang, MD

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 4, 2012

First Posted

June 6, 2012

Study Start

May 1, 2012

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

August 5, 2013

Record last verified: 2013-08

Locations

CN(1)