NCT03337815

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).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
264

participants targeted

Target at P75+ for phase_2 rheumatoid-arthritis

Timeline
Completed

Started Oct 2017

Typical duration for phase_2 rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

October 22, 2017

Completed
6 days until next milestone

Study Start

First participant enrolled

October 28, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 9, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

November 9, 2017

Status Verified

November 1, 2017

Enrollment Period

1.4 years

First QC Date

October 22, 2017

Last Update Submit

November 8, 2017

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • The change 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 scoring system of van der Heijde(Sharp) score

    0 week,24 weeks,52 weeks

  • The number of adverse events

    24 weeks

Study Arms (2)

Treatment of MTX and TwHF placebo

ACTIVE COMPARATOR

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

Drug: Treatment of MTX and TwHF placebo

Treatment of TwHF and MTX placebo

EXPERIMENTAL

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

Drug: Treatment of TwHF and MTX placebo

Interventions

Treatment of MTX and TwHF placeboDRUG

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 and TwHF placebo
Treatment of TwHF and MTX placeboDRUG

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.

Treatment of TwHF and MTX placebo

Eligibility Criteria

Age45 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guang'anmen Hospital

Beijing, Beijing Municipality, 100053, China

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune 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

010-88001060doctor@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 22, 2017

First Posted

November 9, 2017

Study Start

October 28, 2017

Primary Completion

March 31, 2019

Study Completion

September 30, 2019

Last Updated

November 9, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)