NCT02764515

Brief Summary

This is a multicenter, randomized, double blind, double-dummy and controlled clinical trial aimed to compare the clinical efficacy and safety of Kunxian Capsule, a compound of Chinese traditional medicine, and the active comparator,Methotrexate for the treatment of rheumatoid arthritis. The primary end-point is that Kunxian Capsule is not inferior to Methotrexate both in efficacy and safety.

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
428

participants targeted

Target at P75+ for phase_4 rheumatoid-arthritis

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

16 active sites

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

Study Start

First participant enrolled

September 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 6, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

March 9, 2017

Status Verified

March 1, 2017

Enrollment Period

2 years

First QC Date

March 26, 2016

Last Update Submit

March 8, 2017

Conditions

Rheumatoid Arthritis

Keywords

Kunxian Capsuleefficacyrheumatoid arthritisMethotrexate

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with ACR 20/50/70

    the percentage of patients who have ACR 20,50 and 70 treatment response after treated with Kunxian Capsule and Methotrexate for 24 weeks

    24 weeks from baseline

Secondary Outcomes (2)

  • Proportion of patients whose DAS28 score less than 2.6 or 3.2 after treated with Kunxian Capsule and Methotrexate

    24 weeks from baseline

  • Proportion of patients with adverse events in the Kunxian Capsule treatment group

    24 weeks from baseline

Study Arms (2)

Kunxian capsule group

EXPERIMENTAL

Intervention: Drug: Kunxian 2 capsules BID taken by mouth for 24 weeks. Kunxian capsule is composed of 4 ingredients: Tripterygium wilfordii Hook F 300mg, extracts from Gouqizi,Tusizi and yinyanghuo.

Drug: Kunxian Capsule

Methotrexate group

ACTIVE COMPARATOR

Intervention: Drug: Methotrexate tablet 10mg taken by mouth every week for 24 weeks.

Drug: Methotrexate

Interventions

Kunxian CapsuleDRUG

Patients in the Kunxian Capsule group will take Kunxian Capsule 0.6gm orally twice daily for 24weeks

Also known as: Tripterygium wilfordii Hook F.
Kunxian capsule group
MethotrexateDRUG

the Methotrexate group will take Methotrexate 10mg orally every week for 24 weeks

Also known as: jiaandieling
Methotrexate group

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who understand the study protocol and sign the informed consent；
  • Fulfill the 1987 or 2010 ACR classification criteria for RA；
  • Male or female patients, age ranged from 40-70;
  • Male or female who do not plan to have more child,or per-menopausal or menopausal women；
  • Patients with mild or moderate disease activity, ie, whose DAS28 ranged from 3.2-5.1（ie, ESR\>28mm/h，or patients who have 1-5 swollen joints as well as 1-5 tender joints）；
  • Without severe systemic disorders,such as severe pericardial effusion,pulmonary interstitial fibrosis,renal tubual acidosis,atrophic gastritis,autoimmune liver disease etc.
  • Not included in any drug trial 1 month before enrollment

You may not qualify if:

  • Pregnant woman or women who are preparing to pregnant or breast feeding；
  • Patients with active liver diseases or elevated liver enzymes eg, the ALT and/or AST is higher than 1.5 of the upper limit of normal range;
  • Patients with renal function abnormality,eg,serum creatinin higher than the upper limit of normal range；
  • White blood cell count less than 3.0×109/L，or with anemia(hemoglobin level lower than 80g/L），or platelet count less than 80×109/L，or with other hematological diseases;
  • Patients with chronic gastrointestinal diseases；
  • Patients with un-controlled hypertension,metabolic diseases such as diabetes;
  • History of malignant tumor or has malignant tumor at present;
  • With acute and/or chronic contagious diseases；
  • Severe arrhythmia on ECG test;
  • History of adverse reaction with Kunxian capsule,or Tripterygium wilfordii Hook F.,methotrexate or medications contain kunminshanhaitang ingredient；
  • History of psychiatric diseases or alcoholism or drug abuse；
  • Having been diagnosed to have systemic rheumatic diseases;
  • Ever taken immunosuppressive agents or biological agents or Tripterygium wilfordii Hook F or medications contain kunminshanhaitang ingredient in recent 3 months；
  • Had ever taken methotrexate or Kunxian capsule for more than 12 weeks but could not control the arthritis under remission；

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

the Affiliated Hospital to Bangbu Medical University

Bengbu, Anhui, 233000, China

RECRUITING

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

RECRUITING

AnHui provincial hospital

Hefei, Anhui, China

RECRUITING

Nanfang Hospital

Guangzhou, Guangdong, China

RECRUITING

The Third Affiliated Hospital to SUN YAT-SEN University

Guangzhou, Guangdong, China

RECRUITING

The First Affiliated Hospital of Harbin Medcial University

Haerbin, Heilongjiang, China

RECRUITING

The first affiliated hospital of Zhengzhou University

Zhengzhou, Henan, China

RECRUITING

Minda Hospital of Hubei Province

Enshi, Hubei, China

RECRUITING

Jiangsu Province Hospital

Nanjing, Jiangsu, China

RECRUITING

Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

RECRUITING

Xijing Hospital

Xian, Shanxi, 710032, China

RECRUITING

the Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650032, China

RECRUITING

Guang'anmen Hospital,China Academy of Chinese Medical Sciences

Beijing, 100010, China

RECRUITING

Peking Union Medical College Hospital

Beijing, 100032, China

RECRUITING

Guang Hua hospital

Shanghai, China

RECRUITING

Zhongshan Hospital Fudan University

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

kunxianMethotrexate

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

  • XIAOFENG ZENG, MD

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

  • XINPING TIAN, MD

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

XINPING TIAN, MD

CONTACT

86-10-69158707tianxp6@126.com

HAIJUN FU, PHD

CONTACT

13601912507hadrian.fox@shcares.com.cn

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 26, 2016

First Posted

May 6, 2016

Study Start

September 1, 2015

Primary Completion

September 1, 2017

Study Completion

November 1, 2017

Last Updated

March 9, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(16)