Kunxian for the Treatment of Rheumatoid Arthritis

March 8, 2017 updated by: Xinping Tian, Chinese SLE Treatment And Research Group

Comparison of the Efficacy and Safety of Kunxian Capsule and Methotrexate for the Treatment of Rheumatoid Arthritis

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, multicenter, randomized, double blind, double-dummy and controlled clinical trial.The goal is to compare the clinical efficacy and safety of Kunxian Capsule, a compound of 4 ingredients of Chinese herb-derived medication, and the active comparator, Methotrexate for the treatment of mild to moderate active rheumatoid arthritis.This study is basically non-inferiority in design, so 428 subjects will be enrolled. All subjects need to fulfill the inclusion criteria and without exclusion criteria. Subjects are randomized into the Kunxian Capsule treatment group and Methotrexate treatment group.The dosage of Kunxian Capsule used in this study is 0.6g twice daily and the methotrexate dosage is 10mg per week. All subjects will take the medication for 24 weeks. Diclofenic is used as the salvage therapy in case patients experience joint pain. The primary end-point is the proportion of patients who could achieve disease remission or low disease activity treated with Kunxian Capsule and Methotrexate. All patients will be followed at week 2,4,12 and 24 after screening. Baseline information for disease activity measures such as DAS28 score,CDAI score, SDAI score, ACR20, ACR50, ACR70 improvement, HAQ score, patient's VAS score for pain, and lab tests such as CRP, ESR, RF, CCP, blood and urine routine tests, liver as well as renal function tests were collected and recorded. All these measures are performed at each follow-up visit except RF and CCP. In addition, any adverse events or withdrawal happened during each visit will be recorded for data analysis.

Study Type

Interventional

Enrollment (Anticipated)

428

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: XINPING TIAN, MD
  • Phone Number: 86-10-69158707
  • Email: tianxp6@126.com

Study Contact Backup

Study Locations

  • China
      • Beijing, China, 100032
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
      • Beijing, China, 100010
        • Recruiting
        • Guang'anmen Hospital,China Academy of Chinese Medical Sciences
        • Contact:
        • Contact:
      • Shanghai, China
        • Recruiting
        • Zhongshan Hospital Fudan University
        • Contact:
        • Contact:
      • Shanghai, China
    • Anhui
      • Bangbu, Anhui, China, 233000
        • Recruiting
        • the Affiliated Hospital to Bangbu Medical University
        • Contact:
        • Contact:
      • Bengbu, Anhui, China
        • Recruiting
        • The First Affiliated Hospital of Bengbu Medical college
        • Contact:
        • Contact:
      • Hefei, Anhui, China
        • Recruiting
        • Anhui Provincial Hospital
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • Nanfang Hospital
        • Contact:
        • Contact:
      • Guangzhou, Guangdong, China
        • Recruiting
        • The Third Affiliated Hospital to SUN YAT-SEN University
        • Contact:
        • Contact:
    • Heilongjiang
      • Haerbin, Heilongjiang, China
        • Recruiting
        • The First Affiliated Hospital of Harbin Medcial University
        • Contact:
        • Contact:
    • Henan
      • Zhengzhou, Henan, China
        • Recruiting
        • The First Affiliated hospital of Zhengzhou University
        • Contact:
        • Contact:
    • Hubei
      • Enshi, Hubei, China
        • Recruiting
        • Minda Hospital of Hubei Province
        • Contact:
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Recruiting
        • Jiangsu Province Hospital
        • Contact:
        • Contact:
      • Nantong, Jiangsu, China
        • Recruiting
        • Affiliated Hospital of Nantong University
        • Contact:
        • Contact:
    • Shanxi
    • Yunnan
      • Kunming, Yunnan, China, 650032
        • Recruiting
        • the Affiliated Hospital of Kunming Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients who understand the study protocol and sign the informed consent；
  2. Fulfill the 1987 or 2010 ACR classification criteria for RA；
  3. Male or female patients, age ranged from 40-70;
  4. Male or female who do not plan to have more child,or per-menopausal or menopausal women；
  5. 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）；
  6. Without severe systemic disorders,such as severe pericardial effusion,pulmonary interstitial fibrosis,renal tubual acidosis,atrophic gastritis,autoimmune liver disease etc.
  7. Not included in any drug trial 1 month before enrollment

Exclusion Criteria:

  1. Pregnant woman or women who are preparing to pregnant or breast feeding；
  2. 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;
  3. Patients with renal function abnormality,eg,serum creatinin higher than the upper limit of normal range；
  4. 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;
  5. Patients with chronic gastrointestinal diseases；
  6. Patients with un-controlled hypertension,metabolic diseases such as diabetes;
  7. History of malignant tumor or has malignant tumor at present;
  8. With acute and/or chronic contagious diseases；
  9. Severe arrhythmia on ECG test;
  10. History of adverse reaction with Kunxian capsule,or Tripterygium wilfordii Hook F.,methotrexate or medications contain kunminshanhaitang ingredient；
  11. History of psychiatric diseases or alcoholism or drug abuse；
  12. Having been diagnosed to have systemic rheumatic diseases;
  13. Ever taken immunosuppressive agents or biological agents or Tripterygium wilfordii Hook F or medications contain kunminshanhaitang ingredient in recent 3 months；
  14. Had ever taken methotrexate or Kunxian capsule for more than 12 weeks but could not control the arthritis under remission；
  15. With other conditions that are considered to be inconsistent with the inclusion criteria according to the investigators.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Kunxian capsule group

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
Patients in the Kunxian Capsule group will take Kunxian Capsule 0.6gm orally twice daily for 24weeks
Other Names:
  • Tripterygium wilfordii Hook F.
Active Comparator: Methotrexate group

Intervention:

Drug: Methotrexate tablet 10mg taken by mouth every week for 24 weeks.
Drug: Methotrexate
the Methotrexate group will take Methotrexate 10mg orally every week for 24 weeks
Other Names:
  • jiaandieling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients with ACR 20/50/70
Time Frame: 24 weeks from baseline
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients whose DAS28 score less than 2.6 or 3.2 after treated with Kunxian Capsule and Methotrexate
Time Frame: 24 weeks from baseline
Percentage of patients whose DAS28 could be lower than 3.2 or 2.6 after treated with Kunxian Capsule and Methotrexate for 24 weeks
24 weeks from baseline
Proportion of patients with adverse events in the Kunxian Capsule treatment group
Time Frame: 24 weeks from baseline
The adverse events profile such as gastrointestinal tract adverse events, the percentage of patients with gonodal gland toxicities, liver function abnormalities, hematological abnormalities,skin rashes etc in patients treated with Kunxian Capsule will be analyzed and compared with the adverse events in patients treated with Methotrexate during the same time period.
24 weeks from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese SLE Treatment And Research Group

Collaborators

CHENLIJI Pharmaceutical Company,Guangzhou Pharmaceutical Group
CHINESE RHEUMATISM DATA CENTER

Investigators

  • Principal Investigator: Xinping Tian, MD, Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Anticipated)

September 1, 2017

Study Completion (Anticipated)

November 1, 2017

Study Registration Dates

First Submitted

March 26, 2016

First Submitted That Met QC Criteria

May 4, 2016

First Posted (Estimate)

May 6, 2016

Study Record Updates

Last Update Posted (Actual)

March 9, 2017

Last Update Submitted That Met QC Criteria

March 8, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Chenliji001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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