Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Kunxian for the Treatment of Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02764515
Recruitment Status : Unknown
Verified March 2017 by Xinping Tian, Chinese SLE Treatment And Research Group.
Recruitment status was:  Recruiting
First Posted : May 6, 2016
Last Update Posted : March 9, 2017
Sponsor:
Collaborators:
CHENLIJI Pharmaceutical Company,Guangzhou Pharmaceutical Group
CHINESE RHEUMATISM DATA CENTER
Information provided by (Responsible Party):
Xinping Tian, Chinese SLE Treatment And Research Group

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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Kunxian Capsule Drug: Methotrexate Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 428 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of the Efficacy and Safety of Kunxian Capsule and Methotrexate for the Treatment of Rheumatoid Arthritis
Study Start Date : September 2015
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : November 2017

Resource links provided by the National Library of Medicine


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 Name: 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 Name: jiaandieling




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02764515


Contacts
Layout table for location contacts
Contact: XINPING TIAN, MD 86-10-69158707 tianxp6@126.com
Contact: HAIJUN FU, PHD 13601912507 hadrian.fox@shcares.com.cn

Locations
Layout table for location information
China, Anhui
the Affiliated Hospital to Bangbu Medical University Recruiting
Bangbu, Anhui, China, 233000
Contact: Zhijun Li, MD    13955289810    zhijun.li@cstar.org.cn   
Contact: Changhao Xie, MD    15255227208    uglboy2002@126.com   
The First Affiliated Hospital of Bengbu Medical College Recruiting
Bengbu, Anhui, China
Contact: Xin Wang, MD    86-13515529256    273084414@qq.com   
Contact: Zhijun Li, MD    86-13956955150    lizhijundr@126.com   
AnHui provincial hospital Recruiting
Hefei, Anhui, China
Contact: Li Wang, MD    86-15055148790    wang_liy@aliyun.com   
Contact: Xiangpei Li, MD    86-13515605909    13515605909@126.com   
China, Guangdong
Nanfang Hospital Recruiting
Guangzhou, Guangdong, China
Contact: Jinjun Zhao, MD    86-13710596450    zhao7749@126.com   
Contact: Min Yang, MD    86-13802911770    minyanggz@163.com   
The Third Affiliated Hospital to SUN YAT-SEN University Recruiting
Guangzhou, Guangdong, China
Contact: Linkai Fang, MD    86-13751889563    fanglinkai1984@163.com   
Contact: Jieruo Gu, MD    13922280820    gujieruo@163.com   
China, Heilongjiang
The First Affiliated Hospital of Harbin Medcial University Recruiting
Haerbin, Heilongjiang, China
Contact: Juan Gao, MD    86-15304803480    happygigi@163.com   
Contact: Zhiyi Zhang, MD    86-13303608999    zhangzhiyi2014@163.com   
China, Henan
The first affiliated hospital of Zhengzhou University Recruiting
Zhengzhou, Henan, China
Contact: Jiameng Lu, MD    86-18637184930    lujiameng2003@126.com   
Contact: Shengyun Liu, MD    86-13837192659    shengyun@medmail.com.cn   
China, Hubei
Minda Hospital of Hubei Province Recruiting
Enshi, Hubei, China
Contact: Linchong Su, MD    86-15571781515    "linchongsu@126.com   
Contact: Yang Xiang, MD    86-13607249969    xiangy1961@yahoo.com.cn   
China, Jiangsu
Jiangsu Province Hospital Recruiting
Nanjing, Jiangsu, China
Contact: Chengyin Li, MD    86-13914751367    lcyzjf@hotmail.com   
Contact: Miaojia Zhang, MD    86-13611505999    miaojia_zhang@163.com   
Affiliated Hospital of Nantong University Recruiting
Nantong, Jiangsu, China
Contact: Yunfei Xia, MD    15896275028    xiayf1986@163.com   
Contact: Zhanyun Da, MD    86-18962940001    dazhanyun@163.com   
China, Shanxi
Xijing Hospital Recruiting
Xian, Shanxi, China, 710032
Contact: Zhenbiao Wu, MD    13700235112    ping.zhu@cstar.org.cn   
Contact: Weitong Chen, MD    15771943030    chenweitong0818@163.com   
China, Yunnan
the Affiliated Hospital of Kunming Medical University Recruiting
Kunming, Yunnan, China, 650032
Contact: Jian Xu, MD    13888566797    jian.xu@cstar.org.cn   
Contact: Shu Li, MD    15198785584    gglis@126.com   
China
Guang'anmen Hospital,China Academy of Chinese Medical Sciences Recruiting
Beijing, China, 100010
Contact: Hailong Wang, MD    86-13810112190    wang.hailong@139.com   
Contact: Quan Jiang, MD    86-13901081632    doctorjq@126.com   
Peking Union Medical College Hospital Recruiting
Beijing, China, 100032
Contact: Xinping Tian, MD    86-13691165939    tianxp6@126.com   
Contact: Shi Rong, MD    86-13601248311    rongshipumch@126.com   
Sub-Investigator: XInping Tian, MD         
Guang Hua hospital Recruiting
Shanghai, China
Contact: Xiaolin Yang, MD    86-13701816768    lindayoung365@hotmail.com   
Contact: Dongyi He, MD    021-62805833    dongyihe@medmail.com.cn   
Zhongshan Hospital Fudan University Recruiting
Shanghai, China
Contact: Huiyong Chen, MD    86-13817629793    zsneike@163.com   
Contact: Lindi Jiang, MD    86-13701973875    jianglindi@medmail.com.cn   
Sponsors and Collaborators
Chinese SLE Treatment And Research Group
CHENLIJI Pharmaceutical Company,Guangzhou Pharmaceutical Group
CHINESE RHEUMATISM DATA CENTER
Investigators
Layout table for investigator information
Principal Investigator: XIAOFENG ZENG, MD Peking Union Medical College Hospital
Principal Investigator: XINPING TIAN, MD Peking Union Medical College Hospital

Layout table for additonal information
Responsible Party: Xinping Tian, MD, Chinese SLE Treatment And Research Group
ClinicalTrials.gov Identifier: NCT02764515     History of Changes
Other Study ID Numbers: Chenliji001
First Posted: May 6, 2016    Key Record Dates
Last Update Posted: March 9, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Xinping Tian, Chinese SLE Treatment And Research Group:
Kunxian Capsule
efficacy
rheumatoid arthritis
Methotrexate

Additional relevant MeSH terms:
Layout table for MeSH terms
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors