Kunxian for the Treatment of Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02764515
• Other study ID #: Chenliji001
• Status: Recruiting
• Phase: Phase 4
• First received: March 26, 2016
• Last updated: March 8, 2017
• Start date: September 2015
• Est. completion date: November 2017

Study information

• Verified date: March 2017
• Source: Chinese SLE Treatment And Research Group
• Contact: XINPING TIAN, MD
• Phone: 86-10-69158707
• Email: tianxp6[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 428
• Est. completion date: November 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Kunxian Capsule
Patients in the Kunxian Capsule group will take Kunxian Capsule 0.6gm orally twice daily for 24weeks
• Methotrexate
the Methotrexate group will take Methotrexate 10mg orally every week for 24 weeks

Locations

Country	Name	City	State
China	the Affiliated Hospital to Bangbu Medical University	Bangbu	Anhui
China	Guang'anmen Hospital,China Academy of Chinese Medical Sciences	Beijing
China	Peking Union Medical College Hospital	Beijing
China	The First Affiliated Hospital of Bengbu Medical College	Bengbu	Anhui
China	Minda Hospital of Hubei Province	Enshi	Hubei
China	Nanfang Hospital	Guangzhou	Guangdong
China	The Third Affiliated Hospital to SUN YAT-SEN University	Guangzhou	Guangdong
China	The First Affiliated Hospital of Harbin Medcial University	Haerbin	Heilongjiang
China	AnHui provincial hospital	Hefei	Anhui
China	the Affiliated Hospital of Kunming Medical University	Kunming	Yunnan
China	Jiangsu Province Hospital	Nanjing	Jiangsu
China	Affiliated Hospital of Nantong University	Nantong	Jiangsu
China	Guang Hua hospital	Shanghai
China	Zhongshan Hospital Fudan University	Shanghai
China	Xijing Hospital	Xian	Shanxi
China	The first affiliated hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (3)

Lead Sponsor	Collaborator
Chinese SLE Treatment And Research Group	CHENLIJI Pharmaceutical Company,Guangzhou Pharmaceutical Group, CHINESE RHEUMATISM DATA CENTER

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Proportion of patients whose DAS28 score less than 2.6 or 3.2 after treated with Kunxian Capsule and Methotrexate	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
Secondary	Proportion of patients with adverse events in the Kunxian Capsule treatment group	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