Clinical trial NCT02764515: Kunxian for the Treatment of Rheumatoid Arthritis
Official title: Comparison of the Efficacy and Safety of Kunxian Capsule and Methotrexate for the Treatment of Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Keywords: Kunxian Capsule
efficacy
rheumatoid arthritis
Methotrexate
Lead sponsor: Chinese SLE Treatment And Research Group
Sponsor class: OTHER
Collaborators: name: CHENLIJI Pharmaceutical Company,Guangzhou Pharmaceutical Group
name: CHINESE RHEUMATISM DATA CENTER
First posted: 2016-05-06
Enrollment: 428
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Proportion of patients with ACR 20/50/70
timeFrame: 24 weeks from baseline
Secondary outcomes:
measure: Proportion of patients whose DAS28 score less than 2.6 or 3.2 after treated with Kunxian Capsule and Methotrexate
timeFrame: 24 weeks from baseline
measure: Proportion of patients with adverse events in the Kunxian Capsule treatment group
timeFrame: 24 weeks from baseline
Other outcomes:
Locations:
city: Bangbu
country: China
facility: the Affiliated Hospital to Bangbu Medical University
state: Anhui
city: Bengbu
country: China
facility: The First Affiliated Hospital of Bengbu Medical College
state: Anhui
city: Hefei
country: China
facility: AnHui provincial hospital
state: Anhui
city: Guangzhou
country: China
facility: Nanfang Hospital
state: Guangdong
city: Guangzhou
country: China
facility: The Third Affiliated Hospital to SUN YAT-SEN University
state: Guangdong
city: Haerbin
country: China
facility: The First Affiliated Hospital of Harbin Medcial University
state: Heilongjiang
city: Zhengzhou
country: China
facility: The first affiliated hospital of Zhengzhou University
state: Henan
city: Enshi
country: China
facility: Minda Hospital of Hubei Province
state: Hubei
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Nantong
country: China
facility: Affiliated Hospital of Nantong University
state: Jiangsu
city: Xian
country: China
facility: Xijing Hospital
state: Shanxi
city: Kunming
country: China
facility: the Affiliated Hospital of Kunming Medical University
state: Yunnan
city: Beijing
country: China
facility: Guang'anmen Hospital,China Academy of Chinese Medical Sciences
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Shanghai
country: China
facility: Guang Hua hospital
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
Study officials:
affiliation: Peking Union Medical College Hospital
name: XIAOFENG ZENG, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking Union Medical College Hospital
name: XINPING TIAN, MD
role: PRINCIPAL_INVESTIGATOR
References: