Rheumatoid Arthritis
Conditions
Keywords
Kunxian Capsule, efficacy, rheumatoid arthritis, Methotrexate
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.
Interventions
DRUGKunxian Capsule
Patients in the Kunxian Capsule group will take Kunxian Capsule 0.6gm orally twice daily for 24weeks
DRUGMethotrexate
the Methotrexate group will take Methotrexate 10mg orally every week for 24 weeks
Sponsors
CHENLIJI Pharmaceutical Company,Guangzhou Pharmaceutical Group
CHINESE RHEUMATISM DATA CENTER
Chinese SLE Treatment And Research Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with ACR 20/50/70 | 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
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients whose DAS28 score less than 2.6 or 3.2 after treated with Kunxian Capsule and Methotrexate | 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 |
| Proportion of patients with adverse events in the Kunxian Capsule treatment group | 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. |
Countries
China
Contacts
Primary ContactXINPING TIAN, MD
Backup ContactHAIJUN FU, PHD
Outcome results
None listed