Status:
UNKNOWN
Tetrandrine in the Treatment of Rheumatoid Arthritis
Lead Sponsor:
Peking University People's Hospital
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The purpose of this study is to assess the efficacy and safety of tetrandrine, compared with placebo in 12 week or 24 week in RA patients with inadequate response to methotrexate.
Detailed Description
The investigators designed a randomized, double-blinded, placebo-controlled, multicenter study. Adults with active rheumatoid arthritis and inadequate response to methotrexate will be enrolled, meetin...
Eligibility Criteria
Inclusion
- 18-65 years old.
- fulfilled the 1987 revised American College of Rheumatology (ACR) or 2010 ACR/EULAR classification criteria for RA.
- DAS28-ESR\>3.2.
- MTX 7.5-20mg/w for at least 12 weeks before screening and keep stable doses for at least 4 weeks.
- Prednisone (≤10mg/d) or equivalent dose is allowed. However, the dose should be stable for at least 4 weeks before screening and should not increase during follow-up. If glucocorticoids are not used before screening, short- and intermediate-acting glucocorticoids should have been stopped at least 1 week and long-acting glucocorticoids should have been stopped at least 2 weeks.
Exclusion
- Allergic to the drugs involved in the study, or allergic to more than two kinds of food or drugs or pollen.
- Meets the ACR 1991 Revised Criteria for the Classification of Global Functional Status in RA Class IV in the Screening Phase.
- Any history or complication of other autoimmune diseases other than Sjogren's syndrome or Hashimoto Thyroiditis.
- Current active infections.
- Tested positive for any of the following in the Screening Phase: HIV, hepatitis B virus surface antigen (HBs antigen), hepatitis B virus surface antibody (HBs antibody), hepatitis C virus antibody (HCV antibody), or history of AIDs.
- Females of childbearing or breastfeeding.
- Presence of any unstable cardiovascular disease (including congestive heart failure with NYHA class III or IV, unstable angina pectoris, history of myocardial infarction within one year), and the presence of conditions that can lead to QTc prolongation or arrhythmia.
- Presence of progressive, uncontrolled cerebrovascular disease, hematopoietic, endocrine (including diabetes), respiratory (including interstitial pneumonia and pulmonary fibrosis) and other serious diseases and psychiatric diseases, or the investigator believes that participation in the study would place the subject at unacceptable risk.
- History of malignancy.
- Laboratory tests during screening：i. WBC\<3.5×109/L，PLT\<90×109/L， Hb\<90g/L; ii. ALT or AST\>1.5ULN; iii. Scr\>ULN.
- Use of iguratimod or disease-modifying antirheumatic drugs (DMARDs) other than MTX (such as leflunomide, sulfasalazine, hydroxychloroquine, D- penicillamine, azathioprine, cyclosporine, cyclophosphamide, Tripterygium, etc.) within 4 weeks before enrollment.
- Use of traditional Chinese medicines for rheumatoid arthritis within 4 weeks before enrollment.
- Use of b/tsDMARDs within 12 weeks.
- History of alcohol and drug abuse.
- The investigator or subinvestigator would compromise the participant's ability to safely complete the study.
- Participate in other clinical trial within 3 months prior to screening.
Key Trial Info
Start Date :
February 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2024
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT05245448
Start Date
February 22 2022
End Date
March 31 2024
Last Update
February 18 2022
Active Locations (1)
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1
Peking University People's Hospital
Beijing, China, 100044