Tetrandrine in the Treatment of Rheumatoid Arthritis

NCT05245448 | Unknown

• 1 other identifier: 2021-Z-40
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Keywords

rheumatoid arthritis; tetrandrine

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants Achieving American College of Rheumatology (ACR) 20

  The ACR20 was achieved if there was at least a 20% improvement from baseline in swollen joint count 66 (SJC66) and tender joint count 68 (TJC68) and 3 or more of the 5 following assessments: participant's assessment of pain, GH, physician's global assessment of disease activity, participant's assessment of physical function and CRP.

  week 12

Secondary Outcomes (11)

• Proportion of Participants Achieving American College of Rheumatology (ACR) 20

  week 4 and week 24

• Proportion of Participants Achieving American College of Rheumatology (ACR) 50 and ACR70

  week 12 and week 24

• Rates of European League Against Rheumatism (EULAR) Response Using DAS28-CRP

  week 12 and week 24

• Change From Baseline in Disease Activity Score 28 (DAS28)-CRP

  Baseline, week 4, week 12 and week 24

• Change From Baseline in Pain VAS Score

  Baseline, week 4, week 12 and week 24

Study Arms (2)

tetrandrine

EXPERIMENTAL

tetrandrine administered 40milligram (mg) orally thrice daily through Week 24.

Drug: Tetrandrine

placebo

PLACEBO COMPARATOR

Placebo administered orally thrice daily through Week 12. Starting at Week 12, participants were given tetrandrine 40 milligram (mg) orally thrice daily through Week 24.

Drug: Tetrandrine; Drug: Placebo

Interventions

Tetrandrine DRUG

Administered orally

placebo; tetrandrine

Placebo DRUG

Administered orally

placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, 100044, China

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

tetrandrine

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Zhanguo Li

  Department of Rheumatology and Immunology, Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ru Li, MD, PhD

CONTACT

+86 1861161621; doctorliru123@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2022
• First Posted: February 18, 2022
• Study Start: February 22, 2022
• Primary Completion: October 30, 2023
• Study Completion: March 31, 2024
• Last Updated: February 18, 2022

Record last verified: 2022-02

Locations

CN (1)