Rheumatoid ArthritisNCT05245448
Tetrandrine in the Treatment of Rheumatoid Arthritis
A study testing Tetrandrine in people with Rheumatoid Arthritis, run by Peking University People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Tetrandrine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 22 Feb 2022to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University People's Hospital
Beijing, 100044
Zhanguo Li, MD, PhD, +86 10 88324178, li99@bjmu.edu.cn
About this study
Official title: Comparing the Efficacy of Tetrandrine Combined With Methotrexate and Methotrexate Alone in the Treatment of Rheumatoid arthritis---a Randomized, Double-blinded, Placebo-controlled, Multicenter Study
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.
Read the 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, meeting the 1987 revised American College of Rheumatology (ACR) or 2010 ACR \& European alliance of associations for rheumatology (EULAR) classification criteria. Two hundred forty patients at 18 to 65 years of age will be enrolled in the study, and be randomly assigned (in a 1:1 ratio) to one of the two arms (group1: tetrandrine 40mg tid for 24 weeks or group 2: placebo two tablets tid for 12 weeks, and then 40mg tid for 12 weeks). Follow-up visits will occur on weeks 4, 12 and 24. The end points were 20% improvement in American College of Rheumatology criteria (ACR20) in 12 week.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Tetrandrine, Placebo
- Keywords
- rheumatoid arthritis, tetrandrine
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TetrandrineDrug
Administered orally
PlaceboDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| tetrandrine | Experimental | tetrandrine administered 40milligram (mg) orally thrice daily through Week 24. Receives: 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. Receives: Drug: Tetrandrine; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: week 12
Secondary outcomes (11)
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.
Measured: week 4 and week 24
Proportion of Participants Achieving American College of Rheumatology (ACR) 50 and ACR70
The ACR50 or ACR70 was achieved if there was at least a 50% or 70% 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.
Measured: week 12 and week 24
Rates of European League Against Rheumatism (EULAR) Response Using DAS28-CRP
The Disease Activity Score Based on 28-joints Count based EULAR response criteria was used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28-CRP <=3.2; moderate responders: change from baseline >1.2 with DAS28-CRP >3.2 to <=5.1 or change from baseline >0.6 to <=1.2 with DAS28-CRP <=5.1; non-responders: change from baseline <=0.6 or change from baseline >0.6 and <=1.2 with DAS28-CRP >5.1.
Measured: week 12 and week 24
Change From Baseline in Disease Activity Score 28 (DAS28)-CRP
The DAS28 index was a composite score of weighted components including tender joint counts of 28, swollen joint counts of 28, participant global assessment of disease activity score, and CRP value. A positive change in score indicates worsening, and a negative change indicates improvement.
Measured: Baseline, week 4, week 12 and week 24
Change From Baseline in Pain VAS Score
Pain assessments are reported by placing a mark on a 100 millimeter horizontal VAS. The scale ranged from 0-100 mm, where 0 indicated no pain and 100 represented maximum pain).
Measured: Baseline, week 4, week 12 and week 24
Change From Baseline in C-reactive Protein (CRP) Values
CRP (milligrams per deciliter) are blood tests.
Measured: Baseline, week 4, week 12 and week 24
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
The degree of disability was self-evaluated by the participant using the HAQ-DI. The minimum value is 0, and the maximum values is 3. Higher scores mean a worse outcome.
Measured: Baseline, week 4, week 12 and week 24
Change From Baseline to Week 24 in OMERACT RAMRIS Wrist and MCP Bone Marrow Edema.
Bone edema was assessed at 25 locations: 15 in 1 wrist and 10 in attached hand. Bone edema was defined as a lesion within the trabecular bone, with ill-defined margins and signal characteristics consistent with increased water content. Each bone was scored separately; the scale was 0-3 based on the proportion of bone with edema, as follows 0: no edema; 1: 1-33% of bone edematous; 2: 34-66% of bone edematous; 3: 67-100%. OMERACT RAMRIS total bone edema score for hands/wrists was sum of the individual scores for each location. The maximum score per hand/wrist was 75 (range 0-75). Increasing score indicates greater severity.
Measured: Baseline and week 12
Change From Baseline in immune cells
The percentages of immune cells, such as T/B/NK and Th subsets will be detected.
Measured: Baseline, week 12 and week 24
Change From Baseline in Simplified Disease Activity Index (SDAI) Score
The SDAI was calculated from tender joint counts of 28, swollen joint counts of 28, participant's global assessment of disease activity, physician global assessment of disease activity score, and CRP value. A positive change in score indicates worsening, and a negative change indicates improvement.
Measured: Baseline, week 4, week 12 and week 24
Change From Baseline in Clinical Disease Activity Index (CDAI) Score
The CDAI was calculated from tender joint counts of 28, swollen joint counts of 28, participant's global assessment of disease activity, physician global assessment of disease activity score. A positive change in score indicates worsening, and a negative change indicates improvement.
Measured: Baseline, week 4, week 12 and week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start22 Feb 2022 (estimated)
- Primary completion30 Oct 2023 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhanguo Li, Principal investigator, Department of Rheumatology and Immunology, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05245448
- Sponsor's protocol ID
- 2021-Z-40
- Status last verified
- Feb 2022
- First submitted
- 22 Jan 2022
- Last updated
- 18 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Efficacy of Tetrandrine Combined With Methotrexate and Methotrexate Alone in the Treatment of Rheumatoid arthritis---a Randomized, Double-blinded, Placebo-controlled, Multicenter Study
- ClinicalTrials.gov ID
- NCT05245448
- Acronym / sponsor ID
- 2021-Z-40
- Conditions
- Rheumatoid Arthritis
- Keywords
- rheumatoid arthritis, tetrandrine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 22 Feb 2022 (estimated)
- Primary completion
- 30 Oct 2023 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 18 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, meeting the 1987 revised American College of Rheumatology (ACR) or 2010 ACR \& European alliance of associations for rheumatology (EULAR) classification criteria. Two hundred forty patients at 18 to 65 years of age will be enrolled in the study, and be randomly assigned (in a 1:1 ratio) to one of the two arms (group1: tetrandrine 40mg tid for 24 weeks or group 2: placebo two tablets tid for 12 weeks, and then 40mg tid for 12 weeks). Follow-up visits will occur on weeks 4, 12 and 24. The end points were 20% improvement in American College of Rheumatology criteria (ACR20) in 12 week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tetrandrine | Experimental | Drug: Tetrandrinetetrandrine administered 40milligram (mg) orally thrice daily through Week 24. |
| placebo | Placebo comparator | Drug: Tetrandrine, Drug: PlaceboPlacebo administered orally thrice daily through Week 12. Starting at Week 12, participants were given tetrandrine 40 milligram (mg) orally thrice daily through Week 24. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TetrandrineAdministered orally | Drug | placebo, tetrandrine |
| PlaceboAdministered orally | Drug | placebo |
Primary outcome
Proportion of Participants Achieving American College of Rheumatology (ACR) 20
Time frame: week 12
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.
11 secondary outcomes
Proportion of Participants Achieving American College of Rheumatology (ACR) 20
Time frame: week 4 and week 24
Proportion of Participants Achieving American College of Rheumatology (ACR) 50 and ACR70
Time frame: week 12 and week 24
Rates of European League Against Rheumatism (EULAR) Response Using DAS28-CRP
Time frame: week 12 and week 24
Change From Baseline in Disease Activity Score 28 (DAS28)-CRP
Time frame: Baseline, week 4, week 12 and week 24
Change From Baseline in Pain VAS Score
Time frame: Baseline, week 4, week 12 and week 24
Change From Baseline in C-reactive Protein (CRP) Values
Time frame: Baseline, week 4, week 12 and week 24
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
Time frame: Baseline, week 4, week 12 and week 24
Change From Baseline to Week 24 in OMERACT RAMRIS Wrist and MCP Bone Marrow Edema.
Time frame: Baseline and week 12
Change From Baseline in immune cells
Time frame: Baseline, week 12 and week 24
Change From Baseline in Simplified Disease Activity Index (SDAI) Score
Time frame: Baseline, week 4, week 12 and week 24
Change From Baseline in Clinical Disease Activity Index (CDAI) Score
Time frame: Baseline, week 4, week 12 and week 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhanguo Li principal investigator
Department of Rheumatology and Immunology, Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tetrandrine in people with Rheumatoid Arthritis, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ru Li, MD, PhD (+86 1861161621, doctorliru123@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants Achieving American College of Rheumatology (ACR) 20 (time frame: week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2022.