Rheumatoid ArthritisPhase 4NCT05540938
Post-marketing Re-evaluation of WangBi Granules for Rheumatoid Arthritis
A Phase 4 study testing Wangbi granules and Wangbi granules simulant in people with Rheumatoid Arthritis, run by China-Japan Friendship Hospital at 1 site in China.
Trial summary
The group used a randomized controlled trial to conduct a post-marketing re-evaluation study of Wangbi granules. The study was conducted to observe the degree of clinical remission in rheumatoid arthritis patients with low disease activity after standard methotrexate and tofacitinib citrate treatment, using a… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Wangbi granules and Wangbi granules simulant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 1 siteChina
- Study dates
- 23 May 2023to 31 Mar 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years.
- Meeting the 1987 ACR or 2010 ACR/EULAR diagnostic criteria.
- Meeting the diagnostic criteria of Chinese medicine for Kidney deficiency and dampness and stasis blocking channels in Chinese medicine.
- Rheumatoid arthritis disease activity score DAS28 of 2.6 to 3.2.
- Regularly taking methotrexate 7.5-15 mg qw and tofacitab 5 mg bid before enrollment and stable treatment regimen for more than 4 weeks.
- Voluntary participation and signed written informed consent.
Who cannot join
- Patients taking immunosuppressive drugs other than traditional DMARDs for rheumatoid arthritis within 3 months prior to enrollment (traditional DMARDs include hydroxychloroquine sulfate, methotrexate, salazosulfapyridine tablets, and raglan polysaccharide tablets, among others).
- Organ transplant recipients, patients with malignant tumors, patients with heart, brain, liver (ALT/AST > 3 times the normal upper limit), kidney (Ccr <60ml/min) and other important organ function impairment or hematological system diseases.
- Psychiatric disorders such as cognitive disorders, depression, anxiety disorders, somatic dysfunction, cerebral infarction, cerebral hemorrhage, epilepsy, TIA, myelitis, demyelinating lesions and other central neurological disorders, or peripheral neurological disorders such as restless legs syndrome. peripheral neurological disorders such as restless legs syndrome.
- Women and men who are pregnant or breastfeeding or who are planning a pregnancy within the next 6 months; during the trial or within 1 month of the last dose Women of childbearing age who are unable or unwilling to use adequate contraception, or whose spouse is unwilling to use contraception, within one month of the last dose or within one month of the last dose are unwilling to use contraception.
- Persons with a BMI greater than 35 (kg/m2), allergic to the test drug, or participating in other clinical trials.
- Other conditions deemed by the investigator to be inappropriate for trial participation (out-of-town patients unable to be followed up, etc.).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing, 100029
Zihan Wang
About this study
Official title: Reevaluation of Original Research Results of Integrated Traditional Chinese and Western Medicine and Transformation of Hospital Preparations: Post-marketing Re-evaluation of WangBi Granules for Rheumatoid Arthritis
The group used a randomized controlled trial to conduct a post-marketing re-evaluation study of Wangbi granules. The study was conducted to observe the degree of clinical remission in rheumatoid arthritis patients with low disease activity after standard methotrexate and tofacitinib citrate treatment, using a combination of Chinese and Western medicine treatment with Wangbi granules. The study aims to provide evidence-based medical evidence to improve the clinical efficacy of rheumatoid arthritis, enhance the depth of remission, and improve the diagnosis and treatment of rheumatoid arthritis.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Wangbi granules, Wangbi granules simulant
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wangbi granulesDrug
Methotrexate 7.5-15mg qw plus tofacitab 5mg bid, combined with Wangbi granules 12.0g tid, treatment course 3 months.
Wangbi granules simulantDrug
Methotrexate 7.5-15mg qw plus tofacitab 5mg bid, combined with Wangbi granules simulant 12.0g tid, treatment course 3 months.
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | Methotrexate 7.5-15mg qw plus tofacitab 5mg bid, combined with Wangbi granules 12.0g tid, treatment course 3 months. Receives: Drug: Wangbi granules |
| control group | Active comparator | Methotrexate 7.5-15mg qw plus tofacitab 5mg bid, combined with Wangbi granules simulant 12.0g tid, treatment course 3 months. Receives: Drug: Wangbi granules simulant |
What is being measured
The primary outcome is the main question the study is designed to answer.
DAS28
Disease mobility score for 28 joints, higher scores indicate higher disease activity
Measured: 12 weeks
Secondary outcomes (2)
Fatigue Scale-14
assessing the patient's fatigue level, the higher the score, the more severe the fatigue
Measured: 12 weeks
visual analogue scale
Patients score according to the level of pain they feel, there are 10 scales from 0-10, with 0 representing no pain and 10 representing severe pain
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start23 May 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by China-Japan Friendship 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking Union Medical College Hospital, The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine, The 980th Hospital of PLA Joint Logistics Support Force, The Second Affiliated Hospital of Zhejiang Chinese Medical University, Southwest Hospital, China
- Responsible party
- Principal investigator, Zihan Wang, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05540938
- Sponsor's protocol ID
- 2022-NHLHCRF-LX-02-02
- Status last verified
- Jan 2025
- First submitted
- 10 Sep 2022
- Last updated
- 20 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang J, Wang Z, Lan T, Zhang L, Li Z, Wang X, Zou Q, Wang Y, Li Y, Luo R, Zhang N, Xu Y, Li M, Tao Q. Wangbi granule as a combination therapy to achieve clinical deep remission in rheumatoid arthritis: protocol for a multicenter, triple-blind, randomised, placebo-controlled trial. Chin Med. 2023 Feb 28;18(1):22. doi: 10.1186/s13020-023-00728-6.
PubMed 36855169
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reevaluation of Original Research Results of Integrated Traditional Chinese and Western Medicine and Transformation of Hospital Preparations: Post-marketing Re-evaluation of WangBi Granules for Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT05540938
- Acronym / sponsor ID
- 2022-NHLHCRF-LX-02-02
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Collaborators
- Peking Union Medical College Hospital, The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine, The 980th Hospital of PLA Joint Logistics Support Force, The Second Affiliated Hospital of Zhejiang Chinese Medical University, Southwest Hospital, China
- Study start
- 23 May 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 15 Sep 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 group used a randomized controlled trial to conduct a post-marketing re-evaluation study of Wangbi granules. The study was conducted to observe the degree of clinical remission in rheumatoid arthritis patients with low disease activity after standard methotrexate and tofacitinib citrate treatment, using a combination of Chinese and Western medicine treatment with Wangbi granules. The study aims to provide evidence-based medical evidence to improve the clinical efficacy of rheumatoid arthritis, enhance the depth of remission, and improve the diagnosis and treatment of rheumatoid arthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Drug: Wangbi granulesMethotrexate 7.5-15mg qw plus tofacitab 5mg bid, combined with Wangbi granules 12.0g tid, treatment course 3 months. |
| control group | Active comparator | Drug: Wangbi granules simulantMethotrexate 7.5-15mg qw plus tofacitab 5mg bid, combined with Wangbi granules simulant 12.0g tid, treatment course 3 months. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-75 years.
- Meeting the 1987 ACR or 2010 ACR/EULAR diagnostic criteria.
- Meeting the diagnostic criteria of Chinese medicine for Kidney deficiency and dampness and stasis blocking channels in Chinese medicine.
- Rheumatoid arthritis disease activity score DAS28 of 2.6 to 3.2.
- Regularly taking methotrexate 7.5-15 mg qw and tofacitab 5 mg bid before enrollment and stable treatment regimen for more than 4 weeks.
Key exclusion criteria (6 listed)
- Patients taking immunosuppressive drugs other than traditional DMARDs for rheumatoid arthritis within 3 months prior to enrollment (traditional DMARDs include hydroxychloroquine sulfate, methotrexate, salazosulfapyridine tablets, and raglan polysaccharide tablets, among others).
- Organ transplant recipients, patients with malignant tumors, patients with heart, brain, liver (ALT/AST > 3 times the normal upper limit), kidney (Ccr <60ml/min) and other important organ function impairment or hematological system diseases.
- Psychiatric disorders such as cognitive disorders, depression, anxiety disorders, somatic dysfunction, cerebral infarction, cerebral hemorrhage, epilepsy, TIA, myelitis, demyelinating lesions and other central neurological disorders, or peripheral neurological disorders such as restless legs syndrome. peripheral neurological disorders such as restless legs syndrome.
- Women and men who are pregnant or breastfeeding or who are planning a pregnancy within the next 6 months; during the trial or within 1 month of the last dose Women of childbearing age who are unable or unwilling to use adequate contraception, or whose spouse is unwilling to use contraception, within one month of the last dose or within one month of the last dose are unwilling to use contraception.
- Persons with a BMI greater than 35 (kg/m2), allergic to the test drug, or participating in other clinical trials.
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 |
|---|---|---|
| Wangbi granulesMethotrexate 7.5-15mg qw plus tofacitab 5mg bid, combined with Wangbi granules 12.0g tid, treatment course 3 months. | Drug | treatment group |
| Wangbi granules simulantMethotrexate 7.5-15mg qw plus tofacitab 5mg bid, combined with Wangbi granules simulant 12.0g tid, treatment course 3 months. | Drug | control group |
Primary outcome
DAS28
Time frame: 12 weeks
Disease mobility score for 28 joints, higher scores indicate higher disease activity
2 secondary outcomes
Fatigue Scale-14
Time frame: 12 weeks
visual analogue scale
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
- Derived from this study: PubMed 36855169Wang J, Wang Z, Lan T, Zhang L, Li Z, Wang X, Zou Q, Wang Y, Li Y, Luo R, Zhang N, Xu Y, Li M, Tao Q. Wangbi granule as a combination therapy to achieve clinical deep remission in rheumatoid arthritis: protocol for a multicenter, triple-blind, randomised, placebo-controlled trial. Chin Med. 2023 Feb 28;18(1):22. doi: 10.1186/s13020-023-00728-6.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Wangbi granules and Wangbi granules simulant in people with Rheumatoid Arthritis, run by China-Japan Friendship 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 6 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 20 Jan 2025. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zihan Wang, Dr (+8618810902100, wzhbucm@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DAS28 (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05540938, which also lists 1 linked publication.
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 20 Jan 2025; AzTrials last refreshed its copy on 8 Nov 2026.