Rheumatoid Arthritis (RAPhase 4NCT06945666
A Study of Iguratimod in Combination With Tofacitinib in RA Patients
A Phase 4 study testing Combined therapy of Iguratimod and tofacitinib in people with Rheumatoid Arthritis (RA, run by Jie Chang at 1 site in China.
Trial summary
Rheumatoid arthritis (RA) is a common chronic inflammatory autoimmune disease characterized by synovitis, which can cause joint pain, deformity, and extra-articular symptoms, seriously affecting the quality of life and lifespan of patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rheumatoid Arthritis (RA
- What is being tested?
- Combined therapy of Iguratimod and tofacitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2025to 31 May 2027
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old, male or female.
- Meets the classification criteria for rheumatoid arthritis established by the American College of Rheumatology (ACR) and the European League against Rheumatism (EULAR) in 2010.
- Meeting any of the following treatment conditions with poor efficacy (DAS28 score as moderate-high disease activity) : receiving conventional DMARDs therapy such as methotrexate for at least 3 months; Treatment with biological agents such as TNFi for at least 3 months; Treatment with eramode or tofaciib alone for at least 3 months.
- Understand the procedure and content of the test, and voluntarily sign the informed consent.
Who cannot join
- Patients with a known allergy to Iguratimod or tofacitinib.
- Patients who have previously used eramode or tofaciib and discontinued treatment for safety reasons;
- At the time of screening, they are in the acute phase of acute infection or chronic infection;
- At screening, hepatitis B DNA and/or hepatitis C RNA screening is positive, indicating viral hepatitis, HBs only Ag-positive healthy carriers were not considered as exclusion criteria, and inclusion of the patient was determined by the investigator;
- At the time of screening, have a history of active TB or TB screening suggests latent infection with mycobacterium tuberculosis;
- A medical condition or history of congestive heart failure at the time of screening;
- Include other ongoing projects or studies;
- Severe, progressive, uncontrolled disorders of vital organs and systems, as well as other medical conditions Any circumstances that should not be included in this collection.
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
4th Affiliated Hospital, School of Medicine, Zhejiang University
Yiwu, Zhejiang, 322000
Jiayi Ye, +86 0579-89935052, jigoulunli_zy4y@163.com
About this study
Official title: A Multicenter Prospective Study of Iguratimod in Combination With Tofacitinib in Patients With Rheumatoid Arthritis With Poor Response to Conventional or Biological DMARDs
Rheumatoid arthritis (RA) is a common chronic inflammatory autoimmune disease characterized by synovitis, which can cause joint pain, deformity, and extra-articular symptoms, seriously affecting the quality of life and lifespan of patients. Currently, the treatment of RA adopts a target attainment strategy, aiming to control the disease and reduce the disability rate. Although traditional disease-modifying antirheumatic drugs (DMARDs) can alleviate symptoms, they have slow onset, many side effects, and cannot completely stop the disease progression. Among biological DMARDs (bDMARDs), tumor necrosis factor-α (TNF-α) inhibitors have better effects, but some patients have poor responses and their conditions are not effectively controlled, thus new treatment options are urgently needed. This study aims to evaluate the efficacy and safety of the combination of iguratimod and tofacitinib in the treatment of RA patients with poor responses to traditional or biological DMARDs, providing evidence-based support for clinical treatment.
Read the detailed description
This protocol is a multicenter, prospective study on the treatment of RA patients with poor response to conventional or biological DMARDs using a combination of iguratimod and tofacitinib. The study will be conducted simultaneously at 8 research centers, and each center will strictly follow the unified research protocol and standard operating procedures.
Researchers are not allowed to interfere with the treatment of patients. The treatment and follow-up arrangements are determined by the prescribing doctor based on the actual clinical situation. Enrolled patients receive standard-dose treatment with aramodine combined with tofacitinib. The recommended dose of iguratimod is 25mg twice a day, and the recommended dose of tofacitinib is 5mg twice a day. During the treatment period, other background treatment drugs (decided by the prescribing doctor) are allowed, but other anti-rheumatic drugs that may affect the research results are not allowed, in order to simulate the real clinical diagnosis and treatment environment to the greatest extent and ensure the extrapolation of the research results.
The observation period was from the time of patient enrollment to 24 weeks after the end of treatment. For patients who experienced serious adverse events (SAEs), follow-up was conducted until the outcome was clear or the study was terminated. During the study, the patients' disease conditions, adverse drug reactions, and other situations were closely monitored. At each follow-up visit, the researchers would record the patients' symptoms and signs in detail, conduct relevant laboratory tests and necessary imaging examinations, and comprehensively assess the patients' disease status and treatment effects.
This study adopts a parallel controlled design, setting up a combined treatment group without an additional control group. The focus is on evaluating the efficacy and safety of the combined treatment plan in the target patient population. Through multi-center collaboration, data from patients with different characteristics in various regions will be extensively collected to enhance the representativeness and reliability of the research results. Meanwhile, to ensure the quality of the research data, a complete data management and quality control system will be established. Regular audits and evaluations of the data from each center will be conducted to promptly identify and correct any issues in the data.
- Conditions
- Rheumatoid Arthritis (RA
- Being tested
- Combined therapy of Iguratimod and tofacitinib
- Keywords
- iguratimod, tofacitinib
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined therapy of Iguratimod and tofacitinibDrug
Also called Combined therapy, Iguratimod and tofacitinib
This study aims to evaluate the efficacy and safety of the combination of iguratimod and tofacitinib in the treatment of RA patients with poor responses to traditional or biological DMARDs, providing evidence-based support for clinical treatment.
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | This study adopted a parallel controlled design, setting up a combined treatment group without an additional control group. The patients in the group received treatment with the standard dose of Iguratimod combined with tofacitinib. The recommended dose of Iguratimod is 25mg bid and that of tofacitinib is 5mg bid. During the treatment, other background therapeutic drugs were allowed to be used (determined by the prescribers), but other anti-rheumatic drugs that affected the study results were not allowed. Receives: Drug: Combined therapy of Iguratimod and tofacitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
ACR20 (%)
American College of Rheumatology 20% improvement criteria (ACR20) response rates(Expressed as a percentage value) at 12 and 24 weeks of treatment.
Measured: 12 and 24 weeks of treatment
ACR50 (%)
American College of Rheumatology 50% improvement criteria (ACR50) response rates(Expressed as a percentage value) at 12 and 24 weeks of treatment.
Measured: 12 and 24 weeks of treatment
ACR70 (%)
American College of Rheumatology 70% improvement criteria (ACR70) response rates(Expressed as a percentage value) at 12 and 24 weeks of treatment.
Measured: 12 and 24 weeks of treatment
DAS28
Changes in disease activity score (DAS28) from baseline at 12 and 24 weeks of treatment. This score has no unit of measure.
Measured: 12 and 24 weeks of treatment
Secondary outcomes (5)
ESR (mm/h)
Changes in erythrocyte sedimentation rate (ESR, millimeters per hour) from baseline at 4, 8, 12, and 24 weeks of treatment.
Measured: 4, 8, 12, and 24 weeks of treatment
CRP (mg/L)
Changes in C-reactive protein (CRP, milligrams per liter) levels from baseline at 4, 8, 12, and 24 weeks of treatment.
Measured: 4, 8, 12, and 24 weeks of treatment
RF (IU/L)
Changes in rheumatoid factor (RF, international units per liter) levels from baseline at 4, 8, 12, and 24 weeks of treatment.
Measured: 4, 8, 12, and 24 weeks of treatment
CCP (U/L)
Changes in anti-cyclic citrullinated peptide antibody (CCP, units per liter) levels from baseline at 4, 8, 12, and 24 weeks of treatment.
Measured: 4, 8, 12, and 24 weeks of treatment
AE
Incidence of adverse events (AE) of different severity
Measured: From baseline to 24 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study start1 Aug 2025 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis (RAStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jie Chang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jie Chang, The Fourth Affiliated Hospital of Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06945666
- Sponsor's protocol ID
- KY-2025-072
- Status last verified
- Apr 2025
- First submitted
- 2 Apr 2025
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective Study of Iguratimod in Combination With Tofacitinib in Patients With Rheumatoid Arthritis With Poor Response to Conventional or Biological DMARDs
- ClinicalTrials.gov ID
- NCT06945666
- Acronym / sponsor ID
- KY-2025-072
- Conditions
- Rheumatoid Arthritis (RA
- Keywords
- iguratimod, tofacitinib
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Jie ChangUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 25 Apr 2025 (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.
Rheumatoid arthritis (RA) is a common chronic inflammatory autoimmune disease characterized by synovitis, which can cause joint pain, deformity, and extra-articular symptoms, seriously affecting the quality of life and lifespan of patients. Currently, the treatment of RA adopts a target attainment strategy, aiming to control the disease and reduce the disability rate. Although traditional disease-modifying antirheumatic drugs (DMARDs) can alleviate symptoms, they have slow onset, many side effects, and cannot completely stop the disease progression. Among biological DMARDs (bDMARDs), tumor necrosis factor-α (TNF-α) inhibitors have better effects, but some patients have poor responses and their conditions are not effectively controlled, thus new treatment options are urgently needed. This study aims to evaluate the efficacy and safety of the combination of iguratimod and tofacitinib in the treatment of RA patients with poor responses to traditional or biological DMARDs, providing evidence-based support for clinical treatment.
Detailed description
This protocol is a multicenter, prospective study on the treatment of RA patients with poor response to conventional or biological DMARDs using a combination of iguratimod and tofacitinib. The study will be conducted simultaneously at 8 research centers, and each center will strictly follow the unified research protocol and standard operating procedures.
Researchers are not allowed to interfere with the treatment of patients. The treatment and follow-up arrangements are determined by the prescribing doctor based on the actual clinical situation. Enrolled patients receive standard-dose treatment with aramodine combined with tofacitinib. The recommended dose of iguratimod is 25mg twice a day, and the recommended dose of tofacitinib is 5mg twice a day. During the treatment period, other background treatment drugs (decided by the prescribing doctor) are allowed, but other anti-rheumatic drugs that may affect the research results are not allowed, in order to simulate the real clinical diagnosis and treatment environment to the greatest extent and ensure the extrapolation of the research results.
The observation period was from the time of patient enrollment to 24 weeks after the end of treatment. For patients who experienced serious adverse events (SAEs), follow-up was conducted until the outcome was clear or the study was terminated. During the study, the patients' disease conditions, adverse drug reactions, and other situations were closely monitored. At each follow-up visit, the researchers would record the patients' symptoms and signs in detail, conduct relevant laboratory tests and necessary imaging examinations, and comprehensively assess the patients' disease status and treatment effects.
This study adopts a parallel controlled design, setting up a combined treatment group without an additional control group. The focus is on evaluating the efficacy and safety of the combined treatment plan in the target patient population. Through multi-center collaboration, data from patients with different characteristics in various regions will be extensively collected to enhance the representativeness and reliability of the research results. Meanwhile, to ensure the quality of the research data, a complete data management and quality control system will be established. Regular audits and evaluations of the data from each center will be conducted to promptly identify and correct any issues in the data.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Drug: Combined therapy of Iguratimod and tofacitinibThis study adopted a parallel controlled design, setting up a combined treatment group without an additional control group. The patients in the group received treatment with the standard dose of Iguratimod combined with tofacitinib. The recommended dose of Iguratimod is 25mg bid and that of tofacitinib is 5mg bid. During the treatment, other background therapeutic drugs were allowed to be used (determined by the prescribers), but other anti-rheumatic drugs that affected the study results were not allowed. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years old, male or female.
- Meets the classification criteria for rheumatoid arthritis established by the American College of Rheumatology (ACR) and the European League against Rheumatism (EULAR) in 2010.
- Meeting any of the following treatment conditions with poor efficacy (DAS28 score as moderate-high disease activity) : receiving conventional DMARDs therapy such as methotrexate for at least 3 months; Treatment with biological agents such as TNFi for at least 3 months; Treatment with eramode or tofaciib alone for at least 3 months.
- Understand the procedure and content of the test, and voluntarily sign the informed consent.
Key exclusion criteria (8 listed)
- Patients with a known allergy to Iguratimod or tofacitinib.
- Patients who have previously used eramode or tofaciib and discontinued treatment for safety reasons;
- At the time of screening, they are in the acute phase of acute infection or chronic infection;
- At screening, hepatitis B DNA and/or hepatitis C RNA screening is positive, indicating viral hepatitis, HBs only Ag-positive healthy carriers were not considered as exclusion criteria, and inclusion of the patient was determined by the investigator;
- At the time of screening, have a history of active TB or TB screening suggests latent infection with mycobacterium tuberculosis;
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 |
|---|---|---|
| Combined therapy of Iguratimod and tofacitinibAlso: Combined therapy, Iguratimod and tofacitinibThis study aims to evaluate the efficacy and safety of the combination of iguratimod and tofacitinib in the treatment of RA patients with poor responses to traditional or biological DMARDs, providing evidence-based support for clinical treatment. | Drug | treatment group |
Primary outcome
ACR20 (%)
Time frame: 12 and 24 weeks of treatment
American College of Rheumatology 20% improvement criteria (ACR20) response rates(Expressed as a percentage value) at 12 and 24 weeks of treatment.
ACR50 (%)
Time frame: 12 and 24 weeks of treatment
American College of Rheumatology 50% improvement criteria (ACR50) response rates(Expressed as a percentage value) at 12 and 24 weeks of treatment.
ACR70 (%)
Time frame: 12 and 24 weeks of treatment
American College of Rheumatology 70% improvement criteria (ACR70) response rates(Expressed as a percentage value) at 12 and 24 weeks of treatment.
DAS28
Time frame: 12 and 24 weeks of treatment
Changes in disease activity score (DAS28) from baseline at 12 and 24 weeks of treatment. This score has no unit of measure.
5 secondary outcomes
ESR (mm/h)
Time frame: 4, 8, 12, and 24 weeks of treatment
CRP (mg/L)
Time frame: 4, 8, 12, and 24 weeks of treatment
RF (IU/L)
Time frame: 4, 8, 12, and 24 weeks of treatment
CCP (U/L)
Time frame: 4, 8, 12, and 24 weeks of treatment
AE
Time frame: From baseline to 24 weeks of treatment
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 25 Apr 2025.
- Individual participant dataSharing planned: No
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 Combined therapy of Iguratimod and tofacitinib in people with Rheumatoid Arthritis (RA, run by Jie Chang 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 4 inclusion and 8 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: opening soon, as of the sponsor's last update on 25 Apr 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 Jie Chang (+8613705790575, changjie7311@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ACR20 (%) (time frame: 12 and 24 weeks of treatment). The study lists 4 primary outcomes in all. 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 25 Apr 2025.