Rheumatoid ArthritisPhase 4NCT05803135
Iguratimod Combined With Tofacitinib in the Treatment of Rheumatoid Arthritis
A Phase 4 study testing Iguratimod combined with Tofacitinib; in people with Rheumatoid Arthritis, run by Nanfang Hospital, Southern Medical University.
Trial summary
The purpose of this study is to assess the efficacy and safety of Iguratimod combined with Tofacitinib in the treatment of csDMARD-IR patients with active moderate-to-severe rheumatoid arthritis 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?
- Iguratimod combined with Tofacitinib;
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 138 participants
- Where
- No sites listed yet
- Study dates
- 31 Mar 2023to 30 Dec 2025
- Phase
- Phase 4
- 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
- Patients who meet the following inclusion criteria will be eligible to participate in the study:
- Male or female aged 18-65 years old;
- Weight not less than 40kg;
- Since the diagnosis of RA, the course of disease was ≥6 months;
- Patients who meet RA standards in 1987 and 2010 ;
- RA patients with moderate to high disease activity (DAS28 > 3.2) at the time of screening;
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- Active RA (≥6 joints swelling [66 joints count]; ≥Tenderness of 6 joints [68 joint counts]; ESR>28 mm/h or C-reactive protein (CRP) >1.0 mg/dL);
- Poor response or intolerance to at least one DMARD, including csDMARDs, bDMARDs, but not tsDMARDs;
- Previous use of any JAK inhibitor was discontinued for six months before enrollment;
- For patients who have used DMARDs, the washout criteria must be met;
- Written informed consent;
Who cannot join
- Patients who meet any of the following criteria will be excluded from the study:
- Pregnant or lactating women;
- Platelet count < 10^9/L, or white blood cell < 3*10^9/L, or absolute neutrophil count < 1.2*10^9/L, or Hemoglobin < 9 g/dL or hematocrit <30%;
- According to Cockcroft-Gault, the glomerular filtration rate was ≤40 ml/min.
- ALT>1.5×ULN, AST>1.5×ULN, Cr>135umol/L;
- Subjects with serious cardiovascular, renal, hematologic or endocrine diseases;
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- A history of autoimmune rheumatic diseases other than Sjogren's syndrome;
- Subjects with uncontrolled infection;
- Subjects receiving live vaccines within 6 weeks prior to study entry;
- history of alcohol or drug abuse and abstinence for less than 6 months prior to the first use of the study drug;
- Subjects participating in other clinical study within 3 months prior to study entry;
- Have a history of malignant tumor;
- History of recurrent herpes zoster, diffuse herpes zoster;
- People who are allergic to any of the study drugs;
- Other conditions in which the investigator deemed the patient inappropriate for trial entry;
About this study
Official title: Efficacy and Safety of Iguratimod Combined With Tofacitinib in the Treatment of csDMARD-IR Patients With Active Moderate-to-severe Rheumatoid Arthritis： a Prospective, Randomized, Controlled, Multicenter Study
The purpose of this study is to assess the efficacy and safety of Iguratimod combined with Tofacitinib in the treatment of csDMARD-IR patients with active moderate-to-severe rheumatoid arthritis
Read the detailed description
After being informed about the study and potential risks, all patients giving written informed consent will undergo a 1-week screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be randomized in a double-blind manner (participant and investigator) in a 1:1 ratio to Iguratimod (25mg, twice daily) combined with Tofacitinib (5mg, twice daily) or placebo (25mg, twice daily) combined with Tofacitinib (5mg, twice daily).
- Conditions
- Rheumatoid Arthritis
- Being tested
- Iguratimod combined with 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.
Iguratimod combined with Tofacitinib;Drug
Also called Placebo of Iguratimod combined with Tofacitinib
Iguratimod (taken orally, 25mg, bid, daily) combined with Tofacitinib (taken orally, 5mg, bid, daily); Placebo of Iguratimod (taken orally, 25mg, bid, daily) combined with Tofacitinib (taken orally, 5mg, bid, daily)
| Study group | Role | What they receive |
|---|---|---|
| Double-Blind Iguratimod | Active comparator | Iguratimod (25mg twice daily) combined with Tofacitinib (5mg twice daily) for 24 weeks (6 months) Receives: Drug: Iguratimod combined with Tofacitinib; |
| Double-Blind Placebo | Placebo comparator | Placebo (25mg twice daily) combined with Tofacitinib (5mg twice daily) for 24 weeks (6 months) Receives: Drug: Iguratimod combined with Tofacitinib; |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of patients who achieve clinical remission at week 24 using European League Against Rheumatism (EULAR) response criteria DAS28
The proportion of patients with DAS28-CRP<2.6 at the end of 24 weeks was compared between the two groups. The DAS28 is a composite score derived from 4 of these measures，that is the count of tender joint count（TJC, 0-28）and swollen joint count（SJC, 0-28）, measure C reactive protein (CRP, mg/L) and to make a patient assessment of disease activity.
Measured: week 24
Secondary outcomes (12)
Percentage of American College of Rheumatology [ACR] 20 Criteria Responders at the end of 24 weeks was compared between the two groups.
Percentage of American College of Rheumatology [ACR] 20 Criteria Responders at the end of 24 weeks was compared between the two groups.
Measured: week 24
Percentage of American College of Rheumatology [ACR] 50 Criteria Responders at the end of 24 weeks was compared between the two groups.
Percentage of American College of Rheumatology [ACR] 50 Criteria Responders at the end of 24 weeks was compared between the two groups.
Measured: week 24
Percentage of American College of Rheumatology [ACR] 70 Criteria Responders at the end of 24 weeks was compared between the two groups.
Percentage of American College of Rheumatology [ACR] 70 Criteria Responders at the end of 24 weeks was compared between the two groups.
Measured: week 24
The change of DAS28 score between the two groups at the end of 24 weeks was compared with the baseline value (week 0)
The change of DAS28 score between the two groups at the end of 24 weeks was compared with the baseline value (week 0)
Measured: up to week 24
The change of Clinical Disease Activity Index (CDAI) score between the two groups at the end of 24 weeks was compared with the baseline value (week 0)
The CDAI is a composite score derived from these measures，that is the count of tender joint count（TJC, 0-28）, swollen joint count（SJC, 0-28）, Patient global assessment（PGA）and physician global assessment（PHGA）, each of the last two was CDAI score will be calculated with formula CDAI = TJC + SJC + PGA + PHGA. CDAI > 22 is considered high disease activity; 10 <CDAI ≤ 22, moderate disease activity; 2.8 <CDAI ≤10, low disease activity; remission is CDAI score ≤2.8.
Measured: up to week 24
The change of Simplified Disease Activity Index (SDAI) score between the two groups at the end of 24 weeks was compared with the baseline value (week 0)
The SDAI is a composite score derived from these measures，that is the count of tender joint count（TJC, 0-28）, swollen joint count（SJC, 0-28）, C-reactive protein (CRP, mg/L), Patient global assessment（PGA）and physician global assessment（PHGA）, each of the last two was assessed on a visual analog scale ranging from 0-10 cm, with higher scores indicating severe disease. SDAI score will be calculated with formula SDAI = TJC + SJC + PGA+PHGA+ CRP. SDAI score exceeding 26 is considered high disease activity; 11 <SDAI ≤26，moderate disease activity; 3.3 <SDAI ≤11, low disease activity; remission is SDAI score ≤ 3.3.
Measured: up to week 24
The percentage of patients who achieve clinical remission at week 12 using European League Against Rheumatism (EULAR) response criteria DAS28
The proportion of patients with DAS28-CRP<2.6 at the end of 12 weeks was compared between the two groups. The DAS28 is a composite score derived from 4 of these measures，that is the count of tender joint count（TJC, 0-28）and swollen joint count（SJC, 0-28）, measure C reactive protein (CRP, mg/L) and to make a patient assessment of disease activity.
Measured: week 12
The proportion of patients with SDAI≤3.3 at the end of 24 weeks was compared between the two groups.
The proportion of patients with SDAI≤3.3 at the end of 24 weeks was compared between the two groups.
Measured: week 24
The proportion of patients with CDAI≤2.8 at the end of 24 weeks was compared between the two groups.
The proportion of patients with CDAI≤2.8 at the end of 24 weeks was compared between the two groups.
Measured: week 24
The changes of ACPA, RF, serum immunoglobulin (IgG, IgA, IgM) levels between the two groups at the end of 24 weeks were compared with the baseline values (week 0).
The changes of ACPA, RF, serum immunoglobulin (IgG, IgA, IgM) levels between the two groups at the end of 24 weeks were compared with the baseline values (week 0).
Measured: up to week 24
The drug retention rate was compared between the two groups at the end of 12 and 24 weeks.
The drug retention rate was compared between the two groups at the end of 12
Measured: week 12 and 24
The proportion of patients with minimal clinically important difference (MCID) of 0.22 on the Health Assessment Questionnaire Disability Index (HAQ-DI) was compared between the two groups at the end of 24 weeks.
The proportion of patients with minimal clinically important difference (MCID) of 0.22 on the Health Assessment Questionnaire Disability Index (HAQ-DI) was compared between the two groups at the end of 24 weeks.
Measured: week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start31 Mar 2023 (estimated)
- Primary completion30 Jan 2025 (estimated)
- Study completion30 Dec 2025 (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 Nanfang Hospital, Southern Medical UniversityThe 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
- Model description
- prospective, randomized, controlled, multicenter study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05803135
- Sponsor's protocol ID
- NFEC-2022-282
- Status last verified
- Mar 2023
- First submitted
- 26 Mar 2023
- Last updated
- 7 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Iguratimod Combined With Tofacitinib in the Treatment of csDMARD-IR Patients With Active Moderate-to-severe Rheumatoid Arthritis： a Prospective, Randomized, Controlled, Multicenter Study
- ClinicalTrials.gov ID
- NCT05803135
- Acronym / sponsor ID
- NFEC-2022-282
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Collaborators
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Study start
- 31 Mar 2023 (estimated)
- Primary completion
- 30 Jan 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 7 Apr 2023 (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 Iguratimod combined with Tofacitinib in the treatment of csDMARD-IR patients with active moderate-to-severe rheumatoid arthritis
Detailed description
After being informed about the study and potential risks, all patients giving written informed consent will undergo a 1-week screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be randomized in a double-blind manner (participant and investigator) in a 1:1 ratio to Iguratimod (25mg, twice daily) combined with Tofacitinib (5mg, twice daily) or placebo (25mg, twice daily) combined with Tofacitinib (5mg, twice daily).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- prospective, randomized, controlled, multicenter study
| Arm | Type | Receives |
|---|---|---|
| Double-Blind Iguratimod | Active comparator | Drug: Iguratimod combined with Tofacitinib;Iguratimod (25mg twice daily) combined with Tofacitinib (5mg twice daily) for 24 weeks (6 months) |
| Double-Blind Placebo | Placebo comparator | Drug: Iguratimod combined with Tofacitinib;Placebo (25mg twice daily) combined with Tofacitinib (5mg twice daily) for 24 weeks (6 months) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients who meet the following inclusion criteria will be eligible to participate in the study:
- Male or female aged 18-65 years old;
- Weight not less than 40kg;
- Since the diagnosis of RA, the course of disease was ≥6 months;
- Patients who meet RA standards in 1987 and 2010 ;
Key exclusion criteria (15 listed)
- Pregnant or lactating women;
- Platelet count < 10^9/L, or white blood cell < 3*10^9/L, or absolute neutrophil count < 1.2*10^9/L, or Hemoglobin < 9 g/dL or hematocrit <30%;
- According to Cockcroft-Gault, the glomerular filtration rate was ≤40 ml/min.
- ALT>1.5×ULN, AST>1.5×ULN, Cr>135umol/L;
- Subjects with serious cardiovascular, renal, hematologic or endocrine diseases;
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 |
|---|---|---|
| Iguratimod combined with Tofacitinib;Also: Placebo of Iguratimod combined with TofacitinibIguratimod (taken orally, 25mg, bid, daily) combined with Tofacitinib (taken orally, 5mg, bid, daily); Placebo of Iguratimod (taken orally, 25mg, bid, daily) combined with Tofacitinib (taken orally, 5mg, bid, daily) | Drug | Double-Blind Iguratimod, Double-Blind Placebo |
Primary outcome
The percentage of patients who achieve clinical remission at week 24 using European League Against Rheumatism (EULAR) response criteria DAS28
Time frame: week 24
The proportion of patients with DAS28-CRP<2.6 at the end of 24 weeks was compared between the two groups. The DAS28 is a composite score derived from 4 of these measures，that is the count of tender joint count（TJC, 0-28）and swollen joint count（SJC, 0-28）, measure C reactive protein (CRP, mg/L) and to make a patient assessment of disease activity.
12 secondary outcomes
Percentage of American College of Rheumatology [ACR] 20 Criteria Responders at the end of 24 weeks was compared between the two groups.
Time frame: week 24
Percentage of American College of Rheumatology [ACR] 50 Criteria Responders at the end of 24 weeks was compared between the two groups.
Time frame: week 24
Percentage of American College of Rheumatology [ACR] 70 Criteria Responders at the end of 24 weeks was compared between the two groups.
Time frame: week 24
The change of DAS28 score between the two groups at the end of 24 weeks was compared with the baseline value (week 0)
Time frame: up to week 24
The change of Clinical Disease Activity Index (CDAI) score between the two groups at the end of 24 weeks was compared with the baseline value (week 0)
Time frame: up to week 24
The change of Simplified Disease Activity Index (SDAI) score between the two groups at the end of 24 weeks was compared with the baseline value (week 0)
Time frame: up to week 24
The percentage of patients who achieve clinical remission at week 12 using European League Against Rheumatism (EULAR) response criteria DAS28
Time frame: week 12
The proportion of patients with SDAI≤3.3 at the end of 24 weeks was compared between the two groups.
Time frame: week 24
The proportion of patients with CDAI≤2.8 at the end of 24 weeks was compared between the two groups.
Time frame: week 24
The changes of ACPA, RF, serum immunoglobulin (IgG, IgA, IgM) levels between the two groups at the end of 24 weeks were compared with the baseline values (week 0).
Time frame: up to week 24
The drug retention rate was compared between the two groups at the end of 12 and 24 weeks.
Time frame: week 12 and 24
The proportion of patients with minimal clinically important difference (MCID) of 0.22 on the Health Assessment Questionnaire Disability Index (HAQ-DI) was compared between the two groups at the end of 24 weeks.
Time frame: week 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Iguratimod combined with Tofacitinib; in people with Rheumatoid Arthritis, run by Nanfang Hospital, Southern Medical University.
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 11 inclusion and 15 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 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of patients who achieve clinical remission at week 24 using European League Against Rheumatism (EULAR) response criteria DAS28 (time frame: week 24). 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 7 Apr 2023.