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| Name | Class |
|---|---|
| Jiangsu Simcere Pharmaceutical Co., Ltd. | INDUSTRY |
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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
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Double-Blind Iguratimod | Active Comparator | Iguratimod (25mg twice daily) combined with Tofacitinib (5mg twice daily) for 24 weeks (6 months) |
|
| Double-Blind Placebo | Placebo Comparator | Placebo (25mg twice daily) combined with Tofacitinib (5mg twice daily) for 24 weeks (6 months) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iguratimod combined with Tofacitinib; | Drug | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | week 24 |
| Percentage of American College of Rheumatology [ACR] 50 Criteria Responders at the end of 24 weeks was compared between the two groups. |
| Measure | Description | Time Frame |
|---|---|---|
| The change of EULAR Sjögren's Syndrome Discasc Activity Index (ESSDAI) score between the two groups associated with Sjögren's Syndrome (SS) at the end of 24 weeks was compared with the baseline value (week 0) | The change of EULAR Sjögren's Syndrome Discasc Activity Index (ESSDAI) score between the two groups associated with Sjögren's Syndrome (SS) at the end of 24 weeks was compared with the baseline value (week 0) |
Inclusion Criteria:
Patients who meet the following inclusion criteria will be eligible to participate in the study:
Exclusion Criteria:
Patients who meet any of the following criteria will be excluded from the study:
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C479163 | tofacitinib |
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prospective, randomized, controlled, multicenter study
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|
Percentage of American College of Rheumatology [ACR] 50 Criteria Responders at the end of 24 weeks was compared between the two groups. |
| 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. | 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) | 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 \ | 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 \ | 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. | 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. | 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. | 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). | 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 | 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. | week 24 |
| up to week 24 |
| The change of EULAR Sjögren's Syndrome Patient-Reported Index (ESSPRI) score between the two groups associated with Sjögren's Syndrome (SS) at the end of 24 weeks was compared with the baseline value (week 0) | The change of EULAR Sjögren's Syndrome Patient-Reported Index (ESSPRI) score between the two groups associated with Sjögren's Syndrome (SS) at the end of 24 weeks was compared with the baseline value (week 0) | up to week 24 |
| Number of participants with"adverse events (AEs)" | An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants with"adverse events (AEs)"i.e. physical exam abnormalities，vital sign abnormalities，laboratory value abnormalities，symptom or disease (new or exacerbated) temporally associated with the use of a medicinal product. | up to week 24 |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |