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This study is intended to evaluate the efficacy and safety of Iguratimod alone or Iguratimod in combination with Methotrexate (MTX) versus Methotrexate alone in patients with Rheumatoid Arthritis (RA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iguratimod monotherapy | Experimental |
| |
| Iguratimod and MTX combination | Experimental |
| |
| MTX monotherapy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iguratimod | Drug | 25 mg/tablet, taken orally, 2 tablets/day (bid) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with ACR 20 response | week 52 | |
| Change from baseline in modified Total Sharp Score (mTSS) | week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in mTSS | week 24 | |
| Percentage of patients achieving radiographic non-progression | week 24, week 52 | |
| Percentage of patients with ACR 20 response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chunde Bao, MD | RenJi Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine | Shanghai | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39056160 | Derived | Du F, Dai Q, Teng J, Lu L, Ye S, Ye P, Lin Z, Ding H, Dai M, Bao C; SMILE Group. The SMILE study: Study of long-term methotrexate and iguratimod combination therapy in early rheumatoid arthritis. Chin Med J (Engl). 2025 Jul 20;138(14):1705-1713. doi: 10.1097/CM9.0000000000003200. Epub 2024 Jul 26. |
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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 |
|---|---|
| C519076 | iguratimod |
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Methotrexate | Drug | 2.5 mg/tablet, taken orally once a week, 4 tablets/week (week 1-week 4) , 6 tablets/week (week 5- week 52) |
|
| week 12, week 24, week 40 |
| Percentage of patients with ACR 50 response | week 12, week 24, week 40, week 52 |
| Percentage of patients with ACR 70 response | week 12, week 24, week 40, week 52 |
| Percentage of patients with Simplified Disease Activity Index (SDAI) ≤ 3.3 | week 12, week 24, week 40, week 52 |
| Change from baseline in Health Assessment Questionnaire (HAQ) | week 12, week 24, week 40, week 52 |
| Incidence of adverse events | up to 2 years |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |