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Rheumatoid arthritis (RA) is a chronic progressive autoimmune disease with predominantly joint involvement. To compare the efficacy and difference between elamod and tofacitib in the treatment of rheumatoid factor-positive and negative rheumatoid arthritis in RA patients with poor outcome after csDMARDs dosing, in order to better inform the clinical management.
This is an open, controlled, interventional clinical study enrolling patients with active RA who meet the following entry row criteria, and treating patients with IGU 25 mg bid + tofacitinib 5 mg bid for the intervention. The screening period was defined as the screening visit was conducted within 1 month prior to the baseline visit, and efficacy and safety assessments were performed at time points 0, 4, 12, 18, and 24 weeks from the time the subject was treated with the study protocol (see efficacy and safety endpoints for details), and study subjects were asked to come to the hospital for follow-up within ±3 days of the corresponding follow-up point.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RF positive group | Experimental | Iguratimod (25mg per tablet) 25mg twice daily plus tofacitinib (5mg per tablet) 5mg twice daily for 24 weeks. |
|
| RF negative group | Experimental | Iguratimod (25mg per tablet) 25mg twice daily plus tofacitinib (5mg per tablet) 5mg twice daily for 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iguratimod | Drug | Iguratimod 25mg bid + tofacitinib 5mg bid |
|
| Measure | Description | Time Frame |
|---|---|---|
| ACR20 | ACR20 is the gold standard for the degree of disease remission in RA. The specifics are: according to the ACR criteria, the patient's joint tenderness count (TJC) and joint swelling count (SJC) improved by ≥20%, and at least three of the following five parameters improved by ≥20%:①Pain Visual Analog Scale (VAS) ② the Patient Global Assessment (PGA) ③ Physician Global Assessment (MDGA) ④ Health Assessment Questionnaire disability index (HAQ DI) score ⑤ Acute-phase reactants (ESR or CRP). | 24 weeks |
| ACR50 | The specifics are: according to the ACR criteria, the patient's joint tenderness count (TJC) and joint swelling count (SJC) improved by ≥50%, and at least three of the following five parameters improved by ≥50%:①Pain Visual Analog Scale (VAS) ② the Patient Global Assessment (PGA) ③ Physician Global Assessment (MDGA) ④ Health Assessment Questionnaire disability index (HAQ DI) score ⑤ Acute-phase reactants (ESR or CRP). | 24 weeks |
| DAS28 (ESR) | Disease activity was assessed by calculating the DAS28 score; ≤2.6 was considered remission, >2.6 and ≤3.2 was considered low disease activity, >3.2 and ≤5.1 was considered moderate disease activity, and >5.1 was considered high disease activity. | 24 weeks |
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Inclusion Criteria:
Male or female aged 18-65 years old
Body weight not less than 40kg
Patients with a clear diagnosis of rheumatoid arthritis (RA) who meet the diagnostic criteria for RA introduced by the ACR in 1987 or ACR\EULAR in 2010
Joint function grade II-III
Active rheumatoid arthritis (defined as active rheumatoid arthritis if the following three conditions are met: ①≥ 6 joints swollen [66 joints count]
② ≥ 6 joints tenderness [68 joints count]
â‘¢Erythrocyte sedimentation rate (ESR) > 28 mm/h or C-reactive protein (CRP) > 1.0 mg/dL)
The Patients have been treated with csDMARDs for ≥ 3 months and have been treated with stable doses of csDMARDs for 4 consecutive weeks prior to study entry, with poor therapeutic outcomes and are being considered for treatment with a combination of biologics (bDMARDs) (according to the 2018 China Rheumatoid Arthritis Treatment Guidelines, poor outcomes, i.e., no significant improvement in RA disease activity within 3 months or failure to achieve treatment goals within 6 months)
Subjects must be able and willing to perform subcutaneous (SC) injections on their own, or a qualified person must be available to perform SC injections
If taking glucocorticosteroids, prednisone should be ≤10mg or other hormone at a dose equivalent to prednisone and the dose should be kept constant for at least 28d
Understand the purpose of the trial and the test procedures and sign a written informed consent form voluntarily
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yanfeng Hou, Dr. | Contact | 15168888165 | yfhou1016@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yanfeng Hou, Dr. | Yanfeng Hou | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yanfeng Hou | Recruiting | Jinan | Shandong | 250000 | China |
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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 |
| C479163 | tofacitinib |
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| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |