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| Name | Class |
|---|---|
| Central South University | OTHER |
| Tianjin Medical University General Hospital | OTHER |
| Xijing Hospital | OTHER |
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A prospective, multi-centric, cohort study to observe the efficacy difference between intensive classic DMARDs and Infliximab(IFX) with methotrexate(MTX) treatment in sever rheumatoid arthritis(RA) 28 joints disease activity score>5.1(DAS28>5.1) patients with poor prognostic factors.Primary objective is compare the difference of clinical remission rate between classic DMARDs and Infliximab with MTX treatment in severe RA patients with poor prognostic factors at week 30.
Primary objective is compare the difference of clinical remission rate between classic conventional disease-modifying antirheumatic drugs(DMARDs) and Infliximab with methotrexate(MTX) treatment in severe RA patients with poor prognostic factors at week 30.
Secondary objectives are compare the differences of laboratory measurements, clinical remission rate, function score and imageological evaluation between classic DMARDs and Infliximab with MTX treatment in severe RA patients with poor prognostic factors at week 14, 30, 54 and 102.
Infliximab arm:Infliximab with MTX treatment: Infliximab 3mg/kg at week 0, 2, 6 and then once every 8 weeks, MTX>7.5mg per week. To observe the results at week 14, 30, 54 and 102 after 6 times IFX treatment. It recommended that continue to receiving IFX treatment after remission for a period of time in good economic condition patients while receiving MTX with hydroxychloroquine(HCQ) or leflunomide(LEF) in poor economic condition patients.
Classic DMARDs treatment arm: Classic DMARDs treatment combination of 2 or 3 drugs, 2-drugs combination is MTX with LEF or Thunder God Vine, 3-drugs combination is MTX with HCQ and LEF or Thunder God Vine for total 30 weeks.
Effective dose: MTX: 10-15mg per week; LEF: 20mg per day; HCQ: 200-400 mg per day; Thunder God Vine: 40-60 mg per day; It recommended that the maintain regimen is MTX with HCQ or LEF after remission for a period of time.
Study is divided into three stages First stage: day -7 to 0
Second stage: week 0 to week 30, follow-up duration I The subjects are randomized assigned to achieve experimental or control treatment for 30 weeks and follow up at week 2, 6, 14, 22 and 30.
Third stage: Week 30 to 102, follow-up duration II After 30 weeks treatment the subjects are into 72 weeks follow-up duration, the follow up will be conducted at week 38, 46, 54 and 102.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infliximab group | Experimental | Infliximab with MTX treatment |
|
| Classic DMARDs treatment group | Active Comparator | Classic DMARDs treatment(MTX 、LEF 、HCQ 、 LEF ) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infliximab group | Drug | Infliximab with MTX treatment: Infliximab 3mg/kg at week 0, 2, 6 and then once every 8 weeks, MTX>7.5mg per week. To observe the results at week 14, 30, 54 and 102 after 6 times IFX treatment. It recommended that continue to receiving IFX treatment after remission for a period of time in good economic condition patients while receiving MTX with HCQ or LEF in poor economic condition patients. |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of subjects achieving DAS<2.6 | The rate of subjects achieving DAS<2.6 at week 30 | at week 30 |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of subjects achieving DAS<2.6 | The rate of subjects achieving DAS<2.6 at week 14, 54 and 102 | at week 14, 54 and 102 |
| The rate of subjects achieving SDAI<3.3 | The rate of subjects achieving SDAI<3.3 at week 14, 30, 54 and 102; |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiao Zhang, Ph.D | Contact | +86 139 222 55387 | zhangxiao20130724@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiao Zhang, Ph.D | Director | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Xiangya Hospital of Central South University | Changsha | Hunan | 410011 | China |
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| Classic DMARDs treatment group | Drug | Classic DMARDs treatment: combination of 2 or 3 drugs, 2-drugs combination is MTX with LEF or Thunder God Vine, 3-drugs combination is MTX with HCQ and LEF or Thunder God Vine for total 30 weeks. Effective dose: MTX: 10-15mg per week; LEF: 20mg per day; HCQ: 200-400 mg per day; Thunder God Vine: 40-60 mg per day; It recommended that the maintain regimen is MTX with HCQ or LEF after remission for a period of time. |
|
| at week 14, 30, 54 and 102 |
| The rate of subjects achieving ACR/EULAR remission | The rate of subjects achieving ACR/EULAR remission at week 14, 30, 54 and 102; | at week 14, 30, 54 and 102 |
| MRI score | MRI score at week 14, 30, 54 and 102; | at week 14, 30, 54 and 102 |
| The HAQ score | The HAQ score at week 14, 30, 54 and 102; | at week 14, 30, 54 and 102 |
| The SHARP score | The SHARP score at week 14, 30, 54 and 102 | at week 14, 30, 54 and 102 |
| The level of ESR | The level of ESR at week 2, 6, 14, 22, 30, 54 and 102 | at week 2, 6, 14, 22, 30, 54 and 102 |
| The level of CRP | The level of CRP at week 2, 6, 14, 22, 30, 54 and 102 | at week 2, 6, 14, 22, 30, 54 and 102 |
| XIJING Hospital | Xi’an | Shanxi | 710032 | China |
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| Tianjin medical university general hospital | Tianjin | Tianjin Municipality | 300052 | China |
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