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The purpose of this study is:
This was a 24-week open-label randomized study. Forty patients are randomly assigned to receive either combination infliximab plus Methotrexate(MTX) (n=20) or Methotrexate(MTX) alone (n=20)
All participants received oral Methotrexate(MTX), starting at 7.5 mg/week. In patients with persistent tender or swollen joints, the dose was escalated in a graduated manner (2.5 mg/week every 1-2 weeks) to 15 mg/week by week 4 or 20 mg/week by week 8 Patients in combination group receive infliximab 3mg/kg at weeks 0, 2, and 6 and every 8 week thereafter. Comprehensive assessment will be made on week 0, 12, 24.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methotrexate | Active Comparator | A drug for RA patient |
|
| Infliximab | Active Comparator | for RA treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methotrexate | Drug | All participants received oral Methotrexate(MTX), starting at 7.5 mg/week. In patients with persistent tender or swollen joints, the dose was escalated in a graduated manner (2.5 mg/week every 1-2 weeks) to 15 mg/week by week 4 or 20 mg/week by week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the volume of enhancing synovitis measured by Magnetic Resonance Imaging(MRI) as it corresponds to active, inflamed tissue and is therefore expected to be a better marker of disease activity. | week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| changes in the synovitis grading and the perfusion indices | 24 week | |
| proportion of patients achieving ACR and EULAR responses | week 24 | |
| Correlation between the Magnetic Resonance Imaging(MRI) findings and changes on x-ray |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edmund K Li, MD | Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Medicine and Therapeutics | Hong Kong | China | ||||
| Prince of Wales Hospital |
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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 |
|---|---|
| D008727 | Methotrexate |
| D000069285 | Infliximab |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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|
| Infliximab | Drug | Patients in combination group receive infliximab 3mg/kg at weeks 0, 2, and 6 and every 8 week thereafter. |
|
|
| week 24 |
| Hong Kong |
| China |
| The Prince of Wales Hospital | Hong Kong | China |
| 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 |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |