rheumatoid arthritis
Conditions
Interventions
infliximab:intravenous injections of infliximab (3 mg/kg) at weeks 0, 2, 6, 14, with concurrent MTX therapy
placebo:intravenous injections of placebo (3 mg/kg) at weeks 0, 2, 6, 14, with concurrent MTX therapy
Sponsors
People's Hospital, Beijing University; Shanghai Changzheng Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Patients fulfilled the revised 1987 American Rheumatism Association criteria for the classification of RA; 2. Patients with active disease despite consecutive treatment with MTX at a stable dosage of 10-25 mg per week for at least 12 weeks before enrollment. Active RA was defines as four or more swollen joints, six or more tender joints and at least one of the following: a serum C reactive protein (CRP) level of at least 15 mg/l or an erythrocyte sedimentation rate (ESR) of at least 28 mm/hour, or morning stiffness lasting longer than 45 minutes; 3. Patients were allowed to take nonsteroidal antiinflammatory drugs or oral corticosteroids (<=10 mg/day of prednisone or equivalent) if the dose had been stable for at least 4 weeks prior to entry.
Exclusion criteria
Exclusion criteria: 1. Patient were allergic to the drug; 2. Patients receiveded intraarticular corticosteroid injections and disease modifying antirheumatic drugs (except MTX) treatment 4 weeks before the study; 3. Patiients previously received any biologic therapy; 4. Patients had significant systemic disease or autoimmune disease other than RA, acute infections, history of type B or C hepatitis, tuberculosis and malignant tumor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy endpoint(ACR score); | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy endpoint(DAS28); | — |
Countries
China
Contacts
Public ContactFuji Xu
Outcome results
None listed