rheumatoid arthritis
Conditions
Interventions
tocilizumab
Sponsors
General Internal Medicine, Tenri Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Fulfill the RA classification criteria of American College of Rheumatology 1987. 2. More than 3.2 of DAS28-ESR. 3. Aged 16 to 80 years at registration. 4. PSL of 5 to 15mg/day in average is given and PSL of more 1mg/day in average has not been tapered for three months. 5. Both an anti-TNF agent and methotrexate of 4mg/week are given for more than 14weeks. 6. Written informed consent.
Exclusion criteria
Exclusion criteria: 1. Be against the guideline of tocilizumab use by Japanese College of Rheumatology. 2. Infliximab dosage is more than 6mg/kg or administration interval of infliximab is within 6weeks. 3. Be true of class 4 in Steinblocker functional class within four weeks before tocilizumab administration. 4. Has been treated with tocilizumab so far. 5. PSL is increased in its dosage or newly administered within 2weeks before administration of tocilizumab. 6. Patients to whom the following treatments are administered within 4weeks before tocilizumab administration: Newly use or increase in dose of DMARDs or immunosuppressive agents except for methotrexate. Plasma exchange including leukocytapheresis. Surgery such as total knee joint replacement which seems to have an influence on the evaluation of efficacy of tocilizumab. 7. Be pregnant or possible to be pregnant. 8. Have a past medical history of malignancy within 5years. 9. More than three times of ALT levels as high as standard in our institution.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with less than 5mg/day in observation period. | — |
Secondary
| Measure | Time frame |
|---|---|
| In observation period, 1. proportion of patients free from PSL 2. proportion of patients with recurrent RA after tapering PSL dosage 3. proporiton of patients with less than 2.6 of DAS28 4. proportion of patients with less than 5mg/day of PSL to be maintained 5. proportion of improvement of mHAQ 6. severe adverse events | — |
Countries
Japan
Contacts
Public ContactTeruhisa AZUMA
Tenri Hospital General Internal Medicine
Outcome results
None listed