Rheumatoid Arthritis
Conditions
Brief summary
The purpose of this study is to investigate the clinical efficacy and safety of MRA in a double-blind, parallel-group, controlled study using MRA or methotrexate (MTX) in rheumatoid arthritis (RA) patients with MTX administered.
Interventions
DRUGMRA(Tocilizumab)
8mg/kg/4week(i.v.)for 24 weeks
DRUGMRA placebo
0mg/kg/4week(i.v.) for 24 weeks
DRUGMTX
8mg/week(p.o.) for 24 weeks
DRUGMTX placebo
0mg/week(p.o.) for 24 weeks
Sponsors
Chugai Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of RA based on the 1987 classification criteria of the American College of Rheumatology (ACR) * Disease duration of 6 months or more * Treated with 8 mg/week of MTX for at least 8 weeks immediately preceding enrollment, and continued on this treatment up to initiation of the study drug * Active disease at enrollment (less than 2 weeks before initiating treatment with a study drug), Which is defined as having at least 6 tender and 6 swollen joints among 49 and 46 joints stipulated by the Japanese Rheumatism Foundation's Drug Evaluation Committee and ESR at least 30 mm/hr and CRP not less than 1.0 mg/dL
Exclusion criteria
* Assessed as having Class IV Steinbrocker functional activity in the 4 weeks preceding treatment with the study drug * Treated with infliximab, etanercept or leflunomide in the 12 weeks preceding treatment with the study drug * Received any of the following therapies in the 2 weeks preceding initiation of treatment with the study drug. 1. Administration of any DMARD or immunosuppressant other than MTX 2. Administration of corticosteroids exceeding 10 mg/day as prednisolone 3. Dose escalation or initiation of corticosteroids * Received any of the following therapies in the 4 weeks preceding treatment with the study drug 1. Plasma exchange therapy 2. Surgical treatment (operation, etc.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of ACR 20% improvement | week 24 |
Secondary
| Measure | Time frame |
|---|---|
| Frequency and severity of adverse events and adverse drug reactions | throughout study |
| Time course of DAS28 | throughout study |
| time course of the frequency of ACR 20%, 50% and 70% | throughout study |
Outcome results
None listed