Rheumatoid Arthritis
Conditions
Brief summary
To evaluate clinical efficacy and tolerability of MRA, patients with RA are randomized to receive either MRA or conventional DMARDs.
Interventions
8mg /kg /4week for 52 weeks
OTHERcurrent treatment
continue current treatment
Sponsors
Chugai Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed as having RA, on the basis of the criteria stipulated by the American Conference on Rheumatism (ACR) in 1987. * With RA that has continued for at least 6 months but less than 5 years, with the date of first appearance being taken as the date of RA diagnosis. * Active RA despite at least one DMARD or immunosuppressant. Active disease 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 2.0mg/dL.
Exclusion criteria
* Shown to have class-IV Steinbrocker's functional activity in an evaluation carried out within 4 weeks before administration of the study drug. * Treated with drugs that delay joint destruction (infliximab, etanercept, leflunomide, etc.) within 3 months before administration of the study drug. * The oral corticosteroid dose (prednisolone equivalent of up to 10 mg/day)has not been fixed 2 weeks before administration of the study drug. * Subjected to any of the following within 4 weeks before administration of the study drug: (i) Change in dosage of currently administered DMARDs and/or immunosuppressive agents. (ii) Plasma exchange method. (iii) Surgical treatment (operations, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the erosion score, as determined by the modified Sharp method. | week 52 |
| Frequency and severity of adverse events and adverse drug reactions | throughout study |
Secondary
| Measure | Time frame |
|---|---|
| Change in the erosion score | week 28 |
| Changes in the joint space narrowing score and total Sharp score | week 28, 52 |
Outcome results
None listed