Rheumatoid Arthritis
Conditions
Brief summary
An open-label, PhaseⅢ study to evaluate the efficacy and safety of MRA in patients with RA
Interventions
DRUGMRA(Tocilizumab)
8mg/kg/4 weeks
Sponsors
Chugai Pharmaceutical
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
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 * Active RA despite at least one DMARDs or immunosuppressants or Infliximab or Etanercept.Active disease is defined as having at least 6 tender and 6 swollen joints among DAS28 (Modified Disease Activity Scores that include twenty eight joint counts) and ESR at least 30 mm/hr or CRP not less than 2.0mg/dL * Active RA despite over 10mg adrenocortical steroids within 2 weeks before entry of this study
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 Infliximab within 3 months before and with Etanercept within 2 weeks before administration of the study drug * Subjected to any of the following within 4 weeks before administration of the study drug: 1. Surgical treatment (operations,etc.). 2. Plasma exchange method
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of ACR 20％ improvement at the final visit | throughout study |
Secondary
| Measure | Time frame |
|---|---|
| Time course of the frequency of ACR 20％, 50％ and 70％ improvement,time course of individual items within the ACR core set. | throughout study |
| Time course of DAS28 to the final visit. | throughout study |
| Time course of steroid sparing effect from first visit to final visit. | throughout study |
Countries
Japan
Outcome results
None listed